Ibuprofen Tablets Bp 400mg

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Document: leaflet MAH GENERIC_PL 39484-0027 change

Front Side

PACKAGE LEAFLET: INFORMATION FOR THE USER

IBUPROFEN 400mg TABLETS

Ibuprofen

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

• Keep this leaflet, You may need to read it again.

• If you have any further questions, 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 gets serious. or if you notice any side effect 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 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. BEFORE YOU TAKE IBUPROFEN TABLETS

Do not take Ibuprofen Tablets if you:

• are allergic (hypersensitive) to Ibuprofen or any of the other ingredients of Ibuprofen Tablets. See section 6.

• are allergic to Aspirin or other NSAIDs, like cyclooxygenase-2 specific inhibitor.

• suffer from asthma, especially if you also have frequent stuffed or runny nose or swelling of the inside of the nose.

• have swelling of the hands, arms, feet, ankles, or lower legs.

• develop hives (red and sometimes itchy bumps) on your skin after taking this medicine, Aspirin or any other NSAIDs.

• suffer from severe liver, kidney or heart disease.

• if you currently have an active ulcer or a history of recurrent peptic ulcers (more than two) in your stomach or duodenum.

• have ever had bleeding in your digestive tract.

• get blurred or poorer vision, blind spots, or changes in colour vision.

• if you are in the last three months of pregnancy.

Take special care with Ibuprofen Tablets if you:

• have a previous history of bronchial asthma or allergic disease

• have or ever had Crohn’s disease (inflammation of the digestive system) or ulcerative colitis (disease that causes ulcers in the lining of the rectum and colon)

• have or ever had lupus (a condition in which the body attacks many of its own tissues and organs, often including the skin, joints, blood, and kidneys)

• are having surgery, including dental surgery

• are taking more than 75mg Aspirin daily

• Anti-inflammatory/pain-killer medicines like Ibuprofen Tablets may be associated with a small increased risk of heart attack (“myocardial infarction”) 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 tablets, 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 or feet due to narrow or blocked arteries) or any kind of stroke (including ‘mini-stroke’ or transient ischaemic attack “TIA”), high blood pressure, diabetes or high cholesterol, have a family history of heart diseases or stroke or if you are a smoker.

Taking other medicines

You should tell your doctor if you are taking or have taken any of the following medicines as they may interact with your Ibuprofen Tablets. Examples of medicines that can affect Ibuprofen Tablets are:

• any other anti-inflammatory pain killers

• Aspirin

• antibiotics (Aminoglycosides, Quinolones (such as ciprofloxacin))

• diuretics (water tablets)

• Digoxin (cardiac glycosides)

• Lithium to stabilise, normalise or even-out mood swings

• Methotrexate to treat cancer and auto immune diseases

• Ciclosporin to dampen down the body's immune reactions

• Mifepristone used to induce abortion in first two months of pregnancy

• Corticosteroids

• Medicines that are anti-coagulants (i.e. thin blood/prevent clotting e.g. asprin/acetylsalicylic acid, Warfarin, ticlopidine).

• Tacrolimus to prevent rejection of liver transplants

• Phenytoin to treat epilepsy

• Zidovudine to treat human immunodeficiency virus (HIV) infection

• Sulphonylureas (used to treat Type II diabetes)

• Medicines that reduce high blood pressure (ACE-inhbitors such

as captopril, beta-blockers such as atenolol medicines, angiotensin -ll receptor antagonists such as losartan)

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 tablets with other medicines including medicines obtained without prescription.

Children and adolescents

There is a risk of renal impairment in dehydrated children and adolescents.

Pregnancy and breast-feeding

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. Do not take this medicinal product if you are in the last three months of pregnancy. Consult your doctor if you are pregnant, you plan to become pregnant, or you are breast feeding. If you become pregnant while taking Ibuprofen, call your doctor. Ask your doctor or pharmacist for advice before taking any medicine.

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.

If in children and adolescents this medicinal product is required for more than 3 days, or if symptoms worsen a doctor should be consulted.

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 do not get better, or get worse, talk to your doctor. They will tell you if it is safe to carry on taking this medicine.

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.

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, Ibuprofen Tablets 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:

• Rare allergic (hypersensitive) reactions such as difficulty of breathing, wheezing or dizziness

• skin reactions including paling of skin, rash, itching, hives, blisters, blood spots, swelling of the skin with wheals and, less often, blistering skin diseases which may appear like a burn, or as a red/purple rash, or a scaly skin.

• Asthma attacks (condition that affects the airways of the lungs causing breathing difficulties) or worsening of asthma Sensitivity to light

Stomach ulcers, bleeding, or holes in the stomach or intestine,

• High blood pressure, Fluid retention (particularly in the elderly), vomiting a substance that is bloody or looks like coffee grounds, blood in the stool, or black and tarry stools. The risk may be higher for people who are older in age.

• Pass blood in your faeces (stools/ motions)

• Pass black tarry stools

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

• STOP TAKING the medicine if you experience: indigestion or heartburn, abdominal pain (pains in stomach) or other abnormal stomach symptoms.

Common (occurring in less than 1 in 10 patients)

• Nausea, Vomiting

• Gastro-intestinal:

• Diarrhoea , Gas or Bloating, Constipation, Pain in abdomen or Upset stomach

• Worsening of ulcers in the lining of the rectum and colon

• Worsening of inflammation of the digestive system

• Inflammation or irritation of the lining of the stomach

• Indigestion Effects on heart:

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

• Hypertension

Uncommon (occurring in less than 1 in 100 patients)

• Effects on Kidney: Inflammation of kidney tissue, kidneys disorder causing them to leak large amounts of protein from the blood into the urine, kidney failure, appearance of blood in the urine.

• Effects on Liver: Abnormal liver function tests, swelling of the liver that makes it stop working well (hepatitis) and yellowing of skin and the whites of your eyes (jaundice)

• Effects on Nervous system and special senses:

• Visual problems

• Inflammation of eye nerve

• Headache

• Feeling of burning, itching, prickling or tingling in the skin

• Aseptic inflammation of the lining of the brain (With symptoms such as stiff neck, headache, nausea, vomiting, fever or disorientation) especially in patients with diseases like lupus erythromatous ( a condition in which immune system attacks healthy cells and tissues of many parts of the body), mixed connective tissue disease (overlap disease)

• Nervousness, Depression, Confusion, Hallucinations

• Ringing in the ears

• Light-headedness (loss of balance)

• Feeling of general discomfort or uneasiness

• Sleeplessness

• Excessive Tiredness

• Drowsiness

• Effects on blood:

• Low platelet count

• Effected blood cell counts

• Failure of the bone marrow to produce sufficient blood cells for the circulation (Aplastic anaemia)

• Abnormal breakdown of red blood cells Reporting of side effects:

If any of the side effects get serious, 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. FURTHER INFORMATION

What Ibuprofen Tablets contain:

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

What Ibuprofen Tablets look like and contents of the pack:

Ibuprofen 400mg Tablets are pink, biconvex, film-coated tablets and packed in tablet containers of :

21, 100, 250, 500, 1000 and blister packs of 12, 21,24, 28, 48,

56, 84, 96, 100.

MA Holder: Fourrts (UK) Pharmacare Ltd, 2,Victoria Road,

Harpenden, Hertfordshire, AL5 4EA, UK.

Manufacturer:

Rx Farma Limited, Unit 3 colonial Way, Watford,

Hertfordshire, WD24 4YR, UK.

Date of leaflet last revised: 11/2015 Pxxxx/yy

PL 39484/0027

50.87mm

Name of the Artwork Printed Leaflet - Ibuprofen 400mg tablets