(and dosage form):
Paracetamol: 320 mg
Codeine Phosphate 8 mg
A2.9 Special Analgesic Combinations
SPECTRAPAIN CAPSULES have analgesic and antipyretic properties.
SPECTRAPAIN CAPSULES are indicated in the treatment of moderate to severe pain.
Contra-indicated in patients sensitive to either of its ingredients.
DOSAGE AND DIRECTIONS FOR USE:
One or two capsules three times daily or as prescribed.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
WARNING: Do not use continuously for longer than 10 days without consulting your doctor.
Dosages in excess of those recommended may cause severe liver damage.
Side-effects from codeine that may occur are nausea, dizziness, vomiting, mental clouding, dysphoria, constipation and increased pressure in the biliary tract. Very rarely urticaria and skin rashes may occur. Codeine must be used with caution in patients with emphysema, kyphoscoliosis, chronic cor pulmonale or even severe obesity. The depressant actions of codeine are exaggerated and prolonged by phenothiazine, monoamine oxidase inhibitors and imipramine-like drugs.
Sensitivity reactions from Paracetamol resulting in reversible skin rash or blood disorders may occur but these are rare. Consult your doctor if no relief is obtained within the recommended dosage. Patients suffering from liver or kidney disease should take paracetamol under medical supervision.
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.
NOTE: 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:
Advertise to the professions only.
Blue and white capsules.
Containers of 20, 100 and 1 000 capsules.
Store in a cool place (below 25°C).
Protect from light.
Keep out of reach of children.
NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Geo Schwulst Laboratories Limited
Co. Reg. No. 77/3056/06
17 Faraday St.,
Village Main, Jhb
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
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