Source: Health Products Regulatory Authority (ZA) Revision Year: 2022 Publisher: Adcock Ingram Limited, 1 New Road, Erand Gardens, Midrand, 1685, Private Bag X69, Bryanston, 2021 www.adcock.com 0860ADCOCK (232625)
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.
Dosages in excess of those recommended may cause severe liver damage.
Patients suffering from liver or kidney disease should take BESEMAX under medical supervision.
Caution is recommended in patients on other central nervous system depression-producing medication as well as patients on anticholinergics or medication with anticholinergic properties. Use with caution in patients with cardiac disease or arrhythmias, especially tachycardia.
Do not use continuously for more than 10 days without consulting your doctor.
Orphenadrine may increase central nervous system depression if taken concurrently with alcohol or central nervous system depressants. Anticholinergic effects may be intensified if orphenadrine is taken concurrently with anticholinergics or medication with anticholinergic effects.
Risk of hepatotoxicity with single toxic doses or prolonged use of high doses of paracetamol may be increased in alcoholics or in patients taking other hepatotoxic medications or hepatic enzyme inducers.
Chronic use of barbiturates (except butalbital) or primidone has been reported to decrease the therapeutic effects of paracetamol.
Concurrent chronic, high-dose administration of acetaminophen may increase the anticoagulant effect, possibly by decreasing hepatic synthesis of procoagulant factors.
Prolonged concurrent use of paracetamol and a salicylate significantly increases the risk of analgesic nephropathy, renal papillary necrosis, end-stage renal disease, and cancer of the kidney or urinary bladder.
Prolonged concurrent use of acetaminophen and NSAIDS other than aspirin may also increase the risk of adverse renal effects.
Safety in 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.
| System organ class | Undesirable effects |
|---|---|
| Blood and lymphatic system disorders | Thrombocytopenia, leucopenia, pancytopenia, neutropenia, agranulocytosis and anemia. |
| Cardiac disorders | Transient bradycardia followed by tachycardia, with palpitations and arrhythmias |
| Eye disorders | Dilatation of the pupils (mydriasis) with loss of accommodation (cycloplegia) and photophobia |
| Gastrointestinal disorders | Pancreatitis. Dryness of the mouth with difficulty in swallowing and talking, thirst. Reduction in the tone of motility of the gastro- intestinal tract leading to constipation and occasionally vomiting. |
| Hepato-biliary disorders | Hepatitis |
| Nervous system disorders | Confusion, giddiness and staggering |
| Psychiatric disorders | Insomnia |
| Renal and urinary disorders | Difficulty in micturition Renal colic, renal failure, sterile pyuria |
| Respiratory, thoracic and mediastinal disorders | Reduced bronchial secretions |
| Skin and subcutaneous tissue disorders | Skin rashes and other allergic reactions occur occasionally. The rash is usually erythematous or urticarial but sometimes more serious and may be accompanied by fever and mucosal lesions. Dryness of the skin |
| Vascular disorders | Flushing of the skin |
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.
May also report to Adcock Ingram Limited using the following email: Adcock.AEReports@adcock.com.
Not applicable.
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