Ibuprofen Tablets Bp 600mg
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Accord |
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Pantone Black | ||||
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Ibuprofen | ||||||
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UK | ||||||
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170 x 420 mm (PIL) | ||||||
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advertising & communication services ltd. |
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Date |
14-12-11 (Ibuprofen (ACC-UK) POM-PIL) | ||||||
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Prepared By Regulatory Affairs |
Checked By Regulatory Affairs |
Checked By Quality Assurance |
Approved By EU Head - QA | ||||
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PACKAGE LEAFLET - INFORMATION FOR THE USER
IBUPROFEN 200MG TABLETS BP IBUPROFEN 400MG TABLETS BP IBUPROFEN 600MG TABLETS BP
(Ibuprofen)
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 are Ibuprofen tablets and what are they 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
1. WHAT ARE IBUPROFEN TABLETS AND WHAT ARE THEY USED FOR
Ibuprofen belongs to a group of medicines called Non-steroidal Anti-inflammatory Drugs. They can be used to relieve pain and inflammation in conditions such as osteoarthritis, rheumatoid arthritis (including juvenile rheumatoid arthritis or Still’s disease), arthritis of the spine (ankylosing spondylitis), swollen joints, frozen shoulder, bursitis, tendinitis, tenosynovitis, lower back pain, sprains and strains.
Ibuprofen is also used to treat other painful conditions such as toothache, pain after operations, period pain and headache, including migraine.
2. BEFORE YOU TAKE IBUPROFEN TABLETS
Do not take Ibuprofen tablets if any of the following apply to you.
• I f you are allergic (hypersensitive) to Ibuprofen, or to any of the ingredients of Ibuprofen tablets (see What Ibuprofen Tablet contains, section 6).
• If you have ever had a stomach ulcer or other gastric problems.
• If you currently have a peptic ulcer (ulcer in your stomach or duodenum) or bleeding in your stomach,or have had two or more episodes of peptic ulcers, stomach bleeding or perforation in the past.
• If you suffer from a condition which increases your tendency to bleeding.
• If you suffer from asthma or have you ever had an allergic reaction or suffered from wheezing after taking ibuprofen, aspirin or other anti-inflammatory pain killers.
• If you suffer from heart problems.
• If you suffer from liver problems.
• If you suffer from kidney problems.
• If you are pregnant and in the last 3 months of pregnancy.
Take special care with Ibuprofen tablets
Talk to your doctor or pharmacist before taking this medicine:
• If you are pregnant, planning to become pregnant or breast-feeding.
• If you are taking pain killer like aspirin.
• If you are taking medication to help increase urine excretion.
• If you are taking medication to prevent blood clotting.
• If you have a history of ulcerative colitis or crohn’s disease.
• If you suffer from kidney or liver problems.
• If you suffer from heart problems.
Medicines such as Ibuprofen 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. If you have heart problems, previous stroke or think that you might be at risk of these conditions (e.g. if you have high blood pressure, diabetes, high cholesterol or are a smoker) you should discuss your treatment with your doctor or pharmacist.
• If you are suffering or have a previous history of bronchial asthma.
• If you are elderly-you may get more side effects.
• If you suffer from systemic lupus erythematosus (SLE, sometimes known as lupus) or a connective tissue disease (autoimmune diseases affecting connective tissue).
• If you have been told by your doctor that you have an intolerance to some sugars.
Taking other medicines
Please inform your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including those medicines obtained without a prescription.
In particular you should tell your doctor or pharmacist if you are taking any of the following medicines.
• Anti-coagulants (used to thin blood/prevent clotting e.g. aspirin/acetylsalicyclic acid, warfarin, ticlodipine).
• ACE-inhibitors (used to reduce high blood pressure such as captopril, beta-blockers such as atenolol, or angiotensin-II receptor antagonists such as losartan).
• Diuretics (water tablets).
• Cardiac glycosides (used to treat heart conditions e.g. digoxin).
• Lithium (used to treat depression).
• Zidovudine (an anti-viral drug).
• Steroids (used in the treatment of inflammatory conditions).
• Methotrexate (used to treat certain cancers).
• Ciclosporin and tacrolimus (used to dampen down your immune response).
• Selective serotonin reuptake inhibitors (SSRIs)(used to treat 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).
• Glibenclamide (used to treat diabetes).
• Voriconazole or fluconazole (used to reduce fungal infection).
• Gingko biloba herbal medicine (there is a chance you may bleed more easily if you are taking this with ibuprofen).
Pregnancy and Breastfeeding
The use of Ibuprofen tablets 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.
Taking with Food and Drink
Ibuprofen Tablets can be taken with or after food.
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.
Important information about some of the ingredients of Ibuprofen tablets
These tablets contain lactose. If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking Ibuprofen tablets.
3. HOW TO TAKE IBUPROFEN TABLETS
Dosage: To be taken orally.
Always take Ibuprofen Tablets exactly as your doctor has told you. If you are not sure refer to the label on the carton or check with your doctor or pharmacist.
The following dosage guidelines are only for patients taking this medicine on prescription from the doctor.
