Source: Health Products Regulatory Authority (ZA) Revision Year: 2021 Publisher: Adcock Ingram Limited, Address, 1 New Road, Erand Gardens, Midrand, 1685
Hypersensitivity to any of the active ingredients or to any of the excipients of STOPAYNE TABLETS (see section 2 and section 6.1).
STOPAYNE TABLETS should not be given to patients with acute intermittent porphyria or a history of epilepsy.
STOPAYNE TABLETS is contraindicated in respiratory depression, especially in the presence of cyanosis and excessive bronchial secretion, after operations on the biliary tract, 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.
STOPAYNE TABLETS is contraindicated in patients taking monoamine oxidase inhibitors or within fourteen days of stopping such treatment.
STOPAYNE TABLETS are not recommended for use by pregnant or breastfeeding women (see section 4.6).
Do not use continuously for more than ten days without consulting your doctor. Consult your doctor if no relief is obtained with the recommended dosage.
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.
Paracetamol dosages in excess of those recommended may cause severe liver damage. Patients suffering from liver of kidney disease should take paracetamol under medical supervision.
Exceeding the prescribed dose, together with prolonged and continuous use of this medication, may lead to dependency and addiction.
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.
The depressant effects of codeine are enhanced by depressants of the central nervous system such as alcohol, anaesthetics, hypnotics, sedatives, and phenothiazines. The prolonged use of high doses of codeine has produced dependence of the morphine type.
Caffeine should be given with care to patients with a history of peptic ulceration.
Patients receiving meprobamate should be warned that their tolerance to ingested alcohol and other depressants of the central nervous system may be lowered with consequent impairment of judgement and co-ordination. Symptoms of porphyria may be exacerbated (see section 4.3). Prolonged use of meprobamate may lead to the development of dependence of the barbituratealcohol type. Meprobamate may induce the hepatic microsomal enzymes involved in drug metabolism.
Contains the colouring agent sunset yellow FCF (E 110), which may cause allergic type reactions (including bronchial asthma) in certain individuals.
Contains 1 mg lactose monohydrate per tablet. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
No information available.
No information available.
STOPAYNE TABLETS is not recommended for use by pregnant women.
STOPAYNE TABLETS is not recommended for use by breastfeeding women.
No information available.
The use of this medicine may cause drowsiness and care should be taken when driving or operating machinery. Reduce dosage if necessary.
Sensitivity reactions resulting in reversible skin rash or blood disorders may occur.
No information available.
| SYSTEM ORGAN CLASS | ADVERSE REACTIONS |
|---|---|
| Psychiatric disorders | Changes of mood. |
| Nervous system disorders | Drowsiness, confusion, vertigo, restlessness, orthostatic hypotension and raised intracranial pressure may occur. |
| Eye disorders | Miosis. |
| Cardiac disorders | Bradycardia, palpitations. |
| Gastrointestinal disorders | Codeine may cause nausea, vomiting, constipation, and dry mouth. |
| Skin and subcutaneous tissue disorders | Sweating and facial flushing. Reactions such as urticaria and pruritus may occur. |
| Renal and urinary disorders | Micturition may be difficult and there may be ureteric or biliary spasm. |
| General disorders and administration site conditions | Hypothermia. |
| SYSTEM ORGAN CLASS | ADVERSE REACTIONS |
|---|---|
| Nervous system disorders | Caffeine may cause restlessness, excitement, muscle tremor. |
| Eye disorders | Scintillating scotoma. |
| Ear and labyrinth disorders | Tinnitus. |
| Cardiac disorders | Tachycardia and extrasystoles. |
| Gastrointestinal disorders | Caffeine increases gastric secretions and may cause gastric ulceration. |
| SYSTEM ORGAN CLASS | ADVERSE REACTIONS |
|---|---|
| Blood and lymphatic system disorders | Blood disorders including agranulocytosis, eosinophilia, leukopenia, thrombocytopenia, and aplastic anaemia have been reported. |
| Nervous system disorders | The most frequent side effect of meprobamate is drowsiness. Paraesthesia, weakness, headache, excitement, dizziness, ataxia. |
| Eye disorders | Disturbances of vision. |
| Cardiac disorders | Hypotension, tachycardia and cardiac arrhythmias may occur. |
| Gastrointestinal disorders | Nausea, vomiting, diarrhoea. |
| Skin and subcutaneous tissue disorders | Hypersensitivity reactions may occur. They may be limited to skin rashes, urticaria and purpura or may be more severe with angioneurotic oedema, bronchospasm, or anuria. Erythema multiforme has been reported. |
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Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8
No data available.
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