COMPOSITION:
Each 5 ml contains:
Promethazine Hydrochloride 5mg
PHARMACOLOGICAL CLASSIFICATION:
Antihistaminic, anti-emetics
PHARMACOLOGICAL ACTION:
Promethazine hydrochloride acts by occupying the H2-receptor sites in the effector's cells with the resultant exclusion of histamine. Most of the effects of histamine in the body are thus diminished or abolished although the production of histamine is not prevented.
INDICATIONS:
Treatment of allergic conditions where the reaction is due to histamine release e.g. hay fever, motion sickness, vasomotor rhinitis, skin irritations due to serum sickness (Drug Induced Skin Reactions) and other itching skin conditions
CONTRA-INDICATIONS:
This product should not be used in children under 2 years of age because the safety of such use has not been established.
Safety in pregnancy and lactation has not been established.
WARNING:
This medicine may lead to drowsiness and impaired concentration which may be aggravated by the simultaneous intake of alcohol or other central nervous system depressant agents. Patients should be warned not to drive a motor vehicle, operate dangerous machinery or climb dangerous heights, as impaired decision making could lead to accidents.
DOSAGE AND DIRECTIONS FOR USE:
2–5 years: 5 ml to 15ml daily
6–10 years: 10ml to 25ml daily
Over 10 years: 25ml daily
INTERACTION WITH FOOD AND/OR DRUGS
Promicine syrup may enhance the sedative effects of CNS depressants including alcohol, barbiturates, hypnotics, opioid analgesics, anxiolytic sedatives, and antipsychotics. Sedative interactions apply to a lesser extent with the non-sedating antihistamines they do not appear to potentiate the effects of alcohol, but it should be avoided in excess. Food allergy may be the result of hypersensitivity reaction. Management revolves around the identification of the provoking food allergen and its subsequent avoidance.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Sedation, varying from slight drowsiness to deep sleep, lassitude, fatigue, tinnitus, dizziness, diplopia, blurred vision, euphoria, nervousness, insomnia, tremors, muscular weakness and in coordination. Other side-effects include gastro-intestinal disturbances such as nausea, vomiting, diarrhea or constipation, colic and epigastric pain. Dryness of the mouth, urinary frequency and dysuria palpitation, hypotension, headache, tightness of the chest, tingling, heaviness and weakness of the hands may also occur. Promicine Syrup should be used with caution in patients with hepatic disease.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
The dominant effect of over dosage includes drowsiness followed by hallucinations, excitement, ataxia, Incoordination, convulsions and athetosis. Fixed dilated pupils with a flushed face and fever are common in children.
In cases of over dosage, the patient should be kept quiet and convulsions and marked central nervous system stimulation should preferably be treated with diazepam or phenobarbitone intramuscularly.
PREGNANCY AND LACTATION
Safety in pregnancy and lactation has not been established.
Ask your doctor or pharmacist for advice before taking this medicine
PRESENTATION:
125 ml Amber colored bottle.
STORAGE INSTRUCTIONS:
Store below 30°C and protect from light.
KEEP OUT OF REACH OF CHILDREN.
Inactive ingredients:
Sugar, Sorbitol, Glycerin, Ethyl Alcohol, Sodium Citrate, Citric Acid, Sunset Yellow, Raspberry Flavour, Sodium benzoate.
Date of Publication: January 2014
Letap Pharmaceuticals Limited
P. O. Box 3346,
Plot 107, Graphic Road,
Accra, Ghana