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Paracetamol/Chlorzoxazone

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Paracetamol/Chlorzoxazone PARACETAMOL/CHLORZOXAZONE TRADE NAME MYOLGIN™ NAME OF THE MEDICINAL PRODUCT Paracetamol / chlorzoxazone, 300 mg/250 mg, hard capsule QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 300 mg of paracetamol and 250 mg of chlorzoxazone. Excipients Gelatin, Magnesium stearate, Talc. PHARMACEUTICAL FORM Hard gelatin capsules, purple opaque/pink printed Myolgin. CLINICAL INFORMATION Indications Paracetamol/chlorzoxazone is indicated for the treatment of: • sprains, strains, muscle pain, • traumatic muscle spasm, • reflex muscle spasm associated with rheumatic diseases, • lumbago, • myalgia, • tension headache, • torticollis, • cervical root syndrome, • rheumatoid arthritis. This medicinal product offers quick relief of pain and restore mobility even in severely painful spasms of the skeletal muscles in cases as above. Dosage and Administration Route of Administration For oral use. Adults Unless otherwise prescribed by a physician, the dose is 1 to 2 capsules three times daily after meals according to the severity of symptoms. Daily dose should not exceed 4 grams of paracetamol and 3 grams of chlorzoxazone. Do not exceed the stated dose. Minimum dosing interval: 4 hours Children This medicinal product is not recommended for children under 12 years. Elderly There are no relevant data available. Renal impairment Patients who have been diagnosed with renal impairment must seek medical advice before taking this medication (see Section Warnings and Precautions) Page 1 of 8 Hepatic impairment This medicinal product should not be given to patients with impaired liver function (see Section Warnings and Precautions). Contraindications Paracetamol / chlorzoxazone is contraindicated in: • hypersensitivity to the active substances or any of the excipients. Warnings and Precautions Renal impairment Care is advised in the administration of paracetamol/ chlorzoxazone to patients with renal impairment. Hepatic impairment This product should not be given to patients with impaired liver function. Patients should be advised to report to their doctor any signs or symptoms of possible liver toxicity such as fever, rash, jaundice, dark urine, anorexia, nausea, vomiting or right upper quadrant pain. Paracetamol / chlorzoxazone should be stopped if symptoms of liver toxicity appear (see Section Adverse Reactions). Risk of overdose The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease. Porphyria This medicinal product contains chlorzoxazone – active classified as possibly porphyrinogenic. It should be used only when no safer alternative is available and precautions should be considered in vulnerable patients. Bronchospasm There have been cases of bronchospasm with paracetamol, but these are more likely in asthmatics sensitive to aspirin or other NSAIDs (see Section Adverse Reactions). Treatment efficiency If symptoms persist medical advice is necessary. Abnormal urine colour The urine of patients taking paracetamol/chlorzoxazone may be coloured orange or reddish-purple by a phenolic metabolite (see Section Adverse Reactions). Interactions Warfarin and other coumarins The anticoagulant affect of warfarin and other coumarins, may be enhanced by prolonged regular daily use of paracetamol with increased risk of bleeding; occasional doses have no significant effect. Central nervous system depressants, alcohol The central nervous system effects of chlorzoxazone may be enhanced by alcohol and other central nervous system depressants. Isoniazide Isoniazide inhibit the clearance of chlorzoxazone, especially in slow acetylator subjects. This effect is less pronounced in rapid acetylators. Rebound increase in the clearance of chlorzoxazone may occur after stopping isoniazide. Other paracetamol containing products Patients should be advised not to take other paracetamol-containing products concurrently. Page 2 of 8 Metoclopramide, domperidone The speed of absorption of paracetamol may be increased by metoclopramide or domperidone. Colestyramine Absorption of paracetamol may be reduced by colestyramine. Disulfiram Disulfiram reduces plasma clearance of chlorzoxazone, resulting in a doubling of the latter's peak plasma concentrations and prolongation of its elimination half-life. Pregnancy and Lactation Fertility There are no relevant data available. Pregnancy This medicinal product may be used in pregnancy only if, according to physician’s opinion, the benefits for the mother and the child outweigh the potential risk. Lactation This medicinal product may be used during