Ibuprofen Tablets 400mg
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PACKAGE LEAFLET: INFORMATION FOR THE USER
IBUPROFEN TABLETS 200 MG AND 400 MG
Read all of this leaflet carefully before you start taking this medicine.
- 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 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 you 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 200 or 400 mg of the active ingredient ibuprofen.
Ibuprofen belongs to a group of drugs called non-steroidal anti-inflammatory drugs (also known as NSAIDs), which relieve pain and reduce inflammation. Ibuprofen is used to treat mild to moderate pain and mild inflammation caused by rheumatism and other disorders of the muscles and bones, including rheumatoid arthritis or Still’s disease.
2.BEFORE YOU TAKE IBUPROFEN TABLETS
Do not take ibuprofen if you:
- are allergic (hypersensitive) to ibuprofen or any of the other ingredients in Ibuprofen Tablets
(see list of ingredients in Section 6). An allergic reaction may include skin rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue.
- have had attacks of asthma,or an allergic reaction such as urticaria (nettle rash), angioedema (swelling of the face or throat) or rhinitis (inflammation of the lining of the nose) when you have taken aspirin, ibuprofen or any other NSAIDs (non-steroidal anti-inflammatory drugs)
- suffer from, or have previously had stomach ulcers or stomach bleeding
- have long-term indigestion
- have severe heart failure, kidney failure or liver failure
- are in your last trimester of pregnancy.
Take special care with ibuprofen (and talk to your doctor) if you:
- are elderly as you are more likely to develop side effects such as stomach bleeding, you must talk to your doctor immediately if you develop any stomach problems
- are taking any other pain killers, NSAIDs or aspirin,
- are taking steroids or anticoagulants (such as warfarin), SSRI (medicines used to treat depression, anxiety or personality disorders)
- have ever had stomach ulcers or bleeding, you must contact your doctor immediately if you develop any stomach problems
- suffer from systemic lupus erythematosus or mixed connective tissue disease (a condition which causes joint pain, skin rashes and fever)
- suffer from asthma or have ever had asthma
- have had a disease of the digestive tract (such as Crohn’s disease or ulcerative colitis), you must contact your doctor immediately if you develop any stomach problems
- have had hypertension (high blood pressure) or heart failure
- have heart disease, peripheral arterial disease (a disease of the blood vessels), or cerebrovascular disease (a disease of the blood vessels in the brain)
- are at risk of heart disease because you have high blood pressure, high lipid levels, diabetes, or you smoke
- have a kidney, heart or liver disorder
- are trying to become pregnant as ibuprofen may affect your fertility.
Please note
If you suffer from any of the following at any time during your treatment STOP TAKING the medicine and seek immediate medical help:
Pass blood in your faeces (stools/motions)
Pass black tarry stools
Vomit any blood or dark particles that look like coffee grounds STOP TAKING the medicine and tell your doctor if you experience:
Indigestion or heartburn
Abdominal pain (pains in your stomach) or other abnormal stomach symptoms 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.
If you develop any skin reactions you should stop taking this medicine and contact your doctor immediately (see section 4 Possible side effects).
Taking other medicines
Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including medicines obtained without a prescription. This is particularly true of the following as they may interact with your ibuprofen.
- other painkillers (including aspirin)
- corticosteroids (drugs that reduce inflammation such as hydrocortisone)
- anticoagulants (blood thinners)
- cardiac glycosides (treatments for heart failure such as digoxin)
- lithium (a treatment for mental illness)
- methotrexate (used for rheumatoid arthritis and cancer)
- diuretics (water tablets such as frusemide)
- antihypertensives (drugs that reduce blood pressure)
- mifepristone (a drug used for abortion)
- quinolones (a type of antibiotic)
- ciclosporin and tacrolimus (a treatment to prevent rejection after a transplant)
- anti-platelet agents (such as aspirin for circulatory problems and used to prevent blood clots)
- selective serotonin reuptake inhibitors (antidepressants for anxiety and personality disorders)
- zidovudine (anti-viral for the treatment of HIV)
Some medicines that are anti-coagulants (i.e. thin blood and prevent clotting such as aspirin/acetylsalicylic acid, warfarin, ticlopidine), some medicines that reduce high blood pressure (Ace-inhibitors such as captopril, beta-blockers such as atenolol, or angiotensin-II receptor antagonists such as losartan) and other medicines may affect or be affected by treatment with ibuprofen. You should therefore always seek the advice of your doctor or pharmacist before you take ibuprofen with other medicines.
It may still be all right for you to be given ibuprofen and your doctor will be able to decide what is suitable for you.
Taking Ibuprofen Tablets with food and drink
Ibuprofen Tablets should be swallowed with a glass of water or milk. Take with or after food.
