ZAPAIN Capsules Abbreviated Prescribing Information (Consult SPC for Full Prescribing Information) COMPOSITION: Each capsule contains paracetamol 500mg and codeine phosphate 30mg PRESENTATION: In pack sizes of 56, 100 or 112 capsules. INDICATIONS: For relief of severe pain. DOSAGE & ADMINISTRATION: Method of administration: Oral. Adults: One or two capsules every four hours as required – do not exceed 240 mg of codeine phosphate and 4g of paracetamol (8 capsules) in a day. Doses of codeine above 60 mg are associated with an increase in unwanted effects. Elderly: A reduced dosage may be necessary. Children: Not recommended below 12 years. CONTRAINDICATIONS: Hypersensitivity to any of the ingredients; renal or hepatic impairment; acute asthma, obstructive airway disease, respiratory depression, acute alcoholism, head injuries, raised intracranial pressure, after biliary surgery, diarrhoea of any cause, and patients who have taken MAO inhibitors within 14 days. WARNING & PRECAUTIONS: Acute abdominal conditions, elderly, debilitated, hypothyroidism, Addison’s disease, prostatic hypertrophy and urethral stricture. The hazard of paracetamol overdose is greater in those with alcoholic liver disease. Patients to be advised not to exceed the dose and take other products containing paracetamol or opiate derivatives while on Zapain, and to consult doctor if symptoms persist. Cough suppressant effect of codeine may be undesirable in patients with some respiratory conditions. Tolerance to codeine can develop, and the incidence of unwanted effects is dose related. Codeine may impair mental or physical abilities required in the performance of potentially hazardous tasks. INTERACTIONS: Antihypertensive agents, diuretics, quinine, quinidine, CNS depressants, MAOI’s or tricyclic antidepressant, anticholinergics, antidiarrhoel agents, antimuscarine drugs, metoclopramide, domperidone, cholestyramine, mexiletine, cimetidine, warfarin and other coumarins. Opiods may interfere with results of some laboratory tests and codeine may interfere with tests for gastrointestinal function. PREGNANCY & LACTATION: Not recommended. EFFECTS ON ABILITY TO DRIVE & USE MACHINES: Patient should be advised not to drive or operate machinery. UNDESIRABLE EFFECTS: Most common are nausea, vomiting, light headedness, dizziness, sedation, shortness of breath, constipation. Less common are miosis, visual disturbances, headache, bradycardia, respiratory depression, difficult micturition, urinary retention and allergic skin rashes. Codeine at high doses can cause respiratory depression. Zapain capsules may cause euphoria, dysphoria, abdominal pain or pruritus. Paracetamol may cause liver damage, more common in patients with chronic alcohol use. Rarely blood dyscrasias have been reported. LEGAL CATEGORY: POM Product Authorisation Numbers: PL12762/0033
ZAPAIN Capsules Abbreviated Prescribing Information May 2005
Product Authorisation Holder: Goldshield Pharmaceuticals Ltd. NLA Tower, 12-16 Addiscombe Road, Croydon, Surrey, CRO OXT, UK SPC is available from the company. Date of preparation or last review: May 2005
ZAPAIN Capsules Abbreviated Prescribing Information May 2005
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