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IBUPROFEN 400mg TABLETS    ffe/Ofl «

Ibuprofen

PACKAGE LEAFLET: INFORMATION FOR THE USER

Read all of this leaflet carefully before you start taking this medicine 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.

•    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 your 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 Tablets

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

The name of your medicine is Ibuprofen 400mg Tablets. They contain the active ingredient called Ibuprofen.

Ibuprofen belongs to the group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). These drugs are painkillers and reduce inflammation.

Ibuprofen 400mg Tablets are used for:

•    Rheumatic or muscular pain

•    Pain of non-serious arthritic conditions (characterized by pain and stiffness in your body)

•    Back pain

•    Neuralgia (painful disorder of the nerves)

•    Headache including migraine

•    Toothache

•    Period pain

•    Feverishness

•    Symptoms of cold & influenza.

2.    WHAT YOU NEED TO KNOW BEFORE YOU TAKE IBUPROFEN TABLETS

Do not take Ibuprofen Tablets if you:

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

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

•    have had 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 (Non steroidal anti-inflammatory drugs).

•    suffer from severe liver,kidney or heart failure.

•    are in the last 3 months of pregnancy.

Warnings and precautions

Talk to your doctor or pharmacist or nurse before

taking Ibuprofen Tablets if you:

•    have or have had asthma.

•    have kidney, liver or bowel problems.

•    are suffering from blurred

vision,diminished vision or changes in

colour vision.

•    have heart problems, have had a previous stroke or think that you may be at risk of these conditions(for example if you have high blood pressure, diabetes or high cholesterol, are a smoker). 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 recommended dose or duration of treatment (no more than 10 days).

•    have a history of gastrointestinal disease (such as ulcerative colitis, Crohn's disease).

•    are elderly.

•    are in the first 6 months of pregnancy.

•    are trying to become pregnant (Ibuprofen belongs to a group of medicines (NSAIDS) which may impair fertility in women. The effect is reversible upon 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.

•    have Systemic Lupus Erythematosus (a condition of the immune system affecting connective tissue resulting in joint pain, skin change and disorders of other organs)

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

Other medicines and Ibuprofen Tablets

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

Do not use the medicine if you are:

•    taking other NSAID pain killers or aspirin with a daily dose above 75mg.

Some medicines may interact with Ibuprofen Tablets.

•    blood thinning drugs (anti coagulants e.g. warfarin)

•    drugs to prevent clotting (anti platelet drugs e.g. aspirin)

•    drugs to help you passing water (diuretics)

•    drugs to treat high blood pressure (e.g captopril, atenolol, losartan)

•    drugs to treat mania and depression (lithium and SSRIs)

•    corticosteroids (to treat allergic or inflammatory disorders)

•    drugs used to treat HIV (e.g. Zidovudine)

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

•    antibiotics [e.g. ciprofloxacin and drugs used to stimulate your heart (e.g. glycosides)

•    mifepristone (for pregnancy termination).

Fertility

This medicine belongs to a group of medicines which may impair fertility in women. This effect goes away when the medicine is stopped. It is unlikely that this medicine, used occasionally, will affect your chances of becoming pregnant.

Pregnancy and breast-feeding Do not take Ibuprofen Tablets if you are in the last 3 months of pregnancy. Speak to your pharmacist or doctor before taking this product if you are in the first 6 months of pregnancy or are breast feeding.

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3.    HOW TO TAKE IBUPROFEN TABLETS

Always take Ibuprofen Tablets exactly as your doctor or pharmacist has told you. You should check with your doctor or pharmacist if you are not sure. Swallow the tablets with water during or after meals.

The usual dose is:

Adults, the elderly and children over 12 years:

The starting dose is 1 tablet 3 times a day, as required. Leave at least four hours between doses and do not take more than three tablets in any 24 hour period. The risk of side effects is greater in the elderly, so your doctor will give you the lowest dose possible, and take special care of you.

