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Before taking this medicine n This medicine contains paracetamol. Do not take anything else containing paracetamol while taking this medicine. n Do not take for longer than directed by your prescriber. n Taking a painkiller for headaches too often or for too long can make them worse. If you are in any doubt, talk to your doctor or pharmacist. This medicine is suitable for most people but a few people should not use it. n Do not use this medicine… Unless your migraines have been diagnosed by a doctor. 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 ingredients of this medicine (listed in section 6)

n If you are taking other medicines containing paracetamol. n In children under 12 years of age. n In children and adolescents (0-18 years of age) after removal of their tonsils or adenoids for obstructive sleep apnoea syndrome. n If you have recently developed shallow breathing. n If your bowel is obstructed or does not work properly. n If you have a head injury or raised pressure in your skull (may cause painful eyes, change in vision or headache behind the eyes). n If you know that you metabolise codeine into morphine very rapidly. n 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… n If you suffer from liver or kidney disease. n If you suffer from alcoholic liver disease or alcoholic dependence. n If you are taking any other medicines. n If you have closed angle glaucoma (increased pressure in the eye). n If you have difficulty passing water or unable to pass water. n If you have prostate disease. n If you suffer from fits. n If you suffer from asthma or breathing problems or other lung disease. n n If you are taking any other medicines including: metoclopramide or domperidone (used to treat nausea and vomiting) n cholestyramine (used to treat high cholesterol) n 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. n anticoagulants (drugs that thin the blood, such as warfarin) n anticonvulsants such as carbamazepine, phenytoin, fosphenytoin, phenobarbital or primidone (used to treat epilepsy) n antimuscarinic drugs e.g. atropine (drug given prior to surgery and for some eye and bowel conditions) n Drugs affecting the brain: – drugs used to decrease anxiety or to help you sleep (e.g. benzodiazepines or barbiturates) – antidepressants (e.g. tricyclic antidepressants) – drugs used for mental conditions causing delusions or hallucinations (e.g. phenothiazines) n General anaesthetics n Muscle relaxants n Other painkillers containing paracetamol or codeine or products similar to codeine e.g. tramadol, morphine Please inform your doctor or pharmacist if you are taking flucloxacillin (antibiotic), due to a If any of these bullet points apply to you now or in the past, If you are not sure about the medicine you are taking, show the pack to your pharmacist. malnutrition, chronic alcoholism, and if the maximum daily doses of paracetamol are used. sepsis (when bacteria and their toxins circulate in the blood leading to organ damage), have urgent treatment and which may occur particularly in case of severe renal impairment, serious risk of blood and fluid abnormality (high anion gap metabolic acidosis) that must talk to a doctor or pharmacist. n Talk to your prescriber before taking this medicine if you: Warnings and precautions are or have ever been addicted to opioids, alcohol, prescription medicines, or illegal drug

n have previously suffered from withdrawal symptoms such as agitation, anxiety, shaking or sweating, when you have stopped taking alcohol or drugs. n feel you need to take more of Migraleve® to get the same level of pain relief, this may or switch you to an alternative pain reliever. to it. Speak to your prescriber who will discuss your treatment and may change your dose mean you are becoming tolerant to the effects of this medicine or are becoming addicted morphine is people are more likely to get serious side effects because a very high amount of produced in very small quantities, and it will not provide enough pain relief. Other this can affect people in different ways. In some people, morphine is not produced or substance that produces pain relief. Some people have a variation of this enzyme and Codeine is transformed to morphine in the liver by an enzyme. Morphine is the increase the risk of addiction. Overuse and misuse can lead to overdose and/or death. medicine to anyone else. Taking higher doses or more frequent doses of opioid, may symptoms. Opioids should only be used by those they are prescribed for. Do not give your taking the medicine suddenly as you will be more likely to experience withdrawal gradually reduce your dose before stopping the medicine. It is important that you do not stop of appetite, shaking, shivering or sweating. Your prescriber will discuss with you how to your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, loss symptoms can include restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling Addiction can cause withdrawal symptoms when you stop taking this medicine. Withdrawal happens, you need to speak to your prescriber about your treatment. Rarely, increasing the dose of this medicine can make you more sensitive to pain. If this appropriate to stop, how to do this safely. prescriber should have explained how long you will be taking it for and when it is Taking this medicine regularly, particularly for a long time, can lead to addiction. Your produced. If you notice any of the following side effects, you must stop Do not take Migraleve If you are pregnant or breastfeeding symptoms of morphine toxicity may be worse in these children. Codeine is not recommended in children with breathing problems, since the Use in children with breathing problems or adenoids for Obstructive Sleep Apnoea Syndrome. Codeine should not be used in children and adolescents after removal of their tonsils Use in children and adolescents after surgery Children and adolescents confusion, sleepiness, small pupils, feeling or being sick, constipation, lack of appetite. taking this medicine and seek immediate medical advice: slow or shallow breathing, ® if you are pregnant or think you might be pregnant unless you have If you use Migraleve outweigh the potential harm to the baby. discussed this with your prescriber and the benefits of treatment are considered to ® during pregnancy, your baby may become dependent and Do not take Migraleve experience withdrawal symptoms after the birth which may need to be treated. ® while you are breastfeeding as codeine passes into breast milk and n The medicine can affect your ability to drive as it may make you sleepy or dizzy. Driving and using machines Special warnings about drowsiness will affect your baby. Do not drive while taking this medicine until you know how it affects you. n It is an offence to drive if this medicine affects your ability to drive.

However, you would not be committing an offence if: n The medicine has been prescribed to treat a medical or dental problem and n You have taken it according to the instructions given by the prescriber or in the information provided with the medicine and n It was not affecting your ability to drive safely Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine