Paracetamol, codeine, buclizine (Migraleve pink)

How does it work?

Migraleve pink tablets contain three active ingredients, paracetamol, codeine phosphate and buclizine hydrochloride.

Paracetamol is a simple painkilling medicine used to relieve mild to moderate pain. Despite its widespread use for over 100 years, we still don't fully understand how paracetamol works to relieve pain. However, it is now thought that it works by reducing the production of prostaglandins in the brain and spinal cord.

The body produces prostaglandins in response to injury and certain diseases. One of the effects of prostaglandins is to sensitise nerve endings, causing pain (presumably to prevent us from causing further harm to the area). As paracetamol reduces the production of these nerve sensitising prostaglandins it is thought it may increase our pain threshold, so that although the cause of the pain remains, we can feel it less.

Codeine is a slightly stronger painkiller known as an opioid. Opioid painkillers work by mimicking the action of naturally occurring pain-reducing chemicals called endorphins. Endorphins are found in the brain and spinal cord and reduce pain by combining with opioid receptors.

Codeine mimicks the action of natural endorphins by combining with the opioid receptors in the brain and spinal cord. This blocks the transmission of pain signals sent by the nerves to the brain. Therefore, even though the cause of the pain may remain, less pain is actually felt.

Migraleve pink tablets contain 8mg of codeine, which in combination with the paracetamol, is effective at relieving mild pain such as migraine headaches.

Buclizine hydrochloride is a type of medicine called a sedating antihistamine. It is used to treat the sensation of nausea that can occur in a migraine attack and thus prevent vomiting.

Vomiting is controlled by an area of the brain called the vomiting centre. The vomiting centre is responsible for causing feelings of sickness (nausea) and for the vomiting reflex. Buclizine works by blocking histamine receptors in the vomiting centre, which prevents the vomiting centre from receiving nerve messages that would otherwise cause nausea and vomiting.

If taken at the first sign of a migraine, Migraleve pink tablets can prevent the migraine developing fully.

What is it used for?

  • Short-term (up to three days) treatment of nausea and headache associated with a migraine attack when this is not relieved by paracetamol, ibuprofen or aspirin alone.

How do I take it?

  • Migraleve pink tablets can be taken either with or without food.
  • Adolescents over 14 years of age should take two Migraleve pink tablets as it is known that a migraine attack has started or is imminent.
  • Children aged 12 to 14 years should take one Migraleve pink tablet as soon as it is known that a migraine attack has started or is imminent.
  • If the migraine continues, further treatment should be with Migraleve yellow tablets to help relieve the migraine headache. You should not start taking Migraleve yellow until four to six hours after your dose of Migraleve pink.
  • Do not take more than the recommended dose.
  • Do not take this medicine for longer than three days without consulting your doctor. Taking codeine regularly for more than three days can lead to addiction to the medicine and withdrawal symptoms when you stop taking it.
  • Consult your doctor if your symptoms persist despite taking this medicine.

Warning!

