Ibuprofen Tablets Bp 200mg
PACKAGE LEAFLET: INFORMATION FOR THE USER IBUPROFEN TABLETS BP 200 mg (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 further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for personally and you should 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 are and what are they 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 ARE THEY USED FOR
Ibuprofen is used to relieve rheumatic and muscular pain, backache, neuralgia, migraine, headache, dental pain, dysmenorrhoea (bad period pain), feverishness and symptoms of cold and influenza.
It is a non-steroidal anti-inflammatory drug.
2. BEFORE YOU TAKE IBUPROFEN TABLETS
Do not take this medicine if any of the following apply to you
1. You are hypersensitive to Ibuprofen, or any of the listed ingredients e.g. Lactose.
2. You have ever had a stomach ulcer.
3. You get symptoms of asthma, inflammation of the nose or blotches on the skin on taking Aspirin or other non-steroidal anti-inflammatory drugs.
4. You have bleeding in your stomach, or have had two or more episodes of peptic ulcers, stomach bleeding or perforation in the past
5. You have a condition which increases your tendency to bleeding.
6. You suffer from severe liver or kidney disease.
7. You are in your last three months of pregnancy.
This product is not for use by children under 12 years of age without medical advice.
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, 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.
Take special care with Ibuprofen tablets if
• You are pregnant, planning to become pregnant or if you are breast feeding.
• You have kidney, liver or heart problems; you may require a lower dosage or monitoring of kidney function. There is a risk of kidney problems in dehydrated children and adolescents.
• You have systemic lupus erythematosus (SLE, sometimes known as lupus) or a connective tissue disease (autoimmune diseases affecting connective tissue).
• You are an elderly patient
• You have disease of the stomach or intestines (e.g ulcerative colitis or Crohn's disease).
• You have asthma or wheezing attacks (or if you have had asthma in the past).
Tell your doctor if any of the above applies to you.
Taking other medicines
Make sure you tell your doctor or pharmacist about any other medicines you are taking, or have taken recently. This includes medicines bought from a chemist or another shop without a prescription by a doctor.
Some medicines that are anti-coagulants (i.e. thin blood/prevent clotting e.g. aspirin/ acetylsalicyclic acid, warfarin, ticlodipine), some medicines that reduce 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.
Informing your doctor is especially important if you are taking any of these medicines:
• Medication to help increase urine excretion (water tablets e.g. furosemide).
• Any other painkillers (other non-steroidal anti-inflammatory drugs)
• Lithium (used in the treatment of certain mental illnesses)
• Corticosteroids (used to treat various illnesses that involve inflammation in the body e.g. prednisolone, cortisone)
• Methotrexate (medicines for treating cancer)
• Cardiac glycosides, such as digoxin, used to treat heart conditions
• Cholestyramine (a drug used to lower cholesterol)
• Zidovudine (an anti-viral drug)
• Medicines known as immunosuppressants such as ciclosporin and tacrolimus (used to dampen down your immune response)
• Medicines known as selective serotonin reuptake inhibitors (SSRIs), used for the treatment of depression
• Antibiotics called quinolones such as ciprofloxacin
• Aminoglycosides (a type of antibiotic)
• Mifepristone used to cause an abortion
• Medicines known as sulphonylureas such as glibenclamide (used to treat diabetes)
• Voriconazole or fluconazole (types of anti-fungal drugs)
• Antiplatelet drugs such as clopidogrel and abciximab
• Gingko biloba herbal medicine (there is a chance you may bleed more easily if you are taking this with ibuprofen).
Taking Ibuprofen tablets with food and drink
You should take these tablets orally, preferably with or after food.
Pregnancy and breast-feeding:
The use of Ibuprofen whilst pregnant or breast feeding should be avoided.
Ibuprofen should not be used in late (the last three months) of pregnancy and should only be taken in the first six months of pregnancy on the advice of your doctor.
Ibuprofen 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.
Driving and using machines
Ibuprofen may make you feel dizzy, drowsy, tired or you may have difficulty seeing. If the tablets affect you in this way do not drive, operate machinery or do anything that requires you to be alert.
Important information about some of the ingredients of Ibuprofen tablet(s)
Your medicine contains small quantities of an inactive ingredient known as lactose monohydrate. If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicinal product.
3. HOW TO TAKE IBUPROFEN TABLETS
Dosage: To be taken orally.
Adults: One or two tablets three times daily. Not more than 6 tablets in 24 hours.
Children: Not for use by children under 12 years of age without medical advice. If in children aged above 12 years and in adolescents this medicinal product is required for more than 3 days, or if symptoms worsen, a doctor should be consulted.
