PACKAGE LEAFLET: INFORMATION FOR THE USER Maximum Strength Ibuprofen 400mg Coated Tablets

Ibuprofen

(Referred to as Ibuprofen tablets in the remainder of the leaflet)

Read all of this leaflet carefully before you

start to take this medicine.

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

-    If you have any further questions, please ask your doctor or pharmacist.

-    This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

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

In this leaflet:

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

2.    Before you take Ibuprofen tablets

3.    How to take Ibuprofen tablets

4.    Possible side effects

5.    How to store Ibuprofen tablets

6.    Further information

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

The name of your medicine is Ibuprofen tablets. The active ingredient in your medicine is ibuprofen. Ibuprofen belongs to a group of medicines called Non-Steroidal Anti-inflammatory Drugs (NSAIDs). Ibuprofen works by reducing inflammation and relieving pain including period pain, nerve related pain (neuralgia), dental pain, headaches and migraine, backache, swelling and stiffness in the joints and muscles (rheumatic and muscular pain), arthritis, fever and cold and flu symptoms.

2. Before you take Ibuprofen tablets

Do not take Ibuprofen tablets if you

•    are allergic (hypersensitive), or have had an allergic reaction to, ibuprofen, any other NSAID, aspirin, or to any of the other ingredients in this medicine (see section 6. Further information). Symptoms of an allergic reaction may include swollen eyelids, lips, tongue, or throat

•    have ever had a worsening of symptoms of asthma (breathing difficulty), hayfever (runny, itchy and inflamed nose with sneezing), urticaria (an itchy rash), or angioedema (swelling under the skin) when taking ibuprofen, aspirin or similar painkillers

•    currently have or have had a stomach ulcer or bleeding in the stomach on two previous occasions

•    have ever had perforation or bleeding of the gut when taking any NSAID

•    suffer from severe liver, kidney or heart problems

•    are in the last 3 months of pregnancy

•    have abnormal bleeding or problems with abnormal bruising

•    are currently taking mifamurtide (a medicine used to treat bone cancer).

Take special care with Ibuprofen tablets if you

•    develop a skin rash or allergic reaction after taking this medicine. If you have any of these symptoms stop taking this medicine and contact your doctor immediately.

•    are elderly, as you may be more prone to side effects (see section 4. Possible Side Effects) which in some cases may be extremely serious or even life threatening

•    have a history of asthma or other allergy disorders

•    have liver, kidney, or bowel problems

•    have Systemic Lupus Erythematosus (SLE), a condition of the immune system resulting in joint pains, skin rashes, kidney or liver problems

•    have or have had high blood pressure or heart problems. Speak to your doctor who will advise you on your treatment and may wish to monitor you

•    have a history of bleeding in the stomach or gut. Speak to your doctor immediately if you notice any problems with your stomach, especially at the start of your treatment

•    smoke

•    have an infection, as symptoms such as fever, pain and swelling may be masked

•    are a child with chickenpox

•    are in the first 6 months of your pregnancy

•    are taking other NSAID painkillers including a specific type called COX-2 inhibitors, or aspirin, with a daily dose above 75mg

•    if you are on low-dose aspirin (up to 75mg). Speak to your doctor or pharmacist before you take this medicine.

Medicines such as Ibuprofen tablets 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 treatments. Do not exceed the recommended dose or duration of treatment (10 days).

If 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) you should discuss your treatment with your doctor or pharmacist.

Taking other medicines

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. The following medicines can affect or be affected by treatment with:

•    other pain killers including aspirin or other NSAIDs

•    medicines used to treat bacterial infections

•    medicines to prevent blood clotting (anti-coagulants) such as warfarin and heparin, or clopidogrel and ticlopidine

•    medicines used to treat depression, such as selective serotonin re-uptake inhibitors (SSRIs) and lithium

•    medicines used to treat diabetes

•    medicines used to treat epilepsy

•    medicines used to treat high blood pressure including ACE inhibitors such as captopril, angiotensin-II antagonists such as losartan, beta-blockers such as atenolol, and vasodilators

•    medicines used to treat viral infections, such as zidovudine and ritonavir

•    medicines used to treat heart failure

•    medicines used to treat various illnesses that involve inflammation in the body (corticosteroids)

•    medicines used to treat cancer, such as methotrexate and mifamurtide

•    medicines used during abortion, such as mifepristone

•    medicines used to relax muscles

•    pentoxyfylline, used to treat blood circulation problems

•    diuretics, medicines used to help you pass water (urine)

•    medicines used to suppress the immune system in patients who have had a transplant, such as ciclosporin and tacrolimus

•    penicillamine, used to treat a number of conditions such as rheumatoid arthritis, Wilson's disease.

