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PACKAGE LEAFLET: INFORMATION FOR THE USER

MIGRAINE RELIEF FILM-COATED TABLETS

(ibuprofen lysine)

What is in this leaflet

1.    What Migraine Relief is and what it is used for.

2.    What you need to know before you take Migraine Relief.

3.    How to take Migraine Relief.

4.    Possible side effects.

5.    How to store Migraine Relief.

6.    Contents of the pack and other information.

1.    WHAT MIGRAINE RELIEF IS AND WHAT IT IS USED FOR

Migraine Relief contains the active substance ibuprofen. It belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs).

NSAIDs provide relief by changing the body's response to pain, swelling and high temperature. Migraine Relief tablets are used for the relief of headaches and migraine pain.

2.    WHAT DO YOU NEED TO KNOW BEFORE YOU TAKE MIGRAINE RELIEF

Do not take Migraine Relief:

•    if you are allergic to ibuprofen or any other ingredients of this medicine (listed in Section 6)

•    if you have had an allergic reaction such as a worsening of asthma, nettle rash, itchy runny nose or facial swelling to aspirin or other NSAIDs

•    if you have (or have had two or more episodes of) a stomach ulcer, perforation or bleeding

•    if you have had gastrointestinal perforation or bleeding when previously taking NSAIDs

•    if you have severe liver or kidney disease or have severe heart problems

__• if you are taking other NSAID painkillers,

or aspirin with a daily dose above 75 mg, as this will increase the risk of occurrence of adverse effects

•    if you are in the last 3 months of pregnancy.

Warnings and precautions

Talk to your doctor or pharmacist before taking Migraine Relief:

•    if you have or have had asthma

•    if you have kidney, heart, liver or bowel problems

•    if you have high blood pressure, high cholesterol or previously have had a heart attack or stroke

•    if you have a history of gastrointestinal disease (such as ulcerative colitis,

Crohn's disease)

•    if you have Systemic Lupus Erythematosus (a disease affecting the skin, joints

and kidneys)

•    if you are elderly

•    if you are a smoker

•    if you are in the first 6 months of pregnancy.

Medicines such as Migraine Relief may be associated with a small increased risk of heart attack ('myocardial infarction') or stroke. Any risk is more likely with high doses or prolonged treatment. Do not exceed the recommended dose or duration of treatment (10 days).

If you have heart problems, previous stroke or think that you might be at risk of these conditions (for example if you have high blood pressure, diabetes, or high cholesterol or are a smoker), you should discuss your treatment with your doctor or pharmacist.

There is a risk of renal impairment in dehydrated children and adolescents.

Other medicines and Migraine Relief

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

To reduce the risk of side effects, do not take Migraine Relief with:

•    other NSAID containing products including COX-2 inhibitors

(e.g. aspirin, ibuprofen)

•    corticosteroids

•    quinolone antibiotics

•    drugs prescribed to thin your blood or prevent clotting (e.g. warfarin)

•    drugs prescribed to stimulate your heart (e.g. glycosides) or treat high

blood pressure

•    drugs prescribed to help you pass water (diuretics)

•    drugs prescribed for the temporary suppression of your immune system (e.g. methotrexate, cyclosporine, tacrolimus)

•    drugs prescribed for mania and depression (e.g. lithium or selective serotonin reuptake inhibitors)

•    drugs prescribed for pregnancy termination (e.g. mifepristone)

•    drugs prescribed for HIV treatment (e.g. zidovudine).

Low dose aspirin

Do not take this medicine if you are taking aspirin at doses of above 75 mg daily. If you are on low-dose aspirin (up to 75 mg daily) speak to your doctor or pharmacist before you take Migraine Relief.

Pregnancy, breast-feeding and fertility

Do not take in the last 3 months of pregnancy.

If you are in the first 6 months of pregnancy or if you are breast-feeding ask your doctor or pharmacist for advice before taking this medicine.

Migraine Relief tablets belong to a group of medicines which may impair fertility in women. This effect is reversible on stopping the medicine. It is unlikely that Migraine Relief, used occasionally, will affect your chances of becoming pregnant, however, tell your doctor before taking this medicine if you have problems becoming pregnant.

Driving and using machinery

This medicine has no effect on driving or the ability to use machinery at the recommended doses and duration of treatment.

3. HOW TO TAKE MIGRAINE RELIEF

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist told you. Check with your doctor or pharmacist if you are not sure.

The product is for short term use only. You should take the lowest dose for the shortest time necessary to relieve your symptoms. Do not take for longer than 10 days unless your doctor tells you to. If you do not get better, or get worse, talk to your doctor. They will tell you if it is safe to carry on taking the medicine.

Adults, the elderly and children aged 12 years or older:

Take 1 or 2 tablets with water, up to three times a day as required. Leave at least four hours between doses. Do not take more than 6 tablets in 24 hours.

Use in children

Migraine Relief is not recommended for use in children under 12 years.

If in children aged from 12 years and in adolescents this medicinal product is required for more than 3 days, or if symptoms worsen a doctor should be consulted.

Migraine Relief tablets are swallowed whole with plenty of water. Do not chew the tablets.

