Ibuprofen Tablets Bp 200mg
PATIENT INFORMATION LEAFLET
§ IBUPROFEN Tablets 200mg
Please read all of this leaflet carefully before you start taking this medicine.
Keep the leaflet, you may need to read it again. If you have any questions or are not sure about anything, ask 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
Ibuprofen Tablets contain the active ingredient ibuprofen, which belongs to a group of medicines called Non Steroidal Anti-Inflammatory Drugs (known as NSAIDs) which relieve pain, reduce inflammation and lower temperature when you have a fever.
This medicine is used for the relief of rheumatic and muscular pain, pain of non-serious arthritic conditions, backache, neuralgia, migraine, headache, dental pain and period pains. Also for the relief of feverishness, and the symptoms of colds and influenza.
2. Before you take Ibuprofen Tablets
Do not take these tablets if you:
• are allergic to ibuprofen, to any of the other ingredients in the tablets (see section 6), to aspirin or to any other painkillers. (An allergic reaction may be recognised as shortness of breath, blocked nose, rash, itching, swollen face or lips)
• have a stomach ulcer, perforation or bleeding or have previously had 2 or more episodes of these in the past
• have ever had stomach bleeding or perforation caused by taking NSAID painkillers
• are taking other NSAID painkillers, or aspirin with a daily dose above 75mg
• have a condition which increases your tendency to bleeding
• have severe heart, liver or kidney failure
• are in the last 3 months of pregnancy.
Check with your doctor before taking these tablets if you:
• have or have ever suffered from asthma or an allergy
• suffer from heart, liver or kidney problems
• are elderly, as you may be more likely to suffer from side effects (see section 4)
• suffer from systemic lupus erythematosus (SLE) or another connective tissue disorder
• have a history of stomach problems (such as Crohn’s disease or colitis)
• are in the first 6 months of pregnancy or you are breast-feeding.
Taking other medicines:
Ibuprofen Tablets may affect or be affected by some other medicines. For example:
• aspirin (low dose up to 75 mg daily) or any other NSAID painkiller
• medicines that are anti-coagulants (i.e. thin blood/prevent clotting e.g. aspirin/acetylsalicylic acid, warfarin, ticlopidine)
• medicines that reduce high blood pressure (ACE-inhibitors such as captopril, beta-blockers such as atenolol medicines, angiotensin-ll receptor antagonists such as losartan)
• digoxin (for heart problems)
• water tablets (diuretics)
• corticosteroids (eg. hydrocortisone, prednisolone)
• lithium or a selective serotonin reuptake inhibitor (SSRI) drug (for treating depression), eg. citalopram, fluoxetine, sertraline
• methotrexate (a cancer drug which can also be used for treating psoriasis)
• colestyramine (to lower cholesterol)
• medicines known as sulfonylureas such as glibenclamide (for treating diabetes)
• voriconazole or fluconazole (anti-fungal drugs)
• aminoglycosides (a type of antibiotic)
• ginko biloba (a herbal medicine)
• zidovudine (an anti-viral)
• ciclosporin or tacrolimus (to prevent rejection following organ or bone marrow transplants)
• mifepristone (to terminate a pregnancy)
• a quinolone antibiotic for treating infection (eg. ciprofloxacin, ofloxacin).
Some other medicines may also affect or be affected by the treatment of Ibuprofen Tablets. You should therefore always seek the advice of your doctor or pharmacist before you use Ibuprofen Tablets with other medicines.
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 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”).
- 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 kidney damage in dehydrated children and adolescents.
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.
jjj Pregnancy and breastfeeding
8 Do not take this medicine if you are in the last 3 months of pregnancy. Check with your doctor before taking if you are in the first 6 months of pregnancy or if you are breastfeeding.
Important information about an ingredient of this medicine
Contains sucrose. If you have been told by your doctor that you have an intolerance to some sugars, check with your doctor before taking this medicine.
3. How to take Ibuprofen Tablets
The tablets should be swallowed with a drink of water.
