Description
Release form
Gel for external use 1% transparent, colorless, homogeneous.
Packaging
In an aluminum tube 40g. In a pack of cardboard 1 tube.
Pharmacological action
NSAIDs, a derivative of phenylacetic acid. It has a pronounced anti-inflammatory, analgesic and moderate antipyretic effect. The mechanism of action is associated with the inhibition of COX activity – the main enzyme of the metabolism of arachidonic acid, which is a precursor of prostaglandins, which play a major role in the pathogenesis of inflammation, pain and fever. The analgesic effect is due to two mechanisms: peripheral (indirectly, through the suppression of prostaglandin synthesis) and central (due to inhibition of prostaglandin synthesis in the central and peripheral nervous system).
Inhibits proteoglycan synthesis in cartilage.
In rheumatic diseases, it reduces joint pain at rest and during movement, as well as morning stiffness and swelling of the joints, contributes to an increase in range of motion. Reduces post-traumatic and postoperative pain, as well as inflammatory edema.
Suppresses platelet aggregation. With prolonged use it has a desensitizing effect.
When applied topically in ophthalmology, it reduces swelling and pain in inflammatory processes of a non-infectious etiology.
Indications
Inflammatory and degenerative diseases of the musculoskeletal system: rheumatoid arthritis, psoriatic, juvenile chronic arthritis, ankylosing spondylitis rheumatic soft tissue lesions gouty arthritis) traumatic inflammation of the tendons, ligaments in the joints and muscles and joints ( )
Contraindications
– complete or incomplete combination of bronchial asthma, recurrent polyposis of the nose and paranasal sinuses, and intolerance to acetylsalicylic acid or other NSAIDs (history)
– violation of the integrity of the skin
– pregnancy (III trimester)
– lactation period
– childhood (up to 12 years)
– hypersensitivity to diclofenac or other components of the drug other NSAIDs.
With caution
Hepatic porphyria (exacerbation), erosive and ulcerative gastrointestinal tract lesions (in the exacerbation phase), severe hepatic and renal impairment, chronic heart failure, bleeding disorders (including hemophilia, prolonged bleeding time, bleeding tendency ) bronchial asthma, advanced age, pregnancy I and II trimester.
Special instructions
Gel is applied only to intact skin. After application, an occlusive dressing should not be applied.
When applied to large skin surfaces for a long time, the risk of developing systemic side effects increases.
Avoid contact with eyes, mucous membranes or open brine. Use only as an external agent.
Composition
100 g of gel contains:
Active ingredient: diclofenac diethylamine 1.16 g, which corresponds to sodium diclofenac 1, 00 g.
Excipients: Isopropyl alcohol, carbopol 940, polysorbate 80, gasoline alcohol, sodium metabisulfite, sorbitol 70% non-crystallizing, triethanolamine, purified water.
Dosage and Administration
Externally.
For adults and children over 12 years of age, the drug is applied a thin layer over the site of inflammation 3-4 times / day and gently rubbed. The required amount of the drug depends on the size of the painful area. A single dose of the drug: 2-4 g (which is comparable in volume to the size of a large cherry).
After applying the drug, wash your hands.
The duration of treatment depends on the indications and therapeutic effect. After 2 weeks of using the drug, consult your doctor.
Side effects of the
From the digestive system: nausea, vomiting, anorexia, pain and discomfort in the epigastric region, flatulence, constipation, diarrhea in some cases – erosive and ulcerative lesions, bleeding and perforation of the gastrointestinal tract rarely – impaired liver function. With rectal administration in rare cases, inflammation of the colon with bleeding, exacerbation of ulcerative colitis was noted.
From the side of the central nervous system and peripheral nervous system: dizziness, headache, agitation, insomnia, irritability, rare tiredness – paresthesia, visual impairment (vagueness, diplopia), tinnitus, sleep disturbances, convulsions, irritability, tremors, mental disorders, depression.
From the hemopoietic system: rarely – anemia, leukopenia, thrombocytopenia, agranulocytosis.
From the urinary system: rarely – impaired renal function in susceptible patients, edema is possible.
Dermatological reactions: rarely – hair loss.
Allergic reactions: skin rash, itching when applied in the form of eye drops – itching, redness, photosensitivity.
Local reactions: burning may occur at the site of the i / m injection, in some cases – the formation of infiltrate, abscess, adipose tissue necrosis with rectal administration, local irritation, the appearance of mucous secretions with an admixture of blood, painful defecation with external use in rare cases – itching, redness, rash, burning with local application in ophthalmology, a transient burning sensation and / or temporary blurred vision immediately after instillation are possible.
With prolonged external use and / or application to extensive body surfaces, systemic side effects are possible due to the resorptive effect of diclofenac.
Drug Interactions
The drug may enhance the effects of drugs that cause photosensitivity.
No clinically relevant interactions with other drugs have been described.
Storage conditions
Keep out of the reach and sight of children, at temperatures between 15 ° and 25 ° C.
Term hodnosty
3 years
active substance
Diclofenac
Conditions for dispensing from
pharmacies words from the drugstore
Without a prescription
lekarstvennaja form
gel naruzhnej Application
Teva Pharmaceutical Enterprise Co., Ltd., Israel
