Cataflam

Diclofenac K

Short-term treatment in post-traumatic pain inflammation & swelling eg, due to sprains; post-op pain, inflammation & swelling eg, following dental or orthopaedic surgery; painful &/or inflammatory conditions in gynaecology eg, primary dysmenorrhoea or adnexitis; migraine attacks; painful syndromes of the vertebral column; non-articular rheumatism; as adjuvant in severe painful inflammatory infections of the ENT eg, pharyngotonsillitis, otitis.

Adult Initially 100-150 mg daily. In milder cases, 75-100 mg daily. Total daily dose should be divided in 2-3 doses. Primary dysmenorrhoea 50-150 mg daily. Initially 50-100 mg then may be increased over the course of several menstrual cycles up to a max of 200 mg daily. Migraine attacks Initially 50 mg taken at the 1st signs of an impending attack. In cases where pain relief w/in 2 hr after the 1st dose is not sufficient, a further dose of 50 mg may be taken. If needed, further doses of 50 mg may be taken at intervals of 4-6 hr. Max total dose: 200 mg daily. Childn & adolescent ≥14 yr 75-100 mg daily, divided in 2-3 doses. Max daily dose: 150 mg.

Should be taken on an empty stomach: Swallow whole w/ liqd, preferably before meals. Do not divide/chew.

Hypersensitivity. Active gastric or intestinal ulcer, bleeding or perforation. Severe hepatic, renal & cardiac failure. Patients in whom attacks of asthma, urticaria or acute rhinitis are precipitated by ASA or other NSAIDs. Last trimester of pregnancy.

Discontinue treatment at the 1st appearance of skin rash, mucosal lesions or any other sign of hypersensitivity. Risk of GI bleeding, ulceration or perforation. May mask signs & symptoms of infection. Reports of fluid retention & oedema in association w/ NSAID therapy. May temporarily inhibit platelet aggregation. Monitor hepatic function & blood count during prolonged treatment. Caution in patients w/ asthma, seasonal allergic rhinitis, swelling of the nasal mucosa, COPD or chronic infections of the resp tract; patients who are allergic to other substances; patients w/ symptoms indicative of GI disorders or w/ history suggestive of GI ulceration, bleeding or perforation; ulcerative colitis or Crohn's disease; hepatic impairment, hepatic porphyria; cardiac or renal impairment, history of HTN, patients receiving concomitant treatment w/ diuretics or medicinal products that can significantly impact renal function, patients w/ substantial extracellular vol depletion from any cause; elderly; patients w/ defects on haemostasis. Avoid concomitant use w/ systemic NSAIDs including COX-2 inhibitors. Not recommended for patients w/ rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency. May affect ability to drive & use machines. Should not be used during the 1st 2 trimesters of pregnancy unless potential benefit to the mother outweighs risk to the foetus. Should not be administered during breast-feeding. Tab dosage form is not recommended in childn & adolescents <14 yr. Use of Cataflam in migraine attacks has not been established in childn & adolescents.

Headache, dizziness; vertigo; nausea, vomiting, diarrhoea, dyspepsia, abdominal pain, flatulence, anorexia; increased transaminases; rash.

Raised plasma conc of lithium & digoxin. Decreased antihypertensive effect of diuretics or antihypertensive agents (eg, β-blockers, ACE inhibitors). Increased risk of nephrotoxicity w/ diuretics & ACE inhibitors. Increased serum K levels w/ K-sparing drugs. Increased frequency of GI undesirable effects w/ other systemic NSAIDs or corticosteroids. Increased risk of bleeding w/ anticoagulants & anti-platelet agents. Increased risk of GI bleeding w/ SSRIs. Hypoglycaemic or hyperglycaemic effects w/ oral antidiabetic agents. Increased blood conc & increased toxicity of MTX. Increased nephrotoxicity of ciclosporin. Reports of convulsions w/ quinolone antibacterials. Increased peak plasma conc & exposure w/ potent CYP2C9 inhibitors (eg, sulfinpyrazone & voriconazole). Increased exposure of phenytoin.

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)

M01AB05 - diclofenac ; Belongs to the class of acetic acid derivatives and related substances of non-steroidal antiinflammatory and antirheumatic products.

P₁S₁S₃