GALPHARM MIGRAINE RELIEF

Ibuprofen

PATIENT INFORMATION LEAFLET

Read this leaflet carefully because it contains important information for you.

•    Keep this leaflet. You may need to read it again.

•    Ask your pharmacist if you need more information or advice.

•    You must contact a doctor or pharmacist if your symptoms worsen or do not improve.

IN THIS LEAFLET:

1.    What this medicine is for

2.    Before you take the medicine

3.    How to take the medicine

4.    Possible side effects

5.    Storing the medicine

6.    Further information

ll WHAT THIS MEDICINE IS FOR

(Galpharm Migraine Relief contains ibuprofen, which belongs to a group of medicines called ixion-Steroidal Anti-Inflammatory Drugs (NSAIDs). [These medicines work by changing how the body responds to pain, swelling and high temperature. This medicine is used to relieve:

!• rheumatic and muscular pain, backache

•    neuralgia (nerve pain)

|» headache, migraine

» dental pain, period pain

•    fever (high temperature)

|» the symptoms of colds and flu.

H BEFORE YOU TAKE THE MEDICINE

Do not take Galpharm Migraine Relief if you:

•    have or have had a stomach ulcer, perforation or bleeding of the stomach

|» are allergic to ibuprofen, to any of the ingredients (listed in section 6), or to aspirin or other painkillers (an allergic reaction may be recognised as shortness of breath, runny nose, skin rash or itching)

•    have kidney or heart failure or severe liver failure i» are taking more than 75mg of aspirin a day

|» are in the last 3 months of pregnancy.

Warnings and precautions

Anti-inflammatory / pain-killer medicines like ibuprofen may be associated with a small increased risk of heart attack or stroke, particularly [when used at high doses. Do not exceed the recommended dose or duration of treatment.

You should discuss your treatment with your doctor or pharmacist before taking Galpharm Migraine Relief if you:

l» are elderly because you may be at more risk of having serious side effects, particularly stomach problems

i» have or have suffered from asthma or have allergies |» have liver or kidney problems

•    have stomach or bowel disorders including Crohn's l_ disease or a condition known as ulcerative colitis

•Hhave Systemic Lupus trythematosus (SLt) - aril illness which affects your immune system. It causes joint pains, skin changes and problems with other parts of your body

•    have heart problems including heart failure, angina (chest pain), or if you have had a heart attack, bypass surgery, peripheral artery disease (poor circulation in the legs or feet due to narrow or blocked arteries), or any kind or stroke (including 'mini-stroke' or transient ischaemic attack "TIA").

•    have high blood pressure, diabetes, high cholesterol, have a family history of heart disease or stroke, or if you are a smoker.

Children and adolescents:

There is a risk of renal impairment in dehydrated adolescents.

Other medicines and Galpharm Migraine Relief

You must not take these capsules if you are taking certain other medicines - see section 2 ‘Do not take Galpharm Migraine Relief if.

Galpharm Migraine Relief may affect or may be affected by some other medicines. For example:

•    medicines that are anti-coagulants (i.e. thin blood/prevent clotting e.g. aspirin/acetylsalicylic acid, warfarin, ticlopidine)

•    medicines that reduce high blood pressure (ACE-inhibitors such as captopril, beta-blockers such as atenolol medicines, angiotensin-ll receptor antagonists such as losartan)

•    corticosteroids

•    methotrexate (a medicine for cancer)

•    cardiac glycosides (medicines used to treat heart failure)

•    cyclosporin and tacrolimus (immunosuppressant medicines often used following organ transplants)

•    mifepristone (a medicine used to terminate pregnancy - NSAIDs should not be used for 12 days after mifepristone)

•    lithium (for depression or mental problems)

•    zidovudine (a medicine to treat viruses)

•    quinolone antibiotics (medicines used to treat bacterial infections).

Some other medicines may also affect or be affected by the treatment of Galpharm Migraine Relief. You should therefore always seek the advice of your doctor or pharmacist before you use Galpharm Migraine Relief with other medicines. Pregnancy and Breast feeding Do not take Galpharm Migraine Relief if you are in the last 3 months of pregnancy. Talk to your doctor before taking Galpharm Migraine Relief if you are in the first 6 months of pregnancy or are breastfeeding.

