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

Logo INFAPAIN FORTE SYRUP
SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

INFAPAIN FORTE SYRUP

COMPOSITION:
Each 5 mL of the syrup contains:
        Paracetamol:        120,0 mg
        Codeine Phosphate:        5,0 mg
        Promethazine Hydrochloride:        6,5 mg
PRESERVATIVES:
        Methylparaben:        0,2% m/v
        Propylparaben:        0,02% m/v
        Alcohol:        9% v/v

PHARMACOLOGICAL CLASSIFICATION:
A 2.9 Special Analgesic Combinations

PHARMACOLOGICAL ACTION:
INFAPAIN FORTE SYRUP has analgesic, antipyretic and antihistaminic properties.

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

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

WARNINGS:
Do not use continuously for more than 10 days without consulting your doctor.
This medicine may lead to drowsiness and impaired concentration which may be aggravated by a simultaneous intake of alcohol or other central nervous system depressant agents.

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:
Side effects from codeine that may occur are nausea, dizziness, vomiting, mental clouding, dysphoria, constipation and increased pressure in the biliary tract. Urticaria and skin rashes may also occur.
Sensitivity reactions from paracetamol resulting in reversible skin rash or blood disorders may occur but these are rare.
Like most antihistamines, promethazine hydrochloride may have the following side effects: Sedation (marked), inability to concentrate, lassitude, dizziness, muscular weakness and incoordination. In infants and children antihistamines often act as cerebral stimulants and may cause convulsions and hyperpyrexia. Some reports of agranulocytosis and jaundice and photosensitivity reactions have been documented following the use of promethazine. Other side-effects that may occur are nausea, vomiting, diarrhoea and epigastric pain, headache, disturbed vision, tinnitus, sensitivity, anorexia and dryness of mouth.

SPECIAL PRECAUTIONS:
Do not administer INFAPAIN FORTE SYRUP to infants under 4 months of age. Consult your doctor if no relief is obtained with the recommended dosage. Patients suffering from liver or kidney disease should take the medicine under medical supervision only.
Dosage in excess of those recommended may cause severe liver damage.
NOTE:
If INFAPAIN FORTE 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. The use of this medicine leads to drowsiness which is aggravated by the simultaneous intake of alcohol. Adults taking the medicine should not drive a motor vehicle or operate dangerous machinery.

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.
NOTE:
Liver damage which may be fatal may only appear after a few days and kidney failure has been described following acute intoxication.

IDENTIFICATION:
INFAPAIN FORTE SYRUP is a brown coloured syrup with a toffee flavour.

PRESENTATION:
Bottles of 100 mL

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

REGISTRATION NUMBER:
N/2.9/101

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
GEO SCHWULST LABS. LIMITED
Needham Park
1 Manchester Road
Wadeville

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
MAY 1981

PSO-9-11/91

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