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PACKAGE LEAFLET: INFORMATION FOR THE USER

IBUPROFEN 200MG CAPLETS

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you.

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

-    Ask your pharmacist if you need more information or advice

-    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

-    You must talk to a doctor if you do not feel better or if you feel worse. What is in this leaflet

1.    What Ibuprofen Caplets are and What they are used for

2.    What you need to know before you take ibuprofen Caplets

3.    How to take ibuprofen Caplets

4.    Possible side effects

5.    How to store Ibuprofen Caplets

6.    Contents of the pack and other information_

1. What Ibuprofen Caplets are and _what they are used for_

The active substance used in these caplets is Ibuprofen.

Ibuprofen belongs to a group of medicines called non-steroidal antiinflammatory drugs (NSAIDs) which helps relieve pain, reduces inflammation and lowers temperature when you have a fever. These Caplets are used for the relief of rheumatic or muscular pain, pain of non-serious arthritis, backache, neuralgia, migraine, headache, dental pain, period pains, feverishness, and the symptoms of colds and influenza.

2. What you need to know before you take Ibuprofen Caplets

Do not take these Caplets if you:

•    have ever been told you are allergic to ibuprofen, aspirin, other non-steroidal anti-inflammatory drugs, or to any of the other ingredients (these are listed in section 6)

•    have had perforation or a bleeding stomach after taking nonsteroidal anti-inflammatory medicines (you may have been sick and it contained blood or dark particles that looked like coffee grounds, passed blood in your stools or passed black tarry stools)

•    have a stomach ulcer, perforation or bleeding, or have had one twice or more in the past

•    suffer from severe heart, liver or kidney problems

•    have a condition which increases your tendency to bleeding

•    are in the last 3 months of pregnancy

•    have had 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 (Non-Steroidal Anti-inflammatory Drugs)

•    have breathing difficulties

•    are under 12 years of age

•    are taking aspirin at a daily dose above 75mg.

Warnings and Precautions

Talk to your doctor or pharmacist if you:

•    suffer from asthma, or have a past history of asthma

•    have aseptic meningitis or other connective tissue diseases such as SLE (Systemic Lupus Erythematosus)

•    have a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) or suffer from bowel problems

•    are in the first 6 months of pregnancy

•    have kidney or liver problems

•    are elderly, as it increases the frequency of adverse reactions

•    experience prolonged bleeding time

There is a risk of kidney problems in dehydrated children and adolescents.

Other important information Risk of heart attack or stroke:

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 Ibuprofen if you:

-    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 of feet due to narrow or blocked arteries), or any kind of 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.

Women of childbearing age:

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

Other medicines and Ibuprofen Caplets

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

Ibuprofen may affect or be affected by some other medicines. For example:

•    other painkillers, including non-steroidal anti-inflammatory medicines e.g. indometacin or diclofenac, and COX-2 inhibitors e.g. celecoxib

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

•    diuretics e.g. furosemide (drugs to increase urine output)

•    corticosteroids (used to treat inflammatory conditions)

•    methotrexate (used to reduce inflammation)

•    lithium (used as a mood stabiliser)

•    zidovudine (used in retroviral disease like HIV)

•    selective serotonin reuptake inhibitors (SSRIs), e.g. fluoxetine (used for depression)

•    ciclosporin or tacrolimus (given after transplant surgery, or used in psoriasis or rheumatism)

•    mifepristone (for termination of pregnancy) - do not take ibuprofen if you have taken mifepristone in the last 12 days

•    quinolone antibiotics e.g. ciprofloxacin (for infections)

•    medicines that reduce high blood pressure (ACE-inhibitors such as captopril, beta-blockers such as atenolol medicines, angiotensin-II receptor antagonists such as losartan) or drugs for heart disease or to stimulate your heart e. g. glycosides such as digoxin.

•    cholestyramine

•    sulphonyl ureas such as glibenclamide (to treat diabetes)

•    aminoglycosides ( a type of antibiotic)

•    voriconazole or fluconazole (types of anti-fungal drugs)

•    Ginkgo biloba herbal medicine (there is a chance you may bleed more easily if you are taking this with ibuprofen)

Some other medicines may also affect or be affected by the treatment of Ibuprofen. You should therefore always seek the advice of your doctor or pharmacist before you use Ibuprofen with other medicines.

140 mm

Ibuprofen Caplets 200 mg 078 Insert

Front

240 mm

Pregnancy, breast-feeding and fertility

•    Do NOT take this medicine if you are in the last 3 months of pregnancy.

