Ibuprofen Tablets Bp 600mg
Patient Information Leaflet IBUPROFEN TABLETS 600MG
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.
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 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
These tablets contain the active ingredient ibuprofen, which is one of the group of medicines called Non Steroidal AntiInflammatory Drugs (known as NSAIDs) which work by changing the body's response to pain, swelling and high temperatures.
This medicine is used to relieve pain, swelling and redness in a number of conditions affecting the joints and muscles, including rheumatism in adults and children. It may also be used for other conditions such as period pain, dental pain, migraine and pain following surgery.
2. Before you take Ibuprofen Tablets
Do not take these tablets if:
• you are allergic to ibuprofen or any other non steroidal anti-inflammatory drugs (NSAIDs), aspirin or to any of the other ingredients in the tablets (see section 6). (An allergic reaction may be recognised as shortness of breath, blocked nose, rash, itching, swollen face or lips)
• you have a peptic ulcer (ulcer in your stomach or duodenum) or bleeding in your stomach, or have had two or more episodes of peptic ulcers, stomach bleeding or perforation
• you have ever had stomach bleeding or perforation caused by taking NSAID painkillers
• you have a condition which increases your tendency to bleeding
• you have severe heart, liver or kidney failure
• you 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
• you suffer from heart, liver or kidney problems
• you have high blood pressure
• you suffer from a bleeding disorder
• you suffer from systemic lupus erythematosus (SLE) or another connective tissue disorder
• you have a history of stomach or intestinal problems (such as Crohn's disease or colitis)
• you are elderly, as you may be more likely to suffer from side effects
• you are in the first 6 months of pregnancy or you are breastfeeding
• you are undergoing radiation treatment.
Taking other medicines
T ell your doctor or pharmacist if you are taking any other medicines, including any that you can buy without a prescription. This is particularly important if you are taking:
• Aspirin or any other NSAID painkiller
• Medicines to thin the blood/prevent clotting (anti-coagulants or anti-platelet drugs) such as aspirin/acetylsalicylic acid, warfarin, ticlopidine
• Medicines for high blood pressure or heart problems such as ACE inhibitors (eg. captopril), beta-blockers (eg. atenolol), angiotensin-II receptor antagonists (eg. losartan) and water tablets (diuretics)
• Drugs for heart disease eg. digoxin
• Corticosteroids (eg. hydrocortisone, prednisolone)
• Lithium or a selective serotonin reuptake inhibitor (SSRI) drug (for treating depression)
• Methotrexate (for treating cancer and also can 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)
• Drugs such as 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)
• Gold (the drugs sodium aurothiomalate or auranofin) used to treat progressive rheumatoid arthritis.
Other special warnings
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.
There is a risk of kidney damage in dehydrated children and adolescents.
Ibuprofen 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.
Pregnancy and breastfeeding: The use of ibuprofen whilst pregnant or breastfeeding should be avoided. Ibuprofen should not be used in the last 3 months of pregnancy and should only be taken in the first 6 months of pregnancy on the advice of your doctor.
Driving and using machines: Ibuprofen Tablets may make you feel dizzy, tired, drowsy or might affect your vision. If you think this medicine has affected you do not drive or operate machinery.
This medicine contains the colour sunset yellow (E110) which may cause allergic reactions.
3. How to take Ibuprofen Tablets
The tablets should be swallowed with a drink of water after a meal or a snack.
The normal dose will be different for different medical conditions and patients. Always take the medicine exactly as directed by your doctor.
Adults and the elderly:
Initial dose: 2 to 3 tablets in divided doses. The maximum dose per day is 4 tablets.
Maintenance dose: 1 to 2 tablets in divided doses.
Caution should be exercised in older patients. Your doctor will decide the dose that is best for you. The pharmacist's label will also tell you how many tablets to take and how often. If you are not sure about anything, ask your doctor or pharmacist.
Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control the symptoms.
Not recommended for children.
If you miss a dose of this medicine:
Take it as soon as possible. However, if it is almost time for the next dose, skip the missed dose and continue with the regular dosing schedule. DO NOT DOUBLE THE DOSES.
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, like all medicines ibuprofen can cause side effects, although not everybody gets them. The elderly are more at risk of developing problems due to side effects. There may be fewer side
effects if you take the lowest effective dose for the shortest time necessary.
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 grounds (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 or being sick or other abnormal stomach symptoms
• Allergic skin reactions such as rashes, itching, hives
• Inflammation of the pancreas causing severe pain in the abdomen and back.
T ell your doctor, pharmacist or nurse if you suffer from any of the following effects:
• Diarrhoea, constipation, vomiting, flatulence (wind), mouth ulcers
• Worsening of Crohn's disease and colitis.
The following other effects have been reported less commonly:
• Liver problems (symptoms include yellowing of the skin and eyes)
• Kidney damage or kidney failure (symptoms include passing more or less urine than usual, blood in urine, back pain)
• Changes in blood (symptoms may include fever, sore throat, mouth ulcers, flu-like symptoms, tiredness, unexplained bleeding or bruising, or makes infections more likely)
• Aseptic meningitis, especially in people with existing immune disorders (such as “SLE”); symptoms are fever, headache, stiff neck, nausea, vomiting, disorientation and skin rash
• Headache, feeling of dizziness or “spinning”, ringing in the ears, impaired hearing, eyesight problems (such as change in colour vision, blurred, partial or complete loss of vision, blind spots, halos around lights), tingling or numbness in the hands and feet, depression, anxiety, hallucinations, tiredness, difficulty sleeping, drowsiness, confusion, swelling and irritation inside the nose.
Fluid retention (symptoms include swollen ankles), high blood pressure and heart failure have been reported in people being treated with NSAIDs.
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
Ibuprofen Tablets 600 mg contain 600mg of Ibuprofen as the active ingredient. The other ingredients are: colloidal anhydrous silica, maize starch, pregelatinised maize starch, sodium starch glycolate, stearic acid, hypromellose, hydroxypropylcellulose, macrogol, titanium dioxide (E171), erythrosine (E127) and sunset yellow (E110).
What the medicines looks like
Ibuprofen Tablets are oblong, pink film-coated tablets. Each pack contains 28, 42, 50, 56, 84, 100, 112, 250, 500 or 1000 tablets. Not all pack sizes may be marketed.
Who makes this medicine and holds the product licence:
Relonchem Ltd, Cheshire House, Gorsey Lane, Widnes, WA8 0RP.
PL 20395/0132
Date leaflet prepared: October 2014.
If you would like this leaflet in a different format please contact the licence holder at the above address.