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MIGRALEVE

Active substance(s): BUCLIZINE HYDROCHLORIDE / CODEINE PHOSPHATE / PARACETAMOL DC 96%

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®

Paracetamol, Codeine phosphate & Buclizine hydrochloride
n 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.
n You should only take this product for a maximum of three days at a time. If you need to
take it for longer than three days you should see your doctor or pharmacist for advice.
n This medicine contains codeine which can cause addiction if you take it continuously
for more than three days. This can give you withdrawal symptoms from the medicine
when you stop taking it.
n If you take this medicine for headaches for more than three days it can make them worse.
n This medicine is for use by adults and children aged 12 years and over.
Now read this whole leaflet carefully before you use this medicine.
Keep the leaflet: you might need it again.

1 What the medicine is for

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.
There are two types of MIGRALEVE® tablet available:
n MIGRALEVE® Pink tablets
n MIGRALEVE® Yellow tablets
They are available separately or together in one pack.
MIGRALEVE® Pink tablets contain paracetamol and codeine which eases pain and buclizine
which helps relieve nausea and vomiting. The Pink tablets therefore treat all the symptoms
of migraine. If taken at the first sign of a migraine, MIGRALEVE® Pink tablets can prevent an
attack from developing.
MIGRALEVE® Yellow tablets contain paracetamol and codeine for the treatment of pain and
relief of continuing migraine symptoms. They should always be taken after the first dose of
MIGRALEVE® Pink tablets.
Codeine can be used in children over 12 years of age for the short-term relief of moderate
pain that is not relieved by other painkillers such as paracetamol or ibuprofen alone.
This product contains codeine. Codeine belongs to a group of medicines called opioid
analgesics which act to relieve pain. It can be used on its own or in combination with other
pain killers such as paracetamol.

2 Before taking this medicine

n Do not take for longer than directed by your prescriber.
n Taking codeine regularly for a long time can lead to addiction, which might cause you to
feel restless and irritable when you stop the tablets.
n Taking a painkiller for headaches too often or for too long can make them worse.
This medicine is suitable for most people but a few people should not use it.
If you are in any doubt, talk to your doctor or pharmacist.

Do not use this medicine...

Warnings and precautions
Codeine is transformed to morphine in the liver by an enzyme. Morphine is the
substance that produces pain relief. Some people have a variation of this enzyme
and this can affect people in different ways. In some people, morphine is not
produced or produced in very small quantities, and it will not provide enough
pain relief. Other people are more likely to get serious side effects because a
very high amount of morphine is produced. If you notice any of the following
side effects, you must stop taking this medicine and seek immediate medical
advice: slow or shallow breathing, confusion, sleepiness, small pupils, feeling or
being sick, constipation, lack of appetite.

Children and adolescents

Use in children and adolescents after surgery
Codeine should not be used in children and adolescents after removal of their
tonsils or adenoids for Obstructive Sleep Apnoea Syndrome.
Use in children with breathing problems
Codeine is not recommended in children with breathing problems, since the
symptoms of morphine toxicity may be worse in these children.

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 If you are taking any other medicines including:
n 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
If you are not sure about the medicine you are taking, show the bottle or pack to
your pharmacist.
If any of these bullet points apply to you now or in the past, talk to a
doctor or pharmacist.

If you are pregnant or breastfeeding

Ask your doctor or pharmacist for advice before taking this medicine if you are
pregnant.
Do not take codeine while you are breastfeeding. Codeine and morphine passes
into breast milk.

Special warnings about drowsiness

Driving and using machines
The medicine can affect your ability to drive as it may make you sleepy or dizzy.
n 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.

3 How to take this medicine

Check the tables below to see how much medicine to take.
n
n
n
n
n

For oral use only. Swallow the tablets with a glass of water.
Do not take less than four hours after taking other painkillers.
Always start with MIGRALEVE® Pink tablets.
Do not take more than the stated dose shown below.
This medicine should not be taken for more than 3 days. If the pain does not
improve after 3 days, talk to your doctor for advice.

