Besemax 450mg Tablet

BESEMAX Tablet are indicated in generalised pain and the relief of muscle spasm associated with acute painful musculo-skeletal conditions.

Adults: 2 tablets 3 times a day. DO NOT EXCEED THE RECOMMENDED DOSAGE

Hypersensitivity to any of the ingredients. Severe liver function impairment. Prostatic enlargement, achalasia, bladder neck obstruction, glaucoma, myasthenia gravis, peptic ulcer or stenosing and pyloric or duodenal obstruction. Patients with porphyria.

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 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.

Paracetamol Alcohol or Hepatic enzyme inducers or Hepatotoxic medications: 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. Anticoagulants, coumarin or indandione derivative: Concurrent chronic, high-dose administration of acetaminophen may increase the anticoagulant effect, possibly by decreasing hepatic synthesis of procoagulant factors. Anti-inflammatory medicines, nonsteroidal (NSAIDs) or Aspirin or other salicylates. 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

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, malnutrition, 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 possibly 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 transaminase 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 given 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 initially, 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 damage, 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 increased 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. For overdose with an extended/modified release preparation the value of the nomogram is unknown. As there is no information on the plasma levels of paracetamol after an overdose of extended/modified release paracetamol preparations, all patients with suspected or known overdose with such preparations should receive N-acetylcysteine. Because of lack of data for extended/modified release formulations, a level below the u201ctreatment lineu201d of the nomogram may not exclude the possibility of toxicity. Monitor all patients with significant ingestions for at least ninety six hours.