Source: Health Products Regulatory Authority (ZA) Revision Year: 2021 Publisher: Adcock Ingram Limited, 1 New Road, Erand Gardens, Midrand, 1685
This product contains paracetamol which may be fatal in overdose. In the event of overdosage or suspected overdose and notwithstanding the fact that the person may be asymptomatic, the nearest doctor, hospital or Poison Centre must be contacted immediately.
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, together 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 vehicles 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 | Headache, 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 serious and may be accompanied by fever and mucosal lesions. |
Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Health care providers are asked to report any suspected adverse reactions to SAHPRA via the “6.04 Adverse Drug Reactions Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8.
One may also report to Adcock Ingram Limited using the following email: Adcock.AEReports@adcock.com
Not applicable.
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