Clodifen
(Diclofenac)




COMPOSITION

1 suppository contains

Active substance: diclofenac sodium 100 mg.

Excipient: hard fat (Suppocire AM).

THERAPEUTIC INDICATIONS

- inflammatory and degenerative forms of rheumatism (rheumatoid arthritis, ankylosing spondylitis, osteoarthritis, spondylarthritis), gout;

- rheumatic diseases of periarticular soft tissue;

- pain in spinal disease;

- post-traumatic or post-surgical pain syndrome associated with inflammation and edema;

- gynecological diseases associated with pain syndrome and inflammation (e.g., primary algodismenorrhea, adnexitis);

- episodes of migraine.

CONTRAINDICATIONS

- gastric or duodenal ulcer;

- gastro-intestinal bleeding or perforation;

- hypersensitivity to the drug components;

- history of allergic reactions (bronchospasm, asthma, rhinitis, urticaria) after administration of acetylsalicylic acid or other nsaids;

- severe cardiac failure;

- anorectal inflammatory diseases and bleeding;

- ІІІ trimester of pregnancy;

- children and adolescents under 16 years of age.

ADVERSE EFFECTS

Gastro-intestinal tract: epigastric pain, nausea, vomiting, diarrhea, dyspepsia; rare – gastro-intestinal bleeding, gastric and intestinal ulcers, perforations, proctitis.

Central nervous system: headache, dizziness, insomnia, irritation or fatigability, drowsiness.

Urinary system: rare – edemas, very rare – acute renal insufficiency, hematuria, proteinuria, interstitial nephritis, nephrotic syndrome, papillary necrosis.

Hepato-biliary system: increase in level of transaminases in the blood; rare – liver damage, acute hepatitis.

Cardiovascular system: palpitation, chest pain, hypertension, aggravation of congestive heart failure.

Hematopoietic system: very rare – anemia, thrombocytopenia, leucopenia, agranulocytosis.

Dermatologic reactions: skin rash, urticaria.

Allergic reactions: rare – bronchospasm, system anaphylactic and anaphylactoid reactions including arterial hypotension; very rare – vasculitis, pneumonitis.

DOSAGE AND ADMINISTRATION

For rectal administration.

Administer 1 suppository of Clodifen (100 mg of diclofenac sodium) per day. Treatment duration is set by a doctor. Insert the suppositories well into the rectum. It is recommended to insert the suppositories after passing stools. Do not divide suppositories into parts, because the change in storage conditions can lead to maldistribution of active substance.

Dosage adjustment is not necessary for patients with light to moderate renal or liver insufficiency and for elderly patients.

SPECIAL INDICATIONS

As with other NSAIDs, administration of diclofenac requires close monitoring of patients with GIT diseases, suffering from ulcerative colitis or Crohn's disease, with history of ulcerative lesions of stomach or intestine and those with liver function abnormality. Discontinue the drug in case of gastro-intestinal bleeding or GIT ulceration/ perforation.

Control of liver function is recommended in case of continuous therapy due to the possibility of increase in hepatic enzyme level during diclofenac administration. In case of hepatotoxic reaction discontinue the drug. Exercise caution when prescribing the drug to the patients with hepatic porphyria as diclofenac can provoke episodes of porphyria.

Exercise caution when prescribing the drug to the patients with the impairment of cardiac or renal function, who receive diuretics, and to the patients with significant decrease in volume of plasma circulation of any etiology (e.g. in the period before and after profuse surgical interventions). In these cases it is necessary to control renal function during treatment due to the fact that NSAIDs inhibit synthesis of renal prostaglandins which are necessary for maintenance of renal blood flow.

As with other NSAIDs, systemic control of peripheral blood picture is recommended in continuous administration of diclofenac. Diclofenac can temporarily inhibit platelet aggregation that is why it is necessary to monitor closely appropriate laboratory scores in patients with hemostatic abnormalities.

As with other NSAIDs, in rare cases allergic reactions, including anaphylactic/naphylactoid reactions, may occur in first administration of diclofenac.

Diclofenac can mask evidence of infectious diseases.

Exercise caution when prescribing diclofenac to elderly patients, especially to those debilitate or having low body weight.

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 the 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 breast-feeding.

MANUFACTURED FORM AND PACKAGE

3 suppositories in a blister. 2 blisters in a carton box together with an enclosed leaflet.1 or 2 strips together with a leaflet

Musculo-Skeletal system

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