Children under 12 years

Do not give to children below the age of 12 years,
due to the risk of severe breathing problems.

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n 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®.

spot = 12 x 2 centered in
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Distance between cutted line/middel of the spot = 51.6 mm
Barcodes placed at 14 mm
Hight for bars : 10 mm

code Laetus 963
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Children 12 – 15 years
Age
Children
12 – 15 years

Dose
Swallow 1 MIGRALEVE® Pink tablet at the first sign of a migraine
attack. If the migraine persists, then take 1 MIGRALEVE® Yellow
tablet 4 hours after the Pink dose and then every 4 hours.

n Do not take more than 4 tablets (1 pink and 3 yellow) in a 24 hour period.
n If symptoms persist for more than 3 days or get worse, stop use and talk to your doctor.

Adults and Children 16 years and over
Age

Dose

Adults and
children 16
years and over

Swallow 2 MIGRALEVE® Pink tablets at the first sign of a migraine
attack. If the migraine persists, then take 2 MIGRALEVE® Yellow
tablets 4 hours after the Pink dose and then every 4 hours.

n Do not take more than 8 tablets (2 pink and 6 yellow) in a 24 hour period.
n If symptoms persist for more than 3 days or get worse, stop use and talk to your doctor.

If anyone has too much

Talk to a doctor at once if you take too much of this medicine even if you feel well.
This is because too much paracetamol can cause delayed, serious liver damage.

If you forget to take the medicine

You should only take this medicine as required following the dosage instructions
above carefully. If you forget to take a dose, take the next dose when needed
provided that the last dose was taken at least 4 hours ago. Do not take a double
dose. Remember that you can only take one MIGRALEVE® Pink dose in any
24 hour period.

Special warnings about addiction

This medicine contains codeine and can cause addiction if you take it continuously
for more than three days. When you stop taking it you may get withdrawal
symptoms. You should talk to your doctor or pharmacist if you think you are
suffering from withdrawal symptoms.

4 Possible side-effects

MIGRALEVE can have side-effects, like all medicines, although these don’t affect
everyone and are usually mild.
®

If you experience any of the following, stop using the medicine
and tell your doctor straightaway:

n Allergic reactions including swelling of the face, tongue or throat, difficulty swallowing,
unexplained wheezing, shortness of breath which may be accompanied by skin rash or hives.
n Becoming unusually tired, unexpected bruising or bleeding and getting more
infections (such as colds) than usual.
n Very rare cases of serious skin reactions have been reported. Symptoms may include:
skin reddening, blisters, rash. If skin reactions occur or existing skin symptoms worsen,
stop use and seek medical help right away.
n Signs of codeine toxicity e.g. confusion, shallow breathing or extreme sleepiness.

Other effects which may occur include:

Very common:
n Feeling sick, sleepiness (although desire to sleep can be a symptom of migraine).
n Headache.
n Reddening and flushing of face.
Common:
n Constipation, being sick, dry mouth.
n Dizziness, increased sweating.
Uncommon:
n Feeling happy.
n Rash.
Not known:
n Acute inflammation of the pancreas in patients who have had a cholecystectomy
(gall bladder removal).
n Addiction or withdrawal symptoms (e.g., tremor, sweating, increased heart rate, increased
breathing rate, raised blood pressure and feeling or being sick if the medicine is stopped
too quickly).
n Difficulty in passing urine.
n Problems with movements and coordination.
n Kidney problems.
n Loss of appetite, indigestion, abdominal pain or discomfort.
n Itching and hives.
n Liver problems.
n Blurred vision.
n Breathing difficulty, thickened mucus.
n Hypothermia.
n Tiredness.
n Twitching.
n Fits.
n Sensation of spinning.
n Decrease in sex hormones.
n Adrenal glands not working properly (may cause weakness, tiredness, weight loss,
low blood pressure).
People who use medicines containing paracetamol every day for a long time could get certain
side effects, including liver and kidney damage. People taking paracetamol in the usual way
for shorter periods have not had these problems, but liver function tests may be affected.

