Ibuprofen 400mg Coated Tablets
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Ibuprofen 400 mg Coated Tablets
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 to you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
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 (NSAIDs). Ibuprofen for its analgesic, anti-inflammatory effects is used in the treatment of rheumatoid arthritis (including juvenile rheumatoid arthritis or Still’s disease), ankylosing spondylitis, osteoarthritis, other nonrheumatoid (seronegative) arthropathies. In the treatment of non-articular rheumatic conditions, ibuprofen is indicated in periarticular conditions such as frozen shoulder (capsulitis), bursitis, tendinitis, tenosynovitis, low back pain and soft tissue injuries such as sprains and strains.
Ibuprofen is also indicated for its analgesic effect in the relief of mild to moderate pain such as dysmenorrhoea, dental and post-operative pain and for the symptomatic relief of headache, including migraine headache.
2. Before you take Ibuprofen 400 mg Coated Tablets:
You should not take these tablets if you:
• have severe heart, renal and hepatic failure;
• have active or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding;
• are allergic to ibuprofen or any other ingredient of the product, aspirin or other NSAIDs.
Tell you doctor or pharmacist before taking these tablets if you:
• have or have had bronchial asthma;
• have history of gastrointestinal disease (ulcerative colitis, Crohn’s disease);
• are pregnant or trying to become pregnant.
If symptoms persist or worsen, consult your doctor.
Your doctor may wish to monitor your progress while you are taking these tablets.
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 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 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:
• Antihypertensives (medicines for high blood pressure), beta-blockers and diuretics: the concomitant use with ibuprofen may cause reduced anti-hypertensive effect; Diuretics can also increase the risk of nephrotoxicity of NSAIDs;
• Cardiac glycosides: NSAIDs may exacerbate cardiac failure, reduce GFR and increase plasma glycoside levels;
• Cholestyramine: the absorption of ibuprofen in the gastrointestinal tract may be reduced;
• Corticosteroids: there is an increased risk of gastrointestinal ulceration or bleeding;
• Lithium: decreased elimination of lithium;
• Methotrexate: NSAIDs may inhibit the tubular secretion of methotrexate and reduce clearance of methotrexate;
• Ciclosporin: there is an increased risk of nephrotoxicity;
• Quinolone antibiotics: patient taking NSAIDs and quinolones may have an increased risk of developing convulsions;
• Mifepristone;
• Sulfonylureas: hypoglycaemia can be rarely caused;
• Tacrolimus: possible increased risk of nephrotoxicity when NSAIDs are given with tacrolimus;
• 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;
• Anti-platelet agents and selective serotonin-reuptake inhibitors (SSRIs): there is an increased risk of gastrointestinal bleeding;
• Aminoglycosides: the excretion of aminoglycosides may be decreased;
• Herbal extracts: Ginkgo biloba may potentiate the risk of bleeding with NSAIDs;
• CYP2C9 inhibitors (e.g. voriconazole, fluconazole) ;
Avoid concomitant use of ibuprofen and other analgesics including cyclo-oxygenase-2-selective inhibitors.
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.
Remedica
3. How to take Ibuprofen 400 mg Coated Tablets:
Follow you doctor’s instructions on how to take your tablets. Your pharmacist will help you if you are not sure.
The tablets should be taken preferably with or after food.
Adults: recommended dosage is 1200-1800mg daily in divided doses. Some patients can be maintained on 600-1200mg daily. In severe or acute conditions it can be advantageous to increase the dosage until the acute phase is brought under control, provided that the daily dose does not exceed 2400mg in divided doses.
Children: The daily dose is 20 mg/kg of body weight in divided doses. For the treatment of juvenile rheumatoid arthritis, up to 40 mg/kg body weight daily in divided doses may be taken.
The medicine is not recommended for children weighing less than 7 kg.
Elderly: The elderly are at increased risk of the serious consequences of adverse reactions. If an NSAID is considered necessary, the lowest effective dose should be used and for the shortest possible duration.
The patient should be monitored regularly for gastrointestinal bleeding during NSAID therapy.
If renal or hepatic function is impaired, dosage should be assessed individually.
Action in case of a 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 go to your nearest hospital casualty department or contact 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 peptic ulcers, perforation or gastrointestinal bleeding (sometimes fatal, particularly in the elderly), nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn’s disease, gastritis, gastrointestinal perforation and pancreatitis.
• Immune system disorders: non-specific allergic reactions and anaphylaxis; respiratory tract reactivity comprising asthma, aggravated asthma, bronchospasm or dyspnoea; skin disorders including rashes of various types, pruritus, urticaria, purpura, angioedema and more rarely exfoliative and bullous dermatoses (including Stevens-Johnson syndrome, toxic epidermal necrolysis and erythema multiforme).
• Cardiac and vascular disorders: oedema, hypertension, cardiac failure.
Medicines such as Ibuprofen may be associated with a small increased risk of heart attack (“myocardial infarction”) or stroke.
• Renal and urinary disorders: impaired renal function, toxic nephropathy in various forms including interstitial nephritis, nephrotic syndrome and renal failure.
• Hepatobiliary disorders: abnormal liver function, hepatic failure, hepatitis and jaundice.
• Nervous system disorders: optic neuritis, headache, paraesthesia, dizziness, somnolence.
• Blood and lymphatic system disorders: leucopenia, thrombocytopenia, neutropenia, agranulocytosis, aplastic anaemia and haemolytic anaemia.
• Psychiatric disorders: insomnia, anxiety, depression, confusional state, hallucination.
• Skin and subcutaneous tissue disorders: bullous reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis (very rare) and photosensitivity reactions.
• Infections and infestation: rhinitis and aseptic meningitis (especially in patients with existing autoimmune disorders, such as systemic lupus erythematosus and mixed connective tissue disease) with symptoms of stiff neck, headache, nausea, vomiting, fever or disorientation.
• Eye disorders: visual impairment and toxic optic neuropathy.
• Ear and labyrinth: hearing impaired, tinnitus, vertigo.
• General disorders: malaise, fatigue.
If you experience any of these side-effects or any other not listed here, tell your doctor or pharmacist.
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 PAST 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 36, 48, 60, 72, 84, 96 and 100 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:
October 2011.
Product License Number:
PL 11125/0018 Legal classification:
POM