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SAIE.PCP.17.05.0105. Date of Preparation: May 2017
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Solpadol 500mg/30mg Effervescent Tablets
Solpadol Caplets 500mg/30mg Tablets
ABBREVIATED PRESCRIBING INFORMATION
Presentations: Solpadol 500mg/30mg Effervescent Tablets:Effervescent, white tablet containing 500mg paracetamol and 30mg codeine phosphate. Solpadol Caplets 500mg/30mg Tablets:White, to off-white capsule shaped tablet containing 500mg paracetamol and 30mg codeine phosphate. Indications: For the relief of severe pain. Solpadol is indicated in patients older than 12 years of age for the treatment of acute moderate pain which is not considered to be relieved by other analgesics such as paracetamol or ibuprofen (alone). Dosage and Administration: Adults: Two tablets at intervals of not less than six hours as required, up to a maximum of eight tablets per 24 hour period. Elderly: Dosage should be reduced to half the adult dose and titrated to the individual’s need and overall medical condition. Children aged 12 years to 18 years: one to two tablets not to be taken more frequently than every six hours up to a maximum of eight tablets in any 24 hour period. Not recommended for children under 12 years of age. Solpadol Effervescent Tablets and Solpadol Capletsare for oral administration. Solpadol Effervescent Tabletsshould be dissolved in at least half a tumbler full of water. Contraindications: In all paediatric patients (0-18 years of age) who undergo tonsillectomy and/or adenoidectomy for obstructive sleep apnoea syndrome, in women during breastfeeding, known CYP2D6 ultra-rapid metabolisers, hypersensitivity to paracetamol or codeine or any of the excipients, acute asthma, respiratory depression, acute alcoholism, head injuries, raised intra-cranial pressure, following biliary tract surgery or cholecystectomy, with concurrent or within 14 days of stopping monoamine oxidase inhibitor therapy. Precautions andWarnings: In deficiency or absence of liver enzyme CYP2D6 an adequate analgesic effect will not be obtained; in ultra-rapid opiate/codeine metabolisers an increased risk of opioid toxicity. Children given codeine within appropriate dose range post-operatively for tonsillectomy and/or adenoidectomy for obstructive sleep apnoea led to rare life-threatening or fatal adverse effects. Not recommended for use in children in whom respiratory function might be compromised. Use with great care in conditions which may be exacerbated by opioids, particularly in the elderly, those who are on concurrent CNS depressant drugs, those with prostatic hypertrophy or those with inflammatory or obstructive bowel disorders. Use with care if prolonged therapy is contemplated, in patients with severe renal or severe hepatic impairment. Overdose risk increased in those with alcoholic liver disease. In kidney failure (creatinine clearance < 10ml/min) the interval between doses should be increased (minimum 8 hours). Hepatotoxicity may occur with paracetamol at therapeutic doses. Caution is advised in underlying sensitivity to aspirin and/or to non-steroidal anti-inflammatory drugs (NSAIDs). Very rare cases of serious skin reactions such as Stevens-Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) have been reported with the use of paracetamol. Patients should be advised of the signs and symptoms and monitored closely for skin reactions. If symptoms or signs of SJS and TEN (e.g. progressive skin rash often with blisters or mucosal lesions) occur, Solpadol should be stopped immediately. The recommended dose not to be exceeded and other paracetamol containing products not to be taken concurrently. Alcohol during treatment is not recommended. Tolerance and dependence can occur, especially with prolonged high dosage of codeine. The risk-benefit of continued use should be assessed regularly by the prescriber. Prolonged regular use, except under medical supervision, may lead to physical and psychological dependence (addiction) and result in withdrawal symptoms such as restlessness and irritability, once the drug is stopped. Each Solpadol Effervescent Tabletcontains 388mg sodium (16.87 mEq); take this into account when prescribing for patients in whom sodium restriction is indicated. Patients with rare hereditary problems of fructose intolerance should not take this medicine. If the patient has a productive cough, codeine may impede expectoration. Information