  • The information in this factsheet may differ from that found in the leaflet that is provided with the medicine. This is because this factsheet has been updated with the latest advice (released 28 June 2013) from the medicines watchdog, the MHRA, regarding the use of codeine in children. It follows a European safety review of the use of codeine in children. The product information leaflets for medicines affected by the advice will be updated in due course, but in the meantime if you are confused about any of our information, or want further advice, then you should talk to your pharmacist.
  • This medicine may cause drowsiness, dizziness and blurred vision. If you are affected you should not drive or operate machinery and avoid drinking alcohol.
  • Do not take Migraleve with any other products that contain paracetamol. Many over-the-counter painkillers and cold and flu remedies contain paracetamol. It is important to check the ingredients of any medicines you buy without a prescription before taking them in combination with this medicine. Seek further advice from your pharmacist.
  • An overdose of paracetamol is dangerous and capable of causing serious damage to the liver and kidneys. You should never exceed the dose stated in the information leaflet supplied with this medicine. Immediate medical advice should be sought in the event of an overdose with this medicine, even if you feel well, because of the risk of delayed, serious liver damage.
  • Alcohol increases the risk of liver damage that can occur if an overdose of paracetamol is taken. The hazards of paracetamol overdose are greater in persistent heavy drinkers and in people with alcoholic liver disease.
  • Do not take this medicine for longer than three days without consulting your doctor. If this medicine is taken regularly for long periods of time, the body can become tolerant to it and it may become less effective at relieving pain. With prolonged use, the body may also become dependent on the codeine. As a result, when you then stop taking the medicine you may get withdrawal symptoms such as restlessness and irritability.
  • If you need to use this medicine for longer than three days you should consult your doctor or pharmacist for advice.
  • Taking a painkiller for headaches too often or for too long can actually make the headaches worse.
  • People can vary considerably in the way that their body metabolises codeine. For some people this may lead to an increased chance of getting side effects, such as reduced levels of consciousness; sleepiness; slow, shallow breathing; ‘pin-point’ pupils; lack of appetite; constipation; or nausea and vomiting. If you experience any of these you should stop using this medicine and get medical advice straight away. For other people it may mean that the codeine is less effective, so if you find this medicine doesn't relieve your symptoms well enough you should consult your doctor or pharmacist.

Use with caution in

  • Elderly people.
  • Decreased kidney function.
  • Decreased liver function.
  • People with reduced lung function, eg due to asthma.
  • People with a condition called bronchiectasis, in which there is persistent widening of the airways as a result of lung disease, eg infection, inflammation, tumours or cystic fibrosis.
  • People with biliary tract disorders, eg gallstones or recent surgery on the biliary tract.
  • People with acute abdominal conditions such as appendicitis.
  • People who have recently had surgery on the stomach, intestines or urinary tract.
  • People with constipation or potential for blockage in the gut.
  • People with inflammatory bowel disorders such as Crohn's disease or ulcerative colitis.
  • People who have difficulty passing urine, for example men with an enlarged prostate gland (prostatic hypertrophy).
  • People with an underactive thyroid gland (hypothyroidism).
  • People with underactive adrenal glands, eg Addison's disease.
  • People with low blood pressure (hypotension) or shock.
  • A condition involving abnormal muscle weakness called myasthenia gravis.
  • People with a history of convulsions or fits, eg epilepsy.
  • People with an irregular heartbeat (arrhythmia).
  • People with a history or risk of narrow angle glaucoma.
  • People with a history of drug abuse or dependence.

Not to be used in

  • Children under 12 years of age.
  • Relieving pain in children and adolescents under 18 years of age who have had surgery to remove their tonsils or adenoids (tonsillectomy or adenoidectomy or both) for obstructive sleep apnoea.
  • People who are known to have a genetic variation of a liver enzyme called CYP2D6, which metabolises codeine into morphine (CYP2D6 ultra-rapid metabolisers). These people are more likely to experience side effects after taking codeine, because they convert more codeine into morphine than other people. See the warning section above.
  • People with very slow, shallow breathing (respiratory depression).
  • Chronic obstructive pulmonary disease (COPD).
  • People having an asthma attack.
  • Liver failure.
  • People with or at risk of paralysis or inactivity in the intestines that prevents material moving through the gut (paralytic ileus).
  • People with raised pressure inside the skull (intracranial pressure).
  • People with a head injury.
  • Breastfeeding.
  • Codeine is not recommended for adolescents aged 12 to 18 years whose breathing might be compromised, including those with neuromuscular disorders; severe heart or lung conditions; upper airway or lung infections; multiple trauma; or who have had extensive surgical procedures.

This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.

