Ibuprofen 400mg Tablets
H
IBUPROFEN 400mg Tablets BP
PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor, or pharmacist or nurse has told you.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• If you get any side effects, talk to your doctor, or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4
• You must talk to your doctor if you do not feel better or if you feel worse after 10 days.
WHAT IS IN THIS LEAFLET
1. What Ibuprofen 400mg Tablets are and what they are used for
2. What you need to know before you take Ibuprofen 400mg Tablets
3. How to take Ibuprofen 400mg Tablets
4. Possible side effects
5. How to store Ibuprofen 400mg Tablets
6. Contents of the pack and other information
1. WHAT IBUPROFEN 400MG TABLETS ARE AND WHAT THEY ARE USED FOR
Ibuprofen is one of a group of medicines called non-steroidal anti-inflammatory drugs or NSAIDs.
It relieves pain, reduces inflammation and lowers temperature when you are feverish.
Ibuprofen 400mg Tablets are used to provide relief of headache, migraine,dental pain, backache, rheumatic and muscular pains, neuralgia, period pain, feverishness and the symptoms of cold and flu
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE IBUPROFEN 400MG TABLETS
Do not take this medicine if:
You are allergic to ibuprofen, aspirin or any other painkillers or to any of the other ingredients contained in the tablets (see section 6). An allergic reaction may be recognised as a rash, itching, swollen face or lips, or shortness of breath You have an active or a history of recurrent peptic ulcers (more than two)
You have a history of gastrointestinal bleeding or perforation related to the use of NSAIDs You have a history of allergy to aspirin, ibuprofen or NSAIDs, which includes attacks of asthma, swelling of the nose and throat, skin rashes or a runny nose
You have severe heart, kidney or liver failure You are in the last trimester of pregnancy Warnings and Precautions Talk to your doctor, or pharmacist or nurse before taking Ibuprofen 400mg Tablets if:
You suffer from asthma or hives
You are taking aspirin or any other non-steroidal
anti-inflammatory drugs (NSAIDs)
You have liver, kidney or heart problems You are pregnant or breast-feeding You have a history of heart problems or high blood pressure
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine You have Systemic lupus erythematosus (SLE) and mixed connective tissue disorders You have ulcerative colitis and Crohn's disease (these may be worsened)
• There is a risk of kidney damage in dehydrated children and adolescents.
Other Warnings
Low dose Aspirin: Do not take if you are taking more than 75mg of aspirin a day. If you are on low-dose aspirin (up to 75mg daily) speak to your doctor or pharmacist before you take Ibuprofen 400mg Tablets.The elderly have an increased frequency of side effects, especially gastrointestinal bleeding. Anti-inflammatory/pain-killer medicines like Ibuprofen 400mg Tablets 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.
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'1).
■ have high blood pressure, diabetes, high cholesterol, have a family history of heart disease or stroke, or if you are a smoker.
Female fertility: Ibuprofen belongs to a group of medicines which may affect fertility in women. Fertility goes back to normal when you stop taking the medicine. It is unlikely that if you only take Ibuprofen occasionally it will affect your chances of becoming pregnant. If you have problems becoming pregnant talk to your doctor before taking this medicine.
Other medicines and Ibuprofen 400mg Tablets. Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Ibuprofen tablets may affect or be affected by some other medicines. For example 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 asatenolol, orangiotensin-ll receptor antagonists such as losartan), may affect or be affected by treatment with ibuprofen.
In particular you should tell your doctor or pharmacist if you are taking any of the following medicines in addition to those mentioned above:
Diuretics (water tablets)
Cardiac glycosides, such as digoxin, used to treat
heart conditions
Lithium (used to treat mania)
Zidovudine (an anti-viral drug)
Steroids (used in the treatment of inflammatory conditions)
Methotrexate (used to treat certain cancers) 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 induce abortion)
Any other ibuprofen preparations, such as those
you can buy without a prescription
Any other anti-inflammatory pain killer, including
aspirin
Cholestyramine (a drug used to lower cholesterol) Medicines known as sulphonylureas such as glibenclamide (used to treat diabetes) Voriconazole or fluconazole (types of anti-fungal drugs)
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Ibuprofen 400mg Tablets BP (FPL) Leaflet Size: 165 x 310 mm PLL9007NO
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• Ginkgo biloba herbal medicine (there is a chance you may bleed more easily if you are taking this with ibuprofen).
