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Ibuprofen Tablets Bp 200mg

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Document: leaflet MAH GENERIC P_PL 06464-1429 change

Patient Information Leaflet

Ibuprofen Tablets BP 200 mg

What you should know about Ibuprofen Tablets

Please read this leaflet carefully before you start to take your tablets. It provides a summary of the information available on your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.

This medicine is available without prescription. However, you still need to take IBUPROFEN tablets carefully to get the best results from them.

You must contact a doctor if your symptoms worsen or do not improve after 3 days for children or adolescents between 12 and 18 years of age, and after 10 days for adults.

The active ingredient in IBUPROFEN tablets is Ibuprofen. The tablets contain 200 mg of Ibuprofen.

IBUPROFEN Tablets 200 mg tablets are biconvex and pink in colour.

The inactive ingredients in IBUPROFEN Tablets 200 mg are pregelatinised starch, maize starch, maize starch paste, magnesium stearate, colloidal anhydrous silica,

Hydroxypropyl methylcellulose, polyethylene glycol 6000, erythrosine (E127), titanium dioxide (E171), dioctyl sodium and purified water.

IBUPROFEN Tablets 200 mg are available in securitainers of 21 and 50 tablets. IBUPROFEN belongs to a group of medicines called anti-inflammatory pain killers. Product licence holder:

Waymade Plc t/a Sovereign Medical, Sovereign House, Miles Gray Road, Basildon, Essex SS14 3FR.

Manufacturer responsible for release:

Waymade Plc, Sovereign House, Miles Gray Road, Basildon, Essex SS14 3FR.

What are your tablets for?

IBUPROFEN tablets 200 mg are used for the relief of rheumatic or muscular pain, pain of non-serious arthritic conditions, backache, neuralgia, migraine, headache, dental pain, dysmenorrhoea, feverishness, symptoms of colds and influenza.

Do not take this medicine and tell your doctor if:

•    You currently have, or have ever previously had, peptic ulceration (ulcer in your stomach or duodenum) or bleeding in your digestive tract.

•    You have ever had an allergic reaction to ibuprofen or to any of the other ingredients.

•    You have ever suffered asthma, urticaria or other allergic reactions after taking aspirin,

ibuprofen or any similar medicine (known as nonsteroidal anti-inflammatory or NSAIDs).

•    You are already taking other non steroidal anti-inflammatory medicine (NSAIDs e.g. ibuprofen or ketoprofen, or COX-2 inhibitors e.g. celecoxib).

•    You are in the last trimester of pregnancy.

•    You have severe problems with your liver, kidney or heart.

•    You are under 12 years of age.

Make sure your doctor knows if:

•    You suffer from bowel disorders for example, ulcerative colitis, Crohn's disease or have a history of other gastrointestinal disease.

•    You suffer from liver, kidney, heart problems or high blood pressure.

•    You suffer from or have a history of haematological (blood) abnormalities.

•    You suffer from rare conditions known as systemic lupus erythematosus (SLE) or mixed connective tissue disorder.

•    You suffer from or have a history of asthma or other breathing difficulties.

•    You have recently undergone major surgery.

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

Taking other medicines

Ibuprofen and other medicines that you may be taking sometimes affect each other’s

action.

Tell your doctor if you are taking any other medicines, including:

•    Other analgesics for pain relief or non steroidal anti-inflammatory drugs (NSAIDs) including aspirin.

•    Anti-hypertensives to treat high blood pressure (ACE-inhibitors e.g. captopril, betareceptor blocking medicines, angiotensin II antagonists) and diuretics (water tablets).

•    Cardiac glycosides for heart failure e.g. digoxin.

•    Lithium (used to treat manic-depressive psychosis or mania).

•    Methotrexate (used in the treatment of some types of cancer).

•    Ciclosporin and tacrolimus (used to help prevent rejection of transplanted organs).

•    Mifepristone (used to produce an abortion).

•    Corticosteroids used in the treatment of inflammation, allergic and rheumatic conditions (e.g. hydrocortisone).

•    Anticoagulants (e.g. aspirin, warfarin, ticlopidine) to thin your blood.

•    A group of antibiotics known as quinoline antibiotics (e.g. ciprofloxacin)

•    Selective serotonin reuptake inhibitors (medicines used to treat depression)

•    Zidovudine (a medicine used to treat viral infections with the Human Immunodeficiency Virus (HIV)).

•    Anti-platelet agents e.g. ticlodipine, aspirin

•    Some medicines that are anti-coagulants (i.e. thin blood/prevent clotting e.g. aspirin/acetylsalicylic acid, warfarin, ticlopidin), some medicines against high blood pressure (ACE-inhibitors such as captopril, beta-blockers such as atenolol, or angiotensin-II receptor antagonists such as losartan), and other medicines may affect or be affected by treatment with ibuprofen. You should therefore always seek the advice of your doctor before you take ibuprofen with other medicines.

You should also mention to your doctor or pharmacist any other medicines that you are taking, including any that you can buy without a prescription.

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.

If you have heart problems, have previously experienced a 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.