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Artwork No. |
- |
Colours Used | |||||
|
Customer |
Accord |
■ |
Pantone Black | ||||
|
Description |
Ibuprofen | ||||||
|
Market |
UK | ||||||
|
Language |
English | ||||||
|
Size |
170 x 420 mm (PIL) | ||||||
|
V ' ■ advertising & communication services ltd. | |||||||
|
Min. Font Size |
9 | ||||||
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Version No. |
1 (Page 2 of 2) | ||||||
|
Date |
14-12-11 (Ibuprofen (ACC-UK) POM-PIL) | ||||||
|
Prepared By Regulatory Affairs |
Checked By Regulatory Affairs |
Checked By Quality Assurance |
Approved By EU Head - QA | ||||
L
Adults
Usually 1200 to 1800mg daily in divided doses. Some patients can be maintained on 600 to 1200mg daily. The total daily dose must not be more than 2400mg.
Children:
20mg/kg body weight daily in divided doses. For children with rheumatoid arthritis, up to 40mg/kg body weight daily in divided doses. Ibuprofen should NOT be taken by children weighing less than 7 kg.
Elderly:
As for adults, unless there are kidney or liver problems, if so your doctor may decide to prescribe you a lower dose.
The elderly are at increased risk of the serious consequences of adverse reactions. If Ibuprofen is considered necessary your doctor may use the lowest dose and may decide to monitor you regularly for GI bleeding during NSAID therapy.
If you take more Ibuprofen tablets than you should
If you or someone else swallows several of these tablets all together, or you think a child has swallowed any of these tablets, contact your doctor or pharmacist or hospital emergency department immediately. Always take any tablets left over with you, also the box and leaflet as this will allow easier identification of the tablets.
If you forget to take Ibuprofen tablets
If you forget to take a dose, take it as soon as you remember. If it is almost time for your next dose, do not take the missed dose and just carry on as before. Do not take a double dose to make up for a forgotten dose.
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 tablets can cause side effects, although not everybody gets them.
If any of the following happens, stop taking Ibuprofen tablets and tell your doctor immediately or go to the casualty department at your nearest hospital.
• Severe headache, high temperature, stiffness of the neck or intolerance to light.
• Pass blood in your faeces (stools/motions).
• Pass black tarry stools.
• Vomit any blood or dark particles that look like coffee grounds.
Tell your doctor and stop taking the tablets if you experience:
• Unexplained stomach pain or other abnormal stomach symptoms, indigestion, heartburn, feeling sick and/or vomiting,
• 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).
Medicines such as Ibuprofen Tablets have been associated with a small increased risk of heart attack (myocardial infarction) or stroke.
Blood disorders, kidney problems, liver problems or severe skin reactions may occur rarely with ibuprofen.
Very rarely Ibuprofen Tablets may cause aseptic meningitis (inflammation of the protective
membrane surrounding the brain).
Other unusual 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.
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 TABLETS
Keep out of the reach and sight of children.
Do not use your tablets after the expiry date stated on the label or carton.
Tablet container: Do not store above 25°C. Store in the original container. Keep the container tightly closed.
Blister: Do not store above 25°C. Store in the original package.
Medicines should not be disposed of via waste water 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 Tablet contains?
The active substance is Ibuprofen.
The inactive ingredients are Povidone K30, Lactose monohydrate, Starch Maize, Microcyrstalline Cellulose, Sodium Starch Glycollate and Colloidal Anhydrous Silica (see section 2 for Important information about some of the ingredients of Ibuprofen tablets).
Coating ingredients
Ibuprofen 200mg and 400mg tablets contains Opaglos NA 7150(Shellac, Acetylated monoglyceride, Povidone), Sucrose, Titanium dioxide, Starch (maize), Talc, Calcium carbonate, Sodium benzoate, Acacia, Opalux AS-F-1537(Sucrose, Titanium dioxide, Erythrosine, Sodium benzoate),Sugar syrup 70%(sugar and Sodium benzoate) and Opaglos 6000P(Beeswax, Carnauba wax, Shellac). The printing ink is composed of Ferric oxide black and Shellac.
Ibuprofen 600mg tablets contains Talc, Opalux Pink AS 1537(Sucrose, Titanium dioxide, Erythrosine and Sodium Benzoate), Polyethylene Glycol 4000, Citroflex (Triethylcitrate) and Eudragit RL 30D (Methyacrylate Copolymer).
What Ibuprofen Tablet looks like and contents of the pack?
Ibuprofen 200mg tablets are round, pink, sugar coated, plain on one side, IB2 on the other side.
Ibuprofen 400mg tablets are round, pink, sugar coated, plain on one side, IB4 on the other side.
Ibuprofen 600mg tablets are pink, capsule shaped, film coated, (a) embossed R111 or (b) with IBP 600 on one side and R on the reverse.
Ibuprofen tablets 200mg, 400mg, 600mg are available in container packs of 14, 15, 21,28, 42, 50, 56, 70, 84, 100, 250 and 500 tablets. They are also available in blister packs of 14, 15, 21,28, 42, 56, 70 and 84 tablets. Additionally Ibuprofen 200mg tablets is available in blister packs of 24 and 48 tablets. Additionally Ibuprofen 400mg and 600mg tablets are also available in bucket bulk packs of 5000 and 15000 tablets (Not all pack sizes may be marketed).
Marketing Authorisation Holder
Accord Healthcare Limited,
Sage House, 319, Pinner Road,
North Harrow, Middlesex, HA1 4HF,
United Kingdom.
Manufacturer
Ranbaxy Ireland Ltd.,
Spafield, Cork Road, Cashel,
Co. Tipperary, Ireland.