Ibuprofen 400mg Coated Tablets
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Ibuprofen 400 mg Coated Tablets
Read this leaflet carefully because it contains important information for you.
This medicine is available without prescription. However, you still need to take Ibuprofen 400 mg Coated Tablets carefully to get the best results for them.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist or doctor if you need more information or advice.
In this leaflet:
1. What Ibuprofen 400 mg Coated Tablets are and what they are used for.
2. Before you take Ibuprofen 400 mg Coated Tablets.
3. How to take Ibuprofen 400 mg Coated Tablets.
4. Possible side effects.
5. How to store Ibuprofen 400 mg Coated Tablets.
6. Further information.
1. What Ibuprofen 400 mg Coated Tablets are and what they are used for:
Ibuprofen is a member of a class of medicines called non-steroidal anti-inflammatory drugs (NSAID’s). Ibuprofen is used for the symptomatic relief of non-serious arthritic conditions, rheumatic or muscular pain, backache, neuralgia, migraine, headache, dental pain, dysmenorrhoea, feverishness and the symptoms of colds and influenza.
2. Before you take Ibuprofen 400 mg Coated Tablets:
You should not take these tablets if you:
• have or have had a stomach ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding);
• have had gastrointestinal bleeding or perforation when previously taking NSAIDs;
• are allergic to ibuprofen, any of the excipients of the product, aspirin or other non-steroidal antiinflammatory drug;
• are taking other NSAID painkillers or aspirin with a daily dose above 75 mg;
• are in the last 3 months of pregnancy;
• are under 12 years old.
Tell you doctor or pharmacist before taking these tablets if you:
• suffer or have history of bronchial asthma or allergic disease;
• have history of gastrointestinal disease (ulcerative colitis, Crohn’s disease);
• have Systemic Lupus Erythematosus and mixed connective tissue disease;
• have heart, renal and hepatic problems;
• are in the first 6 months of pregnancy.
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 doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment.
If you have heart problems, previously 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 you are a smoker) you should discuss your treatment with your doctor or pharmacist.
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.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Taking other medicines:
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without prescription, such as:
• Antihypertensive agents (medicines for high blood pressure) and diuretics: NSAIDs may diminish the effect of these drugs. Diuretics can increase the risk of nephrotoxicity of NSAIDs;
• Cardiac glycosides: NSAIDs may exacerbate cardiac failure, reduce GFR and increase plasma cardiac glycoside levels;
• Corticosteroids: there is an increased risk of gastrointestinal ulceration or bleeding;
• Anti-platelet agents and selective serotonin-reuptake inhibitors (SSRIs): there is an increased risk of gastrointestinal bleeding;
• Lithium: there is evidence for potential increases in plasma levels of lithium;
• Methotrexate: there is a potential for an increase in plasma methotrexate;
• Ciclosporin: there is an increased risk of nephrotoxicity;
• Quinolone antibiotics: patients taking NSAIDs and quinolones may have an increased risk of developing convulsions;
• Mifepristone: NSAIDs can reduce the effect of mifepristone and therefore they should not be used for 8-12 days after mifepristone administration;
• Tacrolimus: there is a possible increased risk of nephrotoxicity;
• Zidovudine: there is an increased risk of haematological toxicity when NSAIDs are given with zidovudine. There is evidence of an increased risk of haemarthroses and haematoma in HIV(+) haemophilliacs receiving concurrent treatment with zidovudine and ibuprofen;
• Any other Ibuprofen medications or other anti-inflammatory painkiller, such as those you may buy without prescription.
Avoid concomitant use of ibuprofen and other analgesics including cyclo-oxygenase-2-selective inhibitors.
Remedica
Some medicines that are anti-coagulants (i.e. thin blood/prevent clotting e.g. 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.
Do not take Ibuprofen if you are taking aspirin at doses above 75 mg daily. If you are on low-dose aspirin (up to 75 mg daily) speak to your doctor or pharmacist before you take Ibuprofen.
