GB_Migraleve Complete 12s /24s & Pink 12s / 24s & Yellow 24s_PIL 13.05.2021 English 402318125_r1 N/A Brochure/Leaflet/Insert 145 X 250 MM 360146G DC-Pharmalog_Val De Reuil_Upper Normandy_France CHILD 360146F Westrock Saint Pierre des Corps 6 mm 963 Offset Printing 6 mm 6 mm 8521107 / 5209117 / 8525207 / 5209719 / 5210316 N/A EMEA_2021_00043038_000 PC-0002781 12 mm right margin n If you have taken any other painkillers in the last four hours. ® n If you are allergic to paracetamol, codeine or buclizine or any of the other Warnings and precautions ingredients of this medicine (listed in section 6). Codeine is transformed to morphine in the liver by an enzyme. Morphine is the n If you are taking other medicines containing paracetamol. substance that produces pain relief. Some people have a variation of this enzyme Paracetamol, Codeine phosphate & Buclizine hydrochloride n In children under 12 years of age. and this can affect people in different ways. In some people, morphine is not BLACK RHODAMINE n In children and adolescents (0-18 years of age) after removal of their tonsils or n For the short term treatment of acute moderate pain which is not relieved by produced or produced in very small quantities, and it will not provide enough RED adenoids for obstructive sleep apnoea syndrome. pain relief. Other people are more likely to get serious side effects because a paracetamol, ibuprofen or aspirin alone such as migraine attacks, including the n If you have recently developed shallow breathing. LITHO OFFSET LITHO OFFSET symptoms of migraine headache, nausea and vomiting. very high amount of morphine is produced. If you notice any of the following n If your bowel is obstructed or does not work properly. side effects, you must stop taking this medicine and seek immediate medical REPRESENTATION: Colours represented with a diagonal line have been modified to aid PDF approval. n You should only take this product for a maximum of three days at a time. If you need to n If you have a head injury or raised pressure in your skull (may cause painful eyes, take it for longer than three days you should see your doctor or pharmacist for advice. advice: slow or shallow breathing, confusion, sleepiness, small pupils, feeling or change in vision or headache behind the eyes). being sick, constipation, lack of appetite. n This medicine contains codeine which can cause addiction if you take it continuously n If you know that you metabolise codeine into morphine very rapidly. for more than three days. This can give you withdrawal symptoms from the medicine n If you are breastfeeding. Children and adolescents when you stop taking it. If any of these apply to you, get advice from a doctor or pharmacist without Use in children and adolescents after surgery n If you take this medicine for headaches for more than three days it can make them worse. using MIGRALEVE®. Codeine should not be used in children and adolescents after removal of their n This medicine is for use by adults and children aged 12 years and over. tonsils or adenoids for Obstructive Sleep Apnoea Syndrome. Now read this whole leaflet carefully before you use this medicine. Talk to your doctor or pharmacist... Use in children with breathing problems Keep the leaflet: you might need it again. n If you suffer from liver or kidney disease. Codeine is not recommended in children with breathing problems, since the n If you suffer from alcoholic liver disease or alcoholic dependence. symptoms of morphine toxicity may be worse in these children. 1 What the medicine is for n If you are taking any other medicines. n If you have closed angle glaucoma (increased pressure in the eye). If you are pregnant or breastfeeding For the short term treatment of acute moderate pain which is not relieved by n If you have difficulty passing water or unable to pass water. Ask your doctor or pharmacist for advice before taking this medicine if you are paracetamol, ibuprofen or aspirin alone such as migraine attacks, including the n If you have prostate disease. pregnant. symptoms of migraine headache, nausea and vomiting. n If you suffer from fits. FuturaBT-MediumItalic HelveticaNeueLTStd-Cn Smallest Text Size ® Do not take codeine while you are breastfeeding. Codeine and morphine passes There are two types of MIGRALEVE tablet available: n If you suffer from asthma or breathing problems or other lung disease. into breast milk. HelveticaNeueLTPro-Bd Wingdings-Regular 6.25pt n MIGRALEVE® Pink tablets n If you are taking any other medicines including: n ® tablets Special warnings about drowsiness HelveticaNeueLTPro-BdCn Ave. Text Size MIGRALEVE Yellow n metoclopramide or domperidone (used to treat nausea and vomiting) They are available separately or together in one pack. n cholestyramine (used to treat high cholesterol) Driving and using machines HelveticaNeueLTPro-Cn ® 6.5pt MIGRALEVE Pink tablets contain paracetamol and codeine which eases pain and buclizine which n if you are taking or have taken in the last two weeks, Monoamine Oxidase Inhibitors The medicine can affect your ability to drive as it may make you sleepy or dizzy. HelveticaNeueLTPro-CnO helps relieve nausea and vomiting. The Pink tablets therefore treat all the symptoms of migraine. If (MAOIs such as moclobemide, phenelzine, tranylcypromine or selegiline) for n Do not drive while taking this medicine until you know how it affects you. ® HelveticaNeueLTPro-HvCn Largest Text Size taken at the first sign of a migraine, MIGRALEVE Pink tablets can prevent an attack from developing. depression or other conditions. n It is an offence to drive if this medicine affects your ability to drive. MIGRALEVE® Yellow tablets contain paracetamol and codeine for the treatment of pain and relief n anticoagulants (drugs that thin the blood, such as warfarin) However, you would not be committing an offence if: Fonts used Fonts 12.5pt HelveticaNeueLTPro-Roman of continuing migraine symptoms. They should always be taken after the first dose of n anticonvulsants such as carbamazepine, phenytoin, fosphenytoin, phenobarbital or n The medicine has been prescribed to treat a medical or dental problem and 2021-04-13 08:53:37 MIGRALEVE® Pink tablets. primidone (used to treat epilepsy) n You have taken it according to the instructions given by the prescriber or in Codeine can be used in children over 12 years of age for the short-term relief of moderate n antimuscarinic drugs e.g. atropine (drug given prior to surgery and for some eye the information provided with the medicine and pain that is not relieved by other painkillers such as paracetamol or ibuprofen alone. and bowel conditions) n It was not affecting your ability to drive safely This product contains codeine. Codeine belongs to a group of medicines called opioid analgesics n Drugs affecting the brain: Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive which act to relieve pain. It also contains paracetamol, another analgesic to relieve pain. - drugs used to decrease anxiety or to help you sleep (e.g. benzodiazepines or while taking this medicine. barbiturates) - antidepressants (e.g. tricyclic antidepressants) 3 How to take this medicine 2 Before taking this medicine - drugs used for mental conditions causing delusions or hallucinations n This medicine contains paracetamol. Do not take anything else containing paracetamol (e.g. phenothiazines) Check the tables below to see how much medicine to take. while taking this medicine. n General anaesthetics n For oral use only. Swallow the tablets with a glass of water. n Do not take for longer than three days at a time. n Muscle relaxants n Taking codeine regularly for a long time can lead to addiction, which might cause you to n Do not take less than four hours after taking other painkillers. n Other painkillers containing paracetamol or codeine or products similar to codeine n Always start with MIGRALEVE® Pink tablets. feel restless and irritable when you stop the tablets. e.g. tramadol, morphine n Taking a painkiller for headaches too often or for too long can make them worse. n Do not take more than the stated dose shown below. If you are not sure about the medicine you are taking, show the bottle or pack to n This medicine should not be taken for more than 3 days. If the pain does not This medicine is suitable for most people but a few people should not use it. your pharmacist. improve after 3 days, talk to your doctor for advice. If you are in any doubt, talk to your doctor or pharmacist. If any of these bullet points apply to you now or in the past, talk to a Children under 12 years Do not use this medicine... doctor or pharmacist. Do not give to children below the age of 12 years, n Unless your migraines have been diagnosed by a doctor. due to the risk of severe breathing problems. turn over t margin 14 mm f le spot = 12 x 2 centered in the margin of 14 mm Distance between cutted line/middel of the spot = 51.6 mm GB_Migraleve Complete 12s /24s & Pink 12s / 24s & Yellow 24s_PIL 13.05.2021 English 402318125_r1 N/A Brochure/Leaflet/Insert 145 X 250 MM Barcodes placed at 14 mm Hight for bars : 10 mm 360146G DC-Pharmalog_Val De Reuil_Upper Normandy_France code Laetus 963 CHILD 360146F Westrock Saint Pierre des Corps 14 963 Offset Printing 8521107 / 5209117 / 8525207 / 5209719 / 5210316 N/A le f 12 mm t margin EMEA_2021_00043038_000 PC-0002781 Children 12 – 15 years Other effects which may occur include: Very common: 5 Storing this medicine Age Dose n Feeling sick, sleepiness (although desire to sleep can be a symptom of migraine).