Taking Ibuprofen tablets with food and drink

Do not drink alcohol whilst taking this medicine.

Pregnancy

Do not take Ibuprofen tablets if you are in the last 3 months of pregnancy.

Ibuprofen Tablets should be avoided in the first six months of pregnancy.

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

Ask your doctor or pharmacist for advice before taking any medicine.

Breastfeeding

It is possible that this medicine can pass into breast milk. If you are breastfeeding, speak to your doctor or pharmacist for advice before taking this, or any medicine.

Driving and using machinery This medicine may make you feel dizzy, drowsy or tired. You may also experience blurry vision. Do not drive or use tools or machines if you are affected in any way after taking this medicine.

Important information about some of the ingredients of Ibuprofen tablets

This product contains sucrose. If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take Ibuprofen tablets

Always take Ibuprofen tablets exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Adults, Elderly and Children over 12 years 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 tablets for longer than 10 days unless your doctor tells you to. If symptoms persist or worsen consult your doctor.

The usual dose is 400mg (1 tablet) to be taken with a drink of water, preferably with or after food, up to three times a day as required.

The dose should not be repeated more frequently than every 4 hours. Do not take more than 1200mg (3 tablets) in 24 hours.

Taking this medicine with or after food or milk may only partially reduce stomach side effects such as indigestion (see section 4).

If you take more Ibuprofen tablets than you should

If you accidentally take too many Ibuprofen tablets, you should contact your doctor or go to your nearest hospital casualty department immediately. Take this leaflet and any unused tablets with you to show the doctor.

The symptoms of an overdose include vomiting (being sick), nausea (feeling sick), stomach pain and possibly diarrhoea. Dizziness, ringing in the ears (tinnitus) and fainting can also be signs of an overdose. The doctor will assess your condition and decide how to treat your overdose.

If you forget to take Ibuprofen tablets

If you forget to take your medicine take it

102483/7

as soon as you remember. If it is almost time for your next dose do not take the missed dose at all. NEVER take a double dose to make up for the one missed.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

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

For the assessment of side effects, the following descriptions of frequency have been used:

Very common

More than 1 in 10 patients treated Common

Less than 1 in 10 patients treated Uncommon

Less than 1 in 100 patients treated Rare

Less than 1 in 1,000 patients treated Very rare

Less than 1 in 10,000 patients treated Not known

Frequency cannot be established

If you have an allergic reaction to Ibuprofen tablets, tell your doctor straight away. The signs of an allergic reaction include:

•    swelling of your face, lips, or tongue

•    difficulty breathing

•    itchy lumpy rash or a painful rash of dark red spots under the skin which do not go away when you put pressure on them.

The following effects are very rare, but if you suffer from any of the following at any time during your treatment STOP TAKING the medicine and seek immediate medical help:

•    pass blood in your stools or motions (faeces)

•    pass black tarry stools

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

STOP TAKING the medicine and tell your doctor if you experience any of the following uncommon effects:

•    indigestion or heartburn

•    pain in your stomach or any other unusual stomach pains.

The following side effects may be experienced when taking Ibuprofen tablets.

Infections

Very rare

•    stiff neck, headache, nausea, vomiting, fever and disorientation. This can be a sign of inflammation of the brain.

Blood disorders

Very rare

•    frequent infections, fever, bruising more easily, feeling weak, sore throat, mouth ulcers, nose bleeds, bleeding gums, chills, tiredness, pale skin (often with a yellow tinge), shortness of breath. This maybe a sign of a blood disorder.

