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

Logo INFAPAIN SYRUP

SCHEDULING STATUS:
S1

PROPRIETARY NAME
(and dosage form):

INFAPAIN SYRUP

COMPOSITION:
Each 5 mL of the syrup contains:
       
Paracetamol:        120,0 mg
       
Codeine Phosphate:        5,0 mg

PRESERVATIVES:
        Methylparaben:        0,2% m/v
        Propylparaben:        0,02% m/v
        Alcohol:        9% v/v

PHARMACOLOGICAL CLASSIFICATION:
A 2.9 Special Analgesic Combination

PHARMACOLOGICAL ACTION:
INFAPAIN SYRUP has analgesic and antipyretic properties.

INDICATIONS:
INFAPAIN SYRUP is indicated for the treatment of pain associated with fever in children.

CONTRA-INDICATIONS:
Contra-indicated in patients hypersensitive to any of its ingredients.

DOSAGE AND DIRECTIONS FOR USE:
6 months to 1 year: 2,5 mL Three times daily
1 year to 5 years 5 mL or as
5 years and older 10 mL prescribed.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
WARNING: Do not use 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.
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 the medicine under medical supervision.

NOTE:
If INFAPAIN SYRUP is prescribed for adults it should be used with caution in patients with emphysema, kyphoscoliosis, chronic cor pulmonale or even severe obesity. The depressant actions of codeine are exaggerated by phenothiazines, monoamine oxidase inhibitors and imipramine-like drugs.

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 your 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.

IDENTIFICATION:
An orange-flavoured, colourless syrup.

PRESENTATION:
Bottles of 100 mL

STORAGE INSTRUCTIONS:
Store in a cool place (below 25°C).
Protect from light.
Keep out of reach of children.

REGISTRATION NUMBER:
N/2.9/100

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
GEO SCHWULST LABS. LIMITED
42 Wendell Street Lakeview
Johannesburg
2091

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
MAY 1981

PSO-8-8/87

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