270 x180mm - sidel

PACKAGE LEAFLET: INFORMATION FOR THE USER

IBUPROFEN 600mg TABLETS

Ibuprofen

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

•    If you have any further questions, ask your doctor or pharmacist

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

•    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

1. WHAT IBUPROFEN TABLET IS AND WHAT IT IS USED FOR

These tablets contain the active ingredient, ibuprofen. Ibuprofen belongs to a group of medicines called nonsteroidal anti inflammatory drugs (NSAIDs).

Ibuprofen is one of the group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). These drugs are pain killers, reduce inflammation and high temperature.

Ibuprofen 600mg Tablets are used for:

•    Arthritis (characterised by pain and stiffness in your body) like:

•    Rheumatoid arthritis, an inflammatory joint disease (including juvenile rheumatoid arthritis or Still's disease, occurring mainly in children causing joint swelling, stiffness and sometimes reduced motion).

•    Ankylosing spondylitis (a type of arthritis of the spine) & pain affecting the lower part of the back.

•    Osteoarthritis (causing pain, swelling and reduced motion in your joints), often related to aging or to an injury.

•    Bursitis (characterised by local pain and tenderness that may limit the movement of nearby joints) and Tendinitis (Inflammation of a tendon).

•    Tenosynovitis ( characterised by pain, tenderness, and swelling of the affected area, and also stiffness of the joint which is moved by the tendon)

•    Frozen shoulder (characterized by pain and loss of motion or stiffness in the shoulder)

•    Other non-rheumatoid diseases which affect the joints

•    Soft-tissue injuries, such as sprains and strains.

•    Treat painful conditions such as toothache and neuralgia, pain after operations, period pain and headache including migraine.

•    Feverishness and Symptoms of cold & influenza

2. WHAT YOU NEED TO KNOW 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.

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

•    If you have had a worsening of asthma, skin rash, itchy runny nose or facial swelling when previously taking Ibuprofen, aspirin or similar medicines.

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

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

•    If you suffer from liver, kidney or heart disease. 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 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 you are pregnant, especially if you are in the last few months of your pregnancy, you plan to become pregnant, or you are breastfeeding.

If you become pregnant while taking ibuprofen, call your doctor.

•    If you have ever had a peptic ulcer (ulcer in your stomach or duodenum).

•    If you have ever had gastrointestinal bleeding or perforation when previously taking NSAIDs.

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

•    If you are under 12 years

Warnings and precautions

Talk to your doctor or pharmacist before taking Ibuprofen Tablets:

•    If you suffer from high blood pressure

•    If you 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)

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

•    If you are having surgery, including dental surgery

•    If you have kidney, heart, liver or bowel problems

•    If you have high cholesterol or previously have had a heart attack or stroke

•    If you are in the first 6 months of pregnancy

•    If you are a smoker

•    If you have been told by your doctor that you have an intolerance to some sugars, as this medicine contains lactose and sucrose

Other special warnings

Anti-inflammatory/pain-killer medicines like ibuprofen may be associated with a small increased risk of heart attack or 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

•    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 of feet due to narrow or blocked arteries), or any kind of stroke (including ‘mini-stroke' or transient ischaemic attack “TIA”)

•    If you have high blood pressure, diabetes, high cholesterol, have a family history of heart disease or stroke, or if you are a smoker

There is a risk of renal impairment 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.

Avoid taking Ibuprofen with other drugs that are mentioned below.

•    To reduce the risk of side effects, do not take this product with other NSAID containing products (e.g. aspirin, ibuprofen). If you are on low-dose aspirin (up to 75mg daily) speak to your doctor or pharmacist before you take this medicine

•    Medicines that reduce high blood pressure (ACE-inhibitors such as captopril, beta-blockers such as atenolol medicines, angiotensin-II receptor antagonists such as losartan)

•    To help you passing water (diuretics)

•    To stimulate your heart (glycosides e.g. digoxin).

•    Lithium or SSRI's (to stabilise, normalise or even-out mood swings, mania or depression)

•    Methotrexate (used in treatment of cancer and for the temporary suppression of your immune system)

•    Cyclosporin (used to dampen down the body's immune reactions)

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

•    Corticosteroids

•    Warfarin, to prevent blood clots

•    Antibiotics called quinolones (such as ciprofloxacin)

•    Tacrolimus (prevent rejection of liver transplants, for the temporary suppression of your immune system)

•    Phenytoin (used in the treatment of epilepsy)

•    Zidovudine (to treat human immunodeficiency virus (HIV) infection) Pregnancy and Breast Feeding

Ibuprofen belongs to a group of medicines which may impair fertility in women. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Do not take this medicine in the last 3 month of pregnancy. Avoid the use of this medicine in the first 6 months of pregnancy, unless the doctor advises otherwise.

