Summary of Product Characteristics

Transcription

1 1 NAME OF THE MEDICINAL PRODUCT Panadol Baby 120 mg/5 ml, Oral Suspension. Summary of Product Characteristics 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5 ml spoonful of suspension contains paracetamol 120 mg. Excipients: Each 5ml contains: Sorbitol 0.67g, Maltitol 3.5g, Hexacol carmoisine supra (E122) 0.05mg, and Parahydroxybenzoates 7.5mg (E215 E217 E219). For a full list of excipients, see section PHARMACEUTICAL FORM Oral suspension. Opaque, pink oral suspension with an odour of strawberry. 4 CLINICAL PARTICULARS 4.1 Therapeutic Indications Panadol Baby suspension is recommended for the relief of pains of teething, toothache and sore throats and for reducing the fever often associated with colds and flu and childhood infections such as chicken pox, whooping cough, measles and mumps. 4.2 Posology and method of administration This product is intended for oral use in children ages: Age : 2 3 months Dose 1. Post-vaccination fever One 2.5 ml measure 2. Other causes of Pain and Fever only if If necessary, after 4-6 hours, give a o Weighs over 4 kg second 2.5 ml dose o Born after 37 weeks o Do not give to babies less than 2 months of age o Do not give more than 2 doses o Leave at least 4 hours between doses o If further doses are needed, talk to your doctor or pharmacist Date Printed 24/07/2015 CRN page number: 1

2 Child s Age How Much How often (in 24 hours) 3 6 months One 2.5 ml measure 4 times 6 24 months One 5 ml spoonful 4 times 2 4 years One 5ml spoonful and one 4 times 2.5 ml measure 4 8 years Two 5mL spoonfuls 4 times 8 10 years Three 5mL spoonfuls 4 times years Four 5mL spoonfuls 4 times o Do not give more than 4 doses in any 24 hour period o Leave at least 4 hours between doses o Do not give this medicine to your child for more than 3 days without speaking to your doctor or pharmacist It is important to shake the bottle for at least 10 seconds before use If your baby was born prematurely and is less than 3 months old consult your doctor prior to use. Method of Administration Panadol Baby suspension is for oral administration only. 4.3 Contraindications Hypersensitivity to paracetamol or any of the other constituents. 4.4 Special warnings and precautions for use Care is advised in the administration of paracetamol to patients with renal or hepatic impairment. The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease. Do not give with any other paracetamol-containing products. Never give more medicine than shown in the table. Do not overfill the spoon. Always use the spoon supplied with the pack. Do not give to babies less than 2 months of age. For infants 2-3 months no more than 2 doses should be given. Do not give more than 4 doses in any 24 hour period. Leave at least 4 hours between doses. Do not give this medicine to your child for more than 3 days without speaking to your doctor or pharmacist. As with all medicines, if your child is currently taking any medicine consult your doctor or pharmacist before taking this product.keep out of the reach and sight of children. If symptoms persist, consult your doctor. Prolonged use except under medical supervision may be harmful. If your baby was born prematurely and is less than 3 months old consult your doctor prior to use. If your child has a known intolerance to some sugars, contact your doctor before use as this product contains maltitol syrup and sorbitol. Immediate medical advice should be sought in the event of an overdose, even if the patient feels well because of the risk of irreversible liver damage. Contains Hexacol Carmoisine Supra (E122) and parahydroxybenzoates (E219, E215 and E217) which may cause allergic reactions, possibly delayed. Date Printed 24/07/2015 CRN page number: 2

