PATIENT INFORMATION LEAFLET IBUPROFEN 400mg TABLETS

Please read all this leaflet carefully before you start taking this medicine.

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

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

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

WHAT IS IN YOUR IBUPROFEN 400mg TABLETS ?

Ibuprofen 400mg Tablets are round, white, film coated tablets, each containing Ibuprofen BP 400mg and the inactive ingredients Pregelatinised Starch, Maize Starch, Anhydrous Silicon Dioxide, Magnesium Stearate, Polyethylene Glycol and the colour Titanium Dioxide (E171).

Ibuprofen 400mg Tablets are available on prescription from your doctor, who will decide how many to prescribe for you.

Ibuprofen is a non-steroidal anti-inflammatory medicine.

WHO MAKES YOUR MEDICINE?

Product Licence Holder and Manufacturer of these tablets is:

Max Remedies Ltd, William Nadin Way, Swadlincote, Derbyshire, DE11 0BB, UK

WHAT IS YOUR MEDICINE USED FOR?

Ibuprofen works by reducing the production of the chemical messengers in the body, which cause the sensations of swelling and pain.

Ibuprofen therefore is used for its anti-inflammatory effects in the treatment of rheumatoid arthritis, osteoarthritis and other non-rheumatoid arthropathies. Ibuprofen can also be used in the treatment of non-articular rheumatic conditions such as frozen shoulder (capsulitis) and lower back pains. Ibuprofen is also used in the treatment of soft tissue injuries such as sprains and strains.

The analgesic effects of ibuprofen can be used to relieve mild to moderate pain such as dental and postoperative pain and for the symptomatic relief of headache including migraine headache.

BEFORE TAKING YOUR MEDICINE

If you answer YES to any of the following questions, or are not sure, DO NOT TAKE THIS MEDICINE and contact your doctor or pharmacist, as you may need to be given another medicine instead.

•    Do you or have you ever suffered from stomach or duodenal ulcers? Or you have (or have had two or more episodes of) a stomach ulcer, perforation or bleeding.

•    Have you ever had a previous reaction to ibuprofen, aspirin or other "pain killers"?

This might be asthma, skin rash or itching, or inflammation (swelling) of the membranes in your nose.

•    Have you ever had a reaction to any of the other ingredients in Ibuprofen 400 mg Tablets? Check by reading the list above.

•    Do you suffer from any bleeding disorders?

If you suffer from any of the following, make sure that your doctor is aware of this before you take ibuprofen tablets.

•    Bronchial asthma

•    Kidney, liver or heart problems, as you may have to take a lower dose of ibuprofen.

•    Stomach or intestinal disorders.

•    Are you are a smoker?

•    Are you are pregnant?

Pregnancy and breastfeeding

Ibuprofen tablets are NOT recommended if you are pregnant or breastfeeding.

Ibuprofen 400 mg Tablets may make it more difficult to become pregnant. You should inform your doctor if you are planning to become pregnant or if you have problems becoming pregnant.

Other medicines

Ibuprofen may affect how well other medicines work, when taken at the same time. If you take any of these types of medicines make sure that your doctor has taken this into account:

•    Medicine for thinning the blood (anticoagulants).

•    Medicines for high blood pressure (antihypertensives) including water tablets (diuretics).

•    A medicine for epilepsy called Phenytoin sodium.

•    Lithium.

•    Ciclosporin or Methotrexate.

•    A heart medicine called Digoxin.

•    Medicines for inflammation e.g. Steroids (Corticosteroids).

•    Antibiotics containing Quinolone.

•    Mifepristone (to induce early termination of pregnancy).

•    Anti-platelet agents and serotonin reuptake inhibitors (SSRI’s).

•    Tacrolimus.

•    Zidovudine.

•    Anti-hypertensives.

Warnings:

Medicines such as Ibuprofen 400 mg 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 treatment.

Do not exceed the recommended dose or duration of treatment.

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.

If affected by any of the following symptoms, do not drive or operate machinery: Headaches, dizziness, problems with vision, drowsiness, confusions, ringing in the ears (tinnitus) and hallucinations.

HOW TO USE IBUPROFEN 400mg TABLETS?

Your doctor has carefully chosen the correct dose for you and for that reason you should always take the dose of medicine prescribed for you.

You must take your tablets as directed by your doctor. The pharmacist's label on the container will tell you when you should take your tablets.

Ibuprofen tablets should be swallowed whole with a glass of water or milk; it is best to take them with or after some food. The usual doses are given below:

Adults and Elderly Take with or after food.

The recommended dosage is 3 tablets daily in separate doses. This will be adjusted by your doctor as necessary.

If your condition becomes worse, your doctor may ask you to increase the dosage temporarily, up to 3 tablets four times a day.

A lower dose may be prescribed for elderly patients and those with liver, kidney or heart problems.

POSSIBLE SIDE EFFECTS

Like many medicines, Ibuprofen may occasionally cause some unwanted effects. Most people using this medicine as directed by their doctor find it causes them no problems.

STOP TAKING the medicine and tell your doctor if you experience:

•    Indigestion or heartburn

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

•    Headaches

•    Dizziness

•    Drowsiness

•    Confusions

•    ringing in the ears (tinnitus)

•    hallucinations

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 faeces (stools/motions)

•    Pass black tarry stools

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

•    Problems with your vision

Other unwanted effects may also include stomach upsets such as feeling sick (nausea), vomiting, diarrhoea, indigestion and stomach pains, unexplained wheezing or shortness of breath, skin rashes, itching, tingling sensations, bruising or facial swelling, fluid retention, nervousness, depression and insomnia.

•    Medicines such as Ibuprofen 400 mg Tablets may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke.

•    If you experience any other side effects that trouble you, tell your doctor or pharmacist as soon as possible.

•    If someone else has swallowed any of your tablets, immediately tell your doctor and contact your nearest hospital casualty department.

•    If you forget to take a dose, take a dose as soon as you remember, but do not take more than the maximum dose per day.

•    If you take too much Ibuprofen or you feel unwell after taking Ibuprofen, tell your doctor immediately or contact your nearest hospital casualty department.

REMEMBER: The chance of having an unwanted effect can be reduced by keeping the dose

to the minimum number of tablets possible.

FURTHER INFORMATION

•    Do not use after the expiry date.

•    Keep out of the sight and reach of children.

•    Do not store above 25 °C. Store in the original package.

•    If your doctor decides to stop treatment, return any leftover tablets to your pharmacist. Only keep them if your doctor tells you to.

Further information is available from your doctor or pharmacist.

Date of preparation February 2010

Product Licence Number: 31308/0043

POM