Clodifen
(Diclofenac sodium)




COMPOSITION

Clodifen gel 1%:

100 g of gel contains

Active substance: diclofenac sodium 1.0 g.

Excipients: carbomer 980, propylene glycol, trolamine, ethanol 96%, methyl parahydroxybenzoate, purified water.

THERAPEUTIC INDICATIONS

- Post-traumatic inflammation of soft tissues and joints (due to sprains, overstrains and hurts);

- Rheumatic diseases of soft tissues (tendovaginitis, bursitis, injuries of periarticular tissues and so on);

- Pain syndrome and oedema associated with muscle and joint diseases (rheumatoid arthritis, osteoarthrosis, radiculitis, lumbago, ischias and so on).

CONTRAINDICATIONS

Clodifen gel rarely causes side effects. Sometimes redness, pruritus or burning sensation appears in the area of gel application. Photosensibilization can be observed in some patients.

Hypersensitivity reactions (rash, urticaria, bronchial asthma, angioedema) can be notices very rarely.

ADVERSE EFFECTS

Clodifen gel rarely causes side effects. Sometimes redness, pruritus or burning sensation appears in the area of gel application. Photosensibilization can be observed in some patients.

Hypersensitivity reactions (rash, urticaria, bronchial asthma, angioedema) can be notices very rarely.

DOSAGE AND ADMINISTRATION

Administer Clodifen gel externally. Choice in the concentration of Clodifen gel is defined by intensity of inflammatory process and pain syndrome.

In adults and children over 12 years of age administer Clodifen gel 1% 3 to 4 times per day. Apply a strip of gel approximately 5 to 10 cm long (2 to 4 g of gel) to the skin and rub gently. The amount of the drug administered depends on the size of painful area.

In adults and children over 12 years of age administer Clodifen gel 5% 2 to 3 times per day. The amount of the drug administered is up to 2 g (up to 4 cm of gel).

Wash your hands after the application of the drug.

Treatment duration depends on indications and therapy efficiency. In 2 weeks of the drug administration consult a physician about advisability of treatment continuation. The drug should not be administered for more than 14 consecutive days in case of soft tissue injury or rheumatic disease of soft tissues and for more than 21 days in case of pain due to arthritis (unless the physician appointed another therapeutic regimen). If the positive clinic dynamics is not observed or the condition has deteriorated during 7 days, it is necessary to consult a doctor.

SPECIAL INDICATIONS

Apply Clodifen gel only to unbroken skin, avoid contact with open wounds. Do not put occlusive dressing after the application. Avoid the contact of the drug with eyes and mucous membranes.

Exercise caution when administering Clodifen in hepatic porphyria (in active phase), erosions and ulcers of GIT, severe hepatic and renal function abnormalities, chronic cardiac failure, bronchial asthma and in elderly patients.

PREGNANCY AND LACTATION

Clodifen is contraindicated during III trimester of pregnancy. Administration during I and II trimesters of pregnancy is possible only in case if benefit for mother exceeds potential risk for fetus.

Diclofenac and its metabolites penetrate into breast milk that is why it is not recommended to use the drug during breastfeeding.

MANUFACTURED FORM AND PACKAGE

Clodifen gel 1%:

Gel 45 g in an aluminum tube.

1 aluminum tube in a carton box together with an enclosed leaflet.

Clodifen gel 5%:

Gel 45 g in an aluminum tube.

1 aluminum tube in a carton box together with an enclosed leaflet.

Musculo-Skeletal system

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