Ibuprofen 600mg Tablets
PROPOSED
PATIENT INFORMATION LEAFLET
Ibuprofen 600 mg Tablets
PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START TO TAKING THIS MEDICINE
KEEP THIS LEAFLET UNTIL YOU HAVE FINISHED ALL THE PRESCRIBED COURSE OF IBUPROFEN
IF YOU HAVE ANY QUESTIONS CONCERNING YOUR MEDICINE ASK YOUR DOCTOR OR PHARMACIST FOR MORE
INFORMATION
What is your medicine?
Your tablets are called Ibuprofen 600 mg Tablets. Each tablet contains 600 mg of the active ingredient ibuprofen along with the following inactive ingredients: povidone, lactose, maize starch, microcrystalline cellulose, sodium starch glycollate, colloidal anhydrous silica, sucrose, erythrosin (E127), titanium dioxide (E171), talc, sodium benzoate (E211), triethyl citrate, macrogol 4000 and ammonio methacrylate copolymer type A.
Ibuprofen 600 mg tablets are pink capsule shaped, film-coated tablets with a logo imprinted on one side and IBUPR 600 on the other side. They are available in containers of 14, 15, 21, 28, 42, 50, 56, 70, 84, 100, 250 and 500 tablets and blister packs of 14, 15, 21, 28, 42, 50, 56, 70 and 84 tablets.
Ibuprofen belongs to a group of medicines called anti-inflammatory painkillers.
The product licence holder is: Chelonia Healthcare Ltd, 11 Boumpoulinas, 3rd Floor, 1060 Nicosia, Cyprus The manufacturer is: Ranbaxy Ireland Ltd, Spafield, Cork Road, Cashel, Co. Tipperary, Ireland
Treatment with Ibuprofen
Ibuprofen is used in the treatment of painful and inflammatory conditions, such as mild to moderate pain, osteoarthritis, rheumatoid arthritis (including juvenile rheumatoid arthritis or Still's disease) inflammation of the 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.
Before taking this medicine
Do not use this medicine, and tell your doctor, if you:
• are allergic to ibuprofen, or any of the other ingredients in these tablets. These are listed in the section 'What is your medicine?' (see above).
• 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
• have had gastrointestinal bleeding or perforation when previously taking NSAIDs (Non-steroidal anti-inflammatory drugs).
• have a condition which increases your tendency to bleeding
• suffer from severe liver, kidney or heart failure
• have ever had an allergic reaction (such as a runny nose, swelling or hives) or suffered wheezing on taking ibuprofen, aspirin or other non-steroidal anti-inflammatory drugs
• are in the last 3 months of pregnancy
Take special care with Ibuprofen
Talk to your doctor or pharmacist before taking this medicine if you:
• are taking aspirin at doses of 75 mg daily, or if you are on low-dose aspirin (up to 75 mg daily)
• are elderly - you may get more side-effects
• have, or have ever had a gastric complaint
• have a history of ulcerative colitis or Crohn's disease
• are suffering from, or have a previous history of, bronchial asthma
• suffer from kidney or liver problems
There is a risk of renal impairment in dehydrated children and adolescents (between 12 and 18 years).
• 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 (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.
• have systemic lupus erythematosus (SLE, sometimes known as lupus) or a connective tissue disease (autoimmune diseases affecting connective tissue)
• are trying to become pregnant (ibuprofen belongs to a group of medicines (NSAIDs) which may impair fertility in women. This effect is reversible upon stopping the medicines. 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)
Can you take ibuprofen with other medicines?
Tell your doctor or pharmacist, before taking this medicine if you are taking, have recently taken or might take 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 the blood and prevent clotting, such as aspirin, warfarin
• antihypertensives, used to reduce high blood pressure, such as ACE-inhibitors (captopril), beta-blockers (atenolol), or angiotensin-II receptor antagonists (losartan)
• diuretics (water tablets)
• cardiac glycosides, used to treat heart conditions, such as digoxin
• any other anti-inflammatory pain killer, including aspirin
• lithium, used to treat depression
• methotrexate, used to treat certain cancers
• zidovudine, an anti-viral drug
• steroids, used in the treatment of inflammatory conditions
• medicines known as immune-suppressants such as ciclosporin and tacrolimus, used to dampen down your immune response
• medicines known as selective serotonin reuptake inhibitors (SSRIs), used for the treatment of 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
• cholestyramine (a drug used to lower cholesterol)
• medicines known as sulphonylureas, used to treat diabetes, such as glibenclamide
• voriconazole or fluconazole, types of anti-fungal drugs
• gingko biloba, a herbal medicine, (there is a chance you may bleed more easily if you are taking this with ibuprofen)
Pregnancy and breast-feeding:
The use of ibuprofen 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.
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.
This medicine contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine
How and when to take these tablets
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.
Dosage: Take your Ibuprofen tablets with or after food, with a glass of water. 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:
Usually 1200 to 1800 mg daily in divided doses. Some patients can be maintained on 600 to 1200 mg daily. The total daily dose must not be more than 4 tablets (2400 mg).
Children:
PROPOSED
The usual dosage is 20 mg/kg body weight daily in divided doses.
For children with juvenile rheumatoid arthritis up to 40 mg/kg body weight daily in divided doses.
Ibuprofen tablets 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.
If you take more Ibuprofen than prescribed (an overdose)
You should contact your doctor or go to the nearest hospital casualty department IMMEDIATELY taking your tablets with you If you forget to take Ibuprofen
Take them as soon as you remember, unless it is almost time for your next dose. If it is, do not take the missed dose at all. Never double up on a dose to make up for the one you have missed.
What side effects can ibuprofen have?
As with all medicines, Ibuprofen tablets may cause side effects, although they are usually mild and not everyone will suffer from them.
If any side effects become serious or if you notice any side effects that are not listed in this leaflet, please tell your doctor or pharmacist.
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:
• allegic reaction, the symptoms of which may include swelling of the face, lips, tongue or throat, leading to difficulty breathing or swallowing, skin rash, hives
• 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 side 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.
Reporting of side effects
Also you can help to make sure that medicines remain as safe as possible by reporting any unwanted side effects via the internet at www.mhra.gov.uk/yellowcard. Alternatively, you can call Freephone 0808 100 3352 (available from 10 a.m. to 2 p.m. Mondays to Fridays), or fill in a paper form available from your local pharmacy.
Storing your medicine
You must keep this medicine in a safe place where children cannot get at it. Your medicine could harm them.
Do not store your medicine above 25°C. Store in the original package. Keep the container tightly closed.
On the label you will find the words "expiry date" followed by numbers indicating the day, month and year. This is the date after which the medicine is no longer fit for use.
A reminder
REMEMBER this medicine is for you. Only a doctor can prescribe it for you.
Never give it to anyone else even if their symptoms are the same as yours.
This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist who have access to additional information.
PL No: 33414/0049
This leaflet was revised in December 2015
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