Metabolic disorders

Not known

•    tiredness, confusion, and muscle weakness and muscle cramps. This may be due to low levels of potassium in your body

•    tired, weak, confused and have muscles that ache, are stiff or do not work well. This may be due to low sodium levels in your blood.

Psychiatric disorders Not known

•    depression

•    feeling nervous or confused

•    difficulty sleeping (insomnia)

•    seeing or hearing things that are not there (hallucinations).

Nervous system disorders Uncommon

•    headaches

Not known

•    feeling dizzy

•    feeling drowsy

•    unusual feelings such as numbness, tingling, pricking, burning or creeping on the skin (paraesthesia).

Eye disorders

Not known

•    changes in your vision

•    inflammation of the eye.

Ear disorders

Not known

•    ringing in the ears (tinnitus)

•    feeling dizzy with a spinning feeling (vertigo).

Cardiac disorders

Not known

•    high blood pressure

•    fluid retention (swelling) that may cause heart failure

•    heart attack.

Vascular disorders Not known

•    inflammatory disease of the blood vessels, which is often associated with a skin rash or bruising

•    stroke.

Respiratory disorders Not known

•    difficulty breathing, wheezing, tightness in the chest.

Gastrointestinal disorders

Uncommon

•    nausea (feeling sick)

Rare

•    diarrhoea, wind, constipation

•    vomiting (being sick)

Very rare

•    infectious disease of the mouth, characterised by shallow ulcers on the cheeks, tongue and lips

•    inflammation of the bowel or stomach

•    perforation or bleeding of the gut

•    burning, aching pain with an empty feeling and hunger. This may be caused by an ulcer in your stomach or gut

•    inflammatory disease of the intestines, or worsening of Crohn's disease

Not known

•    severe stomach pain which may reach through to your back. This could be a sign of pancreatitis.

Liver disorders

Not known

•    yellowing of your skin or eyes and your urine may become darker in colour. This could be a liver problem, such as jaundice or hepatitis.

Skin disorders

Very rare

•    itchy skin rash that can affect the mouth, genitals, nails and hair

•    blistering or peeling of the skin around the lips, eyes, mouth, nose and genitals, flu like symptoms and fever. This could be a condition called Steven's Johnson syndrome

Not known

•    your skin may become more sensitive to sunlight.

Kidney disorders Very rare

•    changes in the way the kidneys are working

•    renal failure

Not known

•    blood in the urine

•    pain in the side or the small of the back.

General disorders

Not known

•    general feeling of being unwell

•    feeling tired.

Medicines such as Ibuprofen tablets may be associated with a small increased risk of heart attack

("myocardial infarction") or stroke.

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

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 reach and sight of children. Do not use Ibuprofen tablets after the expiry date stated on the blister or carton. The expiry date refers to the last day of that month.

Do not store above 25°C. Store in the original package in order to protect from light and moisture

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

6. Further information

What Ibuprofen tablets contain

The active ingredient is ibuprofen.

Each Maximum Strength Ibuprofen 400mg Coated Tablet contains 400mg of ibuprofen.

The other ingredients are colloidal anhydrous silica, starch, povidone, microcrystalline cellulose, alginic acid, magnesium stearate, sodium lauryl sulfate, sodium starch glycollate and croscarmellose sodium.

The coating contains polyvinyl acetate phthalate, stearic acid, purified talc, sucrose, calcium carbonate, acacia, titanium dioxide (E171) and carnauba wax.

What Ibuprofen tablets look like and the contents of the pack Ibuprofen tablets are round, white, sugar coated tablets.

Ibuprofen tablets are available in the following packs:

•    blister packs of 8, 12, 16, 24, 32, 48, 56, 64, 72, 84, or 96 tablets

•    plastic bottles with a child proof cap, in pack sizes of 25 and 50 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Wockhardt UK Ltd, Ash Road North, Wrexham LL13 9UF, UK

Manufacturer

CP Pharmaceuticals Ltd, Ash Road North, Wrexham, LL13 9UF, UK

Other formats:

To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge: 0800 198 5000 (UK only).

Leaflet Prepared: September 2013.

Twockhardt