PACKAGE LEAFLET: INFORMATION FORTHE USER

IBUPROFEN 200mg SOFT CAPSULES

READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.

This medicine is available without prescription. However, you still need to take Ibuprofen 200mg Soft Capsules carefully to get the best results from it.

Keep this leaflet. You may need to read it again. Askyour pharmacist if you need more information or advice.

You must contact a doctor if your symptoms worsen or do not improve after 10 days.

If any of the side effects gets serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Ibuprofen Soft Capsules are and what they are used for

2.    Before you take Ibuprofen Soft Capsules

3.    How to take Ibuprofen Soft Capsules

4.    Possible side effects

5.    How to store Ibuprofen Soft Capsules

6.    Further information

1.    WHAT IBUPROFEN 200mg SOFT CAPSULES ARE AND WHAT THEY ARE USED FOR

The active ingredient is ibuprofen. It belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDS).They provide relief by changing the body's response to pain, swelling, and high temperature.

Ibuprofen 200mg Soft Capsules are used for the relief of:

•    Headache and migraine pain

•    Dental pain and neuralgia

•    Period pain

•    Rheumatic, muscular and back pain

•    Feverishness and symptoms of cold & flu.

2.    BEFORE YOU TAKE IBUPROFEN 200mg SOFT CAPSULES

Do not take Ibuprofen 200mg Soft Capsules if you:

•    are allergic to ibuprofen or any of the other ingredients (see section 6) or to aspirin or other painkillers

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

•    have had a worsening of asthma, skin rash, itchy runny nose or facial swelling when previously taking ibuprofen, aspirin or similar medicines

•    have had gastrointestinal bleeding or perforation when previously taking NSAIDS.

•    are taking other NSAID painkillers or more than 75mg aspirin per day

•    have severe liver or kidney problems

•    have heart problems, high blood pressure or blood coagulation disorder

•    have breathing difficulties

•    are in the last 3 months of pregnancy

•    are under 12 years old.

Check with your pharmacist or doctor before taking Ibuprofen 200mg Soft Capsules if you:

•    have or have had asthma

•    have kidney, liver, bowel or heart problems.

•    have high cholesterol or have had a heart attack or stroke

•    have a history of gastrointestinal disease such as ulcerative colitis or Crohn's disease

•    have Systemic Lupus Erythematosus (an immune system condition causing joint pain, skin changes and other organ disorders)

•    are a smoker

•    are in the first 6 months of pregnancy

•    have hereditary problems of fructose intolerance or are on a controlled potassium diet (see end of section 2 - Important information about some of the ingredients of this medicine).

Taking other medicines

To reduce the risk of side effects, do not take this medicine with other NSAID containing products such as aspirin, ibuprofen, indometacin etc.

Avoid taking this medicine with corticosteroid tablets, quinolone antibiotics or drugs that are prescribed:

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

•    to stimulate your heart (e.g. glycosides) or prevent high blood pressure

•    to help you pass water (diuretics)

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

•    for mania or depression (e.g. lithium or SSRIs)

•    for pregnancy termination (e.g. mifepristone)

•    for HIV treatment (e.g. zidovudine)

Speak to your pharmacist or doctor before taking ibuprofen with other medicines.

Other warnings

•    Ibuprofen 200mg Soft Capsules belongs to a group of medicines which may impair fertility in women. This is reversible on stopping taking the medicine. It is unlikely that Ibuprofen 200mg Soft Capsules, used occasionally will affect your chances of becoming pregnant. However, tell your doctor before taking this medicine if you have problems becoming pregnant.

•    Medicines such as Ibuprofen 200mg Soft Capsules may be associated with a small increased risk of heart attack or stroke.

Any risk is more likely with high dose or prolonged treatment. Do not exceed the recommended dose.

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

•    If you have heart problems, previous stroke or think that you might be at risk of these conditions (e.g. if you have high blood

pressure, high cholesterol or are a smoker), then discuss treatment with your doctor or pharmacist.