Pregnancy and Breast-feeding

Tell your doctor before taking Ibuprofen if you are or think you may be pregnant or are breast-feeding. If you are trying to become pregnant, Ibuprofen may make it more difficult to become pregnant.

Driving and using machines

Dizziness, drowsiness, fatigue, visual disturbances or headaches are possible undesirable effects after taking NSAIDs. If affected patients should not drive or operate machinery.

What else do you need to know about Ibuprofen tablets?

A small number of people may be sensitive to the sodium benzoate contained in IBUPROFEN 200 mg. If you develop an unexpected skin rash, sore eyes or a sore mouth, stop taking the tablets and contact your doctor for advice.

How to take Ibuprofen Tablets

This product is for short term use only. You should take the lowest dose for the shortest time necessary to relieve your symptoms.

Ibuprofen tablets should be taken with or after food.

Adults, the elderly and children over 12 years of age;

200 mg - 400 mg, up to three times a day as required.

Leave at least four hours between doses. Do not take more than 1200 mg in any 24 hour period.

Do not give to children under 12 years of age.

Children and adolescents between 12 and 18 years of age

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

Adults

Do not take for longer than 10 days unless your doctor tells you to.

If symptoms persist or the pain or fever worsen, a doctor should be consulted.

What to do if you forget a dose, or take too many tablets

If you forget to take a dose, just take the next dose at the usual time, DO NOT take a double dose.

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 hospital casualty department.

Will Ibuprofen Tablets cause any problems?

As with all medicines, ibuprofen can cause unwanted side effects in some people.

If you notice:

•    swelling of the face, lips, tongue or throat

•    itching or skin rashes

•    difficulty breathing or wheeziness

Stop taking the medicine and seek medical advice immediately. These may be signs of an allergic reaction.

If you experience any of the following symptoms at any time during your treatment STOP TAKING the medicine and seek immediate medical help:

•    Passing blood in your faeces (stools/motions).

•    Passing black tarry stools.

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

•    Blisters of the eye, mouth, anus, genitals, skin or urethra; peeling of the skin, usually with a high fever and general weakness (Toxic Epidermal Necrolysis or Stevens Johnson Syndrome).

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

•    Indigestion, heartburn, diarrhoea, constipation, wind, loss of appetite (anorexia).

•    Abdominal pains (pains in your stomach) or other abnormal stomach symptoms, stomach ulcer.

•    Symptoms such as stiff neck, headache, nausea, vomiting, fever or disorientation (Aseptic Meningitis).

•    Sore throats, bruising or bleeding, mouth ulcers, fever, or malaise as NSAID use has been associated with a range of blood disorders.

Gastrointestinal:

The most commonly-observed adverse events are gastrointestinal in nature.

Nausea (feeling sick), vomiting (being sick), diarrhoea, flatulence (wind), constipation, dyspepsia (indigestion), heartburn, anorexia (loss of appetite), and abdominal pain have all been reported.

Non steroidal anti-inflammatory medicines have been associated with ulcers of the stomach and intestine which may perforate or bleed.

NSAID use has also been associated with inflammation of the stomach and mouth ulcers.

Inflammation of the pancreas has also been reported (pancreatitis).

Using non steroidal anti-inflammatory medicines has also lead to an exacerbation of inflammatory bowel conditions (ulcerative colitis and Crohn’s disease).

Hypersensitivity:

Allergic reactions have been reported following use of NSAIDs.

These may include mild symptoms such as itching and/or rash or more severe symptoms such as swelling of the face, lips, tongue and/or throat with difficulty in swallowing or breathing).

If any of the above occur tell your doctor immediately.

Cardiovascular:

Oedema (swelling), high blood pressure (hypertension) and heart failure have been reported with NSAID use.

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

Other side effects include:

•    problems with kidneys including kidney failure and raised levels of protein and blood in the urine.

•    inflammation of the liver (hepatitis) and yellowing of the skin (and whites of eyes) (jaundice)

•    visual disturbances

•    headaches

•    pins and needless

•    depression

•    confusion,

•    hallucinations,

•    a ringing noise in the ears (tinnitus),

•    vertigo,

•    dizziness,

•    vague feelings of discomfort,

•    tiredness

•    drowsiness

•    sensitivity to light

NSAID use has been associated with a range of blood disorders. Your doctor may decide to perform blood cell counts to determine if there are problems with your blood.

There have been isolated cases of aseptic meningitis (especially in patients with existing auto-immune disorders, such as systemic lupus erythematosus).

If you experience any other unusual symptoms whilst taking your tablets, tell your doctor or pharmacist.

Storing your tablets

Do not take your tablets after the expiry date shown on the bottle. Keep them in a safe place where children cannot see or reach them. Your medicine could harm them.

IBUPROFEN Tablets should be stored below 25°C and protected from light.

If your doctor decides to stop the treatment, return any left over to your pharmacist. Only keep the tablets if your doctor tells you to.

This leaflet does not contain the complete information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist who have access to additional information.

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Date of preparation: March 2016