Voltaren gel is an NSAID for topical use.
It is used to relieve pain and inflammatory reactions. It has a warming effect at the site of application. The product significantly increases the regeneration of joint and connective tissue cells. Under the influence of the medication, muscles and tendons recover much faster.
On this page you will find all the information about Voltaren: complete instructions for use for this drug, average prices in pharmacies, complete and incomplete analogues of the drug, as well as reviews of people who have already used Voltaren. Would you like to leave your opinion? Please write in the comments.
NSAIDs for external use.
Available without a prescription.
How much does Voltaren gel cost? The average price in pharmacies is 270 rubles.
There are two forms of release of Voltaren gel - in aluminum tubes and plastic bottles for the drug and one percent and two percent concentrations.
The volume of gel content in one tube can vary from 10 to 100 g; Each tube, in addition to the cap, has an additional protective membrane under it. The laminated bottle contains gel from 70 to 100 ml. In both forms of release, the medicine is additionally packaged in a cardboard box, and instructions for use of the drug must be attached to each unit of product.
Voltaren Emulgel contains the active ingredient diclofenac.
Diclofenac is a non-steroidal anti-inflammatory drug, a derivative of phenylacetic acid. The drug has anti-inflammatory, analgesic and some antipyretic effects. By inhibiting the activity of both isomers of the cyclooxygenase enzyme, the drug disrupts the synthesis of prostaglandins from arachidonic acid. This leads to a decrease in the amount of prostaglandins at the site of inflammation. When applied topically, the drug has an analgesic, anti-inflammatory and decongestant effect. The use of the drug for injuries promotes the regeneration of connective tissue cells of ligaments and joints, leading to accelerated recovery of damaged tendons and muscles.
In addition, the aqueous-alcohol base of the drug Voltaren Emulgel promotes cooling and the development of some anesthesia at the site of application.
The use of Voltaren gel is directly related to the effect it has on the body. If a person experiences pain or an inflammatory process develops in his muscles or joints, then this remedy can be considered as an option for help. Most often, doctors suggest buying the drug if the pain or inflammation is traumatic or rheumatic in nature.
The instructions for Voltaren gel will demonstrate the following list of indications for use:
Any other degenerative and inflammatory pathologies of the spinal column are also among the indications for use.
Voltaren is contraindicated for use if the patient has the following conditions:
Voltaren gel is contraindicated during pregnancy in the third trimester, as this can lead to a decrease in uterine tone and/or premature blockage of the ductus arteriosus in the fetus.
In the first and second trimesters, the doctor considers the possibility of external use of Voltaren individually, comparing the expected benefits for the mother with the potential risk for the fetus.
At this time, the degree of penetration of the active ingredient Voltaren Emulgel into the milk of a nursing mother is unknown. For this reason, combining breastfeeding and therapy is not recommended. If it is absolutely necessary to use Voltaren emulgel, its application is possible only in minimal quantities and in small areas, bypassing the area of the mammary glands.
The instructions for use indicate that Voltaren Emulgel is used externally.
To remove the protective membrane, use the screw cap as a key (the recess with protrusions on the outside of the cap). Align the indentation on the outside of the cap with the shaped protective membrane of the tube and turn. The membrane should separate from the tube.
The following adverse reactions are possible:
If these or other side effects worsen, you should consult a doctor.
Given the low systemic absorption, an overdose is unlikely when the gel is applied topically. If the drug is accidentally taken orally, systemic adverse reactions may occur.
If the gel is taken orally, treatment should include gastric lavage, induction of vomiting, the use of activated charcoal, and symptomatic therapy. Due to the high degree of binding of diclofenac to plasma proteins (approximately 99%), dialysis and forced diuresis are ineffective.
Voltaren Emulgel can only be applied to undamaged areas of the skin. If there are existing scratches, wounds, or ulcerative lesions, the use of the gel is unacceptable! Avoid contact of the drug with mucous membranes and eyes. If this happens accidentally, it is necessary to rinse the mucous membranes with plenty of running water.
If allergic skin reactions occur, treatment with the drug should be stopped immediately and consult a doctor. In case of accidental ingestion of the drug, the patient should take activated charcoal and seek medical attention.
With the combined use of Voltaren Emulgel and other diclofenac-based products, as well as photosensitizing agents, the effect is enhanced.
We have selected some people's reviews about the drug Voltaren:
Synonyms for gel, patch and spray Voltaren are the following drugs:
Before using analogues, consult your doctor.
Store the drug out of the reach of children at a temperature not exceeding 30 degrees Celsius. Shelf life 3 years.
The highly effective drug Voltaren can relieve pain in the joints - knees, elbows, feet and wrists. It is intended for pain relief and relief of inflammation at the site of application. "Voltaren" is considered a fairly popular remedy, even despite its relatively high cost, and this is not without reason. It helps patients get rid of debilitating pain in just a few hours. But in order for the result of the drug to be as positive as possible, it is important to use it correctly, and how exactly, you can find out from your doctor and by reading the annotation.
Manufacturers offer the following types of Voltaren:
The selection of a particular dosage form should be carried out exclusively by a qualified physician. But usually, “Voltaren” gel is prescribed to cure diseased joints of the knee or elbow. It allows medicinal substances to penetrate as deeply as possible into the dermis without having a systemic effect on the human body. The gel is placed in tubes of various volumes: 20, 50 or 100 g. The active component, diclofenac, which has a pronounced anti-inflammatory and analgesic effect, is responsible for the therapeutic effect of the drug. Contains "Voltaren" and auxiliary substances that improve the penetration of drug elements through the skin, with minimal irritation. Includes ointment and eucalyptus fragrance, which provides the product with a scent.
If your knee hurts or your elbow is twisted, at first glance, the problem is insignificant, but if it occurs frequently and the pain symptom intensifies, you should consult a doctor. Joint pain causes a person a lot of discomfort: it becomes difficult to walk, stiffness and sometimes unbearable pain appear. Then the well-known pharmaceutical drug Voltaren comes to the aid of many.
The ointment relieves joint pain and eliminates swelling.
The active substance diclofenac acts as follows: it suppresses the activity of cyclooxygenase, an enzyme responsible for the development of the inflammatory reaction, and disrupts the formation of arachidonic acid, which acts as a conductor of the pain reaction. Thus, Voltaren reduces inflammation, pain and swelling in the knee or other treated area. The gel accelerates the regeneration of joint cells and connective tissues, and also restores damaged tendons and muscles.
It is advisable to use Volatren in such cases as:
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Before you start using Voltaren, you need to study the instructions for it to make sure there are no contraindications and to find out how to properly carry out the treatment.
If the patient is bothered by his knee joints, he will need to wash and dry his knees and check the integrity of the skin, otherwise the use of the gel is contraindicated. After this, squeeze out about 4 g of the contents of the tube and lightly rub into the skin. Voltaren is effective for 12 hours, so you should not apply the gel more often.
It is prohibited to use Voltaren gel to relieve pain in the joints by patients who are allergic to the active component of the drug, as well as its derivatives. The medication is not recommended for children under 12 years of age, pregnant women for more than 6 months and during lactation. You should avoid Voltaren if you experience attacks of difficulty breathing, an allergic runny nose and urticaria while using analgin. Do not apply the gel to skin with wounds and abrasions.
Voltaren should be used with extreme caution in the following cases:
While using Voltaren ointment, various undesirable effects may occur, if observed, you should stop therapy and consult a doctor to review the dosage or select a similar remedy. The following side symptoms are noted:
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Typically, several medications are used to treat diseased joints. But whether it is possible to combine them should be checked with your doctor, since many combinations of medications can provoke undesirable effects. Voltaren is incompatible with other non-steroidal anti-inflammatory drugs. Negative effects may also develop when used together with diuretics and anticoagulants.
