Ibuprofen 400mg Tablets
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Ibuprofen 400 mg Tablets
This medicine will be called Ibuprofen Tablets in this leaflet.
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 need more information or advice, please ask your doctor or pharmacist.
• You must contact a doctor if your symptoms get worse or do not improve after 10 days.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
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
These tablets contain the active ingredient, ibuprofen. Ibuprofen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). It relieves pain, reduces inflammation and lowers temperature when you have a fever.
Ibuprofen Tablets are used for the relief of rheumatic and muscular pain, pain of non-serious arthritic conditions, backache, neuralgia (nerve pain), migraine, headache, dental pain and period pains. They are also for the relief of feverishness and the symptoms of colds and influenza.
Some people lilUSt 11 Ot take these 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)
• You have a stomach ulcer, perforation or bleeding or have previously had 2 or more episodes of these in the past
• You have ever had stomach bleeding or perforation caused by taking NSAID painkillers
• You are taking other NSAID painkillers, or aspirin with a daily dose above 75mg
• You have severe heart, liver or kidney failure
• You are in the last 3 months of pregnancy.
You must be especially careful if:
• You have or have ever suffered from asthma or an allergy
• You suffer from heart, liver or kidney problems
• You are elderly, as you may be more likely to suffer from side effects (see section 4)
• You suffer from systemic lupus erythematosus (SLE) or another connective tissue disorder
• You have a history of stomach or bowel problems (such as Crohn’s disease or colitis)
• You are in the first 6 months of pregnancy or you are breastfeeding
• You have been told by your doctor that you have an intolerance to some sugars, as this medicine contains lactose and sucrose.
If any of the conditions above apply to you, please discuss with your doctor or pharmacist before taking this medicine.
Taking other medicines
Ibuprofen 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), water tablets (diuretics), digoxin
• 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)
• 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).
Always tell your doctor or pharmacist about all the medicines you are taking. This means medicines you have bought yourself as well as those you have on prescription from your doctor. 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.
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 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.
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.
Pregnancy and breastfeeding
Do not take if you are in the last 3 months of pregnancy and if you are in the first 6 months of pregnancy or you are breastfeeding talk to your doctor before taking this medicine.
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Driving and using machinery
Ibuprofen Tablets should not affect your ability to drive or operate machinery.
The tablets should be swallowed with a drink of water.
Unless this product has been prescribed by your doctor it 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.
Adults, the elderly and children over 12 years: Take one tablet up to 3 times a day as required, or as instructed by your doctor.
Leave at least 4 hours between doses, and do not take more than 3 tablets in any 24 hour period.
If these tablets were prescribed for you by your doctor, you should take the tablets exactly as the doctor has told you; the dose will be on the pharmacist’s label.
Do not give to children under 12 years of age.
If you take more tablets than you should
You should contact your doctor or pharmacist straightaway. Take the pack with you.
If you forget to take a dose of Ibuprofen Tablets
If you miss a dose don’t worry. Do NOT take a double dose to make up for the forgotten dose, just carry on with the normal routine.
Very rare effects (may occur in 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)
• 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, disorientation and skin rash.
Side effects for which the frequency cannot be estimated from available data:
• Fluid retention (symptoms include swollen ankles), high blood pressure, heart failure
• Worsening of Crohn's Disease and colitis.
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.
Ibuprofen is usually well tolerated, however, like all medicines, this medicine can cause side effects, although not everybody gets them. The elderly are 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.
The following other effects have been reported with ibuprofen:
Uncommon effects (may occur in less than 1 in 100 people):
• Headache.
Rare effects (may occur in less than 1 in 1,000 people):
• Diarrhoea, constipation, vomiting, flatulence (wind).
Keep out of the sight and reach of children
Do not store above 25°C. Store in the original package (carton) / Keep the container (bottle) tightly closed in order to protect the tablets from moisture.
Do not use the tablets after the expiry date shown on the label or carton.
Please take any unused medicine back to your pharmacist to be destroyed.
Ingredients
Each tablet contains 400 mg of the active ingredient, ibuprofen. The other ingredients are lactose, potato starch, hypromellose, sodium starch glycollate, colloidal anhydrous silica, magnesium stearate, sucrose, talc, pregelatinised maize starch, maize starch and titanium dioxide E171.
What the medicine looks like
The tablets are round and white sugar coated. Packs contain 6, 12, 24, 48, 84, 96 or 250 tablets.
Not all pack sizes may be marketed.
MA Holder:
Special Concept Development (UK) Ltd., Units 1-7 Colonial Way, Watford, Hertfordshire, WD24 4YR, United Kingdom.
Manufacturer:
Ascenders Consulting Services Limited,
110 Butterfield, Great Marlings, Luton, Bedfordshire, LU2 8DL
Product Licence Number:
PL 36722/0012
Date of revision: June 2015
If you would like this leaflet in a different format, please contact the licence holder at the above address.