Voltaren/Voltaren SR

EC tab/SR-FC tab/supp: Painful syndromes of the vertebral column. Inflammatory, degenerative & non-articular forms of rheumatism. Post-traumatic & post-op pain & inflammation. Primary dysmenorrhoea or adnexitis. EC tab/supp: Acute gout. Adjuvant in severe ENT infections. Supp: Migraine attacks.

EC tab/supp Adult 75-150 mg/day in divided doses. Dysmenorrhoea Up to 200 mg/day. Adolescent & childn >1 yr 0.5-3 mg/kg/day. SR-FC tab Usual daily dose: 100 mg. In milder cases & for long-term therapy: 75 or 100 mg/day. Max daily dose: 100 mg. Supp Migraine attacks Max daily dose: 150 mg in divided doses.

EC tab: Should be taken on an empty stomach: Swallow whole w/ liqd, preferably before meals. Do not divide/chew. SR-FC tab: Should be taken with food: Swallow whole w/ liqd.

Known hypersensitivity to diclofenac or other NSAIDs. Active gastric &/or duodenal ulcers, GI bleeding or perforation. Hepatic failure (Child-Pugh class C) (cirrhosis of the liver & ascites). Renal failure (GFR <15 mL/min/1.73 m²). Severe cardiac failure (NYHA III-IV). 3rd trimester of pregnancy. EC tab/supp: Patients in whom attacks of asthma, urticaria, or acute rhinitis are precipitated by ASA or other NSAIDs. SR-FC tab: History of bronchospasm, angioedema, urticaria, acute rhinitis, nasal polyps or allergy-like symptoms after taking ASA or other NSAIDs. History of GI bleeding or perforation related to previous NSAID therapy. Active, or history of recurrent peptic ulcer/haemorrhage. Inflammatory bowel disease (eg, Crohn's disease or ulcerative colitis). Treatment of post-op pain after coronary bypass surgery (or use of heart-lung machine). Supp: Proctitis.

Symptoms/history of GI disorders, asthma, impaired hepatic, cardiac, or renal function. May mask infections or temporarily inhibit platelet aggregation. Porphyria. Extracellular vol depletion. Periodic monitoring of liver function & CBC are recommended during prolonged therapy. Risk of GI ulceration, bleeding or perforation; serious skin reactions eg, exfoliative dermatitis, SJS & TEN; allergic reactions. Caution in patients w/ asthma, seasonal allergic rhinitis, swelling of nasal mucosa, COPD or chronic resp tract infections. Combination w/ lithium, digoxin, diuretics, antihypertensives, other NSAIDs, corticosteroids, anticoagulants & antiplatelets, SSRIs, antidiabetics, MTX, ciclosporin, quinolones, potent CYP2C9 inhibitors, & phenytoin. May impair the ability to drive & operate machinery. May impair female fertility. Pregnancy & lactation. Elderly & patients w/ low body wt. EC tab (50 mg)/SR-FC tab/supp (100 mg): Not suitable for childn & adolescents. EC tab: Rare hereditary problems of galactose intolerance, severe lactase deficiency or glucose-galactose malabsorption. SR-FC tab: Risk of serious skin reactions eg, DRESS; serious CV thrombotic events (including MI & stroke). Caution in patients w/ clinically confirmed CHD, cerebrovascular disorders, peripheral arterial occlusive disease or considerable risk factors (eg, HTN, hyperlipidaemia, DM, smoking); cardiac impairment & other conditions predisposing to fluid retention; increased risk of hypovolaemia. Combination w/ tacrolimus, drugs known to cause hyperkalemia, & CYP2C9 inducers. Not recommended in patients w/ rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase deficiency; advanced renal disease; established CV disease or uncontrolled HTN.

Common: Headache, dizziness, vertigo, nausea, vomiting, diarrhoea, dyspepsia, abdominal pain, flatulence, anorexia, increased transaminases, rash. Rare: Hypersensitivity, anaphylactic & anaphylactoid reactions (including hypotension & shock), somnolence, asthma (including dyspnoea), gastritis, GI haemorrhage, haematemesis, diarrhoea haemorrhagic, melaena, GI ulcer (w/ or w/o bleeding or perforation), hepatitis, jaundice, liver disorder, urticaria, oedema. SR-FC tab: Common: HTN, decreased appetite, fluid retention, oedema. Uncommon: MI, heart failure, palpitations, chest pain. Supp: Common: Application site irritation. Rare: Proctitis.

Increased plasma conc of lithium & digoxin. Decreased antihypertensive effect of diuretics or antihypertensives (eg, β-blockers, ACE inhibitors). Increased frequency of GI adverse effects w/ other systemic NSAIDs or corticosteroids. Increased risk of bleeding w/ anticoagulants & antiplatelets. Increased risk of GI bleeding w/ SSRIs. Hypoglycaemic or hyperglycaemic effects w/ oral antidiabetics. Raised blood conc & increased toxicity of MTX. Increased nephrotoxicity of ciclosporin. Risk of convulsions w/ quinolones. Increase in peak plasma conc & exposure w/ potent CYP2C9 inhibitors (eg, sulfinpyrazone & voriconazole). Increase in exposure to phenytoin. Increased plasma K levels w/ K-sparing diuretics, ciclosporin, tacrolimus or trimethoprim. SR-FC tab: Significant decrease in plasma conc & exposure w/ CYP2C9 inducers (eg, rifampicin). Increased nephrotoxicity of tacrolimus. Risk of metabolic acidosis w/ metformin.

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.

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