Ibuprofen 400mg Tablets
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PACKAGE LEAFLET: INFORMATION FOR THE USER
Ibuprofen 400mg tablets BP
ibuprofen
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
• 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Ibuprofen Tablets are and what they are used for
2. What you need to know before you take Ibuprofen Tablets
3. How to take Ibuprofen Tablets
4. Possible side effects
5. How to store Ibuprofen Tablets
6. Contents of the pack and other information
1. What Ibuprofen Tablets are and what are they used for
Ibuprofen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs), which relieve pain and reduce inflammation.
The tablets are used for the relief of rheumatic and muscular pain, backache, migraine, headache, dental pain, period pains, fever, cold and flu symptoms.
2. What you need to know before you take Ibuprofen Tablets
DO NOT take Ibuprofen Tablets if you:
• are allergic to ibuprofen, aspirin or any other painkillers, or to any of the other ingredients contained in these tablets (listed in section 6 and end of section 2)
• have or ever had stomach ulcers, bleeding or perforation or experienced any of these symptoms in the past while taking NSAIDs
• are taking other NSAIDs, painkillers or aspirin with a daily dose above 75 mg
• suffer from severe liver, kidney or heart problems
• are in the last three months of pregnancy (see “Pregnancy and breast-feeding)
• have taken mifepristone in the last 12 days (see “Other medicines and Ibuprofen Tablets”).
Warnings and precautions
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.
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There is a risk of renal impairment in dehydrated adolescents.
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
of 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.
• have asthma, breathing difficulty or suffer from allergies
• suffer from liver, kidney or bowel problems
• suffer from certain rheumatic conditions (such as Systemic Lupus Erythematosus (SLE) or mixed collagenosis)
• have had a stomach or duodenal ulcer
• have had ulcerative colitis or Crohn's disease
• are in the first six months of pregnancy
• are having problems becoming pregnant
• are elderly, as you might be at higher risk of developing side effects.
• have been told that you have an intolerance to some sugars as this medicine contains lactose (see “Ibuprofen Tablets contain lactose”).
Use in children
This medicine is NOT recommended for children under 12 years of age (see section 3). Other medicines and Ibuprofen Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Ibuprofen may affect or be affected by some other medicines. For example:
• water pills (diuretics such as furosemide, hydrochlorothiazide, triamterene)
• medicines that are anti-coagulants (i.e. thin blood/prevent clotting e.g. aspirin/acetyl salicylic acid, warfarin, ticlopidine)
• medicines that reduce high blood pressure (ACE-inhibitors such as captopril, beta-blockers such as atenolol medicines, angiotensin-II receptor antagonists such as losartan)
• cardiac glycosides such as digoxin (a heart medicine)
• methotrexate used to treat arthritis and certain forms of cancer
• lithium used to treat depression
• corticosteroids (an anti-inflammatory drug)
• zidovudine (an anti-viral drug)
• tacrolimus and ciclosporin (used to dampen down you immune response)
• quinolone antibiotics (e.g. ciprofloxacin)
• mifepristone (for termination of pregnancy). DO NOT take Ibuprofen Tablets if you have taken mifepristone in the last 12 days
• cox-2 inhibitors e.g. celecoxib
• sulphonylureas such as glibenclamide (used to treat diabetes)
• anti-platelet agents and selective serotinin reuptake inhibitors (SSRIs) (used to for treatment of depression)
• aminoglycosides (a type of antibiotic)
• ginkgo biloba herbal medicine (there is a chance you may bleed more easily if you are taking this with ibuprofen)
• voriconazole or fluconazole (type of anti-fungal drugs)
• cholestyramine (a drug used to lower cholesterol).
Some other medicines may also affect or be affected by the treatment of Ibuprofen. You should therefore always seek the advice of your doctor or pharmacist before you use Ibuprofen with other medicines.
Ibuprofen Tablets with food and drink
The tablets should be swallowed with a drink of water. Take with or after food to reduce the possibility of side effects (see section 3).
