Ibuprofen Tablets Bp 600mg
24mm
PACKAGE LEAFLET: INFORMATION FOR THE USER
IBUPROFEN TABLETS BP 600 MG
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
• 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Ibuprofen Tablets are and what they are used for
2. What you need to know before you take Ibuprofen Tablets
3. How to take Ibuprofen Tablets
4. Possible side effects
5. How to store Ibuprofen Tablets
6. Contents of the pack and other information
1. What Ibuprofen Tablets are and what they are used for
Ibuprofen Tablets belong to a group of medicines called nonsteroidal 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 spine (ankylosing spondylitis), swollen joints, frozen shoulder, bursitis, tendinitis, tenosynovitis, lower back pain, sprains and strains.
Ibuprofen Tablets can also be used to treat other painful conditions such as toothache, pain after operations, period pain and headache, including migraine.
2. What you need to know before you take Ibuprofen Tablets Do not take these tablets if you:
• have ever been told you are allergic to ibuprofen, aspirin, other non-steroidal anti-inflammatory drugs, or to any of the other ingredients (listed in Section 6,).
• have had perforation or a bleeding stomach after taking non-steroidal anti-inflammatory medicines (you may have been sick and it contained blood or dark particles that looked like coffee
grounds, passed blood in your stools or passed black tarry stools)
• suffer from asthma or have ever had an allergic reaction or suffered from wheezing after taking ibuprofen, aspirin or other anti-inflammatory pain killers.
• have a stomach ulcer, perforation or bleeding, or have had one twice or more in the past
• suffer from severe heart, liver or kidney problems
• are in the last 3 months of pregnancy Warning and Precautions
Talk to your doctor or pharmacist if you:
• have poor circulation in the legs (peripheral arterial disease)
• suffer from asthma, or have a past history of asthma
• have a connective tissue disorder such as SLE (Systemic Lupus Erythematosus)
• have kidney or liver problems
• have a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) or suffer from bowel problems
• are elderly, as it increases the frequency of adverse reactions There is a risk of kidney problems in dehydrated children and adolescents.
Other important information Risk of heart attack or stroke:
Anti-inflammatory/pain-killer medicines like Ibuprofen may be associated with a small increased risk of heart attack or stroke, particularly when used at high doses. Do not exceed the recommended dose or duration of treatment.
You should discuss your treatment with your doctor or pharmacist before taking Ibuprofen 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").
- have high blood pressure, diabetes, high cholesterol, have a family history of heart disease or stroke, or if you are a smoker.
Women of childbearing age:
Ibuprofen may make it more difficult to become pregnant. You should inform your doctor if you are planning to become pregnant or if you have problems becoming pregnant.
Other medicines and Ibuprofen Tablets
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines.
Ibuprofen may affect or be affected by some other medicines. For
example:
• other painkillers, including non-steroidal anti-inflammatory medicines e.g. ibuprofen, indometacin or diclofenac, and COX-2 inhibitors e.g. celecoxib
• medicines that are anti-coagulants (i.e. thin blood/prevent clotting e.g. aspirin/acetylsalicylic acid, warfarin, ticlopidine)
• diuretics e.g. furosemide (drugs to increase urine output)
• corticosteroids (used to treat inflammatory conditions)
• methotrexate (used to reduce inflammation)
• lithium (used as a mood stabiliser)
• zidovudine (used in retroviral disease like HIV)
• selective serotonin reuptake inhibitors (SSRIs) e.g. fluoxetine (used for depression)
• cholestyramine (a drug used to lower cholesterol)
• voriconazole or fluconazole (types of anti-fungal drugs)
• Ginkgo biloba herbal medicine (there is a chance you may bleed more easily if you are taking this with ibuprofen)
• ciclosporin or tacrolimus (given after transplant surgery, or used in psoriasis or rheumatism)
• mifepristone (for termination of pregnancy) - do not take ibuprofen if you have taken mifepristone in the last 12 days
• quinolone antibiotics e.g. ciprofloxacin (for infections)
• aminoglycosides (a type of antibiotic)
• medicines that reduce high blood pressure (ACE-inhibitors such as captopril, beta-blockers such as atenolol medicines, angiotensin-II receptor antagonists such as losartan) or cardiac glycosides, such as digoxin used to treat heart conditions.
