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Ibuprofen Tablets Bp 200mg

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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 effects not listed in this leaflet please tell your doctor or pharmacist.

In this leaflet:

1.    What Ibuprofen Tablets BP 200 mg are what they are used for

2.    Before you take Ibuprofen Tablets BP 200 mg

3.    How to take Ibuprofen Tablets BP 200 mg

4.    Possible side effects

5.    How to store Ibuprofen Tablets BP 200 mg

6.    Further information

1.    What Ibuprofen Tablets BP 200 mg are and what they are used for:

Ibuprofen is a member of a class of medicines called non-steroidal anti-inflammatory dru (nSaIDs). Ibuprofen Tablets BP 200 mg are indicated for:

(a) . The treatment of rheumatoid arthritis (including juvenile rheumatoid arthritis or Still’s disease osteoarthritis and ankylosing spondylitis.

(b) . The treatment of non-articular rheumatoid conditions and soft tissue injuries (tendinit tenosynovitis, bursitis, low-back pain, strains and sprains.

(c) . The relief of dental and post-operative pain, dysmenorrhoea, headache and migraine.

(d) . Neuralgia (nerve pain).

2.    Before you take Ibuprofen Tablets BP 200 mg:

Do not take Ibuprofen Tablets BP 200 mg:

•    If you are taking other NSAID painkillers, or aspirin with a daily dose above 75mg. If y are on low-dose aspirin (up to 75mg daily) speak to your doctor or pharmacist befc you take Ibuprofen Tablets BP 200 mg

•    If you are allergic (symptoms asthma, skin rash, itchy runny nose or facial swelling) ibuprofen or any other ingredient of the product, aspirin or other related painkillers

•    If you have a peptic ulcer (ulcer in your stomach or duodenum) or bleeding in yo stomach, or have had two or more episodes of peptic ulcers, stomach bleeding perforation.

•    If you have had gastrointestinal bleeding or perforation when previously taking NSAID;

•    If you have severe heart, kidney or liver problems

•    If you are in the last 3 months of pregnancy

Speak to your pharmacist of your doctor before taking if you:

•    Have or have had    asthma or allergic disease

•    Have Systemic Lupus Erythematosus (a condition of the immune system causing jo pain, skin changes and other organ disorders)

•    Have history of gastrointestinal disease (such as ulcerative colitis, Crohn’s disease)

•    Have or have had diabetes, high cholesterol, high blood pressure, a stroke, heart, live kidney or bowel problems

•    Are a smoker

•    Are pregnant

Take special care with Ibuprofen Tablets BP 200 mg:

Medicines such as Ibuprofen Tablets BP 200 mg may be associated with a small increased risk heart attack ("myocardial infarction") or stroke. Any risk is more likely with high doses and prolongtreatment. 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 (f example if you have high blood pressure, diabetes or high cholesterol or are a smoker) you shou discuss your treatment with your doctor or pharmacist.

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

If you have been told by your doctor that you have an intolerance to some sugars, contact yo doctor before taking this medicine.

The elderly have an increased frequency of adverse reactions to NSAIDs, especially gastrointestin bleeding and perforation which may be fatal.

Taking other medicines:

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicine including medicines obtained without prescription.

Some medicines that are anti-coagulants (i.e. thin blood/prevent clotting e.g. aspirin/acetylsalicy acid, warfarin, ticlopidine), some medicines that reduce high blood pressure (ACE-inhibitors such 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 therefo always seek the advice of your doctor or pharmacist before you take ibuprofen with other medicine

Do not take ibuprofen with other NSAIDs (e.g. aspirin, cyclooxygenase-2 selective inhibitors). Ibuprofen should be used with caution in combination with:

•    Anticoagulants (drugs used to thin your blood or prevent clotting): warfarin.

•    Antihypertensives (drugs used to treat high blood pressure).

•    Diuretics (drugs to help you passing water)

•    Corticosteroids

•    Lithium or SSRIs (drugs for mania or depression)

•    Cardiac glycosides (drugs to stimulate your heart)

•    Tacrolimus, cyclosporine, methotrexate (drugs for the temporary suppression of yo immune system)

•    Mifepristone (drug used for pregnancy termination)

Remedic

•    Zidovudine (drug used for HIV treatment)

•    Quinolone antibiotics

Taking Ibuprofen Tablets BP 200 mg with food or drink:

Take the tablets preferably with or after food.

Pregnancy and Breastfeeding:

Ibuprofen should not be used during the first two trimesters of pregnancy or labour unless th potential benefit to the patient outweighs the potential risk to the foetus. The use of ibuprofen in t last trimester of pregnancy is contraindicated.

