PHARMACOLOGICAL CLASSIFICATION: A 5.7 Antihistaminics, anti-emetics and antivertigo preparations.
PHARMACOLOGICAL ACTION: Promethazine hydrochloride acts by occupying the H2-receptor sites in the effector 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. hayfever, motion sickness, vasomotor rhinitis, skin irritations due to serum sickness and other itching skin conditions.
CONTRA-INDICATIONS: Known hypersensitivity.
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:
Adults: Four to ten 5 mL medicine measures daily in divided doses. Children:
Up to 1 year Half a 5 mL medicine measure, three times daily. 2 - 5 years One 5 mL medicine measure, three times daily. 6 - 12 years One to one and a half 5 mL medicine measures, three times daily.
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 inco-ordination. Other side-effects include gastro-intestinal disturbances such as nausea, vomiting, diarrhoea 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. Lenazine Elixir should be used with caution in patients with hepatic disease.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT: The dominant effect of overdosage includes drowsiness followed by hallucinations, excitement, ataxia, inco-ordination, convulsions and athetosis. Fixed dilated pupils with a flushed face and fever are common in children.
In cases of overdosage, the patient should be kept quiet and convulsions and marked central nervous system stimulation should preferably be treated with diazepam or phenobarbitone intramuscularly.
IDENTIFICATION: Clear, light yellow syrup.
PRESENTATION: Bottles of 2,5 litres.
STORAGE INSTRUCTIONS: Store below 25°C and protect from light.
KEEP OUT OF REACH OF CHILDREN.
APPLICATION NUMBER: C829 (Act 101/1965).
NAME AND BUSINESS ADDRESS OF APPLICANT: Lennon Limited
7 Fairclough Road