This medicine is intended for short term use only. You should take the lowest dose for the shortest time necessary to relieve your symptoms. You should not take Ibuprofen for longer than 10 days unless your doctor tells you to. If symptoms persist or worsen consult your doctor.
In adolescents (age range a 12 years to < 18 years):
If in adolescents this medicinal product is required for more than 3 days, or if symptoms worsen a doctor should be consulted.
Adults, the elderly and children over 12 years: Take one or two tablets up to 3 times a day.
Leave at least 4 hours between doses, and do not take more than 6 tablets in any 24 hour period.
Do not give to children under 12 years of age.
If you have taken too many tablets:
Contact your doctor straight away or go to the nearest hospital casualty department. Take with you any remaining tablets and the pack so that the medicine can be identified.
4. Possible Side Effects
Ibuprofen is usually well tolerated, however, ibuprofen can cause side effects, although not everybody gets them. The elderly may be more at risk of developing problems due to side effects.
If you suffer from any of the following at any time while you are taking these tablets, STOP TAKING them and seek IMMEDIATE medical help:
• pass blood in your faeces (stools/motions), pass black tarry stools, or vomit any blood or dark particles that look like coffee granules (these may be signs of a stomach ulcer or bleeding)
• worsening of asthma, unexplained wheezing, shortness of breath, swelling of the face, tongue or throat, collapse (these may be signs of a severe allergic reaction)
• severe skin reactions including skin peeling, blistering, red swellings or blistering of the mouth, eyes or genitals.
STOP TAKING the tablets and tell your doctor if you experience any of the following:
• indigestion or heartburn
• pains in your stomach, feeling sick or other abnormal stomach symptoms
• allergic skin reactions such as rashes, itching, hives.
Tell your doctor, pharmacist or nurse if you suffer from any of the following effects:
Uncommon effects (that could happen to less than 1 in 100 people):
• headache
Rare effects (that could happen to less than 1 in 1,000 people):
• diarrhoea, constipation, vomiting, flatulence (wind).
Very rare effects (that could happen to less than 1 in 10,000 people):
• changes in blood (symptoms may include fever, sore throat, mouth ulcers, flu-like symptoms, tiredness or unexplained bleeding or bruising)
• worsening of Crohn’s Disease and colitis
• mouth ulcers
• kidney damage or kidney failure (symptoms include passing more or less urine than usual, blood in urine, back pain)
• liver problems (symptoms include yellowing of the skin and eyes)
• aseptic meningitis, especially in people with existing immune disorders (such as “SLE”); symptoms are fever, headache, stiff neck, nausea, vomiting and skin rash.
Other effects:
• anxiety, difficulty sleeping, impaired hearing, eyesight problems such as change in colour vision, blurred, partial or complete loss of vision, swelling and irritation inside the nose.
Fluid retention (symptoms include swollen ankles), high blood pressure and heart failure have been reported in people taking ibuprofen. Medicines such as ibuprofen may be associated with a small increased risk of heart attack (“myocardial infarction”) or stroke.
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 in the pack provided and protect from heat, light and moisture.
KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF CHILDREN.
Do not take the tablets if the expiry date on the pack has passed.
If you have any medicines that are out of date, return them to your pharmacist for safe disposal.
6. Further Information
Ingredients:
Each tablet contains 200mg of Ibuprofen as the active ingredient. The other ingredients are: colloidal anhydrous silica, microcrystalline cellulose, pregelatinised maize starch, purified talc, sodium starch glycolate, magnesium stearate, sucrose, gum acacia, erythrosine (E127), titanium dioxide (E171), shellac, beeswax and carnauba wax.
What the medicine looks like:
Ibuprofen Tablets are round, pink sugar-coated tablets. Each pack contains 84 tablets.
The product licence holder and manufacturer of this medicine is:
Crescent Pharma Limited, Units 3 & 4, Quidhampton Business Units, Polhampton Lane, Overton, Hants, RG25 3ED.
Date leaflet prepared: December 2015.
If you would like this leaflet in a different format please contact the licence holder at the above address.