Source: Health Products Regulatory Authority (ZA) Revision Year: 2023 Publisher: Adcock Ingram Limited, 1 New Road, Erand Gardens, Midrand, 1685, Private Bag X69, Bryanston, 2021, 0860 ADCOCK (232625), www.adcock.com
PYNSTOP tablets are contraindicated in:
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 doctor, hospital or Poison Centre must be contacted immediately.
Codeine: Exceeding the prescribed dose, together with prolonged and continuous use of this medication may lead to dependence and addiction.
Codeine should be given with extreme caution to patients taking monoamine oxidase inhibitors or within 14 days of stopping such treatment.
Caffeine: to be used with care by patients with a history of peptic ulceration.
Large doses may precipitate fits in epileptics. Use with care in conditions such as glaucoma and prostatic hypertrophy.
Consult a doctor if no relief is obtained from the recommended dosage.
Do not use continuously for more than 10 days without consulting your doctor.
Dosages in excess of those recommended may cause severe liver damage.
PYNSTOP tablets should not be given to children under 12 years of age.
Patients suffering from liver or kidney disease should only take paracetamol under medical supervision.
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.
Doxylamine succinate may enhance the sedative effect of central nervous system depressants including alcohol, barbiturates, hypnotics, narcotic analgesics, sedatives and tranquillisers.
The depressant effects of codeine are enhanced by depressants of the central nervous system such as alcohol, anaesthetics, hypnotics and sedatives.
Safety of PYNSTOP during fertility, pregnancy and lactation has not been established.
Patients should be warned against taking charge of vehicles or machinery or performing potentially hazardous tasks where loss of concentration may 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 | |
| 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, restlessness, 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. | |
| Vascular disorders | Orthostatic hypotension, facial flushing |
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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