Drugs that are similar in principle of action and active substance can replace Voltaren. These include:
You can purchase the medication at a pharmacy without a prescription from a doctor. Store Voltaren in its original packaging at a temperature not exceeding 30 degrees Celsius, and as far as possible from small children. The shelf life of the medicine is 3 years, after which its use is strictly contraindicated.
FAQ
The site provides reference information. Adequate diagnosis and treatment of the disease is possible under the supervision of a conscientious doctor.
In the treatment of rheumatic diseases, the anti-inflammatory and analgesic effect of this drug is important, which provides a clinical effect that helps reduce pain at rest and movement, joint swelling and stiffness in the morning.
When recovering from surgery, Voltaren can be used as an analgesic and as a means to reduce swelling.
In addition, this drug can reduce blood loss during dysmenorrhea.
After achieving the optimal effect, the dose is reduced to 50 mg per day.
For juvenile arthritis, the tablets are taken on an empty stomach and washed down with water after taking it.
Voltaren retand tablet in a film shell.
Suppository for rectal administration Voltaren.
1 ml of solution for intramuscular administration of Voltaren.
The Voltaren transdermal patch, which delivers the active substance ( diclofenac sodium ) into the circulatory system through the skin in doses, must be applied to the painful area for a period of 24 hours. It is strongly not recommended to use more than 1 patch per day.
A larger patch should only be used when large painful areas need to be covered. Treatment of various diseases of the joints and muscles, as a rule, should be carried out for no more than 3 weeks, and treatment of muscle diseases - no more than 2 weeks. If your condition does not improve within one week, you should consult your doctor.
For children over twelve years of age, as well as adults, Voltaren gel should be applied lightly to the painful area 2 to 4 times a day. At a time, it is necessary to apply 2–4 grams of gel ( this volume corresponds to the size of a cherry ), which is enough to treat a skin segment with an area of 500–700 cm2. After the gel has been applied to the skin, you should wash your hands to avoid getting the medication on the mucous membranes of the eyes.
In most cases, suppositories are prescribed after a two-day course of Voltaren injections. Also, rectal suppositories can be used in combination with other forms of release of this drug ( gel, tablets, patch, injections ). In this case, the daily dose of the active substance ( diclofenac sodium ) should not exceed 150 milligrams.
It is worth noting that suppositories with Voltaren are most often prescribed at night.
1g of gel for external use contains:
Diclofenac sodium – 10 mg;
Voltaren Emulgel contains the active ingredient diclofenac. Diclofenac is a non-steroidal anti-inflammatory drug, a derivative of phenylacetic acid. The drug has anti-inflammatory, analgesic and some antipyretic effects. By inhibiting the activity of both isomers of the cyclooxygenase enzyme, the drug disrupts the synthesis of prostaglandins from arachidonic acid. This leads to a decrease in the amount of prostaglandins at the site of inflammation. When applied topically, the drug has an analgesic, anti-inflammatory and decongestant effect. The use of the drug for injuries promotes the regeneration of connective tissue cells of ligaments and joints, leading to accelerated recovery of damaged tendons and muscles.
After entering the systemic circulation, diclofenac binds well to plasma proteins, mainly albumin (the degree of binding reaches 99%).
When applied topically, the concentration of diclofenac in synovial fluid is significantly higher than in blood plasma. Diclofenac metabolites are significantly less active than diclofenac itself. The half-life is 1-3 hours. It is excreted in the urine and through bile along with feces.
The drug is intended for topical use in the following conditions:
Bursitis, arthritis, periarthritis, tendonitis, other forms of rheumatic diseases of soft tissues.
For the symptomatic treatment of pain, swelling and inflammation caused by injuries to ligaments, muscles, tendons resulting from dislocation, sprain, hematoma.
For the treatment of sports injuries.
For the treatment of patients suffering from osteoarthritis of the spinal joints.
The drug is used in adults and children over 12 years of age. Voltaren Emulgel is applied to clean, dry skin in a thin layer 3-4 times a day. The course of treatment is determined by the attending physician; however, continuous use of the gel for more than 2 weeks in case of soft tissue lesions and longer than 3 weeks in case of joint damage is not recommended. Before and after using the drug, you must wash your hands; it is not recommended to let the drug get into your eyes.
If no positive dynamics are observed within a week from the start of using the drug, you should inform your doctor about this. No dose adjustment is required when treating patients over 60 years of age.
Due to the low degree of absorption of diclofenac into the systemic circulation, the risk of developing systemic side effects is low. However, it is extremely rare that bronchospasm and allergic reactions may develop. Among the most common allergic reactions when using diclofenac are: skin itching, urticaria, allergic dermatitis. In isolated cases, angioedema and photosensitivity may develop.
The occurrence of side effects should be reported to your doctor.
The drug is contraindicated for use in patients who have individual sensitivity to the components of the drug and analgin. The drug is not prescribed to patients with a history of bronchospasm, allergic rhinitis and urticaria caused by the use of analgin. Third trimester of pregnancy.
In the first and second trimester of pregnancy, the drug is prescribed as a last resort, when the expected benefit to the mother is higher than the potential risks to the fetus. In the third trimester, the use of Voltaren Emulgel is contraindicated, since diclofenac penetrates well through the placental barrier and can cause disturbances in the development of the cardiovascular system in fetuses with a long gestational age.
The drug is not recommended for use during lactation.
When prescribing the drug with other non-steroidal anti-inflammatory drugs, you should exercise caution and carefully calculate the dosage of the drugs.
Due to low systemic absorption, interactions with other medicinal products of Voltaren Emulgel have not been identified.
When using the drug according to the instructions, an overdose is unlikely.
In case of accidental ingestion of the drug orally, gastric lavage and the use of enterosorbents are indicated. Treatment is symptomatic. There is no specific antidote.
Gel for external use 1%, 20 g or 50 g in a tube, 1 tube in a cardboard package.
Gel for external use 1%, 100 ml per container, 1 container per carton.
It is recommended to store the drug in a dry place at a temperature of 15 to 25 degrees Celsius.
Shelf life: 3 years.
Diclofenac gel, Diclak, Diclobene, Dicloberl, Olfen.