Pregnancy and breast-feeding
Do not take Ibuprofen Tablets during your last trimester of pregnancy. You should not take Ibuprofen Tablets while pregnant or breast-feeding unless your doctor has advised you to do so. Ask your doctor or pharmacist for advice before taking any medicine.
Ibuprofen may make it more difficult for you to become pregnant. You should inform your doctor if you are planning to become pregnant or if you have problems becoming pregnant.
Driving and using machines
Do not drive or use any tools or machines if you experience any of the side effects such as dizziness, drowsiness or any problems with your eye sight.
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Important information about some of the ingredients of Ibuprofen Tablets
Ibuprofen Tablets contain lactose. If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3.HOW YOU TAKE IBUPROFEN TABLETS
Dosage
Always take ibuprofen exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Adults
- The usual dose for adults is 600 mg to 1200 mg daily in 3 or 4 divided doses, preferably with or after food.
- The maximum dose is 2400 mg (12 x 200mg or 6 x 400 mg tablets) per day.
Children
- The usual dose for children is 20 mg per kg (bodyweight) daily.
- For children under 30 kg, the maximum dose is 500 mg in 24 hours.
Elderly
- The elderly are more susceptible to side effects from ibuprofen so the lowest effective dose should be taken.
- Elderly patients should be monitored regularly during treatment to check that there is no bleeding in the stomach or gut.
If you take more Ibuprofen Tablets than you should
If you have accidentally taken more tablets than you should, you must contact your doctor or local casualty department straight away. Symptoms of an overdose include nausea (feeling sick), vomiting (being sick), stomach pains, stomach bleeding, diarrhoea, headaches, drowsiness, dizziness, feeling excitable, disorientation, fainting, fits and coma. If you are asthmatic your condition may get worse.
If you forget to take your Ibuprofen Tablets
If you have forgotten to take your tablet, take it as soon as you remember unless it is almost time for your next dose. Do not take a double-dose to make up for the one you missed.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4.POSSIBLE SIDE EFFECTS
Like all medicines, ibuprofen can cause side effects, although not everybody gets them.
All medicines can cause allergic reactions, although serious allergic reactions are very rare. Stop taking Ibuprofen Tablets and tell your doctor straight away if you get any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, skin peeling, skin rash or itching (especially affecting your whole body).
The following side effects have been reported:
Nausea (feeling sick), vomiting, diarrhoea, dyspepsia (indigestion), constipation, flatulence (wind), abdominal (tummy) pain, inflammation and ulcers of the stomach or gut rarely leading to bleeding and perforation, hypersensitivity (allergic) reactions such as asthma, worsening asthma, breathlessness, skin disorders including itchiness, nettle rash, bleeding into the skin, and swelling of the face and hands.
Occasionally, bleeding of the stomach or intestines may occur (signs of this are blood in your vomit or passing black stools). If you notice any of these symptoms or if you notice an increased tendency to bleed or bruise easily stop taking the tablets and tell your doctor straight away.
Less commonly reported:
Serious skin conditions including peeling, blistering, red spots, and swelling, and sensitivity to light. Ibuprofen can sometimes cause kidney damage, abnormal liver function, liver inflammation, and jaundice (yellow skin and eyes).
Visual disturbances, headaches, pins and needles, depression, confusion, hallucinations, (seeing and hearing things that are not there), ringing in the ears, vertigo (spinning sensation), dizziness, weakness, tiredness, sleepiness and generally feeling unwell.
Heart problems such as heart failure, high blood pressure, swelling and fluid retention.
If you have systemic lupus erythematosus you may get side effect such as a stiff neck, headache, nausea (feeling sick), vomiting (being sick), fever or disorientation.
Blood disorders include reduction in red and white blood cells and blood platelets.
Medicines such as ibuprofen may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.
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.
5.HOW TO STORE IBUPROFEN
Ibuprofen Tablets should be kept out of the reach and sight of children.
There are no special storage instructions for this medicine.
Do not take this medicine after the expiry date shown on the label.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6.FURTHER INFORMATION
What Ibuprofen Tablets contain:
The active substance is ibuprofen. The other ingredients are
Tablet: Lactose, maize starch, methylcellulose , sodium starch glycollate, magnesium stearate and colloidal silicon dioxide
Film Coating: Hydroxypropylmethylcellulose E15, titanium dioxide (E171), talc, propylene glycol, and erythrosine supra
What Ibuprofen Tablets look like and contents of the pack
Ibuprofen Tablets are rosy red film-coated tablets.
Blister packs containing 12, 24, 48, 84, 100, 250 and 500 tablets. Not all pack sizes may be marketed. Marketing Authorisation Holder:
Fannin (UK) Limited, 42-46 Booth Drive, Park Farm South, Wellingborough, Northamptonshire, NN8 6GT UK
Manufacturer and site responsible for batch release:
Fannin (UK) Limited, 57 High Street Odiham, Hants RG29 1LF, UK
This leaflet was last approved in August 2011.
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