Microsoft word - zapain capsule api.doc

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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