Country: মাল্টা
ভাষা: ইংরেজি
সূত্র: Medicines Authority
PARACETAMOL, CODEINE PHOSPHATE
McNeil Products Limited Foundation Park, Roxborough Way, Maidenhead, Berkshire SL6 3UG, United Kingdom
N02CX
PARACETAMOL 500 mg CODEINE PHOSPHATE 8 mg
FILM-COATED TABLET
PARACETAMOL 500 mg CODEINE PHOSPHATE 8 mg
OTC
ANALGESICS
Withdrawn
2006-08-10
If you have taken any other painkillers in the last four hours. If you are allergic to paracetamol, codeine or buclizine or any of the other ingredients of this medicine (listed in section 6). If you are taking other medicines containing paracetamol. In children under 12 years of age. In children and adolescents (0-18 years of age) after removal of their tonsils or adenoids for obstructive sleep apnoea syndrome. If you have recently developed shallow breathing. If your bowel is obstructed or does not work properly. If you have a head injury or raised pressure in your skull (may cause painful eyes, change in vision or headache behind the eyes). If you know that you metabolise codeine into morphine very rapidly. If you are breastfeeding. If any of these apply to you, get advice from a doctor or pharmacist without using MIGRALEVE ® . Talk to your doctor or pharmacist... If you suffer from liver or kidney disease. If you suffer from alcoholic liver disease or alcoholic dependence. If you are taking any other medicines. If you have closed angle glaucoma (increased pressure in the eye). If you have difficulty passing water or unable to pass water. If you have prostate disease. If you suffer from fits. If you suffer from asthma or breathing problems or other lung disease. If you are taking any other medicines including: _metoclopramide_ or _domperidone_ (used to treat nausea and vomiting) _cholestyramine_ (used to treat high cholesterol) if you are taking or have taken in the last two weeks, _Monoamine Oxidase Inhibitors_ (MAOIs such as moclobemide, phenelzine, tranylcypromine or selegiline) for depression or other conditions. _anticoagulants_ (drugs that thin the blood, such as warfarin) _anticonvulsants _such as carbamazepine, phenytoin, fosphenytoin, phenobarbital or primidone (used to treat epilepsy) _antimuscarinic drugs e.g. _ _atropine_ (drug given prior to surgery and for some eye and bowel conditions) Drugs সম্পূর্ণ নথি পড়ুন
Version No:18.0 Draft 1 SNAS No: BV 2965 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Migraleve Yellow 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each Migraleve Yellow tablet contains: Paracetamol DC 96% 520 mg (equivalent to Paracetamol 500 mg) Codeine Phosphate 8 mg For full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablets. Yellow, capsule-shaped, film-coated tablets marked MGE on one face. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the short term treatment of acute moderate pain which is not relieved by Paracetamol, ibuprofen or aspirin alone such as migraine attacks including the symptoms of migraine headache, nausea and vomiting. Codeine is indicated in children 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). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Route of administration – oral. The duration of treatment should be limited to 3 days and if no effective pain relief is achieved the patients/carers should be advised to seek the views of a physician Adults and Children 16 years and over: Two Migraleve Pink tablets to be swallowed immediately it is known that a migraine attack has started or is imminent. If further treatment is required, two Migraleve Yellow tablets every 4 hours. Maximum dose: 8 tablets (two Migraleve Pink and six Migraleve Yellow) in 24 hours. Version No:18.0 Draft 2 SNAS No: BV 2965 Children 12 - 15 years: One Migraleve Pink tablet to be swallowed immediately it is known that a migraine attack has started or is imminent. If further treatment is required, one Migraleve Yellow tablet every 4 hours. Maximum dose: 4 tablets (one Migraleve Pink and three Migraleve Yellow) in 24 hours. Children aged less than 12 years: Codeine should not be used in children below the age of 12 years because of the risk of opioid toxicity due to the variable and unpredictable metabolism of codeine to morphine (see sections 4.3 a সম্পূর্ণ নথি পড়ুন