IBUPROFEN COATED TABLETS 200 mg

Relon 3 an

PACKAGE LEAFLET: INFORMATION FORTHE USER

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 or nurse has 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 or nurse. 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 after 10 days.

What is in this leaflet:

1.    What Ibuprofen tablets are and what they are used for

2.    What you need to know before you take Ibuprofen

3.    How to take Ibuprofen tablets

4.    Possible side effects

5.    How to store Ibuprofen tablets

6.    Contents of the pack and other information

1. What Ibuprofen tablets are and what they are used for

Ibuprofen is one of a group of medicines called non-steroidal anti-inflammatory drugs or NSAIDs, which work by changing the body's response to pain, swelling and high temperature. These tablets are used to provide relief of headache, muscular pain, rheumatic pain, pain of non serious arthritic conditions, backache, neuralgia (nerve pain), migraine, period pain, dental pain, feverishness and the symptoms of colds and flu.

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

Do not take these tablets if:

•    you have had an allergic reaction to aspirin, ibuprofen, any other NSAIDs or any of the ingredients (see section 6 for further information)

•    youhavehadworseningofasthma, developed an allergic rash, facial swelling or an itchy runny nose when taking Ibuprofen, aspirin orsimilar medicines

•    you have had liver, kidney or severe heart problems

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

•    you are in the last 3 months of pregnancy

•    you are under 12 years of age

Warnings and precautions

Talk to your doctor, or pharmacist or nurse

before taking Ibuprofen Tablets if:

•    you have high blood pressure

•    you have asthma or have suffered from asthma

•    you have kidney, heart, bowel or liver problems

•    you have a condition known as Systemic Lupus Erythematosus (SLE) - an illness which affects your immune system. It causes joint pain, skin changes and problems with other parts of your body

• you are elderly

• you are pregnant or breastfeeding (see section Pregnancy, breast-feeding and fertility)

•    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), in which case, you should discuss your treatment with your doctor or pharmacist

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

Important warning

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

Other medicines and Ibuprofen Tablets

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

Tell your doctor or pharmacist ifyou are taking, have recently taken or might take any other medicines, in particular:

•    other pain relievers or products containing Aspirin, Ibuprofen orother NSAIDs

•    medicines for high blood pressure e.g. diuretics (frusemide, bendroflumethiazide, hydrochlorothiazide), ACE inhibitors (enalapril, ramipril). Angiotensin II receptor blockers (losartan), beta blockers (atenolol), calcium channel blockers (amlodipine)

•    medicines for treating heart conditions e.g. digoxin for atrial fibrillation (a condition with an irregular heart beat)

•    medicines for thinning the blood (e.g. warfarin and ticlopidine)

•    corticosteroids (e.g. prednisolone)

•    mifepristone (a medicine which is used to start labour)

•    medicines which weaken the immune system (ciclosporin)

•    methotrexate (a medicine for cancer) and rheumatoid arthritis

•    medicines for depression and mood stabilising drugs (lithium, citalopram and fluoxetine)

•    quinolone antibiotics and zidovudine (medicines used to treat bacterial and viral infection)

You should therefore always seek the advice of your doctor or pharmacist before you take Ibuprofen with other medicines.

Pregnancy, breast-feeding and fertility

Fertility

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

Pregnancy and breast-feeding

The use of Ibuprofen whilst pregnant or breast feeding should be avoided.

Ibuprofen should not be used in late (the last three months) of pregnancy and should only be taken in the first six months of pregnancy on the advice of your doctor.

Driving and using machinery

Taking Ibuprofen will not affect your ability to drive or use machines.

Ibuprofen Tablets contain lactose and sucrose

Ifyou have been told by your doctor that you have intolerance to some sugars you should not take this medicine.

Taking with food and drink

Ibuprofen tablets should be taken with water, preferably with or after food.

3. How to take Ibuprofen

This product is intended for short term use only. You should take the lowest dose for the shortest time necessary to relieve your symptoms. You should not take Ibuprofen for longer than 10 days unless your doctor tells you to. If symptoms persist orworsen cansult your doctor.