Galpharm Migraine Relief belong to a group of medicines which may affect fertility in women. Fertility goes back to normal when you stop taking the medicine. It is unlikely that if you only take these capsules occasionally it will affect your chances of becoming pregnant. If you have problems becoming pregnant talk to your doctor before taking this medicine.

_Further information overleaf

El HOW TO TAKE THE MEDICINE

•    This medicine is for short-term use only

•    Take the lowest dose for the shortest time necessary

In Adults: Do not take Galpharm Migraine Relief for longer than 10 days unless your doctor tells you to. Talk to a doctor or pharmacist if you do not get better or get worse, or if new symptoms occur.

In Children and Adolescents between 12 and 18 years: If in children and adolescents this medicinal product is required for more than 3 days, or if symptoms worsen, a doctor should be consulted.

Do not give to children under 12 years.

If you take too many capsules:

Talk to a doctor straight away, or go to your nearest hospital casualty department. Take the carton and this leaflet with you.

pi POSSIBLE SIDE EFFECTS

Most people take Galpharm Migraine Relief without lany problems, but it can have side effects, like all medicines.

.To reduce the chance of side effects, especially if you are elderly, use the lowest effective dose for the shortest possible time.

If you get any of the following at any time during your treatment STOP TAKING, and get medical help straight away:

Allergic reactions:

The following reactions may mean you are having ,an allergic reaction to this medicine:

\* asthma, worsening of asthma, unexplained wheezing or shortness of breath i» swelling of the face, lips, tongue and throat (causing difficulty in swallowing or breathing)

•    rapid heart rate, low blood pressure, collapse.

i» also, there may be skin reaction (including hives, rash and itching) - very rarely these can be severe with blistering and peeling skin.

Stomach and bowel problems including:

» indigestion or heartburn

•    pains in your stomach (abdomen) or other abnormal stomach problems

•    pass blood in your stools or motions

•    pass black tarry stools or motions

•    vomit any blood or dark particles that look like coffee grounds

,• worsening of bowel problems (ulcerative colitis or Crohn's disease).

Blood disorders which can cause: p_ unexplained or unusual bruising or bleeding

sore throat or mouth ulcers

•    fever (high temperature)

•    extreme paleness or weakness and exhaustion.

Heart and circulation effects: Medicines such as Galpharm Migraine Relief may be associated with a small increased risk of heart attack (myocardial infarction), high blood pressure, heart failure, swelling due to fluid build-up (oedema) or stroke.

Other side effects that may occur include:

Other stomach and intestine effects including: diarrhoea, flatulence, constipation and vomiting.

Liver problems that might be indicated by yellowing of the skin and eyes (jaundice) and/or pale coloured stools and dark urine.

Kidney problems that might be indicated by passing less or more urine than normal, cloudy urine] blood in the urine, pain in the back and/or swelling (particularly of the legs) - very rarely kidney failure.

Nervous system problems including headache and aseptic meningitis (which can have symptoms such as severe headache, stiff neck, disorientation, fever and eye sensitivity to light in those with existing autoimmune disorders such as lupus).

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.aov.uk/vellowcard.

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

El STORING THE MEDICINE

Do not use after the expiry date shown on the pack. Do not store above 25°C.

Store in the original container.

Keep out of the sight and reach of children.

El FURTHER INFORMATION

What is in this medicine:

The active ingredient is: Ibuprofen 200mg per capsule.

The other ingredients are: Maize Starch, Methylcellulose , Magnesium Stearate, Gelatin, Erythrosine (E172), Titanium Dioxide (E171), Colour S-1-8215 (E171, E172).

What this medicine looks like and contents of the pack

Galpharm Migraine Relief are white and pink capsules printed with “IBU 200”.

This pack contains 16 capsules.

Marketing Authorisation Holder:

Galpharm Healthcare Ltd., Wrafton, Braunton, Devon, EX33 2DL, United Kingdom.

Manufacturer:

Galpharm International Ltd., Elmhirst Park,

Middle Field Road, Barnsley, South Yorkshire,

S75 4LS, United Kingdom.

Text revised: November 2015._    _ _4006irg