Tell your doctor if you are pregnant, especially if you are in the last few months of your pregnancy. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

NSAIDs can cause dizziness, drowsiness, fatigue and visual changes.

If you are affected, do not drive or use machinery.

3. HOW TO TAKE IBUPROFEN TABLETS

Always take this medicine exactly as your doctor or pharmacist has told you. 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 & adolescents between 12 and 18 years: The starting dose is 1 tablet 3 times a day.

The maintenance dose is 1 to 3 tablets a day.

In severe or acute conditions you may need 4 tablets a day.

In adults: Do not take for longer than 10 days unless your doctor tells you to. If symptoms persist or the pain or fever worsen, or if any new symptoms occur, consult your doctor or pharmacist.

Elderly: 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.

In children and adolescents between 12 and 18 years:

If in children aged from 6 months and in adolescents this medicinal product is required for more than 3 days, or if symptoms worsen a doctor should be consulted. Do not give to children under 12 years of age.

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.

Always take the tablets with, or after, food.

DO NOT BREAK THE TABLET INTO HALF.

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 may feel drowsy or nauseous. You should contact a doctor immediately or go to the nearest A&E hospital.

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

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:

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

•    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, swelling of face, tongue or throat

•    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)

•    Passing less or more urine, cloudy urine or blood in urine

•    pain in back and/or swelling (particularly in legs)

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

Common (may affect up to 1 in 10 people)

•    Nausea, Vomiting or feeling sick

•    Gastro-intestinal: 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

•    Effects on heart:

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

•    Hypertension

Uncommon (may affect up to 1 in 100 people)

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

•    Gastrointestinal: Indigestion, heartburn or feeling sick, pains in your stomach (abdomen) or other abnormal stomach problems

•    Headache

•    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, passing more or less urine, pain in the back and/or swelling (particularly in legs).

•    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, Nervousness, Depression, Confusion, Hallucinations, Ringing in the ears, Light-headedness (loss of balance), Feeling of general discomfort or uneasiness, Sleeplessness, Excessive Tiredness, Drowsiness.

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).

Rare side effects (may affect up to 1 in 1000 people)

•    Gastrointestinal: Diarrhoea , Gas or Bloating, Constipation and Vomiting, Pain in abdomen or Upset stomach

Very rare side effects (may affect up to 1 in 10000 people)

•    Effects on blood: Blood disorder resulting in unexplained or unusual bruising, or bleeding, fever, sore throat, mouth ulcers, flu like symptoms, and severe exhaustion, 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

•    Drop in blood pressure or irregular heart beat

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

•    Liver problems

Not known (frequency cannot be estimated from the available data)

•    Worsening of asthma or bronchospasm

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

•    Worsening of colitis and Crohn's disease

If any of the side effects gets 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 this medicine out of the sight and reach of children.

Do not store the tablets above 25°C. Keep them in the original pack. Do not use this medicine after the expiry date which is stated on the pack. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Ibuprofen Tablets contain:

The active substance is Ibuprofen 600mg Tablets. The other ingredients are Pregelatinised starch, Maize starch, Maize starch as a 22% paste, Aerosil, Magnesium stearate, Hypromellose, Macrogol 6000, En/throsine lake (E127), titanium dioxide (E171) and Dioctyl sodium sulphosuccinate.

What Ibuprofen Tablets look like and contents of the pack:

Ibuprofen tablets 600mg are pink, capsule shaped, film coated tablets with “LPC/I600” on one side and breakline on the other and packed in tablet containers of 12, 21,24, 28, 48, 56, 84, 96, 100,

250, 500, 1000 and blister packs of 12, 21,24, 28, 48, 56, 84, 96, 100. Marketing Authorisation Holder :

Special Concept Development (UK) Limited, Unit 1-7 Colonial Way, Watford, Hertfordshire WD24 4Yr.

Manufacturer:

Kleva SA 189 Parnithos Avenue, 136 75 Acharnai, Greece.

Product Licence Number: PL 36722/0028 This leaflet was last revised in April 2016