Pharmacological groups : Non-narcotic analgesics, including non-steroidal and other anti-inflammatory drugs
Nosological classification (ICD-10): G43 Migraine. G54.1 Lesions of the lumbosacral plexus. H10 Conjunctivitis. H10.5 Blepharoconjunctivitis. H10.9 Conjunctivitis, unspecified. H16.2 Keratoconjunctivitis. H18.3 Changes in the membranes of the cornea. H25 Senile cataract. H26 Other cataracts. H60 Otitis externa H60-H95 CLASS VIII Diseases of the ear and mastoid process. H66 Purulent and unspecified otitis media. H74 Other diseases of the middle and mastoid process. I05-I09 Chronic rheumatic heart disease. J00-J06 Acute respiratory infections of the upper respiratory tract. J02 Acute pharyngitis. J03 Acute tonsillitis [tonsillitis]. K13.7 Other and unspecified lesions of the oral mucosa. K62 Other diseases of the anus and rectum. K62.8.1 Proctitis. K80.5 Bile duct stones without cholangitis or cholecystitis. M00-M25 Arthropathy. M00-M99 CLASS XIII Diseases of the musculoskeletal system and connective tissue. M05 Seropositive rheumatoid arthritis. M05-M14 Inflammatory polyarthropathy. M06.9 Rheumatoid arthritis, unspecified. M07.3 Other psoriatic arthropathies. M08 Juvenile arthritis. M10 Gout. M13.0 Polyarthritis, unspecified. M13.9 Arthritis, unspecified. M15-M19 Arthrosis. M16 Coxarthrosis [arthrosis of the hip joint]. M25.5 Joint pain. M35.3 Polymyalgia rheumatica. M42 Osteochondrosis of the spine. M45 Ankylosing spondylitis. M47 Spondylosis. M54 Dorsalgia. M54.3 Sciatica. M54.4 Lumbago with sciatica. M60 Myositis. M65 Synovitis and tenosynovitis. M65-M68 Lesions of synovial membranes and tendons. M70 Diseases of soft tissues associated with stress, overload and pressure. M71 Other bursopathies. M77.9 Enthesopathy, unspecified. M79.0 Rheumatism, unspecified. M79.1 Myalgia. M79.2 Neuralgia and neuritis, unspecified. N23 Renal colic, unspecified. N70 Salpingitis and oophoritis. N71 Inflammatory diseases of the uterus, except the cervix. N73.2 Parametritis and pelvic cellulitis, unspecified. N76 Other inflammatory diseases of the vagina and vulva. N94.0 Pain in the middle of the menstrual cycle. N94.3 Premenstrual tension syndrome. N94.4 Primary dysmenorrhea. N94.6 Dysmenorrhea, unspecified. R10.4 Other and unspecified pain in the abdominal area. R50 Fever of unknown origin. R52 Pain not elsewhere classified. R52.0 Acute pain. R52.2 Other persistent pain. R60.0 Localized edema. R68.8 Other specified general symptoms and signs. R68.8.0 Inflammatory syndrome. S05 Injury to the eye and orbit. T08-T14 Injury to an unspecified part of the trunk, limb, or area of the body. T14.0 Superficial injury to an unspecified area of the body. T14.3 Dislocation, sprain and damage to the capsular-ligamentous apparatus of a joint of an unspecified area of the body. Z100 CLASS XXII Surgical Practice
Application of Voltaren: Inflammatory joint diseases (rheumatoid arthritis, rheumatism, ankylosing spondylitis, chronic gouty arthritis), degenerative diseases (osteoarthrosis deformans, osteochondrosis), lumbago, sciatica, neuralgia, myalgia, diseases of extra-articular tissues (tenosynovitis, bursitis, rheumatic soft tissue damage) , post-traumatic pain syndromes accompanied by inflammation, postoperative pain, acute attack of gout, primary dysalgomenorrhea, adnexitis, migraine attacks, renal and hepatic colic, infections of the ENT organs, residual effects of pneumonia. Locally - injuries of tendons, ligaments, muscles and joints (to relieve pain and inflammation during sprains, dislocations, bruises), localized forms of soft tissue rheumatism (elimination of pain and inflammation). In ophthalmology - non-infectious conjunctivitis, post-traumatic inflammation after penetrating and non-penetrating wounds of the eyeball, pain syndrome when using an excimer laser, during surgery for removal and implantation of the lens (pre- and postoperative prevention of miosis, cystoid edema of the optic nerve).
Treatment: gastric lavage, administration of activated carbon, symptomatic therapy aimed at eliminating increased blood pressure, renal dysfunction, convulsions, gastrointestinal irritation, respiratory depression. Forced diuresis and hemodialysis are ineffective.
Orally: adults - 75–150 mg/day in several doses; retard forms - 1 time per day (if necessary - up to 200 mg/day). Once the clinical effect is achieved, the dose is reduced to the minimum maintenance dose. Children aged 6 years and older and adolescents are prescribed only tablets of regular duration of action at the rate of 2 mg/kg/day.
As initial therapy (for example, in the postoperative period, in acute conditions) IM or IV . IM - 75 mg/day (in severe cases, 75 mg 2 times a day with a break of several hours) for 1–5 days. In the future, they switch to taking tablets or suppositories.
Rectally: 50 mg 1–2 times a day.
Cutaneously: gently rub 2–4 g of gel or ointment into the skin 2–4 times a day; After application, you must wash your hands.
Instillation: instill 1 drop into the conjunctival sac 5 times within 3 hours before surgery, immediately after surgery - 1 drop 3 times, then 1 drop 3-5 times a day for the time required for treatment; other indications - 1 drop 4-5 times a day.
Transdermal patch, 15 mg/day. Rectangular in shape with rounded edges, consisting of a beige polyester base with a uniformly applied adhesive layer of colorless to pale yellow color with a faint aromatic odor. The adhesive surface is covered with a transparent protective film made of PE with two transverse cuts, one of which has a wavy line. The transparent protective film has a drawing showing how to remove the film from the surface of the patch. Dimensions - 70 × 100 mm.
Transdermal patch, 30 mg/day. Rectangular in shape with rounded edges, consisting of a beige polyester base with a uniformly applied adhesive layer of colorless to pale yellow color with a faint aromatic odor. The adhesive surface is covered with a transparent protective film made of PE with two transverse cuts, one of which has a wavy line. The transparent protective film has a drawing showing how to remove the film from the surface of the patch. Dimensions - 100 × 140 mm.
Voltaren ® in the form of a transdermal patch is a base with an applied adhesive layer containing diclofenac, which has pronounced analgesic and anti-inflammatory properties. The mechanisms of action of diclofenac are based on inhibition of PG synthesis. The Voltaren ® patch provides anti-inflammatory and analgesic effects at the site of application, eliminating pain and reducing swelling associated with the inflammatory process.
Absorption and distribution in the body. The amount of diclofenac absorbed systemically from the Voltaren ® patch over 24 hours is similar to that when using an equivalent amount of Voltaren ® Emulgel ® (gel for external use 1%). 99.7% of diclofenac is bound to serum proteins, mainly to albumin (99.4%).
Elimination. The total systemic clearance of diclofenac from plasma is (263 ± 56) ml/min.
The final T1 /2 in blood plasma is 1-2 hours. Four metabolites, including two active ones, also have a short T1 /2 - 1-3 hours. One metabolite - 3′-hydroxy-4′-methoxydiclofenac - has a longer the half-life, however, is inactive. Diclofenac and its metabolites are excreted mainly in the urine.
In patients with impaired renal function, accumulation of diclofenac and its metabolites does not occur. In patients suffering from chronic hepatitis or undecompensated cirrhosis, the kinetics and metabolism of diclofenac follow the same pattern as in patients without liver disease. Preclinical studies have shown the safety of using the drug.
back pain due to inflammatory and degenerative diseases of the spine (sciatica, osteoarthritis, lumbago, sciatica);
joint pain (finger joints, knee joints, etc.) with rheumatoid arthritis, osteoarthritis;
muscle pain (due to sprains, strains, bruises, injuries);
inflammation and swelling of soft tissues and joints due to injuries and rheumatic diseases (tenosynovitis, bursitis, lesions of periarticular tissues).
hypersensitivity to diclofenac or other components of the drug;
tendency to experience attacks of bronchial asthma, skin rashes or acute rhinitis when using acetylsalicylic acid or other NSAIDs;
pregnancy (III trimester);
violation of the integrity of the skin at the site where the patch is supposed to be applied;
children's age (up to 15 years).
With caution: hepatic porphyria (exacerbation); erosive and ulcerative lesions of the gastrointestinal tract; severe dysfunction of the liver and kidneys; chronic heart failure; bronchial asthma; elderly age.
The use of the drug in pregnant women has not been studied, therefore the Voltaren ® transdermal patch should not be used during pregnancy, especially in the third trimester due to the possibility of decreased uterine tone and/or premature closure of the fetal ductus arteriosus.
Animal studies have not revealed any direct or indirect negative effects on pregnancy, childbirth, embryonic or post-embryonic development.
There is no data on the penetration of the drug into breast milk, therefore the Voltaren ® transdermal patch is not recommended for use during breastfeeding.
Adverse reactions are mainly characterized by moderate and transient skin manifestations at the site of application of the patch.
Very rare manifestations (<1/10000)
Local reactions: pustular rashes.
Systemic reactions: generalized skin rash; allergic reactions (urticaria, hypersensitivity - angioedema, asthma attacks, bronchospastic reactions), photosensitivity reactions.
Local reactions: bullous dermatitis.
Frequent manifestations (≥1/100, <1/10)
Local reactions: erythema, dermatitis, incl. contact dermatitis (symptoms - erythema, itching, swelling of the treated skin area, rash, papules, vesicles, peeling), eczema.
