PAINRITE S.A. Capsules

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

PAINRITE S.A. Capsules

SCHEDULING STATUS:
S1

PROPRIETARY NAME
(and dosage form):

PAINRITE S.A. Capsules

COMPOSITION:
Each capsule contains:

Paracetamol	320 mg
Codeine Phosphate	8 mg

PHARMACOLOGICAL CLASSIFICATION:
2.9 Special analgesic combinations

PHARMACOLOGICAL ACTION:
PAINRITE S.A. has analgesic and antipyretic properties.

INDICATIONS:
PAINRITE S.A. is indicated for the relief of pain and/or fever.

CONTRA-INDICATIONS:
Patients with severe liver or kidney complications. Patients with a history of hypersensitivity to any of the ingredients.

WARNINGS :
Dosage 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 to two capsules every four to six hours 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, pruritis and itching of the nose occur in some individuals and idiosyncrasy to Codeine and other narcotic analgesics is fairly common.

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.
Kidney failure has been described, following acute intoxication.

CONDITIONS OF REGISTRATION:
None

IDENTIFICATION:
A light and dark coloured green capsule.

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/2.9/241

NAME AND BUSINESS ADDRESS OF APPLICANT:
Columbia Pharmaceuticals (Pty) Ltd.
Tempelhof South
Bonaero Park
1619

PUBLICATION DATE:

8/2/83

Britepak