(and dosage form):
Each 5 mL contains:
Promethazine Hydrochloride 7,0 mg
Codeine Phosphate 5,0 mg
Paracetamol 120,0 mg
Phenylpropanolamine Hydrochloride 2,5 mg
Alcohol 96 % 20,0 % v/v
Propyl hydroxybenzoate 0,01 % m/v
Methyl hydroxybenzoate 0,10 % m/v
A 2.8 Special Analgesic combinations.
Analgesic, antipyretic, decongestant syrup, for paediatric use.
For the alleviation of mild to moderate pain and fever in infants and children and for nasal congestion associated with colds, influenza and sinusitis.
Infacet Syrup should not be used by epileptics or in conjunction with M.A.O. inhibitors. It must be used with caution in patients with hepatic or kidney disease, cardiac disorders, hypertension, hyperthyroidism or diabetes mellitus. Contra-indicated in cases of hypersensitivity to any of the ingredients.
1. Infacet Syrup should not be used continuously for more than 10 days without consulting your doctor.
2. This medicine may lead to drowsiness and impaired concentration, which may be aggravated by simultaneous intake of alcohol or other central nervous system depressant agents.
3. Dosages in excess of those recommended may cause severe liver damage.
DOSAGE AND DIRECTIONS FOR USE:
6 months to 1 year: 1/2 medicine measureful [ 2,5 mL] *
1 to 6 years: 1 medicine measureful [ 5,0 mL] *
Over 6 years: 2 medicine measuresful [10,0 mL] *
* Three times daily or as otherwise prescribed.
Consult your doctor if no relief is obtained with the recommended dosage.
SIDE EFFECTS AND SPECIAL PRECAUTIONS:
1. Promethazine Hcl: Side-effects vary in incidence and severity with each patient. The most common side effect is sedation, varying from slight drowsiness to deep sleep, and including inability to concentrate, lassitude, dizziness, hypotension, muscular weakness and incoordination. Sedative effects may diminish after a few days.
Other side effects include gastro- intestinal disturbances, nausea, vomiting, diarrhoea, constipation, epigastric pain. Also headache, blurred vision, tinnitus, elation or depression, irritability, nightmares, anorexia, difficulty in micturition, dryness of the mouth, tightness of the chest, and tingling, heaviness and weakness of the hands.
2. Codeine Phosphate: Nausea, vomiting, constipation, drowsiness and confusion. Micturition may be difficult and there may be ureteric or biliary spasm; there is also an anti-diuretic effect.
Dry mouth, sweating, facial flushing, vertigo, bradycardia, palpitations, orthostatic hypotension, hypothermia, restlessness, changes of mood and miosis may occur.
3. Paracetamol: Side-effects of paracetamol are usually mild, though haematological reactions have been reported. Skin rashes and other allergic reactions may occur.
4. Phenylpropanolamine HCl:In large doses, giddiness, headache, nausea, vomiting, sweating, thirst, tachycardia, precordial pain, palpitations, difficulty in micturition, muscular weakness and tremors, anxiety, restlessness and insomnia may occur; some patients may exhibit these symptoms with usual therapeutic doses.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Refer to side-effects described above.
Symptoms of overdosage include nausea and vomiting. Liver damage, which may be fatal, may only appear after a few days. Kidney failure has been described following acute intoxication.
In the event of overdosage, consult a doctor or take the patient to the nearest hospital immediately. Specialized treatment is essential as soon as possible.
The latest information regarding the treatment of overdosage can be obtained from the nearest poison centre.
Empty the stomach by aspiration and lavage. Further treatment is symptomatic and supportive.
A clear red syrup with a raspberry flavour.
Bottles of 100 mL and 500 mL.
Store below 25 °C. Protect from light.
KEEP OUT OF REACH OF CHILDREN.
B.1499 [Act 101/1965]
NAME AND BUSINESS ADDRESS OF THE APPLICANT:
PROTEA PHARMACEUTICALS [PTY] LIMITED
[Co. Reg. No. 05/13587/07]
8 Skietlood Street, ISANDO 1600
P O Box 553, ISANDO 1600
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
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