Voltaren/Voltaren SR

Inflammatory & degenerative forms of rheumatism (eg, RA, ankylosing spondylitis, OA, spondylarthritis, painful syndromes of vertebral column, non-articular rheumatism). Post-traumatic & post-op pain, inflammation & swelling (eg, following dental or orthopaedic surgery). Painful &/or inflammatory conditions in gynaecology (eg, primary dysmenorrhoea or adnexitis). Supp: Migraine attacks. EC tab/Supp: Acute gout attacks. Adjuvant in severe painful inflammatory ENT infections (eg, pharyngotonsillitis, otitis). Juvenile RA.

EC tab Adult Initially 100-150 mg daily. Milder cases/long-term therapy 75-100 mg daily. Total daily dose should be in 2-3 divided doses. Primary dysmenorrhoea 50-150 mg daily. Max: 200 mg daily. Adolescent & childn ≥1 yr 0.5-2 mg/kg daily in 2-3 divided doses. Juvenile RA Max: 3 mg/kg daily in divided doses. SR tab Adult Initially 100-150 mg daily. Milder cases/long-term therapy 75-100 mg daily. Take in the evening if symptoms are more pronounced in the morning or during the night. Supp Adult Initially 100-150 mg daily. Milder cases/long-term therapy 75-100 mg daily. Total daily dose should be in 2-3 divided doses. Suppression of nocturnal pain & morning stiffness Max: 150 mg daily. Primary dysmenorrhoea 50-150 mg daily. Max: 200 mg daily. Migraine attacks Initially 100 mg at the 1st signs of an impending attack. Additional doses up to 100 mg may be taken on the same day if required. Max: 150 mg daily in divided doses. Adolescent & childn ≥1 yr 0.5-2 mg/kg daily in 2-3 divided doses. Juvenile RA Max: 3 mg/kg daily in divided doses.

EC tab/SR FC tab: Should be taken on an empty stomach: Swallow whole, do not divide/chew.

Hypersensitivity. Active gastric or intestinal ulcer, bleeding or perforation. Severe cardiac failure. Patients in whom asthma, angioedema, urticaria or acute rhinitis are precipitated by ASA &/or other NSAIDs. Treatment of peri-op pain in setting of CABG surgery. Use of high dose diclofenac (150 mg/day) for >4 wk in patients w/ established CV disease or uncontrolled HTN. Hepatic & renal (GFR <15 mL/min/1.73 m²) failure. Pregnancy (3rd trimester). Supp: Proctitis.

Possible serious skin reactions including exfoliative dermatitis, SJS & TEN. Discontinue use at the 1st appearance of skin rash, mucosal lesions or any other sign of hypersensitivity. Allergic reactions including anaphylactic/anaphylactoid reactions may occur w/o earlier drug exposure. Possible GI bleeding, ulceration or perforation. Discontinue use if GI bleeding or ulceration occurs. Initiate treatment & maintain at lowest effective dose in patients w/ history of ulcer particularly if complicated w/ haemorrhage or perforation & in elderly to reduce risk of GI toxicity; consider combination therapy w/ protective agents (eg, PPIs or misoprostol) for these patients & those requiring concomitant use of low dose ASA or other drugs likely to increase GI risk. Concomitant use w/ systemic corticosteroids, anticoagulants, antiplatelets or SSRIs. Patients w/ ulcerative colitis or Crohn's disease. Increased risk of GI anastomotic leak; close medical surveillance when using after GI surgery. Small increased risk of serious CV thrombotic events (including MI & stroke) at high doses & in long-term treatment. Periodically re-evaluate patient's need for symptomatic relief & therapy response especially when treatment continues for >4 wk. Advise patient to remain alert for signs & symptoms of serious arteriothrombotic events (eg, chest pain, shortness of breath, weakness, speech slurring). Monitor blood count during prolonged treatment. May temporarily inhibit platelet aggregation. Carefully monitor patients w/ defects of haemostasis. More frequent NSAIDs reactions (eg, asthma exacerbations, Quincke's edema or urticaria) in patients w/ asthma, seasonal allergic rhinitis, nasal mucosa swelling, COPD or chronic resp tract infections. Regularly monitor hepatic function during prolonged treatment. Discontinue use if abnormal LFTs persist or worsen, clinical signs or symptoms consistent w/ liver disease develop or if other manifestations occur (eg, eosinophilia, rash). Possible hepatitis may occur when used w/o prodromal symptoms. May trigger an attack when used in patients w/ hepatic porphyria. Patients w/ impaired cardiac or renal function, history of HTN, receiving concomitant treatment w/ diuretics or medicinal products that can significantly impact renal function & those w/ substantial extracellular vol depletion of any cause (eg, before or after major surgery); monitor renal function. Avoid concomitant use w/ systemic NSAIDs including cyclooxygenase-2 selective inhibitors. May mask signs & symptoms of infection. May impair female fertility & not recommended in women attempting to conceive. Pregnancy (1st & 2nd trimesters). Not to be administered during breastfeeding. Frail elderly or those w/ low body wt. EC tab & SR FC tab: Contains lactose; not recommended for patients w/ rare hereditary problems of galactose intolerance, severe lactase deficiency or glucose-galactose malabsorption. SR FC tab: Not suitable for childn & adolescent.

Headache, dizziness; vertigo; nausea, vomiting, diarrhea, dyspepsia, abdominal pain, flatulence, decreased appetite; increased transaminases; rash. Supp: Application site irritation.

Significant increase in peak plasma conc & exposure w/ CYP2C9 inhibitors (eg, voriconazole). May raise plasma conc of lithium & digoxin. May decrease antihypertensive effect of diuretics & antihypertensive agents (eg, β-blockers, ACE inhibitors). May increase nephrotoxicity of ciclosporin & tacrolimus. May increase serum K levels w/ K-sparing diuretics, ciclosporin, tacrolimus or trimethoprim. Potential convulsions w/ quinolones. May increase frequency of GI undesirable effects w/ other systemic NSAIDs or corticosteroids. May increase risk of bleeding w/ anticoagulants & antiplatelets; GI bleeding w/ SSRIs. Possible hypoglycaemic & hyperglycaemic effects w/ antidiabetics. May increase exposure to phenytoin. May raise blood conc & toxicity of MTX when diclofenac is administered <24 hr before or after MTX treatment. Significant decrease in plasma conc & exposure w/ CYP2C9 inducers (eg, rifampicin).

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.

POM