PAINRITE FORTE Capsules

INDICATIONS CONTRA-INDICATIONS DOSAGE SIDE-EFFECTS PREGNANCY OVERDOSE IDENTIFICATION PATIENT INFORMATION

PAINRITE FORTE Capsules

SCHEDULING STATUS:
S5

PROPRIETARY NAME
(and dosage form):

PAINRITE FORTE Capsules

COMPOSITION:
Each capsule contains:

Paracetamol	320 mg
Codeine Phosphate	8 mg
Caffeine	48 mg
Meprobamate	150 mg

PHARMACOLOGICAL CLASSIFICATION:
2.9 Special analgesic combinations

PHARMACOLOGICAL ACTIONS:
Painrite forte acts as an analgesic in pain tension states

INDICATIONS:
Painrite forte is indicated in the treatment of various types of pain, particularly pain associated with tension

CONTRA INDICATIONS :
Patients with severe liver or kidney complications. Patients with acute intermittent porphyria or with a history of hypersensitivity to any of the ingredients. Meprobamate may induce convulsions in patients with a history of epilepsy.

WARNINGS :
Dosages in excess of those recommended may cause severe liver damage. Do not use continuously for more than 10 days without consulting your doctor.

DOSAGE AND DIRECTIONS FOR USE:
One or two capsules three times a day or as prescribed.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Side effects of paracetamol are usually mild, though haematological reactions have been reported. Skin eruptions have also occurred. In normal doses the commonest side-effects of codeine phosphate are constipation, nausea and vomiting, dizziness and drowsiness, but these are less common than with morphine. Dry mouth, facial flushing, vertigo, bradycardia, palpitations, faintness, sedation, restlessness, changes of mood, and meiosis may also occur. These effects occur more commonly in ambulant patients than in those at rest in bed. Raised intracranial pressure occurs in some patients. Allergic reactions such as urticaria, pruritus, and itching of the nose occur in some individuals and idiosyncrasy to codeine and other narcotic analgesics is fairly common.
Side-effects of caffeine include nausea, headache and insomnia. Caffeine increases gastric secretions and may cause ulceration.
Drowsiness is the most frequent side-effect of meprobamate. Other effects include nausea, vomiting, diarrhoea, paraesthesia, weakness, and central effects such as headache, excitement, dizziness, ataxia and disturbances of vision. There may be hypotension, tachycardia, and cardiac arrhythmias. Hypersensitivity reactions may occur occasionally. These may be limited to skin rashes, urticaria and purpura or may be more severe with angioneurotic oedema, bronchospasm or anuria. Erythema multiforme has been reported. Treatment should be discontinued as soon as these reactions occur. Blood disorders including agranulocytosis, oesinophilia, leucopenia, thrombocytopenia, and aplastic anaemia have been reported. Symptoms of porphyria may be exacerbated. There is a serious dependence risk with a typical withdrawl syndrome.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Acute poisoning may produce nausea, vomiting, stupor, coma and respiratory collapse. In the event of overdosage consult a doctor or take the patient to the nearest hospital immediately as specialised treatment is essential as soon as possible. Treatment is symptomatic and details of the latest information can be obtained from the nearest poison centre.
Liver damage which may be fatal may only appear after a few days and kidney failure has been described following acute intoxication.

CONDITIONS OF REGISTRATION:
Professional advertising only

IDENTIFICATION:
Yellow and white capsules

PRESENTATION:
Containers with 20 and 100 capsules.

STORAGE INSTRUCTIONS :
Store in a dry place below 25°C, in well closed containers
Keep out of reach of children

REGISTRATION NUMBER:
Q/2.9/242

NAME AND BUSINESS ADDRESS OF APPLICANT:
Columbia Pharmaceuticals (Pty) Ltd.
P.O. Box 7026
Bonaero Park
1622

PUBLICATION DATE:

23.2.83

Britepak