Voltaren ® patch may enhance the effect of drugs that cause photosensitivity.
Clinically significant interactions with other drugs have not been described.
Externally, in the form of applications to the skin.
Adults and adolescents over 15 years of age: Voltaren ® transdermal patch is applied to the skin over the painful area for 24 hours. Only 1 patch is allowed to be used per day.
Transdermal patch Voltaren ® 30 mg/day (140 cm 2 ) is intended for gluing to large painful areas.
When treating soft tissue injuries, the Voltaren ® transdermal patch is used for no more than 14 days, and when treating diseases of muscles and joints - no more than 21 days, unless there are special recommendations from a doctor.
If there is no improvement after 7 days and if your health worsens, you should consult a doctor.
Children. The use of the Voltaren ® patch in children under the age of 15 is not recommended.
Elderly. Similar to the method of administration and doses for adults.
The extremely low systemic absorption of the active components and the dosage form of the drug when used externally makes overdose almost impossible.
Voltaren ® transdermal patch should be applied only to intact skin, avoiding contact with open wounds. The drug should not come into contact with the eyes and mucous membranes.
When using the Voltaren ® transdermal patch for too long a time, the possibility of systemic adverse reactions cannot be excluded. When additionally using other dosage forms of diclofenac, its quantitative content in the patch should be taken into account so as not to exceed the maximum daily dose of diclofenac (150 mg/day).
Impact on the ability to drive vehicles and operate machinery. Does not affect.
Transdermal patch, 15 mg/day (area 70 cm2). 2, 5, 7 or 10 patches in an aluminum foil bag. The information from the Labeling section is applied to the package or a label is affixed to which information from this section is applied. The package is placed in a cardboard box.
Transdermal patch, 30 mg/day (area 140 cm2). 2, 5, 7 or 10 patches per aluminum foil bag with Zip-Lock for multiple openings. The information from the Labeling section is applied to the package or a label is affixed to which information from this section is applied. The package is placed in a cardboard box.
Novartis Consumer Health SA, Rue de Letraz, 1260 Nyon, Switzerland.
Produced by: Dojin Iyaku-Kako Ko. Ltd., 5-2-2, Yayoi-cho, Nakano-ku, 164-0013, Tokyo, Japan.
Packed by: Famar S.A., 48 km National Road Athens-Lamia, Avlona Attiki, 190 11, Greece.
Consumer complaints should be directed to Novartis Consumer Health LLC
Legal address: 123317, Moscow, Presnenskaya embankment, 10.
Actual and postal address: 125315, Moscow, Leningradsky Prospekt, 72, bldg. 3.
Tel.: (495) 969-21-65; fax: (495) 969-21-66.
Keep out of the reach of children.
Do not use after the expiration date stated on the package.
Shelf life: 36 months.
Storage: 15-25C (room temperature)
Shelf life: 24 months.
Sale: by prescription
Shelf life: 60 months.
If we look at the statistics of medical prescriptions in any individual clinic, we don’t need to be a prophet to answer the question of which group of medications is prescribed most often: these are nonsteroidal anti-inflammatory drugs (NSAIDs). The range of their use is very wide: from inflammatory processes of various etiologies and febrile conditions to pain relief and prevention of thrombosis. The reason for this is the “explosive mixture” of pharmacological effects, including, in fact, anti-inflammatory, and in addition to it, analgesic, antipyretic and antiaggregation. Currently, more than 60 NSAIDs are known, including a relatively new subgroup - selective cyclooxygenase-2 (COX-2) inhibitors. However, the most popular NSAID remains the “pioneer” voltaren (INN - diclofenac), which still remains the first-line drug in the treatment of rheumatic diseases. Voltaren has a pronounced analgesic and anti-inflammatory effect and is widely used in such fields of medicine as rheumatology, gynecology, traumatology, surgery, and dentistry.
In the human body, voltaren lives a short but very rich life. The bioavailability of the tablet form of this drug is 50%, with its peak concentration reaching 2-3 hours from the moment of administration. With the injection method of administration, the maximum of the active substance in the blood is observed after 20 minutes, with the rectal route - half an hour. If prolonged-release tablets are used in the therapeutic process (there are such), then the peak content of voltaren in the blood plasma will be lower, but the effective concentrations will last longer.
The basis of the mechanism of action of voltaren is its ability to suppress COX, an enzyme that controls the synthesis of inflammatory and pain mediators prostaglandins, prostacyclins and thromboxane. As is known today, the lion's share of the positive effects of NSAIDs is associated with the suppression of COX-2, while the risk of adverse reactions is closely related to the inhibition of COX-1. Many NSAIDs are non-selective and inhibit both enzymes, and even more so the “beneficial” COX-1. Voltaren, in turn, suppresses both of these enzymes equally, which reduces the risk of developing negative effects characteristic of NSAIDs (mainly gastrointestinal lesions).
One of the advantages of Voltaren is the variety of dosage forms: these are tablets (including prolonged action), and an injection solution, and suppositories, and gel. This gives specialists ample opportunity to individually select the dose and method of administration, and also allows them to combine different routes of administration in order to achieve the optimal effect while minimizing adverse reactions. According to statistics, Voltaren helps in 75-82% of cases, which cannot but be considered a worthy result. In most cases, the drug relieves pain on the first day of its use, and the anti-inflammatory effect is fully realized after 1-2 weeks. Despite the large number of generic diclofenac preparations, the manufacturer of the original Voltaren (the Swiss pharmaceutical company Novartis) announces the advantages of its “brainchild” both in terms of purification and safety.
I widely prescribe Voltaren in suppositories of 50 and 100 mg in the complex therapy of prostatitis. An excellent analgesic and anti-inflammatory effect was noted.
Urge to defecate, sometimes loose stools. The stomach should be “covered” to avoid the formation of acute ulcers of the stomach and duodenum.
It can be prescribed by a urologist in complex therapy of various forms of prostatitis.
The patch is very effective for acute forms of dorsalgia and radicular syndrome. Patients note a quick and long-lasting effect, ease of use.
Counterfeits are often found on the territory of the Russian Federation. Contraindicated for long-term use.
There are contraindications! For use, it is better to consult with your doctor before use.
A worthy drug in the complex treatment of diseases of the musculoskeletal system of various origins. Can be used in pediatric practice.
The patches have less analgesic effect than Voltaren gel.
Recommended for use only after consultation with the attending physician (pediatrician, rheumatologist, traumatologist).
A good, proven drug with proven effectiveness. Sold in any pharmacy without a doctor's prescription. Ideal for inflammation, neurological, rheumatic, traumatic pain.
Counterfeits are often found in Russia.
I use the gel itself, I haven’t tried injections on myself, but doctors I know give them a good description too.
A classic, time-tested drug with proven effectiveness. It is the drug of choice in many countries for pain relief.
There is a high probability of developing side effects. There are counterfeits of the drug.
I use a sports doctor in my practice. For me, this is the drug of choice for relieving persistent pain that other NSAIDs cannot cope with.
I would like to talk about the TDTS preparation, that is, a patch. The drug is really effective, it only takes 1-2 days to achieve results. A transdermal therapeutic system is an effective way to administer a substance directly to the site of inflammation.
It does not stick well, and additional fixation of the plaster on top with regular plaster strips helps prevent this.
In my practice, I often use Voltaren suppositories to relieve inflammatory diseases and relieve pain. The drug is well tolerated by patients. It is effective, since the analgesic effect appears 15-20 minutes after administration. An affordable pricing policy makes it one of the leaders among its analogues.
The drug of this group is the “gold standard” in the treatment of many diseases of the musculoskeletal system. It has established itself as a means of choice for inflammatory and pain syndromes of a number of neurological, rheumatic, and traumatological pathologies.
Contrary to the common misconception of many patients, we should not forget that the gastrotoxicity of the drug when used uncontrolled is observed regardless of the route of administration (parenteral, rectal, oral)!
