Summer 2010 - The British Pain Society

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® (tramadol) ONCE DAILY AT BEDTIME When you need continuous 24 hour pain relief, when short acting tramadol dosing is not optimal .... Before prescribing controlled drugs consider ONCE DAILY AT BEDTIME ® 200 mg* * The starting dose is one 100 mg tablet. The usual dose is one 200 mg tablet. The maximum dose is 400 mg daily. TRADOREC ® XL prolonged-release tablets tramadol hydrochloride ABRIDGED PRESCRIBING INFORMATION Refer to Summary of Product Characteristics (SPC) before prescribing Adverse events should be reported. Reporting forms and information can be found at www.yellowcard.gov.uk. Adverse events should also be reported to Merck Sharp & Dohme Ltd (tel: 01992 467272). PRESENTATION Prolonged-release, white, round tablets containing 100 mg, 200 mg or 300 mg tramadol hydrochloride. USES Treatment of moderate to severe pain. DOSAGE AND ADMINISTRATION The tablets should be swallowed whole with or without food, with a suffi cient quantity of liquid and not divided or chewed. Adults and adolescents (12 years and over): Starting dose 100 mg orally, once 04-11 TRA.10.GB.49160.Jg daily. The usual dose is 200 mg once daily preferably in the evening. Dosage can be increased to 300 mg or to a maximum of 400 mg once daily. Elderly: No adjustment of daily dosage is required in patients up to 75 years. Not recommended for patients over 75 years. Children (under 12): Not recommended. Use in renal or hepatic dysfunction: Use with caution in moderate hepatic or renal impairment. In general, the lowest effective dose should be chosen. Should not be used longer than absolutely necessary. If continued treatment is necessary, careful regular surveillance should be carried out. CONTRA-INDICATIONS Hypersensitivity to tramadol or any ingredient. Acute intoxication or overdose with CNS depressants. Concomitant treatment with MAO inhibitors or within 2 weeks. Concomitant treatment with linezolid. Severe hepatic or renal impairment. Uncontrolled epilepsy. Breastfeeding for more than 2-3 days. PRECAUTIONS Alcohol consumption or concomitant treatment with carbamazepine is not recommended. Tolerance and psychological/physical dependence may develop with long-term use. Caution in patients at risk of respiratory depression, epilepsy, patients with head trauma or shock. Not suitable as a substitute for opioid dependent patients. Concomitant medications not recommended: mixed agonists-antagonists (buprenorphine, nalbuphine, pentazocine), naltrexone. Use with caution with morphine derivatives, CNS depressants, SSRI’s, other anti-depressants, mefl oquine, bupropion, venlafaxine, coumarin derivatives, e.g. warfarin. Pregnancy: Do not use Tramadol during pregnancy unless clearly necessary. Lactation: A single administration of tramadol does not usually require breastfeeding to be interrupted. If repeated administration is needed for several days, i.e. more than 2 to 3 days, breastfeeding should be suspended. If long-term treatment after birth is necessary, breastfeeding is contraindicated. SIDE EFFECTS Refer to SPC for complete information on side effects. The most commonly reported undesirable effects, nausea and dizziness, have been observed in more than 10% of patients. Cardiac disorders Uncommon (≥1/1,000,
® (tramadol) ONCE DAILY AT BEDTIME For continuous 24hr pain relief, type T R A D into your prescribing system Incorporating Contramid ® technology under licence from Labopharm recommended doses and in the case of concomitant administration of other CNS depressant medicinal products. Epileptiform seizures primarily occurred following administration of high doses of tramadol or following concomitant treatment with medicinal products that lower the seizure threshold or trigger seizures. Psychiatric disorders Rare (≥1/10,000,
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Summer 2010 - The British Pain Society

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