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MIGRALEVE PINK

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

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„ If you have difficulty passing water (urinary retention).
„ If you have prostate disease.
„ If you drink large amounts of alcohol, you may be more open to
the side effects of paracetamol.
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.

2 Before taking this medicine
Paracetamol, Codeine & Buclizine
„ 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.
„ 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.
„ 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.
„ If you take this medicine for headaches for more than three days it can
make them worse.
„ 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:
„ Migraleve Pink tablets
„ 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.

„ 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.
„ If you take a painkiller for headaches for more than three days it can
make them worse.
„ If you have been prescribed this product do not take it for longer than
directed by your doctor.
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.

Warnings and precautions

Do not use this medicine...

„ Unless your migraines have been diagnosed by a doctor.
„ If you have taken any other painkillers in the last four hours.
„ If you have ever had a bad reaction to Migraleve or any of its
ingredients.
„ If you are taking other medicines containing paracetamol.
„ If it is for a child under 12 years of age.
„ For pain relief in children and adolescents (0-18 years of age) after
removal of their tonsils or adenoids due to obstructive sleep apnoea
syndrome
„ If you know that you metabolise very rapidly codeine into morphine
„ 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 prescribed medicines.
„ If you are taking, or have taken in the last two weeks, drugs for
depression known as Monoamine Oxidase Inhibitors (MAOIs).
„ If you have closed angle glaucoma (increased pressure in the eye).
„ If you are taking any other medicines including:
„ metoclopramide or domperidone (used to treat nausea and
vomiting)
„ colestyramine (used to treat high cholesterol)
„ anticoagulants (drugs that thin the blood, such as warfarin)
„ antimuscarinic drugs e.g.:
- atropine (drug used to treat some eye conditions and
occasionally bowel conditions)
- tricyclic antidepressants (drugs to treat mood disorders)
„ CNS depressants e.g.:
- hypnotics (sleeping tablets including barbiturates)
- sedatives (drugs used to produce calmness or to help you
sleep)
- tranquilisers (drugs used to relax muscles or decrease anxiety)
- opioid analgesics (drugs used to relieve pain eg. codeine,
tramadol, morphine)

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 for pain relief in children and adolescents
after removal of their tonsils or adenoids due to 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.

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
These tablets may cause drowsiness. If affected do not operate
machinery.
This medicine can affect your ability to drive.
Do not drive whilst taking this medicine until you know how this
medicine affects you.
It may be an offence to drive when taking this medicine if your ability
to drive safely is affected. Talk to your doctor or pharmacist if you are
not sure whether it is safe for you to drive while taking this medicine.
There is further information for patients who are intending to drive in
the UK - go to https://www.gov.uk/drug-driving-law.
Avoid alcoholic drink.
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3 How to take this medicine
„ 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
This medicine should not be taken by children below the age of 12
years, due to the risk of severe breathing problems.

Children 12 – 15 years
Age
Children
12 – 15
years

5 Storing this medicine

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.

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

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.

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

Adults and Children 16 years and over

4 Possible side-effects

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.

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

If anyone has too much
Immediate medical advice should be sought in the event of an
overdose, even if you feel well, because of the risk of delayed, serious
liver damage. Take this leaflet and any remaining tablets with you.

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.

6 Further information

Some people may have side-effects when taking this medicine. If you have
any unwanted side-effects you should seek advice from your doctor or
other healthcare professional.
Also you can help to make sure that medicines remain as safe as possible
by reporting any unwanted side-effects via the internet
at www.yellowcard.gov.uk; alternatively you can call Freephone
0808 100 3352 (available between 10am-2pm Monday - Friday) or
fill in a paper form available from your local pharmacy.
Migraleve can have side-effects, like all medicines, although these don’t
affect everyone and are usually mild.

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).

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

„ 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.
„ Becoming unusually tired, unexpected bruising or bleeding and getting
more infections (such as colds) than usual. These are very rare and not
necessarily related to paracetamol.

Other effects which may occur include:

Age

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

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.

„ Constipation.
„ Itching.
„ Sweating.
„ Dry Mouth.
„
Drowsiness (although the desire to sleep can be a symptom of migraine),
nausea (feeling sick or queasy) and vomiting (being sick).
„
Indigestion, pain or discomfort in the abdomen.
„
Acute inflammation of the pancreas in patients who have had a
cholecystectomy (gallbladder removal).
„
Difficulty in passing urine.
„
Headache, dizziness, problems with movements and coordination, upset
stomach, thickened mucus and blurred vision.
Taking a painkiller for headaches too often or for too long can make them worse.
„

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:
„
You need to take the medicine for longer periods of time.
„
You need to take more than the recommended dose.
„
When you stop taking the medicine you feel unwell but you feel better
when you start taking the medicine again.

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.
This leaflet was revised October 2016.
McNeil Products Ltd is the licensee of the registered trade mark MIGRALEVE.

365002F
16-0548

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Job No: 16-0548
Version: 1
16-0548
Date:
10-10-2016
Job Bag
No.
Version
1
Size:
145 x 210
mm
Migraleve (12s/24s/48s)
Product
Main
body Text:
6.5 pts
Description

Pil

Country

UK

Date

10/10/2016

Manufacturer Val De Reuil
Software

Illustrator CS5

COLOURS:

BLACK

Rhodamine
Red

SIZE:
145 x 210 mm

PROFILE

Main body text
(PIL’s only)

6.5 pts

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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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