•    Speak to your doctor or pharmacist before taking this medicine if you are in the first 6 months of pregnancy, are breast feeding or are planning to breastfeed.

Ibuprofen Caplets contain Lactose and Sucrose

•    If you have been told by your doctor that you have intolerance to some sugars, check with your doctor before taking this medicine as it contains LACTOSE and SUCROSE.

3. How to take Ibuprofen Caplets

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

•    The caplets should be swallowed with a drink of water.

•    Take with or after food to reduce the possibility of side effects. Adults, the elderly and adolescents of 12 to 17 years:

•    Take one or two Caplets up to 3 times a day.

•    The dose should not be repeated more frequently than every 4 hours. Do not take more than 6 Caplets in any 24 hour period.

This product is intended for short term use only. You should take the lowest dose for the shortest time necessary to relieve your symptoms. Adults and the elderly: If this medicinal product is required for more than 10 days, or if symptoms persist or worsen, consult your doctor. Adolescents: If this medicinal product is required for more than 3 days, or if symptoms persist or worsen, consult your doctor.

Do not give to children under 12 years of age.

If you take more Ibuprofen Caplets than you should Contact your nearest hospital A&E (casually department) or your doctor immediately. Take your medicine in its original packaging with you in order to enable the doctor to identify your medication easily.

If you forget to take a dose of Ibuprofen Caplets If necessary, take the missed dose when you remember.

DO NOT TAKE A DOUBLE DOSE TO MAKE UP FOR A FORGOTTEN DOSE.

4. Possible side effects

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

If you experience any of the following serious effects then STOP taking this medicine immediately and contact your doctor or pharmacist:

•    Peptic ulceration or perforation. Symptoms could include severe abdominal pain, vomiting blood (or liquid with what looks like coffee grounds), blood in the faeces (stools/motions) or passing black tarry stools

•    Inflammation of the brain lining. Symptoms could include stiff neck, headache, feeling or being sick, fever or feeling disorientated

•    Severe allergic reactions. Symptoms could include fainting, faster heart rate, swelling of the face, tongue and throat

•    Worsening of asthma and wheezing or difficulty breathing

•    Severe forms of skin reactions including peeling and blistering of the skin, mouth and genitals (Stevens Johnson syndrome, erythema multiforme and toxic epidermal necrolysis)

Other possible side effects

Uncommon (may affect up to 1 in 100 people)

•    Allergic reactions such as hives, skin rashes and itching

•    Abdominal pain, indigestion, heartburn and feeling sick

•    Headache

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

•    Diarrhoea, wind, constipation or being sick

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

•    Reduction in blood cells, which can make the skin pale or yellow, cause fever, sore throat, mild mouth ulcers, flu-like symptoms, exhaustion or weakness, easy bruising, or bleeding from the skin or nose

•    High blood pressure, heart failure or chest pain

•    Nervousness, visual disturbance, ringing in the ears and dizziness

•    Liver problems. Symptoms could include yellowing of the skin or the whites of the eyes

•    Kidney problems. Symptoms could include swelling of the ankles Not Known (frequency cannot be estimated from the available data)

•    Skin eruptions

Medicines such as Ibuprofen may be associated with a small increased risk of heart attack ("myocardial infarction”) or stroke.

Reporting of side effects

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 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. How to store Ibuprofen Caplets

•    Keep this medicine out of the sight and reach of children.

•    Do not store above 25⁰C. Store in the original package.

•    Do not use this medicine after the expiry date (EXP.) which is stated on the carton. The expiry date refers to the last day of that month.

•    Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information

What Ibuprofen Caplets contain

•    The active substance is Ibuprofen. Other ingredients are lactose, potato starch, methylcellulose, sodium starch glycolate, colloidal anhydrous silica, magnesium stearate, sucrose, talc, pregelatinised maize starch, maize starch and titanium dioxide (E171).

What Ibuprofen Caplets look like and contents of the pack

•    The caplets are white capsule shaped sugar coated.

•    The caplets are available in packs containing 24, 48 or 96 Caplets.

•    Not all pack sizes may be marketed.

Marketing authorisation holder and Manufacturer

Name and address:    Bristol Laboratories Ltd,

Unit 3, Canal side, Northbridge Road, Berkhamsted, Hertfordshire,

HP4 1EG, United Kingdom Telephone:    0044 (0)1442 200922

Fax:    0044 (0)1442 873717

E-mail:    info@bristol-labs.co.uk

Ibuprofen 200mg Caplets; PL 17907/0078 This leaflet was last revised in December 2015

To request a copy of this leaflet in Braille, large print or audio format, please contact the licence holder at the address (or telephone, fax, email) above.

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