on the concomitant use of opioids with, benzodiazepines and alcohol can be found in the SmPC. When prescribe concomitant benzodiazepines, the lowest effective dosages and minimum duration should be used. Interaction with other medicinal products: Paracetamol may increase the elimination half-life of chloramphenicol. Oral contraceptives may increase rate of clearance of paracetamol. The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and reduced by colestyramine. The risk of paracetamol toxicity may be increased in patients receiving other potentially hepatotoxic drugs or drugs that induce liver microsomal enzymes, such as antiepileptics (such as phenobarbital, phenytoin, carbamazepine, topiramate), rifampicin and alcohol. Paracetamol may increase the risk of bleeding in patients taking warfarin, antivitamin K and other coumarins. These patients should be monitored for appropriate coagulation and bleeding complications. Co-administration of flucloxacillin with paracetamol may lead to metabolic acidosis, particularly in patients presenting risk factors of glutathione depletion, such as sepsis, malnutrition or chronic alcoholism. Treatment with paracetamol may interfere with the assay of blood uric acid by the phosphotungstic acid method. Treatment with paracetamol may interfere with the assay of blood glucose when concentrations are abnormally high. Inadvisable combinations with codeine: morphine agonists-antagonists (buprenorphine, nalbuphine, pentazocine - reduced analgesic effect due to competitive receptor blockade, with a risk of withdrawal syndrome); naltrexone (risk of reduced analgesic effect - the doses of the morphine derivative should be increased if necessary). Combinations to be taken into account: The effects of CNS depressants (including alcohol) may be potentiated by codeine; Increased risk of respiratory depression in combination with morphine agonist analgesics, morphine-like antitussives, true opioid antitussives, benzodiazepines and related derivatives, barbiturates, methadone. Pregnancy and Lactation: This product should not be used during pregnancy or lactation. Adverse Reactions: For full information about adverse events please consult the summary of Product Characteristics. Paracetamol.Immune system: hypersensitivity, anaphylactic shock, angioedema. Blood and lymphatic system disorders: thrombocytopenia, agranulocytosis, leukopenia, neutropenia, haemolytic anaemia in patients with underlying glucose 6-phosphate-dehydrogenase deficiency. Skin and subcutaneous disorders: erythema, urticarial, rash. Very rarely, serious skin reactions such as Toxic Epidermal Necrolysis (TEN), Stevens-Johnson syndrome (SJS), acute generalized exanthematous pustulosis, and fixed drug eruption. Cardiac disorders: Kounis syndrome. Respiratory, thoracic and mediastinal disorders: bronchospasm. Hepatobiliary disorders: cytolytic hepatitis, which may lead to acute hepatic failure. Codeine. At therapeutic doses, the adverse effects of codeine can produce typical opioid effects which are less frequent and more moderate and include: sedation, euphoria, dysphoria, constipation, nausea, vomiting, dizziness, light-headedness, confusion, drowsiness, hypersensitivity reactions (pruritus, urticaria and rash), myosis, urinary retention, bronchospasm, respiratory depression, acute biliary or pancreatic abdominal pain (suggesting a spasm of the sphincter of Oddi and occurring mainly in patients who have had a cholecystectomy), pancreatitis (very rare). At supratherapeutic doses there is a risk of dependence and withdrawal syndrome if treatment is suddenly discontinued; this may occur both in the patient and in the neonates of mothers with codeine intoxication. Overdosage: Paracetamol. Immediate hospital treatment is essential. Codeine. General symptomatic and supportive measures including a clear airway and monitoring of vital signs until stable. Marketing Authorisation Number: PA 540/159/1 & PA 540/159/3. Legal Category: POM. Further information is available on request from: Sanofi, 18 Riverwalk, Citywest Business Campus, Dublin 24 or contact IEmedinfo@sanofi.com Tel.: (01) 4035600. Date of Revision: May 2017.
Suspected adverse events should be reported. Reporting forms and information can be found at: www.hpra.ie; E-mail: firstname.lastname@example.org.
Suspected adverse events can also be reported to Sanofi Ireland Ltd. directly by emailing IEPharmacovigilance@sanofi.com or calling 01 403 5600