Good old “Diclofenac”, which, apparently, is being improved over time, so, in my opinion, there are fewer gastrointestinal exacerbations with it. I use it as a one-time injection for exacerbation of myofascial syndromes, as an “ambulance”.
Injecting for a long time is still risky. 2-3 injections usually already give results.
A good non-steroidal anti-inflammatory drug, time-tested. Reliable manufacturing company.
Like all NSAIDs, there are side effects, mainly damage to the gastrointestinal tract.
To reduce the side effect on the gastrointestinal tract, taking Voltaren can be combined with taking Omeprazole 20 mg x 2 times a day.
Excellent analgesic effect, especially when administered intramuscularly. Comfortable administration compared to similar drugs.
Not intended for long-term use. It often has side effects on the gastrointestinal tract, so the prescription must be made by a doctor and treatment must be adequately monitored.
Original high-quality drug of diclofenac. Good for acute pain (back pain, gout, toothache, menstrual pain). I always have it in my home medicine cabinet.
Time-tested remedy. Good lasting application effect. When combined with massage and physical therapy, the effect of treatment increases significantly.
Do not forget that this is only a means of symptomatic therapy. Be sure to identify and treat the cause, i.e. the disease itself that led to the symptoms.
One day I was walking and somehow stood on my leg so uncomfortably that it twisted and I fell. By evening, the ankle area was very swollen - dislocated. I bought Voltaren-gel. In just a couple of hours the swelling decreased. I anointed it for a couple more days for prevention, and it was all over without even going to the doctor.
Hello. In March of this year I broke my leg. How did this happen? And just like that, I was walking, fell out of the blue and injured my leg. Sparks fly from the eyes. So after a month my leg began to swell. So I had to go to the clinic, where they gave me a full examination and said: “Friend, your leg is broken.” Then the doctor prescribed Voltaren ointment for me to lubricate my leg. And just imagine, the swelling in my leg went down, and it became easier for me to walk.
Voltaren gel is indispensable for bruises, bruises, joint and back pain. It is sold in any pharmacy, the price is good, since the drug gives a noticeable effect from the first or second use. Removes bruises very well. For pain in the joints and back, it is enough to anoint it several times and the pain noticeably subsides or disappears altogether. My doctor once advised me to smear the swollen mammary gland with Voltaren for one week. The pain subsided with the first applications, and after 10 days the problem disappeared. I can’t single out any negative aspects; I’m happy with everything about this drug.
I have been saving myself with Voltaren for a long time, since other drugs do not help. She was born with two fused cervical vertebrae, they compress the nerve endings, which often causes pain, numbness, and radiates to the eyes and teeth. Once every three months I inject a course of Voltaren of 50 ampoules, which relieves the symptoms almost completely. The only drawback for me is that I get very tired and constantly want to sleep when I complete the course. So far there have never been any other side effects. I plan to soon switch to a less expensive analogue, they advised me at the pharmacy. Voltaren ointment practically does not help in my case, but it is understandable that the ointment will not pass through the bones, but the ampoules are very effective.
When the exacerbation of osteochondrosis began and she simply could not turn her neck from the acute pain, she began to apply all ointments in a row, including warming ones. But when I finally got to the surgeon, he said that these were only distracting effects and prescribed Voltaren. I rubbed this ointment into the sore spot for a week, and gradually the pain in the spine and muscles subsided. I read it and realized that “Voltaren” is one of the names of this medicine, and the active ingredient is “Diclofenac”, which is included in other, much less expensive ointments. Now I buy analogues, the effect is the same therapeutic, but costs ten times less.
Arthritis is an insidious disease with periodic exacerbations. Mom successfully uses Voltaren. Saved in the autumn-spring period to eliminate pain and relieve inflammation. A time-tested product that gives lasting results. When rubbing the drug, it produces a light massage, which improves blood circulation and doubles the therapeutic effect. After rubbing, relief occurs within 10 - 15 minutes. A certain course of use provides long-term relief. Considering that this disease is chronic, achieving long-term remission is important. After eliminating the pain, he leads an active lifestyle.
After the birth of the child, my lower back began to hurt severely. Voltaren helped me very well, the pain was relieved. But my grandmother recommended Diclofenac, which is part of Voltaren. The price of Diclofenac is much lower, but in terms of pain relief it is not. It helps just as much. Now I use diclofenac gel and tablets of the same name.
Once I sat on a bench, rocking a child in a stroller. It was cold and windy, the next day I felt severe pain in my back, it was hard to walk, my whole body was distorted. I tried different rubbings, but it didn’t help, until I bought Voltaren at the pharmacy, a very effective remedy that relieves pain in literally 20 minutes, and even heals. I noticed improvements from taking this remedy already on the third day. I’m very pleased, although the price is high, it helps well. Be healthy and protect your backs from the wind and cold so that you don’t get into trouble like I did.
"Voltaren" is a drug that really heals, and not just helps relieve pain. In case of exacerbation of chronic radiculitis, taking 1 tablet in the morning and in the evening relieves pain almost completely within three days. True, during periods of exacerbation I take not only Voltaren, but also Ibuflam, and Novominsulfone as an anesthetic. Additionally, I use Voltaren Emulgel ointment, which is applied to painful areas.
This drug is always not even in the medicine cabinet, on the shelf in the room. My husband's back is a problem area. The effectiveness of Voltaren for pain of this kind is quite high. I bought it at the pharmacy on the advice of a pharmacist and used it for acute pain - the gel really did its job from the first days of use. Although, to be honest, I thought it was just another advertised drug. Easily absorbed and does not stain anything. Doesn't burn your hands. Does not have a pungent odor. True, due to the fact that it has a thinner consistency than similar products, it is consumed faster. This is its only disadvantage, since the price of medicines has risen.
I work out at the gym, sometimes I overdo it and that’s it. A sprain or bruise is ready. I used different ointments and gels, sometimes it helped immediately, and sometimes it didn’t. One dentist is working with me, of course, it takes strength to pull out a tooth! It was he who advised me to try Voltaren. At first I was skeptical, then I bought it, applied it to my sore knee, and it helped. Use the drug with caution, it belongs to the group of non-steroidal anti-inflammatory drugs. Do not exceed the permissible dosage. There are contraindications and possible side effects. I haven’t noticed any side effects on myself, but this is purely individual.
We have a lot of drafts at home, and it so happened that my neck was blown very hard, I couldn’t turn my head either to the right or to the left. They advised me to take a couple of medications, but the only one I didn’t have on hand was Voltaren gel, which my mother uses because she has constant problems with her joints. The drug is very good, effective, after just five minutes the neck pain went away, I was able to turn it, and after applying the gel a couple more times I completely said goodbye to the neck pain. It’s also good that the gel is immediately absorbed. But before use, consult your doctor; voltaren has many contraindications.
The drug Voltaren is very strong and effective. I drank it for a severe knee injury, and my mother for osteochondrosis. The effect came in about an hour and lasted all night. It contains the usual diclofenac, but our drugs with the same active ingredient do not help me. Now I keep Voltaren in my home medicine cabinet and take it for almost everything: for headaches, for menstrual pain, for colds to relieve body aches.
Tell me, could the bone be deformed with the pin during a strong stretch in the lotus position or when climbing stairs? I went to the emergency room, they took a strange x-ray of only the lower part of the lower leg and the joint where the bolts were. They said there was no displacement, everything was fine, and supposedly nothing would happen to the bone higher up. They refused to take a full picture, which is completely incomprehensible to me. They prescribed Voltaren and complete rest. I’m lying at home in compression stockings, wool socks and a splint, smeared with Voltaren. This dent is about 2 cm - what could it be? Will the shin straighten out? Or can this deformation remain? What to do? How long does it take?
NSAIDs. Voltaren ® contains diclofenac sodium, a non-steroidal substance that has a pronounced anti-inflammatory, analgesic and antipyretic effect.
