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

Logo MEGAPYN SYRUP

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

MEGAPYN SYRUP

COMPOSITION:
Each 5 mL of syrup contains:
Paracetamol 120 mg
Codeine phosphate 5 mg
Promethazine hydrochloride 6,5 mg
Preservatives: 
Methylparaben 0,10% m/v
Propylparaben 0,01% m/v
Alcohol content 12,5% v/v

PHARMACOLOGICAL CLASSIFICATION:
A 2.8 Special analgesic combinations.

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

INDICATIONS:
For the relief of mild to moderate pain, associated with fever.

CONTRA-INDICATIONS:
Hypersensitivity to paracetamol, opiates or phenothiazines. During an attack of bronchial asthma, respiratory depression, especially in the presence of cyanosis and excessive bronchial secretion heart failure secondary to chronic lung disease, liver or kidney damage, head injuries and where intracranial pressure is raised.
Acute alcoholism. Premature infants or neonates.

WARNINGS:
1. If the patient does not respond, a doctor should be consulted.
2. Do not take continuously for more then 10 days without consulting a doctor.
3. This medicine may cause 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 against performing potentially hazardous activities where loss of concentration may lead to accidents.
4. Pigments should be examined periodically for abnormal skin pigmentation or eye changes.
5. Should be used with extreme caution in patients receiving monoamine-oxidase inhibitors.
6. Dosages of paracetamol in excess of those recommended may cause severe liver damage.

DOSAGE AND DIRECTIONS FOR USE:
6 to 12 months: Half a medicine measureful (2,5 mL) three times a day.
1 to 5 years: One medicine measureful (5 mL) three times a day.
6 to 12 years: One to two medicine measurefulls (5 to 10 mL) three times a day.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Constipation and sensitivity reactions resulting in skin rash or blood disorders may occur. Side-effects from codeine that may occur are respiratory depression, bradycardia, circulatory failure, hypotension, orthostatic hypotension, palpitations, deepening coma, confusion, drowsiness, euphoria, mood changes, restlessness, vertigo(dizziness), flushing, hypothermia, increased intracranial pressure, miosis, dry mouth, muscle rigidity, nausea, vomiting, constipation, pruritus, urticaria, sweating, urinary retention, uteric and billiary spasm and an antidiuretic effect.
Precautions:
Should be used with caution or in reduced doses in patients with adrenocortical insufficiency, and hypothyroidism. Should be used with caution in patients with obstructive bowel disorders, liver impairment, myasthenia gravis, impaired renal function or shock.
Dosage should be reduced in debilitated patients.
Prolonged use of high doses of codeine may lead to dependence.
The following side-effects with promethazine have been reported: dizziness, lassitude, hypotension, muscular weakness and inco-ordination, nausea, vomiting, diarrhoea or constipation, colic and epigastric pain. It may also produce headache, hallucinations, blurred vision, tinnitus, elation or depression, irritability, anorexia, difficulty in micturition, dryness of the mouth, tightness of the chest and weakness of the hands. Large doses may precipitate fits in epileptics. Blood dyscrasias, including agranulocytosis, leucopenia, haemolytic anaemia and thrombocytopenic purpura have been reported.
Idiosyncrasy and angioedema have been reported.
Other side-effects are polyuria, tiredness and weakness, lowering of temperature (occasionally pyrexia), increase in heart rate, restlessness, insomnia, photosensitivity and skin rash. Extra-pyramidal dysfunction. Deposition of pigment in the eyes, corneal and lens opacities.
Jaundice of the obstructive type and a lupus erythematous-like sydrome have been reported.
Promethazine should be used with caution in patients with cardiovascular disease, glaucoma, liver impairment and urinary retention. The positive results of skin allergy tests may be suppressed.
Interactions:
The anticholinergic effects of agents with anticholinergic properties may be enhanced. The depressant effects are aggravated by alcohol, anaesthetics, hypnotics, sedatives, tricyclic antidepressants and phenothiazines. Monoamine oxidase inhibitors may enhance the anticholinergic effects. The warning signs of damage caused by ototoxic agents may be masked. May effect the activity of the other medicines by delaying their absorption.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Symptoms of overdosage of paracetamol include nausea, and vomiting. Kidney failure has been reported and liver damage which could be fatal, may only appear a few days later. Specialised treatment of overdosage is essential and the patient should be removed to a hospital as soon as possible.
Promethazine:
Overdosage may be fatal, especially in infants and children in whom main symptoms are central nervous system stimulation and antimuscarinic effects including ataxia, excitement, hallucinations, muscle tremor, convulsions, dilated pupils, dry mouth, flushed face and hyperpyrexia, respiratory collapse.
Death may occur from respiratory failure. Drowsiness and hypotension may occur.
Codeine:
Symptoms of overdosage that may arise include excitement, convulsions and respiratory failure.
Treatment is symptomatic and supportive.

IDENTIFICATION:
Mauve to maroon-coloured clear syrup with a distinctive flavour of blackcurrent.

PRESENTATION:
Amber plastic bottles containing 100 mL of syrup.

STORAGE INSTRUCTIONS:
Store below 25°C, in a cool place and protect from light.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
X/2.6/241

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Compu Pharmaceutical Products Limited
476 Kings Highway
LYNNWOOD
0081

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
1 December 1989

CX24195
Britepak

SAEPI HOME PAGE      TRADE NAME INDEX      GENERIC NAME INDEX      FEEDBACK
Information presented by Malahyde Information Systems © Copyright 1996-2000