3. How to take Ibuprofen 400 mg Coated Tablets:
Adults, the elderly and children over 12 years: This product 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.
Take 1 tablet with water, up to three times a day, as required. Leave at least 4 hours between doses. Do not take more than 3 tablets (1200mg) in any 24 hour period.
Action in case of missed dose:
If you forget to take a dose at the right time take it as soon as you remember. If it is almost time to take the next dose, wait until then and then carry on as before. Do not take two doses together (do not double up on a dose) to make up for the one you have missed.
Action in case of overdose:
If you or someone you know take too many tablets contact your nearest hospital casualty department or your doctor immediately. Take any remaining tablets and the container with you, it will help the doctor.
4. Possible side effects:
These tablets may cause side-effects in some patients. These may include:
• Gastrointestinal disorders are the most commonly observed side effects. These may include dyspepsia, nausea, abdominal pain; Rarely, vomiting, flatulence, constipation, diarrhoea. Very rare, peptic ulcer, perforation or gastrointestinal haemorrhage, melaena, haematemesis, sometimes fatal particularly in elderly, ulcerative stomatitis, gastritis, exacerbation of colitis and Crohn’s disease.
• Hypersensitivity reactions: non-specific allergic reactions and anaphylaxis; respiratory tract reactivity comprising asthma, aggravated asthma, bronchospasm or dyspnoea; skin disorders e.g. pruritus, urticaria, angioedema and more rarely exfoliative and bullous dermatoses (including epidermal necrolysis and erythema multiforme); facial, tongue and laryngeal swelling, tachycardia, hypotension.
• Nervous system disorders: headache; Very rare, aseptic meningitis.
• Renal disorders: acute renal failure, papillary necrosis, especially in long-term use, associated with increased serum urea and oedema;
• Hepatic disorders;
• Haematological disorders: haematopoietic disorders (anaemia, leucopenia, thrombocytopenia, pancytopenia, agranulocytosis). First signs are fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe exhaustion, unexplained bleeding and bruising;
• Dermatological disorders: various skin rashes. Very rare: Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis;
• Immune system disorders: in patients with pre-existing auto-immune disorders (such as systemic lupus erythematosus, mixed connective tissue disorders) the following have been observed: symptoms of aseptic meningitis such as stiff neck, headache, nausea, vomiting, fever or disorientation;
• Cardiovascular and Cerebrovascular: oedema, hypertension, cardiac failure have bee reported. Medicines such as Ibuprofen may be associated with a small increased risk of heart attack (“myocardial infarction”) or stroke.
If you suffer from any of these side-effects or any other effects that are not included in this list, talk to your doctor or pharmacist as soon as possible.
5. How to store Ibuprofen 400 mg Coated Tablets:
Store below 25°C. Store in the original container. Keep the container in the outer carton.
KEEP ALL MEDICINES OUT OF THE REACH AND SIGHT OF CHILDREN.
DO NOT USE AFTER THE EXPIRY DATE STATED ON THE CONTAINER.
Take any unused tablets back to your pharmacist for disposal.
6. Further information:
What Ibuprofen 400 mg Coated Tablets contain:
These sugar-coated tablets contain the active ingredient Ibuprofen 400 mg as well as the following inactive ingredients: microcrystalline cellulose, sodium starch glycolate (type A), pregelatinised starch, colloidal anhydrous silica, purified talc, gelatin, macrogol 6000, PVP (povidone), sucrose, calcium carbonate, Erythrosine (E127), carnauba wax, beeswax, spemaceti wax, trichloroethylene.
Packs:
These tablets come in pack sizes of 10, 12, 20 or 24 sugar-coated tablets.
Marketing Authorisation Holder:
Remedica (UK) Ltd., Suite 20, 42 Upper Brook Street, London, W1K 7QP, England.
Manufacturer:
Remedica Ltd., Industrial Estate, PO Box 51706, CY-3508 Limassol, Cyprus.
The leaflet was last approved on:
The leaflet was revised on:
December 2011.
Product Licence Number:
PL 11125/0019 Legal Classification:
P