lactation only if, according to physician’s opinion, the benefits for the mother and the child outweigh the potential risk. Ability to perform tasks that require judgement, motor or cognitive skills Paracetamol / chlorzoxazone may cause drowsiness (see Section Adverse Reactions). Patients affected should not drive or operate machinery. Adverse Reactions Clinical Trial Data Not relevant for this product. Post Marketing Data Adverse reactions are ranked under headings of frequency using the following convention: Very common ≥1/10 Common ≥1/100 to <1/10 Uncommon ≥1/1000 to <1/100 Rare ≥1/10000 to <1/1000 Very rare <1/10000 Not known (cannot be estimated from the available data). Blood and lymphatic system disorders Not known: thrombocytopenia, agranulocytosis Immune system disorders Not known: anaphylactic reaction, hypersensitivity (see Skin and subcutaneous tissue disorders), anaphylactoid reaction Nervous system disorders Not known: headache, somnolence, dizziness (see Section Ability to perform tasks that require judgement, motor or cognitive skills) Respiratory, thoracic and mediastinal disorders Not known: bronchospasm (see Section Warnings and Precautions) Gastrointestinal disorders Page 3 of 8 Not known: mild and transient gastrointestinal disturbances, gastrointestinal tract irritation, gastrointestinal haemorrhage. Hepatobiliary disorders Not known: hepatic function abnormal, jaundice, hepatotoxicity (sometimes fatal), liver injury (see Section Warnings and Precautions) Skin and subcutaneous tissue disorders Not known: rash, angioedema, Stevens-Johnson syndrome, toxic epidermal necrolysis, petechiae, ecchymosis, urticaria, pruritus Renal and urinary disorders Not known: chromaturia (see Section Warnings and Precautions) General disorders and administration site conditions Not known: malaise, restlessness, overstimulation Overdosage Symptoms and signs Paracetamol Liver damage is possible in adults who have taken 10g or more of paracetamol. Ingestion of 5g or more of paracetamol may lead to liver damage if the patient has risk factors Risk factors for liver damage include: • long term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St John's Wort or other drugs that induce liver enzymes, • regular ethanol consumption in excess of recommended amounts, • glutathione depletion e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia. Symptoms of paracetamol overdosage in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, haemorrhage, hypoglycaemia, cerebral oedema and death. Acute renal failure with acute tubular necrosis, strongly suggested by loin pain, haematuria and proteinuria, may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported. Chlorzoxazone Following chlorzoxazone overdosage there may be gastrointestinal disturbances, drowsiness, dizziness, headache, malaise and sluggishness followed by marked loss of muscle tone, hypotension and respiratory depression. Treatment Immediate treatment is essential in case of overdose. Treatment with activated charcoal should be considered if the overdose has been taken within 1 hour. Despite a lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention. Symptoms may be limited to nausea or vomiting and may not reflect the severity of overdose or the risk of organ damage. Supportive therapy should be instituted. Management of patients who present with serious hepatic dysfunction beyond 24h from ingestion should be discussed with a liver unit. Page 4 of 8 Due to paracetamol component treatment with N-acetylcysteine may be used up to 24 hours after ingestion. The maximum protective effect is obtained up to 8 hours post- ingestion. The effectiveness of the antidote declines sharply after this time. If required the patient should be given intravenous N-acetylcysteine, in line with the established dosage schedule. If vomiting is not a problem, oral methionine may be a suitable alternative for remote areas, outside hospital. Clinical Pharmacology Pharmacodynamics Pharmacotherapeutic group Chlorzoxazone, combinations excluding psycholeptics ATC Code M03BB53 Pharmacodynamic effects This medicinal product is combined medication and has muscle relaxant, analgesic and antipyretic effect. Pharmacokinetics Paracetamol Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract. Binding to plasma proteins is minimal at therapeutic concentrations. Paracetamol is metabolised in the liver and excreted in the urine mainly as glucoronide and sulphate conjugates less than 5% is excreted as unmodified paracetamol. Chlorzoxazone Chlorzoxazone is reported to be completely absorbed after oral administration and peak
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