Ibuprofen appears in breast milk in very low concentrations and should, if possible, be avoid when breastfeeding.

Driving and using machines:

Dizziness, sleepiness, fatigue and eye problems are possible after taking NSAIDs and therefore, you are affected you should not drive or operate machinery.

3.    How to take Ibuprofen Tablets BP 200 mg:

Follow you doctor’s instructions on how to take your tablets. Your pharmacist will help you if you a not sure.

These tablets are for oral use.

Adults: The recommended dosage is 1200 - 1800 mg daily in divided doses. Some patients can b maintained on 600 - 1200 mg taken daily. In severe or acute conditions the dosage may b increased up to a maximum daily dose of 2400mg in divided doses.

Children: The usual daily dose for children is 20 mg/Kg of body weight given in divided doses. F the treatment of Juvenile Chronic Arthritis, the recommended dose is 40 mg/kg body weight dai given in divided doses.

Ibuprofen is not recommended for children weighing less than 7 Kg.

Elderly: The elderly are at increased risk of serious consequences of adverse reactions a therefore the lowest dose should be used and the patient should be monitored regularly f gastrointestinal bleeding.

Follow your doctor’s directions about when and how to take your medicine.

Action in case of a missed dose:

If you forget to take a dose at the right time take it as soon as you remember. If it is almost time take the next dose, wait until then and then carry on as before. Do not take two doses together ( not double up on a dose) to make up for the one you have missed.

Action in case of overdose:

If you take too many tablets contact your nearest hospital casualty department or your doct immediately. Take any remaining tablets and the container with you, it will help the doctor.

4.    Possible side effects:

Like all medicines, Ibuprofen Tablets BP 200 mg can cause side effects, although not everybody gets them.

If you suffer from any of the following at any time during your treatment STOP TAKING the medici 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.

•    Serious hypersensitivity reactions, which may include difficulties in breathing (asthm bronchospasm or dyspnoea) and skin disorders (various types of rashes and Steven Johnson syndrome).

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.

Tell your doctor if you experience any of the following:

-    Serious gastrointestinal side effects such as peptic (stomach) ulcers, perforation or gastrointestin bleeding which is sometimes fatal, particularly in the elderly.

-    Oedema, hypertension (high blood pressure) and cardiac failure.

Medicines such as Ibuprofen Tablets BP 200mg may be associated with a small increased risk of heart attack (“myocardial infarction”) or stroke.

Other side effects which are less serious include: nausea, vomiting, diarrhoea, flatulence (breaking wind), constipation, dyspepsia (disturbed digestion), abdominal pain, ulcerative stomatitis (mouth ulcers), exacerbation of colitis and Crohn’s disease, gastritis (inflammation of the lining of the stomach), pancreatitis (inflammation of the pancreas), problems in the kidneys and liver, eye problems, headache, parasthesia (tingling or a “pins and needles” feeling), aseptic meningitis (symptoms: stiff neck, headache, nausea, vomiting, fever, disorientation), depression, confusion, hallucinations, tinnitus, vertigo, dizziness, malaise (fatigue), feeling exhausted and sleepy, blood problems (first signs: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe exhaustion, unexplained bleeding and bruising) and photosensitivity.

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

5.    How to store Ibuprofen Tablets BP 200 mg:

Store below 25°C. Store in the original container. Keep the container in the outer carton.

DO NOT USE BEYOND THE EXPIRY DATE STATED ON THE CONTAINER. The expiry da refers to the last day of that month.

KEEP ALL MEDICINES OUT OF THE REACH OF CHILDREN.

7. Further Information:

What Ibuprofen Tablets BP 200 mg contain:

-    The active substance is Ibuprofen.

-    The other ingredients are: Pregelatinised Starch, Colloidal Silicon Dioxide, Sodium Starc Glycollate, Microcrystalline Cellulose, Sucrose, Gelatin, Macrogol 6000, Purified Talc, Calciu Carbonate, Povidone (PVP), Erythrosine (E127), Carnauba Wax, White Beeswax a Spermaceti Wax.

What Ibuprofen Tablets BP 200 mg look like and contents of the pack:

-    Ibuprofen Tablets BP 200 mg have the appearance of pink, round, sugar coated tablets.

-    The medicine comes in pack sizes of 48, 84, 96, 100 or 500 sugar-coated tablets.

Marketing Authorisation Holder:

Remedica (UK) Ltd., Suite 20, 42 Upper Brook Street, London, W1K 7QP.

Manufacturer:

Remedica Ltd., Aharnon Street, Industrial Estate, Limassol, Cyprus.

The leaflet was last approved in:

04/2007

Leaflet last revised:

08/2012

Authorisation Number:

PL 11125/0001