Elderly: As for adults, unless there are kidney or liver problems, if so consult your doctor. NOTE:
If you forget to take a dose take one as soon as you remember and then take your next dose at the usual time. If it is almost time to take the next dose, skip the missed dose and continue as usual.
Never take two doses at the same time. If you take too many tablets contact your doctor or pharmacist at once for advice.
DO NOT EXCEED THE STATED DOSE
IMPORTANT:
If symptoms persist contact your doctor.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Ibuprofen tablets can cause side effects, although not everybody gets them.
If any undesirable effects occur, they are likely to be mild and temporary. However, some effects may be serious and require medical attention.
Very Serious Side Effects
If any of the following happens, stop taking Ibuprofen tablets and tell your doctor immediately and go to the casualty department at your nearest hospital:
• Rashes, hives, itching, chest constriction, shortness of breath or swelling of face, lips, hands / feet, fever, fainting. Severe skin reactions such as blisters, sores or ulceration. If you have them you may have had a serious allergic reaction to Ibuprofen. You may need urgent medical attention or hospitalization.
• If you have severe stomach pain
• If you pass black, tarry stools
• If you vomit any blood or dark particles that look like coffee grounds
• Severe headache, high temperature, stiffness of the neck or intolerance to light
Other side effects:
• Abnormal stomach symptoms,
indigestion, heartburn, feeling sick and/or vomiting
• Unexplained wheezing, shortness of breath, skin rash, itching or bruising
• Yellowing of the eyes and/or skin.
• Severe sore throat with high fever
• Blurred or disturbed vision or seeing/hearing strange things.
• Fluid retention (e.g. swollen ankles)
• High blood pressure
• If you suffer from a sore throat, high fever, feel very tired, become pale, develop bruises and nose bleeds. These may indicate blood problems developing as a result of using this medicine.
• Liver problems , abnormal liver function tests
• Severe skin reactions may occur rarely with ibuprofen.
• Kidney problems (symptoms may include swelling of face, ankles or other parts of the body, with sudden increase or decrease in the amount of urine passed or blood in urine.
• Very rarely Ibuprofen Tablets may cause aseptic meningitis (inflammation
of the protective membrane surrounding the brain) and may be associated with stiff neck, headache, nausea, vomiting, fever or disorientation.
Other unusual effects may include headache, hallucinations, dizziness, mouth ulcers, tingling of hands and feet, ringing in the ears, depression, confusion, difficulty sleeping, anxiety, impaired hearing, diarrhoea, constipation, flatulence (wind), unexpected sensitivity of the skin to the sun, tiredness, malaise, mood swings, sleepiness and swelling and irritation inside the nose. Medicines such as Ibuprofen Tablets have been associated with a small increased risk of heart attack (myocardial infarction) or stroke.
Ibuprofen has also been shown to sometimes worsen the symptoms of Crohn’s disease or colitis. If any side effect gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE IBUPROFEN TABLETS.
Keep out of the sight and reach of children.
Do not take after the expiry date that is printed on the packaging Store in the original package and in a dry place at or below 25°C.
If your doctor tells you to stop taking the tablets, please take them back to the pharmacist to be destroyed. Do not throw them away with your normal household water or waste. This will help to protect the environment.
6. FURTHER INFORMATION
If you would like more information on your disease or treatment, you should ask your doctor or pharmacist.
What Ibuprofen tablet contains:
Each tablet contains the active ingredient Ibuprofen.
The tablets are available in 200mg strength.
Each tablet also contains Povidone, Lactose, Starch Maize, Microcrystalline Cellulose (E460(i)), Sodium Starch Glycollate, Colloidal Anhydrous Silica, Sugar, Erythrosin (E127), Titanium Dioxide (E171), Talc (E553 (b)) and Sodium Benzoate (E211), Acacia (E414), Beeswax (E901), Carnauba Wax (E903), Calcium Carbonate and Shellac (E904). The ink is composed of Ferric Oxide Black, Isopropyl Alcohol, Ethyl Alcohol and Shellac (E904).
What Ibuprofen looks like and contents of pack:
Ibuprofen 200mg tablets are round pink sugar coated tablets, plain on one side, IB2 on the other side.
The tablets are available in containers of 14, 15, 21, 28, 42, 50, 56, 70, 84, 100, 250 and 500 tablets and are available in blister packs of 12, 14, 15, 21, 24, 28, 42, 48, 56, 70 and 84 tablets.
Marketing Authorisation Holder and Manufacturer
Mercury Pharmaceuticals Ltd Capital House, 85 King William Street,
London EC4N 7BL, UK
This leaflet was prepared in February 2016.