Adults, the elderly and children over 12 years: Dose for Ibuprofen:

•    take one to two tablets with water to start with, preferably with or after food, followed by one to two tablets every four hours if necessary up to three times a day

•    Do not take more than six tablets in any twenty-four hour period

Children under 12 years:

Do not give Ibuprofen to children under 12 years old.

Ifyou thinkyou have taken more Ibuprofen than you should:

If you take too many Ibuprofen tablets talk to your doctor straight away or go to the nearest hospital casualty unit.

Ifyou forget to take Ibuprofen:

If you have missed a dose, do not double up on a dose to make up for the forgotten dose. Take the next dose at the usual time.

Ifyou stop using Ibuprofen:

Please speak to your doctor or pharmacist before stopping this or any medicine.

4. Possible side effects

Like all medicines Ibuprofen can have side effects, although not everybody gets them.

If you get any of these SERIOUS side effects, stop taking the tablets and go to your nearest casualty department at once:

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

•    Pass blood in your faeces (stools/motions)

•    Pass black tarry stools

•    Stomach problems including pain, indigestion or heartburn

•    Severe skin conditions, causing peeling and blistering ofthe skin, mouth and eyes

•    Unexplained wheezing, shortness of breath, swelling ofthe lips, face or neck, skin rash or itching, fast heart beat, or low blood pressure, as these may be signs of an allergic reaction

•    Meningitis (e.g. stiff neck, fever, disorientation).

These other effects are LESS SERIOUS. If they bother you talk to a doctor or pharmacist:

•    Kidney or liver problems

•    Nausea (feeling sick)

•    Headaches

•    Abdominal pain (pains in your stomach) or other abdominal stomach symptoms

•    Indigestion or heartburn

•    Fever, sore throat, mouth ulcers, flu-like symptoms, severe exhaustion, unexplained bleeding and bruising.

Uncommon side effects (less than 1 per100 but more than 1 perlOOO) which may occur are as follows:

•    Headaches, dizziness

•    Nausea (feeling sick)

•    Various skin rashes

•    Drowsiness

•    Difficultywithsleeping.

Rare side effects (less than 1 perlOOO but more than 1 per10,000) which may occur are as follows:

•    Diarrhoea

•    Flatulence (passing wind)

•    Constipation

•    Vomiting.

Very rare side effects (less than 1 per10,000) which may occur are as follows:

•    Kidney or liver problems

•    Symptoms of aseptic meningitis (stiff neck, headache, feeling sick, vomiting, fever or disorientation)

•    Feeling nervous

•    Visual disturbances including optic nerve problems (Toxic amblypia)

•    Ringing in the ears (Tinnitus) and a feeling of 'spinning' (vertigo)

•    Changes in the blood which will be picked up by a blood test

•    Abnormal fluid accumulation in tissues of the body (oedema).

The following side effects may also occur but it is not known how frequently they occur:

•    Worsening of a previous asthmatic condition

•    High blood pressure

•    Heart failure, a condition in which the heart is unable to pump blood and oxygen to the rest of the body, chest pain

•    Worsening of inflammatory bowel conditions such as ulcerative colitis and Crohn's disease

•    Shortnessofbreath.

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

5. How to store Ibuprofen

KEEP OUT OF THE SIGHT AND REACH OF CHILDREN

•    do not store above 25°C

•    store in the original package to protect from moisture

•    do not use after the expiry date shown on the package

6. Contents of the pack and other information

What does each Ibuprofen tablet contain:

Each tablet contains the active ingredient Ibuprofen BP 200mg. Other ingredients are lactose monohydrate, microcrystalline cellulose, sodium starch glycollate, starch, colloidal anhydrous silica, magnesium stearate, sucrose, talc and titanium dioxide (El 71).

What is in the pack:

This product contains white round shaped sugar coated tablets. Ibuprofen is available in blister packs of6, 12, 16, 24,48, 84 and 96 tablets*.

Marketing Authorisation Holder and Manufacturer:

Relonchem Limited

Cheshire House, Gorsey lane, Widnes,

Cheshire, WA8 ORP, UK

*not all pack sizes may be marketed

PL 20395/0090

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Leaflet was last revised in March 2015.