How do I know if I am addicted?

If you take the medicine according to the instructions on the pack it is
unlikely that you will become addicted to the medicine. However, if the following apply to
you it is important that you talk to your doctor:
n You need to take the medicine for longer periods of time.
n You need to take more than the recommended dose.
n When you stop taking the medicine you feel unwell but you feel better when you start
taking the medicine again.
Reporting of side-effects:
If you get any side-effects, talk to your doctor, pharmacist or nurse. This includes any
possible side-effects not listed in this leaflet. You can also report side-effects directly via
the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

The following details are applicable for Malta:
ADR Reporting, The Medicines Authority, Post-Licensing Directorate, 203 Level 3,
Rue D'Argens, GŻR-1368 Gżira
Website: www.medicinesauthority.gov.mt e-mail: postlicensing.medicinesauthority@gov.mt
By reporting side-effects you can help provide more information on the safety of this medicine.

5 Storing this medicine

There are no special storage instructions for this medicine. Keep out of the sight and reach
of children. Do not use after the end of the month shown as an expiry date on the
packaging. Do not throw away any medicines via wastewater or household waste.
Ask your pharmacist how to throw away medicines you no longer use. These measures
will help protect the environment.

6 Further information
What’s in this medicine?

The active ingredients in each MIGRALEVE® Pink tablet are: Paracetamol DC 96%
520 mg equivalent to Paracetamol 500 mg, Codeine phosphate 8 mg and Buclizine
hydrochloride 6.25 mg.
Other ingredients are: magnesium stearate, colloidal anhydrous silica, stearic acid,
pregelatinised maize starch, gelatin, hypromellose, macrogol, E127 (erythrosine),
aluminium oxide and E171 (titanium dioxide).
The active ingredients in each MIGRALEVE® Yellow tablet are: Paracetamol DC 96%
520 mg equivalent to Paracetamol 500 mg and Codeine phosphate 8 mg.
Other ingredients are: magnesium stearate, colloidal anhydrous silica, stearic acid,
pregelatinised maize starch, gelatin, hypromellose, macrogol, E104 (quinoline yellow),
aluminium oxide, E171 (titanium dioxide) and E172 (iron oxide yellow).

What the medicine looks like

There are two types of MIGRALEVE® tablets available: MIGRALEVE® Pink and
MIGRALEVE® Yellow. These are film coated tablets which are available separately or
together in one pack.
Packs on sale in your Pharmacy
MIGRALEVE®: 12 tablet pack containing
8 MIGRALEVE® Pink and 4 MIGRALEVE® Yellow tablets
MIGRALEVE®: 24 tablet pack containing
16 MIGRALEVE® Pink and 8 MIGRALEVE® Yellow tablets
MIGRALEVE® Pink: packs of 12 and 24 tablets
MIGRALEVE® Yellow: packs of 24
Packs available only on prescription from your Doctor
MIGRALEVE®: 48 tablet pack containing
32 MIGRALEVE® Pink and 16 MIGRALEVE® Yellow tablets
MIGRALEVE® Pink: packs of 48 tablets
Please Note: Because MIGRALEVE® packs contain both
MIGRALEVE® Pink and MIGRALEVE® Yellow tablets, a double
prescription charge must be made.
Product Licence holder: McNeil Products Ltd, Maidenhead, Berkshire, SL6 3UG, UK.
Manufacturer: Janssen-Cilag, Domaine de
Maigremont, 27100 Val de Reuil, France.
360146B
This leaflet was revised November 2017.
17-0152

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6 mm

6 mm

Component: 360146B, 17-0152
Version: 7
Dimension: 145x250mm
Date: 01/11/2017

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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