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.
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.
Driving and Using Machines
Ibuprofen may make you feel dizzy or drowsy.
If the tablets affect you in this way do not drive, operate machinery or do anything that requires you to be alert.
Ibuprofen 400mg tablets contain lactose, sucrose and sunset yellow (E110)
These tablets contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before taking these tablets.
These tablets contain sunset yellow (E110), which can cause allergic-type reactions including asthma. Allergy is more common in those people who are allergic to aspirin.
3. HOW TO TAKE IBUPROFEN 400MG TABLETS:
Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you. Check with your doctor, pharmacist or nurse if you are not sure.
The recommended dose is:
Adults, the elderly and children over 12 years:
• Take one tablet with water to start with, preferably with or after food, followed by one tablet every four hours if necessary.
• Do not take more than three tablets in any twenty four hour period.
• This medicine is for short-term use only.
• Take the lowest dose for the shortest time necessary.
• Do not take Ibuprofen 400mg tablets for longer than 10 days.
If you do not get better, or get worse, talk to your doctor.
They will tell you if it is safe to carry on taking the medicine.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them. Gastrointestinal Effects:
If you get any of the following at any time during your treatment STOP TAKING and get medical help straight away:
- Pass blood in your stools or motions.
- Pass black tarry stools or motions.
- Vomit any blood or dark particles that look like coffee grounds
STOP TAKING and tell your doctor if you experience:
- Indigestion or heartburn
- Pains in your stomach (abdomen) or other abnormal stomach problems.
Other side effects that could occur include:
- Feeling sick and/or vomiting, peptic ulcers
- 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)
Blood disorders, kidney problems, liver problems or severe skin reactions may occur rarely with ibuprofen.Very rarely Ibuprofen 400mg Tablets may cause aseptic meningitis (inflammation of the protective membrane surrounding the brain).
Other side effects may include headache, hallucinations, dizziness, 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 and swelling and irritation inside the nose. Ibuprofen has also been shown to sometimes worsen the symptoms of Crohn's disease or colitis. Medicines such as Ibuprofen 400mg Tablets 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.aov.uk/vellowcard By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE IBUPROFEN 400MG TABLETS
Keep this medicine out of the sight and reach of children
Store below 25°C.
Blister packaging: Store in the original package. Securitainer/Pharmapac bottles: Keep the bottle tightly closed.
Do not use after the expiry date shown on the package.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What does each tablet contain?
Each tablet contains the active ingredient Ibuprofen 400mg. The tablets also contain:
Lactose monohydrate, maize starch, hypromellose, sodium starch glycollate, colloidal anhydrous silica, magnesium stearate, sucrose, purified talc, titanium dioxide (E171), carnauba wax, colouring agent (sucrose, titanium dioxide (E171), sunset yellow lake (E110), erythrosine lake (E127), sodium benzoate (E211), hydrochloric acid (E507).
What is in the pack?
This product contains pink, shiny, biconvex, circular, sugar coated tablets. Ibuprofen 400mg Tablets BP are available in blister packs of 6,12,
24, 48, 84 and 96 tablets. The product is also available in pots of 12 or 250 tablets.
Marketing Authorisation holder:
Flamingo Pharma (UK) Ltd.
1st Floor, Kirkland House, 11-15 Peterborough Road Harrow, Middlesex, HA1 2AX, UK.
Manufacturer:
Wave Pharma Ltd.
4th Floor Cavendish House, 369 Burnt Oak Broadway, Edgware, HA8 5AW, United Kingdom.
If you would like this leaflet in different format information or want to report any side effects please contact marketing authorization holder listed above This leaflet was last revised in December 2015.
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MH/DRUGS/AD-096