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, breast-feeding and fertility
• Do NOT take this medicine if you are in the last 3 months of pregnancy.
• Speak to your doctor or pharmacist before taking this medicine if you are in the first 6 months of pregnancy, are breast feeding or are planning to breastfeed.
• Always ask your doctor or pharmacist for advice before taking any other medicine.
Driving and operating machinery
• These tablets may cause dizziness, drowsiness, fatigue and visual disturbance. If affected do not drive or operate machines.
140 mm
Ibuprofen tablets 240 mm
600 mg 004 Insert
Front
3. How to take Ibuprofen Tablets
• Always take this medicine exactly as advised by your doctor.
• You should check with your doctor or pharmacist if you are not sure.
• The tablets should be swallowed with a drink of water.
Take with or after food to reduce the possibility of side effects.
• Ibuprofen tablets should be swallowed whole and not chewed, broken, crushed or sucked to help prevent discomfort in the mouth or irritation in the throat.
Adults:
• Take one tablet initially, followed by one tablet every 6 hours if necessary.
• Do not take more than 4 tablets in any 24 hour period.
Elderly: The lowest effective dose should be used and for the shortest possible duration.
Your doctor may have prescribed a slightly different dose to the usual dose stated above; you should always follow your doctor's instructions for taking medicines.
Children: The usual daily dosage is 20mg per kg of body weight, given in divided doses. Ibuprofen tablets should not be taken by children weighing less than 7 kg.
In cases of severe juvenile arthritis your doctor may increase the dosage up to 40mg/kg in divided doses.
Do not exceed the recommended dose or duration of treatment (2days). If symptoms persist consult your doctor.
If you take more Ibuprofen Tablets than you should Contact your nearest hospital A&E (casualty department) or your doctor immediately. Take your medicine in its original packaging with you in order to enable the doctor to identify your medication easily.
If you forget to take a dose of Ibuprofen Tablets If necessary, take the missed dose when you remember.
DO NOT TAKE A DOUBLE DOSE TO MAKE UP FOR A FORGOTTEN DOSE.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible Side Effects |
Like all medicines, this medicine may cause side effects, although they are usually mild and not everyone will suffer from them. You can minimise the risk of side effects by taking the least amount of tablets for the shortest amount of time necessary to control your symptoms.
If you suffer from any of the following at any time during your treatment STOP TAKING Ibuprofen Tablets and seek immediate medical help:
• 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 abdominal 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 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 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, skin reactions/lesions which recur (not known frequency).
Ibuprofen has also been shown to sometimes worsen the symptoms of Crohn's disease or colitis.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via Yellow Card Scheme website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
| 5. How to store Ibuprofen Tablets 1
• Keep this medicine out of the sight and reach of children
• Blisters: Do not store above 25oC. Store in the original package.
Containers: Do not store above 25oC. Store in the original container. Keep the container tightly closed.
• Do not use this medicine after the expiry date (EXP.) which is stated on the carton. The expiry date refers to the last day of that month.
• Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Ibuprofen Tablets Contain
• The active substance is Ibuprofen
• The other ingredients are: maize starch, microcrystalline cellulose, croscarmellose sodium, povidone, colloidal silicon dioxide, alginic acid, sodium lauryl sulfate, sodium starch glycolate, magnesium stearate, hydroxypropylcellulose, hydroxypropylmethylcellulose, polyethylene glycol 400, erythrosine aluminium lake (E127) and titanium dioxide (E171).
What Ibuprofen Tablets look like and contents of the pack
• Ibuprofen Tablets are pink coloured capsule shaped film coated tablets.
• They are available in packs of 50, 56, 84, 100, 250 or 500 tablets.
• Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer Name and address: Bristol Laboratories Ltd,
Unit 3, Canalside, Northbridge Road, Berkhamsted, Hertfordshire,
HP4 1EG, United Kingdom Telephone: 0044 (0)1442 200922
Fax: 0044 (0)1442 873717
Email: info@bristol-labs.co.uk
Ibuprofen Tablets BP 600mg; PL 17907/0004 This leaflet was last revised in December 2015 To request a copy of this leaflet in Braille, large print or audio, please contact the licence holder at the address (or telephone, fax, email) above.
V8 04-12-15 DO
140 mm
SAME SIZE ARTWORK
240 x 140 mm
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240 mm