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
• DO NOT use Ibuprofen Tablets in the last three months of pregnancy.
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• Speak to your doctor or pharmacist before taking Ibuprofen Tablets if you are in the first six months of pregnancy, are breast-feeding or planning to breast-feed.
Driving and using machines
These tablets do not affect your ability to drive or use machinery.
Ibuprofen Tablets contain lactose
If you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. How to take Ibuprofen Tablets
For oral administration and short term use only.
Adults, the elderly and children over 12 years:
Take one tablets up to three times a day. The tablet should be taken with water. If you are not sure how much to take, ask your doctor or your pharmacist.
DO NOT take more than 3 tablets (1200 mg) in any 24 hour period. You should NOT take this medicine for longer than 10 days unless your doctor tells you to. If your symptoms persist or worsen, consult your doctor.
If in adolescents (age range: > 12 years to < 18 years) this medicinal product is required for more than 3 days, or if symptoms worsen a doctor should be consulted.
Use in children
This medicine is NOT recommended for children under 12 years of age.
If you take more Ibuprofen Tablets than you should
If you have taken more tablets than you should, speak to your doctor or pharmacist straight away. Signs of overdose may include headache, nausea (feeling sick), vomiting (being sick), stomach pain, drowsiness, dizziness and fainting.
If you forget to take Ibuprofen Tablets
If you have missed a dose, take it as soon as you remember. DO NOT take a double dose to make up for the missed dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Ibuprofen Tablets may sometimes cause side effects although not everyone gets them.
STOP taking these tablets and seek medical help IMMEDIATELY if you experience any of the following reactions:
• difficulty breathing or swallowing, swelling of the face, lips, tongue or throat
• severe itching of the skin, with a red rash or raised lumps
• pass blood in your faeces (stools/motions)
• pass black tarry stools
• vomiting any blood or dark particles that look like coffee grounds
• indigestion or heart burn Other possible side effects:
Uncommon side effects (affecting between 1 in 100 and 1 in 1,000 people)
• hypersensitive reactions with hives and itchy rash
• nausea (feeling sick), indigestion and abdominal pain
• headache.
Rare side effects (affecting between 1 in 1,000 and 1 in 10,000 people)
• diarrhoea
• wind
• constipation
• vomiting (being sick).
Very rare side effects (affecting 1 in 100,000 people)
• high blood pressure, heart failure or chest pain
• kidney damage or kidney failure with symptom such as swelling of the ankle
• liver problems including hepatitis and jaundice (yellowing of the skin or the white of the eyes)
• severe hypersensitive reactions such as face, tongue and larynx swelling, water retention and increased heart rate
• Blood disorders (signs of these are easier bruising or bleeding or developing infections more than normal).
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible
side effects not listed in this leaflet. You can also report side effects directly via the Yellow
Card Scheme: 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 out of the sight and reach of children.
Do not store above 25°C. Store in the original package.
Do not use the tablets after the expiry date which is stated on the label or carton, after EXP. (“EXP” will need to be confirmed by yourselves first). The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information.
What Ibuprofen Tablets contain
The active substance is ibuprofen.
The other ingredients are lactose monohydrate, potato starch, hypromellose, sodium starch glycolate type A, colloidal anhydrous silica, magnesium stearate, sucrose, talc, titanium dioxide (E171), maize starch and pregelatinised starch.
What Ibuprofen Tablets look like and contents of the pack The tablets are white and sugar coated.
They are available in packs of 6, 12, 24, 25, 48, 84, 96 or 250 tablets (not all pack sizes may be marketed).
Marketing Authorisation Holder
Aurobindo Pharma Limited,
Ares, Odyssey Business Park,
West End Road South Ruislip, HA4 6QD United Kingdom
Manufacturer
Bristol Laboratories Limited,
Unit 3, Canal side, Northbridge road,
Berkhamsted, Herts, HP4 1EG,
United Kingdom
This leaflet was last revised in 11/2015