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

Logo BETAPYN Tablets

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

BETAPYN Tablets

COMPOSITION:
Each tablet contains:

Paracetamol         450 mg
Codeine phosphate         10 mg
Doxylamine succinate         5 mg
Caffeine alkaloid         50 mg
Nipastat (preservative) 0,124% m/m

PHARMACOLOGICAL CLASSIFICATION:
A 2.8 Special analgesic combinations.

PHARMACOLOGICAL ACTION:
Betapyn tablets
combine the analgesic and antipyretic action of paracetamol with the analgesic action of codeine phosphate. Doxylamine succinate has sedative and antihistaminic properties and in combination with the above analgesic is of value, especially in tension states.
NOTE: BETAPYN tablets may be used to advantage by people who cannot tolerate aspirin e.g. aspirin sensitivity, peptic ulcer patients, acute and chronic gastritis, patients on steroid therapy.

INDICATIONS:
For the symptomatic treatment of mild to moderate pain and/or fever.

CONTRA-INDICATIONS:
Sensitivity to paracetamol or any of the components. Severe liver function impairment. Caffeine should be given with care to patients with peptic ulceration. Safety of Betapyn during pregnancy and lactation has not been established.
Betapyn is contra-indicated in respiratory depression, especially in the presence of cyanosis and excessive bronchial secretion. It is also contra-indicated in the presence of acute alcoholism, head injuries, and conditions in which intracranial pressure is raised. It should not be given during an attack of bronchial asthma or in heart failure secondary to chronic lung disease.

WARNINGS:
Dosages in excess of those recommended may cause severe liver damage. Do not administer to children under 12 years of age.

DOSAGE AND DIRECTIONS FOR USE:
Do not exceed the stated dose.
Adults and Children over 12 years: 1 or 2 tablets, repeated 4-hourly if necessary. Do not exceed 8 tablets per day.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
1. Consult your doctor if no relief is obtained with the recommended dosage.
2. Do not use continuously for longer than ten days without consulting your doctor.
3. Store in a safe place, out of reach of children.
4. Patients suffering from liver or kidney disease should take paracetamol under medical supervision.
Paracetamol: Skin rashes and other allergic reactions may occur. The rash is usually erythematous or urticarial but sometimes more serious and may be accompanied by fever and mucosal lesions. The use of paracetamol has been associated with the occurrence of neutropenia, pancytopenia and leucopenia.
Caffeine: Side-effects include nausea, headache, insomnia, irritability and symptoms of anxiety neurosis. Large doses may cause restlessness, excitement, muscle tremor, tinnitus, scintillating scotoma, tachycardia and extrasystoles. Caffeine increases gastric secretions and may cause gastric ulceration.
Codeine: May cause nausea, vomiting, constipation, drowsiness, confusion, dry mouth, sweating, facial flushing, vertigo, bradycardia, palpitation, orthostatics hypotension, hypothermia, restlessness, changes of mood and moisis. Micturition may be difficult and there may be ureteric or biliary spasm. Raised intracranial pressure may occur. Reactions such as urticaria and pruritus may occur.
Codeine should be given with caution to patients with hypothyroidism, adrenocortical insufficiency, impaired liver function, prostatic hypertrophy or shock. It should be used with caution in patients with inflammatory or obstructive bowel disorders. The dosage should be reduced in elderly and debilitated patients. Should be used with caution inpatients with myasthenia gravis. The prolonged use of high doses of codeine has produced dependence of the morphine type.
Doxylamine Succinate: Drowsiness, dizziness, constipation and gastro-intestinal disturbances may occur.
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.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Paracetamol
: symptoms of paracetamol overdosage in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion.
Abnormalities of glucose metabolism and metabolic acidosis may occur.
Acute renal failure and tubular necrosis may develop even in the absence of severe liver damage. Cardiac arrhythmia's have been reported. Symptoms during the first two days of acute poisoning do not reflect the potential seriousness of the overdosage. Nausea, vomiting, anorexia and abdominal pain may persist for a week or more. Liver injury may become manifest on the second day, (or late), initially by elevation of serum transaminase and lactic dehydrogenase activity, increased serum billirubin concentration and prolongation of prothrombin time. The liver damage may progress to encephalopathy, coma and death. Cerebral oedema and nonspecific myocardial depression have also occurred.
Codeine: Symptoms of overdosage with codeine include excitement and in children, convulsions may occur. Treatment is symptomatic and supportive.
Doxylamine Succinate: the most common symptom of overdosage is impaired consciousness and additionally psychotic behaviour. In the event of overdosage consult a doctor or take the patients to the nearest hospital immediately. Specialised treatment is essential as soon as possible. Any patient who has ingested 7,5 g or more paracetamol in the preceding 4 hours should undergo gastric lavage. Specific therapy with an antidote such as acetylcysteine should be administered IV as soon as possible.

ACETYLCYSTEINE:
Acetylcysteine should be administered as soon as possible, preferably within 8 hours of overdosage.
IV: An initial dose of 150 mg/kg in 200 mL glucose injection, given intravenously over 15 minutes, followed by an intravenous infusion of 50 mg/kg in 500 mL glucose injection over the next 4 hours, and then 100 mg/kg in 1000 mL over the next 16 hours.
The volume of intravenous fluids should be modified for children.
ORALLY: 140 mg/kg as a 5% solution initially, followed by 70 mg/kg solution every 4 hours for 17 doses. Acetylcysteine is effective if administered within 8 hours of overdosage.

IDENTIFICATION:
Round yellow flat tablets, bisected on one side and embossed with “Betapyn”on reverse side.

PRESENTATION:
Blister packs of 18 and 54 tablets. Securitainers containing 100 tablets and HDPE bottles containing 1 000 tablets.

STORAGE INSTRUCTIONS:
Store in a cool dry place (below 30°C).
KEEP OUT OF REACH OF CHILDREN

REGISTRATION NUMBER:
F/2.8/7

NAME AND BUSINESS ADDRESS OF APPLICANT:
Adcock Ingram Limited
Adcock Ingram Park
17 Harrison Avenue
Bryanston
Private Bag X69
Bryanston
2021

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
6.05.1974

New addition to this site: April 2004
Source: Pharmaceutical Industry

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