The drug is intended for symptomatic therapy, reducing pain and inflammation at the time of use; does not affect the progression of the disease. The main mechanism of action of diclofenac, established under experimental conditions, is considered to be inhibition of prostaglandin biosynthesis. Prostaglandins play an important role in the development of inflammation, pain and fever.
In vitro, diclofenac sodium in concentrations equivalent to those achieved in the treatment of patients does not suppress the biosynthesis of proteoglycans in cartilage tissue.
In rheumatic diseases, the anti-inflammatory and analgesic properties of Voltaren provide a clinical effect, characterized by a significant reduction in the severity of such manifestations of diseases as pain at rest and during movement, morning stiffness and swelling of the joints, as well as an improvement in the functional state.
In case of post-traumatic and postoperative inflammatory phenomena, Voltaren ® quickly relieves pain (arising both at rest and during movement), reduces inflammatory swelling and swelling of the postoperative wound.
This dosage form is especially applicable in patients who require long-term use of the drug at a dose of 100 mg/day.
Judging by the amount of unchanged diclofenac and its hydroxylated metabolites excreted in the urine, after taking a film-coated extended-release tablet, the same amount of active substance is released and absorbed from it as from a regular enteric-coated tablet. However
However, the systemic bioavailability of diclofenac released from extended-release film-coated tablets averages 82% of the value of the same indicator after taking film-coated tablets at the same dose. This is possibly due to a different severity of the “first pass” effect through the liver for dosage forms with sustained release of the active substance. Because the active substance is slower
is released from a film-coated extended-release tablet, then the Cmax of diclofenac in plasma is less than when taking an enteric-coated tablet.
After taking an extended-release film-coated tablet, 100 mg, Cmax of diclofenac in plasma is achieved on average after 4 hours; its average value is 0.5 µg/ml (1.6 µmol/l). Food intake does not have a clinically significant effect on the absorption of the active substance from extended-release film-coated tablets and its systemic bioavailability. During a 24-hour observation period after taking a 100 mg extended-release film-coated tablet, the plasma concentration of diclofenac averaged 13 ng/ml (40 nmol/l). The amount of absorbed active substance is directly dependent on the dose of the drug. Because during the “first pass” through the liver, about half of the amount of diclofenac is metabolized; AUC after taking extended-release film-coated tablets is approximately 2 times less than in the case of parenteral administration of an equivalent dose of the drug.
After repeated doses of the drug, pharmacokinetic parameters do not change. Provided that the recommended dosage regimen of the drug is followed, cumulation is not observed. The basal concentration of diclofenac, determined in the morning before taking the next dose, is about 22 ng/ml (70 nmol/l) during treatment with Voltaren ® in the form of extended-release film-coated tablets, at a dose of 100 mg 1 time/day.
Communication with serum proteins is 99.7%, mainly with albumin (99.4%). The apparent volume of distribution is 0.12-0.17 l/kg.
Diclofenac penetrates into the synovial fluid, where its Cmax is reached 2 to 4 hours later than in blood plasma. The apparent T1 /2 from synovial fluid is 3-6 hours. 2 hours after reaching Cmax in plasma, the concentration of diclofenac in synovial fluid is higher than in plasma, and its values remain higher over a period of time up to 12 hours.
Diclofenac was found in low concentrations (100 ng/ml) in the breast milk of one nursing mother. The estimated amount of the drug entering the child's body through breast milk is equivalent to 0.03 ng/kg/day.
The metabolism of diclofenac is carried out partly by glucuronidation of the unchanged molecule, but mainly through single and multiple hydroxylation and methoxylation, which leads to the formation of several phenolic metabolites (3′-hydroxy-, 4′-hydroxy-, 5′-hydroxy-, 4′, 5-dihydroxy- and 3′-hydroxy-4′-methoxydiclofenac), most of which are converted to glucuronide conjugates. Two phenolic metabolites are biologically active, but to a much lesser extent than diclofenac.
The total systemic plasma clearance of diclofenac is 263±56 ml/min. The final T1 /2 is 1-2 hours. T1 /2 of 4 metabolites, including two pharmacologically active ones, is also short-lived and is 1-3 hours. One of the metabolites, 3′-hydroxy-4′-methoxy-diclofenac, has a longer half - , but this metabolite is completely inactive.
About 60% of the drug dose is excreted in the urine in the form of glucuronic conjugates of the unchanged active substance, as well as in the form of metabolites, most of which are also glucuronic conjugates. Less than 1% of diclofenac is excreted unchanged. The remainder of the drug dose is excreted in the form of metabolites in bile.
The concentration of the active substance in blood plasma depends linearly on the dose taken.
Pharmacokinetics in certain groups of patients
Absorption, metabolism and excretion of the drug do not depend on age. In patients with impaired renal function
If the recommended dosage regimen is followed, no accumulation of unchanged active substance is observed. With a QC of less than 10 ml/min, the calculated equilibrium concentrations of diclofenac hydroxymetabolites are approximately 4 times higher than in healthy volunteers, while the metabolites are excreted exclusively in bile.
In patients with chronic hepatitis or compensated liver cirrhosis, the pharmacokinetics of diclofenac are similar to those in patients with preserved liver function.
Extended-release, pink, film-coated tablets, round, biconvex, chamfered, marked “CG” in black ink on one side and “CGC” on the other.
Excipients: anhydrous colloidal silicon dioxide - 3 mg, cetyl alcohol - 59 mg, magnesium stearate - 3 mg, povidone K30 - 6 mg, sucrose - 119 mg.
Shell composition: hypromellose - 4.242 mg, iron dye red oxide (E172) - 0.039 mg, polysorbate 80 - 0.195 mg, talc - 3.768 mg, titanium dioxide - 0.754 mg.
Polishing composition: macrogol 8000, crystalline sucrose, marking ink, black (pharmaceutical glaze (shellac solution in ethanol), black iron oxide dye (E172), propylene glycol (E1520), ammonium hydroxide 28% (E527)).
10 pieces. - blisters (1) - cardboard packs.
10 pieces. - blisters (3) - cardboard packs.
The dose of the drug is selected individually, and in order to reduce the risk of side effects, it is recommended to use the minimum effective dose, if possible, with the shortest possible treatment period, in accordance with the purpose of treatment and the patient’s condition. The tablets should be swallowed whole, preferably with meals.
The recommended initial dose is 100 mg/day (1 extended-release film-coated tablet). The same daily dose is used for moderately severe symptoms, as well as for long-term therapy. In cases where the symptoms of the disease are most pronounced at night or in the morning, extended-release tablets
actions. film-coated, preferably taken at night.
Children and teenagers up to 18 years old
Elderly patients (>65 years)
No initial dose adjustment is required in patients aged 65 years and older. In weakened patients and patients with low body weight, it is recommended to adhere to the minimum dose.
Patients with cardiovascular disease or high risk of cardiovascular disease
The drug should be used with extreme caution in patients with diseases of the cardiovascular system (including uncontrolled hypertension) or a high risk of developing cardiovascular diseases. At
the need for long-term therapy (more than 4 weeks), in such patients the drug should be used in a daily dose not exceeding 100 mg.
Patients with mild to moderate renal impairment
There is no data on the need for dose adjustment when using the drug in patients with mild to moderate renal impairment due to the lack of safety studies of the drug in this category of patients.
Symptoms: vomiting, gastrointestinal bleeding, diarrhea, dizziness, tinnitus, convulsions. In case of significant poisoning, acute renal failure and liver damage may develop.
Treatment: supportive and symptomatic treatment is indicated for complications such as decreased blood pressure, renal failure, seizures, gastrointestinal disorders and respiratory depression. Forced diuresis, hemodialysis or hemoperfusion are ineffective for diclofenac, because the active substances of these drugs are largely
bind to plasma proteins and undergo intensive metabolism.