Patients with sensitive stomachs should take Migraine Relief tablets during a meal.

If you take more Migraine Relief than you should

You may experience nausea, vomiting, stomach pain or diarrhoea. Ringing in the ears, headache, vomiting blood and blood in stools are also possible. More serious poisoning can lead to drowsiness, and sometimes excitation, disorientation, coma or convulsions. You should seek immediate medical advice in the event of an overdose, even if you feel well.

If you forget to take Migraine Relief

Simply refer to the directions above on how to take the medicine and do not take more than is advised.

Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you think you have any of the following side effects or symptoms, stop taking this medicine and seek immediate medical help:

•    intestinal bleeding with bright red faeces (stools/motions), black tarry stools, vomiting blood or dark particles that look like coffee grounds (very rare: may affect up to 1 in 10,000 people)

•    serious allergic reaction (very rare: may affect up to 1 in 10,000 people), symptoms include:

*    difficulties in breathing or unexplained wheezing

*    dizziness or faster heartbeat

*    swelling of your face, tongue or throat

•    Stevens Johnson Syndrome - a rare skin condition with severe blisters and bleeding in the lips, eyes, mouth, nose and genitals (very rare: may affect up to 1 in 10,000 people)

•    heart failure (frequency not known)

•    severe condition of the skin that may affect the mouth and other parts of the body (very rare: may affect up to 1 in 10,000 people)

•    severe skin disease that starts with painful red areas, then large blisters and ends with peeling of layers of skin. This is accompanied by fever and chills, aching muscles and generally feeling unwell (very rare: may affect up to 1 in 10,000 people).

•    aseptic meningitis (infection around the brain or spinal cord with the following symptoms: fever, nausea, vomiting, headache, stiff neck and extreme sensitivity to bright light) (very rare: may affect up to 1 in 10,000 people) particularly in patients with pre-existing autoimmune disorders such as systemic lupus erythematosus and mixed connective tissue disease

•    small increased risk of heart attack ('myocardial infarction') or stroke. Any risk is more likely with high doses or prolonged treatment (see section 2 'Warnings and precautions').

Stop taking the medicine and tell your doctor if you experience:

•    indigestion or heartburn (uncommon: may affect up to 1 in 100 people)

•    pains in your stomach (abdomen) or other abnormal stomach symptoms (uncommon: may affect up to 1 in 100 people).

Tell your doctor if you experience any of the below side effects:

Uncommon (may affect up to 1 in 100 people):

•    nausea

•    headache

•    skin rash, allergies with itching and nettle rash.

Rare (may affect up to 1 in 1,000 people):

•    diarrhoea, wind, constipation, vomiting.

Very rare (may affect up to 1 in 10,000 people):

•    stomach and intestinal ulcers, sore mouth, inflammation of the stomach, worsening of colitis (inflammation of the colon, symptoms include diarrhoea, usually with blood and mucus, stomach pain, fever) and worsening of Crohn's disease (an inflammatory disease that can affect any part of the gastrointestinal tract with the following symptoms: pain, fever, diarrhoea and loss of weight)

•    reduction in the number of red blood cells, white blood cells and platelets. Symptoms include: fever, sore throat, mouth ulcers, flu-like symptoms, severe exhaustion, unexplained bleeding or bruising

•    acute kidney disease where you pass little or no urine (drowsiness, nausea, vomiting, breathlessness)

•    liver disorders.

Not known (frequency cannot be estimated from the available data):

•    excessive fluid in the body

•    high blood pressure

•    purple or red-brown spots visible through the skin.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

You can also report side effects directly via:

The Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard

By reporting side effects you can help provide more information on the safety of this medicine.

5.    HOWTO STORE MIGRAINE RELIEF

Keep this medicine out of the sight and reach of children. Do not use Migraine Relief after the expiry date which is stated on the blister, carton after 'EXP'. The expiry date refers to the last day of that month. This medicine does not require any special storage conditions. 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.    CONTENTS OF THE PACK AND OTHER INFORMATION

What Migraine Relief contains

The active substance is ibuprofen. Each tablet contains 342 mg of ibuprofen lysine (equivalent to 200 mg of ibuprofen).

The other ingredients of a tablet are cellulose, microcrystalline; silica, colloidal anhydrous; crospovidone; povidone; magnesium stearate; talc (E553b). The tablet coating contains polyvinyl alcohol, hydrolysed; titanium dioxide (E171); macrogol; talc (E553b). The printing ink contains shellac; iron oxide black (E172); ammonium hydroxide (E527).

What Migraine Relief looks like and contents of the pack

White to off-white, film-coated, round, biconvex, bevelled edge tablet imprinted with 'M' over 'IL1' in black ink on one side of the tablet and blank on the other side.

Migraine Relief is available in blister packs of 8, 12, 16 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Mylan, Potters Bar, Hertfordshire,

EN6 1TL, United Kingdom.

Manufacturer

Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland.

Generics [UK] Limited, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom. Mylan Hungary Kft, H-2900 Komarom, Mylan utca 1, Hungary.

This leaflet was last revised    418219

in: April 2014    00000000

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