Children below 12 years: Not recommended.

Ibuprofen Tablets are for short term use only. Take the lowest dose for the shortest time necessary to relieve your symptoms. Do not take Ibuprofen for longer than 10 days.

If you take more Ibuprofen Tablets than you should

If you or someone you know accidentally takes a lot more than the stated dose (an overdose), you should contact a doctor immediately or go to the nearest A& E department.

If you forget to take Ibuprofen Tablets

If you forget to take a dose, take it as soon as you remember unless it is almost time for your next dose. Do not take a double dose to make up for a forgotten tablet.

4.    POSSIBLE SIDE EFFECTS

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

If any of the following happens, STOP TAKING Ibuprofen Tablets and tell your doctor immediately or go to the nearest hospital emergency department:

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

•    Signs of serious allergic reaction such as:

. Difficulties in breathing or unexplained

wheezing

. Dizziness or faster heartbeat . Severe forms of skin reactions such as itchiness, skin rash with redness, peeling, flaking or blistering (e.g. Steven-Johnson Syndrome)

.    Swelling of your face, tongue or throat

•    Signs of kidney problems such as:

. Passing less or more urine

. Cloudy urine or blood in urine . Pain in the back and/or swelling (particularly in the legs)

•    Signs of aseptic meningitis. You may have a stiff neck, headache, feeling sick, being sick, fever or confusion. Patients with autoimmune disorders (lupus, mixed connective tissue disease) may be more likely to be affected

STOP TAKING the medicine and tell your doctor if you experience any of the following uncommon side effects (affects 1 to 10 patients in 1,000)

•    Indigestion, heartburn or feeling sick

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

Other side effects include:

Uncommon (affects 1 to 10 patients in 1,000)

•    Allergic reactions such as skin rashes (urticaria) itching, peeling

•    Headache

Rare (affects 1 to 10 patients in 10,000)

•    Diarrhoea, flatulence (wind), constipation and vomiting

Very rare (affects less than 1 user in 10,000)

•    Blood disorders resulting in unexplained bruising or bleeding, fever, sore throat, mouth ulcers, flulike symptoms and severe exhaustion

•    drop in blood pressure or irregular heart beat

•    stomach or intestinal ulcers, sometimes with bleeding and perforation, inflammation of the lining of the mouth with ulceration (ulcerative stomatitis), inflammation of the stomach (gastritis)

•    liver problems

Side effects for which the frequency can not be estimated from available data:

•    worsening of asthma or bronchospasm

•    swelling (oedema), high blood pressure, heart failure or attack

•    worsening of colitis and Crohn's disease

Medicines such as Ibuprofen Tablets may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. See section 2, Warnings and precautions.

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 TABLETS

Keep out of the sight and reach of children.

Do not store the tablets above 25°C. Keep them in the original pack.

Do not take these tablets after the expiry date shown on the pack.

The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer required. These measures will help to protect the environment.

6.    CONTENTS OF THE PACK AND OTHER INFORMATION

What Ibuprofen Tablets contain:

The active substance is Ibuprofen. The other ingredients are Pregelatinised Starch, Maize Starch, Colloidal Anhydrous Silica, Magnesium Stearate, Hypromellose, Macrogol 6000, Erythrosine Lake (E127), Titanium Dioxide (E171) and Docusate Sodium.

What Ibuprofen Tablets look like and contents of the pack:

Ibuprofen 400mg Tablets are pink, biconvex, film-coated tablets with “I 400” on one side and packed in tablet containers of 21, 100, 250, 500, 1000 and blister packs of 12, 21,24, 28, 48, 56, 84, 96, 100.

Marketing Authorisation Holder and Manufacturer:

Relonchem Limited

Cheshire House, Gorsey Lane, Widnes, Cheshire

WA8 0RP, UK

Tel: 02074195043

Fax: 02074195024

Email: Info@relonchem.com

PL 20395/0080

Date leaflet revised: July 2015.