In case of a life-threatening overdose when taking the drug orally, in order to quickly prevent the absorption of diclofepak, gastric lavage should be performed and activated charcoal should be prescribed.
Potent CYP2C9 inhibitors. Caution should be exercised when co-prescribing diclofenac and strong CYP2C9 inhibitors (such as vornconazole) due to the possible increase in diclofenac serum concentrations and increased systemic effects caused by inhibition of diclofenac metabolism.
Lithium, digoxin. Diclofenac may increase plasma concentrations of lithium and digoxim. It is recommended to monitor the concentration of lithium and digoxin in the blood serum.
Diuretics and antihypertensive drugs. When used simultaneously with diuretics and antihypertensive drugs (for example, beta-blockers, ALP inhibitors), diclofenac may reduce their hypotensive effect. Therefore, in patients, especially elderly patients, when diclofenac is co-administered with diuretics or antihypertensive drugs, blood pressure should be regularly measured, renal function and hydration levels monitored (especially when combined with diuretics and ACE inhibitors due to the increased risk of nephrotoxicity).
Cyclosporine. The effect of diclofenac on the activity of prostaglandins in the kidneys may enhance the nephrotoxicity of cyclosporine. Therefore, the doses of diclofenac used should be lower than in patients not using cyclosporine.
Drugs that can cause hyperkalemia: Concomitant use of diclofenac with potassium-sparing diuretics, cyclosporine, tacrolimus and trnmethoprinum can lead to an increase in the level of potassium in the blood plasma (in the case of such a combination, this indicator should be monitored frequently).
Antibacterial agents quinolone derivatives. There are isolated reports of the development of seizures in patients receiving concomitant quinolone derivatives and diclofenac.
NSAIDs and GCS. Simultaneous systemic use of dnclofenac and other systemic NSAIDs or GCS may increase the incidence of adverse events (in particular, from the gastrointestinal tract).
Anticoagulants and antiplatelet agents. It is necessary to combine dnclofenac with drugs of these groups with caution due to the risk of bleeding. Despite the fact that clinical studies have not established the effect of diclofenac on the action of anticoagulants, there are isolated reports of an increased risk of bleeding in patients taking this combination of drugs. Therefore, in the case of such a combination of drugs, careful monitoring of patients is recommended.
Selective serotonin reuptake inhibitors. Concomitant use of diclofenac with selective serotonin reuptake inhibitors increases the risk of gastrointestinal bleeding.
Hypoglycemic drugs. Clinical studies have established that the simultaneous use of diclofenac and hypoglycemic drugs is possible, while the effectiveness of the latter does not change. However, there are isolated reports of the development in such cases of both hypoglycemia and hypoglycemia, which necessitated the need to change the dose of hypoglycemia! drugs during the use of diclofenac. Therefore, during the combined use of diclofenac and hypoglycemia of its drugs, it is recommended to monitor the concentration of glucose in the blood.
Methotrexate. Caution should be exercised when prescribing diclofenac less than 24 hours before or 24 hours after taking methotrexate, because in such cases, the concentration of methotrexate in the blood may increase and its toxic effect may increase.
Phenytoin. When using phenytoin and diclofenac simultaneously, it is necessary to monitor the concentration of phenytoin in the blood plasma due to a possible increase in its systemic effect.
Below are the adverse events that were identified during clinical studies, as well as when using diclofenac in clinical practice.
To assess the frequency of adverse events, the following criteria were used: very often (>1/10), often (>1/100, <1/10) infrequently (>1/1000, <1/100), rarely (>1/10,000 , <1/1000), very rare (<1/10,000), For each organ system, adverse events are grouped in descending order of their frequency of occurrence. Within each group, identified by frequency of occurrence, adverse events are distributed in order of decreasing importance.
From the blood and lymphatic system: very rarely - thrombocytopenia, leukopenia, hemolytic anemia, aplastic anemia, agranulocytosis.
From the immune system: rarely - hypersensitivity, anaphylactic/anaphylactoid reactions, including decreased blood pressure and shock; very rarely - angioedema (including facial swelling).
Mental disorders: very rarely - disorientation, depression, insomnia, nightmares, irritability, mental disorders.
From the nervous system: often - headache, dizziness; rarely - drowsiness; very rarely - sensory disturbances, including paresthesia; memory disorders, tremor, convulsions, anxiety, acute cerebrovascular accidents, aseptic meningitis.
From the organ of vision: very rarely - visual impairment (blurred vision), diplopia.
From the organ of hearing and labyrinthine disorders: often - vertigo; very rarely - hearing impairment, tinnitus.
From the heart: uncommon - myocardial infarction, heart failure, palpitations, chest pain.
From the side of blood vessels: very rarely - increased blood pressure, vasculitis.
From the respiratory system, chest mediastinal organs: rarely - bronchial asthma (including shortness of breath); very rarely - pneumonitis.
From the gastrointestinal tract: often - abdominal pain, nausea, vomiting, diarrhea, dyspepsia, flatulence, loss of appetite: rarely - gastritis, gastrointestinal bleeding, vomiting blood, melena, diarrhea mixed with blood, stomach and intestinal ulcers (with or without bleeding or perforation); very rarely - stomatitis, glossitis, damage to the esophagus. the occurrence of diaphragm-like strictures in the intestine, colitis (nonspecific hemorrhagic colitis, exacerbation of ulcerative colitis or Crohn's disease), constipation, pancreatitis, dysgeusia.
From the liver and biliary tract: often - increased activity of aminotransferases in the blood plasma; rarely - hepatitis, jaundice, liver dysfunction; very rarely - fulminant hepatitis, liver necrosis, liver failure.
From the skin and subcutaneous tissues: often - skin rash; rarely - urticaria; very rarely - bullous dermatitis, eczema, erythema, erythema multiforme, Stevens-Johnson syndrome, Lyell's syndrome (toxic epidermal necrolysis), exfoliative dermatitis, itching, alopecia, photosensitive reactions, purpura, Henoch-Schönlein purpura.
From the kidneys and urinary tract: very rarely - acute renal failure, hematuria, proteinuria, tubulointerstitial nephritis, nephrotic syndrome, papillary necrosis.
General disorders and disorders at the injection site: rarely - swelling.
Data from clinical studies indicate a slight increase in the risk of developing cardiovascular thrombotic complications (for example, myocardial infarction), especially with long-term use of diclofenac in high doses (daily dose more than 150 mg).
If any of the side effects listed in the instructions get worse, or you notice any other side effects not listed in the instructions, tell your doctor.
- inflammatory and degenerative diseases of the musculoskeletal system: rheumatoid arthritis, ankylosing spondylitis and other spondyloarthropathy, osteoarthritis, bursitis, tendovaginitis;
- diseases of the spine accompanied by pain (lumbago, sciatica, ossalgia, neuralgia, myalgia, arthralgia, radiculitis);
- post-traumatic and postoperative pain syndromes accompanied by inflammation (for example, in dentistry and orthopedics);
- algodismenorrhea; inflammatory processes in the pelvis, incl. adnexitis.
- exacerbation of gastric or duodenal ulcers, ulcerative bleeding, perforation;
- hypersensitivity to diclofenac or to any other ingredients of the drug or to other NSAIDs;
— III trimester of pregnancy;
- patients with attacks of bronchial asthma, urticaria or acute rhinitis, which are provoked by taking acetylsalicylic acid or other NSAIDs;
- severe hepatic, renal (creatinine clearance <30 ml/min) and heart failure;
- conditions accompanied by a risk of bleeding;
— coronary artery bypass grafting (perioperative period);
- inflammatory bowel diseases (Crohn's disease, ulcerative colitis) in the acute phase;
- active liver diseases;
Not recommended for patients with hereditary fructose intolerance, glucose-galactose malabsorption and sucrase-isomaltase deficiency, because The drug contains sucrose. Extended-release film-coated tablets should not be used in children.