If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

  • Paracetamol is not known to be harmful when used during pregnancy. The safety of buclizine during pregnancy has not been fully established. The safety of codeine has not been established. If codeine is used regularly in the third trimester it may cause withdrawal symptoms in the baby after birth. If used during labour it may cause breathing difficulties in the baby after birth. This medicine should be avoided during pregnancy and the late stages of labour, unless considered essential by your doctor, and then only if the expected benefit to the mother outweighs any potential risk to the baby. Seek medical advice from your doctor before using this medicine if you are pregnant.
  • It is not known if buclizine passes into breast milk. Paracetamol and codeine may pass into breast milk in amounts that are probably too small to be harmful in most people. However, because some people metabolise codeine in a slightly different way that can increase the risk of getting side effects from the medicine, it is recommended that women who are breastfeeding do not take codeine. It is impossible to predict which women and babies will metabolise codeine differently. Potential side effects in a nursing baby may include drowsiness or sedation, difficulty breastfeeding, vomiting, breathing difficulties and floppiness. If you are breastfeeding you should not take this medicine.

Label warnings

  • This medicine may cause drowsiness. If affected do not drive or operate machinary. Avoid alcohol.
  • Do not take this medication with any other products containing paracetamol.
  • Do not exceed the recommended dose of this medicine, which will be stated in the information leaflet supplied with the medicine.

Side effects

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here does not mean that all people using this medicine will experience that or any side effect.

  • Drowsiness.
  • Dizziness.
  • Constipation.
  • Nausea and vomiting.
  • Dry mouth.
  • Sweating.
  • Itching.
  • Skin rash.
  • Difficulty passing urine.
  • Headache.
  • Confusion.
  • Blurred vision.
  • Dependence on the medicine if used regularly or for long periods of time (see warning section above).

The side effects listed above may not include all of the side effects reported by the medicine's manufacturer.

For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

How can this medicine affect other medicines?

It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you take this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while taking this one, to make sure that the combination is safe.

You should not take other medicines that contain paracetamol in combination with Migraleve, as this can easily result in exceeding the maximum recommended daily dose of paracetamol. Many cold and flu remedies and over-the-counter painkillers contain paracetamol, so be sure to check the ingredients of any other medicines before taking them with this one.

This medicine should not be used by people who are currently taking a monoamine oxidase inhibitor (MAOI) or who have taken one of these medicines in the last 14 days. MAOIs include the antidepressants phenelzine, tranylcypromine, isocarboxazid and moclobemide and the anti-Parkinson's medicine selegiline.

This medicine may cause drowsiness. This is more likely if the medicine is taken in combination with any of the following, which can also cause drowsiness:

  • alcohol
  • antipsychotics, eg haloperidol, chlorpromazine
  • benzodiazepines, eg temazepam, diazepam
  • sleeping tablets, eg zopiclone
  • other sedating antihistamines, eg chlorphenamine, promethazine, triprolidine, hydroxyzine (some of these may be found in non-prescription cough and cold or hayfever remedies)
  • other strong opioid painkillers, eg dihydrocodeine, morphine, tramadol
  • tricyclic antidepressants, eg amitriptyline.

Codeine phosphate can reduce the muscular activity in the gut and so may oppose the effect of the following medicines on the gut:

  • domperidone
  • metoclopramide.

There may be an increased risk of side effects such as constipation, dry mouth and blurred vision if this medicine is taken with antimuscarinic medicines that can cause these type of side effects, such as the following:

  • antimuscarinic medicines for Parkinson's symptoms, eg procyclidine, orphenadrine, trihexiphenidyl
  • antimuscarinic medicines for urinary incontinence, eg oxybutynin, flavoxate, tolterodine, propiverine, trospium
  • antispasmodics, eg atropine, hyoscine.

There is a risk of severe constipation if codeine is used with antimotility medicines for diarrhoea, such as loperamide.

Quinidine reduces the painkilling effect of codeine.

Rifampicin and ritonavir may also reduce the effects of codeine.

Cholestyramine reduces the absorption of paracetamol from the gut. It should not be taken within an hour of taking paracetamol or the effect of the paracetamol will be reduced.

Long-term or regular use of paracetamol may increase the anti-blood-clotting effect of warfarin and other anticoagulant medicines, leading to an increased risk of bleeding. This effect does not occur with occasional pain-killing doses. If you are taking an anticoagulant medicine and you are also taking co-codamol regularly, your blood clotting time (INR) should be regularly monitored.

Other medicines containing the same active ingredients

Migraleve contains a combination of Migraleve pink and Migraleve yellow tablets.