Pregnancy and breast-feeding

Do not take

•    in the last 3 months of pregnancy

•    if you are breast-feeding.

Speak to your doctor if you are in the first 6 months of pregnancy.

Important information about some of the ingredients of this medicine:

This medicine contains:

•    Ponceau 4R red (El 24).

May cause allergic reactions.

•    58.6 mg of sorbitol, a source of 14.7 mg of fructose per capsule. Patients with rare hereditary problems of fructose intolerance should not take this medicine.

•    17.4 mg of potassium per capsule; to be taken into consideration by patients on a controlled potassium diet.

3.    HOWTO TAKE IBUPROFEN 200mg SOFT CAPSULES

This medicine is for short term use.

Take the lowest dose for the shortest time needed to relieve your symptoms.

Adults, the elderly and adolescents of 12 to 17 years:

Take 1 or 2 capsules with water, up to three times a day as required.

Leave at least four hours between doses.

Adults and the elderly:

If this medicinal product is required for more than 10 days, or if symptoms persist or worsen, contact your doctor.

Adolescents:

If this medicinal product is required for more than 3 days, or if symptoms worsen a doctor should be consulted

Do not take more than 6 capsules in 24 hours. Do not give to children under 12 years.

Do not take for longer than 10 days unless your doctor tells you to. If symptoms persist or pain or fever worsen, or if any new symptoms occur, consult your doctor or pharmacist.

If you take more Ibuprofen 200mg Soft Capsules than you should, you may feel drowsy or nauseous. You should seek immediate medical advice in the event of an overdose, even if you feel well.

If you forget to take Ibuprofen 200mg Soft Capsules

Refer to the directions above on how to take this medicine and do not take more than advised.

4.    POSSIBLE SIDE EFFECTS STOPTAKING the medicine and seek immediate medical help if you develop:

•    signs of intestinal bleeding such as: bright red faeces (stools), black tarry stools, vomiting blood or dark particles that look like coffee grounds.

•    signs of serious allergic reaction such as:

-    breathing difficulties or unexplained wheezing

-    dizziness or faster heartbeat

-    severe skin reaction (rashes, itchiness, peeling, flaking or blistering)

-    swelling of your face or throat

Tell your doctor if you experience:

•    fever, flu-like symptoms, sore throat, mouth ulcers, headache, a stiff neck, vomiting, unexplained bleeding and bruising, severe exhaustion.

•    indigestion, stomach or abdominal pain, constipation, diarrhoea, flatulence, or if you feel sick, chest pain or fast irregular heart beat.

•    liver or kidney problems associated with swelling in your arms and legs.

Medicines such as Ibuprofen 200mg Soft Capsules may be associated with a small increased risk of heart attack or stroke, (see section 2 'Other warnings').

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

5.    HOWTO STORE IBUPROFEN 200mg SOFT CAPSULES

Keep out of the sight and reach of children.

Do not use after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

Do not store above 25°C.

Store in the original pack.

6.    FURTHER INFORMATION

What Ibuprofen 200mg Soft Capsules contains

•    Each capsule contains 200mg of the active ingredient ibuprofen.

•    The other ingredients are Macrogol 400, sorbitan mono oleate, sorbitol (E420), potassium hydroxide (E525), gelatin (E441), Ponceau 4R red (El 24), triglycerides, shellac, titanium dioxide (El 71), propylene glycol and water.

What Ibuprofen 200mg Soft Capsules looks like and contents of the pack

Wine red colour oval shaped soft gelatin capsules containing pink to dark pink viscous liquid, printed'142'in white colour on capsule shell. Available in blister packs of 10,12 or 16 capsules.

Marketing Authorisation Holder and Manufacturer:

Bell, Sons & Co. (Druggists) Ltd.

Southport PR9 9AL. UK PL 03105/0105

This leaflet is available in either large print or Braille format upon request; telephone 0151 422 1200 or write to the above address.

C73-0006Ver B Revised December 2015

D24-0385

D24-0380