When using the drug Voltaren ® and other NSAIDs, careful medical monitoring is necessary for patients who have symptoms/signs indicating a history of gastrointestinal lesions/diseases: gastric or intestinal ulcers, bleeding or perforation, a history of Helicobacter pylori infection, ulcerative colitis, disease Crohn's disease, liver dysfunction. The risk of developing gastrointestinal bleeding increases with increasing doses of diclofenac or with a history of ulcers, especially bleeding and ulcer perforation in elderly patients.
Particular caution should be exercised when using the drug Voltaren ® in patients receiving drugs that increase the risk of gastrointestinal bleeding: systemic corticosteroids (including prednisolone), anticoagulants (including warfarin), antiplatelet agents (including clopidogrel, acetylsalicylic acid) or selective serotonin reuptake inhibitors (including citalopram , fluoxetine, paroxetine, sertraline).
Caution must be observed when using the drug Voltaren ® in patients with mild to moderate liver dysfunction, as well as in patients with hepatic porphyria, because the drug can provoke attacks of porphyria.
The drug should be used with caution in patients with bronchial asthma, seasonal allergic rhinitis, swelling of the nasal mucosa (including nasal polyps), COPD, chronic infectious diseases of the respiratory tract (especially those associated with allergic rhinitis-like symptoms).
Particular caution is required when treating patients with heart disease.
Voltaren ® should be used with caution in patients with defects in the hemostatic system. Caution should be exercised when using the drug Voltaren ® in patients at risk of developing cardiovascular thrombosis (including myocardial infarction and stroke).
Caution should be exercised when using Voltaren ® in elderly patients. This is especially true for frail or low-weight elderly people; they are recommended to prescribe the drug at the minimum effective dose.
There is insufficient data on the safety of diclofenac in pregnant women. Therefore, the drug Voltaren ® should be prescribed in the first and second trimesters of pregnancy only in cases where the expected benefit to the mother outweighs the potential risk to the fetus. Voltaren ®, like other inhibitors of prostaglandin synthesis, is contraindicated in the last 3 months of pregnancy (possible suppression of uterine contractility and premature closure of the ductus arteriosus in the fetus).
Despite the fact that the drug Voltaren ®, like other NSAIDs, passes into breast milk in small quantities, the drug should not be prescribed to nursing women to prevent undesirable effects on the child. If it is necessary for a nursing woman to use the drug, breastfeeding should be stopped.
Since Voltaren ®, like other NSAIDs, can have a negative effect on fertility, women planning pregnancy are not recommended to take the drug.
For patients undergoing examination and treatment for infertility, the drug should be discontinued.
During the period of use of the drug Voltaren ®, an increase in the activity of one or more liver enzymes may be observed; with long-term therapy with the drug, monitoring of liver function is indicated as a precaution. If liver dysfunction persists or progresses or signs of liver disease or other symptoms (for example, eosinophilia, rash, etc.) occur, the drug should be discontinued. It should be borne in mind that hepatitis during the use of the drug Voltaren ® can develop without prodromal phenomena.
During therapy with Voltaren ® it is recommended to monitor renal function in patients with hypertension, impaired cardiac or renal function, the elderly, patients receiving diuretics or other drugs that affect renal function, as well as in patients with a significant decrease in the volume of circulating blood plasma of any etiology, for example, during the period before and after major surgical interventions. After discontinuation of drug therapy, normalization of renal function indicators to pre-baseline values is usually observed.
The drug in this dosage should not be used in children and adolescents under 18 years of age.
When using diclofenac, phenomena such as bleeding or ulceration/perforation of the gastrointestinal tract, in some cases with fatal outcome, were observed. These events may occur at any time when using drugs in patients with or without previous symptoms and a history of serious gastrointestinal diseases. In older patients, such complications can have serious consequences. If patients receiving Voltaren ® develop bleeding or ulceration of the gastrointestinal tract, the drug should be discontinued. To reduce the risk of toxic development of gastrointestinal complications, as well as in patients receiving therapy with low doses of acetylsalicylic acid (Aspirin) or other drugs that can increase the risk of gastrointestinal damage, gastroprotectors (for example, proton pump inhibitors or misoprostol) should be taken.
Patients with a history of gastrointestinal lesions, especially the elderly, should inform their doctor about all symptoms of the digestive system.
Patients with bronchial asthma
Exacerbation of asthma (NSAID intolerance/NSAID-induced asthma), angioedema and urticaria are most often observed in patients suffering from bronchial asthma, seasonal allergic rhinitis, nasal polyps, COPD or chronic infectious diseases of the respiratory tract (especially those associated with allergic rhinitis-like symptoms). In this group of patients, as well as in patients with allergies to other drugs (rash, itching or urticaria), when using the drug Voltaren ®, you should observe
special caution (preparedness for resuscitation measures).
Serious dermatological reactions such as exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, in some cases fatal, have been reported very rarely with the use of diclofenac. The highest risk and incidence of severe dermatological reactions were observed in the first month of treatment with diclofenac. If patients receiving Voltaren ® develop the first signs of skin rash, damage to the mucous membranes or other symptoms of hypersensitivity, the drug should be discontinued. In rare cases, in patients who are not allergic to diclofenac, anaphylactic/anaphylactoid reactions may develop when using the drug Voltaren ®.
Effects on the liver
Since during the period of use of the drug Voltaren ® there may be an increase in the activity of one or more liver enzymes, during long-term therapy with the drug, monitoring of liver function is indicated as a precautionary measure. If liver dysfunction persists and progresses or signs of liver disease or other symptoms (for example, eosinophilia, rash, etc.) occur, the drug should be discontinued. It should be borne in mind that hepatitis during the use of the drug Voltaren ® can develop without prodromal phenomena.
Effects on the kidneys
During therapy with Voltaren ®, it is recommended to monitor renal function in patients with hypertension, impaired cardiac or renal function, the elderly, patients receiving diuretics or other drugs that affect renal function, as well as in patients with a significant decrease in the volume of circulating blood plasma of any etiology , for example, in the period before and after major surgical interventions. After discontinuation of drug therapy, normalization of renal function indicators to pre-baseline values is usually observed.
Effects on the cardiovascular system
NSAID therapy, incl. Diclofenac, particularly long-term and high-dose therapy, may be associated with a small increase in the risk of serious cardiovascular thrombotic events (including myocardial infarction and stroke).
In patients with diseases of the cardiovascular system and a high risk of developing diseases of the cardiovascular system (for example, with arterial hypertension, hyperlipidemia, diabetes mellitus, smokers), the drug should be used with extreme caution, at the lowest effective dose for the shortest possible duration of treatment, since the risk of thrombotic complications increases with increasing dose and duration of treatment. With long-term therapy (more than 4 weeks), the daily dose of diclofenac in such patients should not exceed 100 mg. The effectiveness of treatment and the patient's need for treatment should be periodically assessed.
symptomatic therapy, especially in cases where its duration is more than 4 weeks. When the first symptoms of thrombotic disorders appear (for example, chest pain, feeling short of breath, weakness, speech impairment), the patient should immediately seek medical help.
Impact on the hematopoietic system
The drug Voltaren ® may temporarily inhibit platelet aggregation. Therefore, in patients with hemostasis disorders, it is necessary to carefully monitor relevant laboratory parameters. With long-term use of the drug Voltaren ® it is recommended to conduct regular clinical tests of peripheral blood.
Masking signs of an infectious process
The anti-inflammatory effect of the drug Voltaren ® may complicate the diagnosis of infectious processes.
Use simultaneously with other NSAIDs
Voltaren ® should not be used concomitantly with NSAIDs, including selective COX-2 inhibitors, due to the risk of increased adverse events.
Impact on the ability to perform potentially hazardous activities that require special attention and quick reactions (driving vehicles, working with moving mechanisms, etc.)
Patients who experience visual disturbances, dizziness, drowsiness, vertigo or other central nervous system disorders while using the drug Voltaren ® should not drive vehicles or operate machinery.