3 Maltitol & Sorbitol liquid: Patients with rare hereditary problems of fructose intolerance should not take this medicine. Each 120mg/5 ml suspension contains sorbitol (E 420) at mg per 5 ml suspension. Contains parahydroxybenzoates which may cause allergic reactions (possibly delayed). 4.5 Interaction with other medicinal products and other forms of interaction The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by cholestyramine. The anticoagulant effect 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. 4.6 Fertility, pregnancy and lactation There is epidemiological evidence of the safety of paracetamol in human pregnancy. However as with all drugs, caution should be exercised in its use during the first trimester. Paracetamol is excreted in breast milk. However the level of paracetamol present is not considered to be harmful. 4.7 Effects on ability to drive and use machines None. 4.8 Undesirable effects There have been rare reports of blood dyscrasias including thrombocytopenia and agranulocytosis but these were not necessarily causally related to paracetamol. The frequency of adverse events associated with paracetamol are tabulated below. Body System Undesirable Effect Frequency Paracetamol Blood and lymphatic Thrombocytopaenia Very rare system disorders Immune System disorders Anaphylaxis Very rare Cutaneous hypersensitivity Very rare reactions Angiodema Very rare Stevens Johnson syndrome Very rare Respiratory, thoracic and Bronchospasm in patients sensitive Very rare mediastinal disorders to aspirin and other NSAIDs Hepatobiliary disorders Hepatic dysfunction Very rare 4.9 Overdose Immediate medical attention (in-hospital if possible) is required in the event of overdose, even if there are no significant early symptoms. There may be no early symptoms following a life-threatening overdose. Ingestion of more than 12g paracetamol (24 standard 500mg tablets) or more than 150mg paracetamol per kg bodyweight (9g paracetamol in a 60kg individual), whichever is the smaller, can cause severe liver damage. Liver damage (as demonstrated by a rise in plasma transaminase levels) may be apparent between 8 and 36 hours following overdose. Biochemical evidence of maximal damage, however, may not be attained until hours after ingestion of the overdose. Date Printed 24/07/2015 CRN page number: 3

4 Intravenous N-acetylcysteine (NAC) is effective when initiated within 8 hours of the overdose. Efficacy declines progressively after this time, but NAC may provide some benefit up to and possibly beyond 24 hours. Oral methionine is also effective provided that it is given within 10 to 12 hours of the overdose. Activated charcoal should be considered if the dose of paracetamol ingested exceeds 12g or 150mg/kg, whichever is the smaller, and the procedure can be undertaken within 1 hour of the overdose. There is little evidence that undertaking gastric lavage will be of benefit to a patient in whom paracetamol is known to have been the only substance ingested. Symptoms of paracetamol overdose in the first 24 hours may induce pallor, nausea, vomiting, anorexia, and abdominal pain. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, coma and death. Liver damage results when excess quantities of a toxic metabolite (usually adequately detoxified by glutathione when normal doses of paracetamol are ingested) become irreversibly bound to liver tissue. Acute renal failure with acute tubular necrosis may develop even in the absence of severe liver damage. Cardiac arrythmias and pancreatitis have been reported. 5 PHARMACOLOGICAL PROPERTIES 5.1 Pharmacodynamic properties ATC code/pharmacotherapeutic group: N02BE01 Paracetamol has analgesic and antipyretic actions. 5.2 Pharmacokinetic properties Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract. Concentration in plasma generally reaches a peak in minutes; plasma half-life is 1-4 hours. It is metabolised in the liver and excreted in the urine, mainly as the glucuronide and sulphate conjugates. 5.3 Preclinical safety data There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of this SPC. 6 PHARMACEUTICAL PARTICULARS 6.1 List of excipients Malic acid Hexacol carmoisine supra (E122) Keltrol F (Xanthan Gum) Maltitol syrup Strawberry flavour L10055 Sorbitol, Liquid (Crystallising) Sodium Methylparaben (E219) Sodium Ethylparaben (E215) Sodium Propylparaben (E217) Sorbitol powder Citric acid Purified water Date Printed 24/07/2015 CRN page number: 4

5 6.2 Incompatibilities Not applicable. 6.3 Shelf life 3 years. 6.4 Special precautions for storage Do not store above 25 o C. Do not freeze. 6.5 Nature and contents of container Amber glass bottles fitted with clic-loc closures with expanded polyethylene liners. Pack sizes: 60 ml, 100 ml and 140 ml. A spoon with 2.5ml and 5ml measures is supplied. Not all pack sizes may be marketed. 6.6 Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product No special requirements. 7 MARKETING AUTHORISATION HOLDER GlaxoSmithKline Consumer Healthcare (Ireland) Limited 12 Riverwalk Citywest Business Campus Dublin 24 Ireland 8 MARKETING AUTHORISATION NUMBER PA0678/039/003 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 22 December 1992 Date of last renewal: 22 December DATE OF REVISION OF THE TEXT July 2015 Date Printed 24/07/2015 CRN page number: 5