Betapyn 10 mg Tablets

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

Posology
Adu lts and children over 12 years: 1 or 2 tablets taken orally, repeated 4 - hourly if necessary. Do not exceed 8 tablets per day. DO NOT EXCEED THE RECOMMENDED DOSE.

• Sensitivity to paracetamol or any of the components.
• Severe liver f unction 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 contraindicated in respiratory depression, especially in the presence of cyanos is and excessive bronchial secretion.
• It is also contraindicated 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.

Patients suffering from liver or kidney disease should take paracetamol under medical supervision. Dosages in excess of those recommended may cause severe liver damage. 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 in patients with myasthenia gravis. The prolonged use of high doses of codeine has produced dependence of the morphine type. Exceeding the prescribed dose, tog ether with prolonged and continuous use of this medication, may lead to dependency and addiction. This medicine contains Doxylamine succinate, and may lead to drowsiness and impaired concentration, which may be aggravated by simultaneous intake of alcohol or other central nervous system depressant agents. Doxylamine succinate, and should be used with care in patients with glaucoma and prostatic hypertrophy. Patients should be advised, particularly at the initiation of therapy, against taking charge of vehic les or machinery or performing potentially hazardous tasks where loss of concentration could lead to accidents. (See Interaction with other medicines and other forms of interactions). Do not administer to children under 12 years of age.

This medicine may lead to drowsiness and impaired concentration that may be aggravated by the simultaneous intake of alcohol or other central nervous system depressants (see Special warnings and precautions for use). Doxylamine may decrease emetic response to apomorphine. The effects of atropine and tricyclic antidepressants may be enhanced.

Safety of BETAPYN during fertility, pregnancy and lactation has not been established.

This medicine may lead to drowsiness and impaired concentration that may be aggravated by the simultaneous intake of alcohol or other central nervous system depressants. Patients should be advised, particularly at the initiation of therapy, against taking charge of vehicles or machinery or performing potentially hazardous tasks where loss of concentration could lead to accidents.

Frequency System organ class Undesirable effects Frequent Nervous system disorders Insomnia, drowsiness, confusion, sedation, deep sleep, inability to concentrate, lassitude, incoordination, dizziness, headache, dry mouth, nervousness, tremors, convulsions. Vascular disorders Heada che, facial flushing, vertigo, orthostatic hypotension, hypotension . Frequency Unknown Blood and the lymphatic system disorders Neutropenia, pancytopenia and leucopoenia, agranulocytosis, anaemia, thrombocytopenia, haemolytic anaemia. Cardiac disorders Tachycardia, extrasystoles, bradycardia, palpitation. Ear and labyrinth disorders Tinnitus, vertigo. Eye disorders Scintillating scotoma, miosis. Gastrointestinal disorders Increases in gastric secretions and gastric ulceration, nausea, vomiting, constipation, dry mouth, gastrointestinal disturbances, diarrhoea. General disorders and administration site conditions Hypothermia. Hepato - biliary disorders Hepatitis, biliary spasm. Immune system disorders Allergy, anaphylaxis. Musculoskeletal, connective tissue and bone disorders Muscle tremor, muscular weakness. Psychiatric disorders Irritability, anxiety, neurosis, restlessness, excitement, mood changes, raised intracranial pressure. Renal and urinary disorders Renal colic, renal failure, sterile pyuria, difficulty in micturition, ureteric spasm. Skin and subcutaneous tissue disorders Urticaria, pruritus and sweating. Skin rashes and other allergic reactions may occur. The rash is usually erythematous or urticarial but sometimes more seri ous and may be accompanied by fever and mucosal lesions.

Prompt treatment is essential. In the event of an overdosage, consult a doctor immediately, or take the person directly to a hospital. A delay in starting treatment may mean that antidote is given too late to be effective. Evidence of liver damage is often delayed until after the time for effective treatment has lapsed. Susceptibility to paracetamol toxicity is increased in patients who have taken repeated high doses (greater than 5 - 10 g/day) of paracetamol for several days, in chronic alcoholism, chronic liver disease, AIDS, malnutrit ion, and with the use of drugs that induce liver microsomal oxidation such as barbiturates, isoniazid, rifampicin, phenytoin and carbamazepine. Symptoms of paracetamol overdosage in the first 24 hours include pallor, nausea, vomiting, anorexia and possib ly abdominal pain. Mild symptoms during the first two days of acute poisoning, do not reflect the potential seriousness of the overdosage. Liver damage may become apparent 12 to 48 hours, or later after ingestion, initially by elevation of the serum transa minase and lactic dehydrogenase activity, increased serum bilirubin concentration and prolongation of the prothrombin time. Liver damage may lead to encephalopathy, coma and death. Acute renal failure with acute tubular necrosis may develop even in the absence of severe liver damage. Abnormalities of glucose metabolism and metabolic acidosis may occur. Cardiac arrhythmias have been reported. Treatment for paracetamol overdosage: Although evidence is limited it is recommended that any adult person who has ingested 5 - 10 grams or more of paracetamol (or a child who has had more than 140 mg/kg) within the preceding four hours, should have the stomach emptied by lavage (emesis may be adequate for children) and a single dose of 50 g activated charcoal give n via the lavage tube. Ingestion of amounts of paracetamol smaller than this may require treatment in patients susceptible to paracetamol poisoning (see above). In patients who are stuperose or comatose endotracheal intubation should precede gastric lavage in order to avoid aspiration. N - acetylcysteine should be administered to all cases of suspected overdose as soon as possible preferably within eight hours of overdosage, although treatment up to 36 hours after ingestion may still be of benefit, especially if more than 150 mg/kg of paracetamol was taken. An initial dose of 150 mg/kg N - acetylcysteine in 200 ml dextrose injection given intravenously over 15 minutes, followed by an infusion of 50 mg/kg in 500 ml dextrose injection over the next four hours, and then 100 mg/kg in 1 000 ml dextrose injection over the next sixteen hours. The volume of intravenous fluid should be modified for children. Although the oral formulation is not the treatment of choice, 140 mg/kg dissolved in water may be administered init ially, followed by 70 mg/kg every four hours for seventeen doses. A plasma paracetamol level should be determined four hours after ingestion in all cases of suspected overdosage. Levels done before four hours may be misleading. Patients at risk of liver d amage, and hence requiring continued treatment with N - acetylcysteine, can be identified according to their 4 - hour plasma paracetamol level. The plasma paracetamol level can be plotted against time since ingestion in the nomogram below. The nomogram should be used only in relation to a single acute ingestion. Those whose plasma paracetamol levels are above the u201cnormal treatment lineu201d, should continue N - acetylcysteine treatment with 100 mg/kg IV over sixteen hours repeatedly until recovery. Patients with incr eased susceptibility to liver damage as identified above, should continue treatment if concentrations are above the u201chigh risk treatment lineu201d. Prothrombin index correlates best with survival.