PACKAGE LEAFLET: INFORMATION FOR THE USER
IBUPROFEN TABLETS BP
200 mg, 400 mg & 600 mg
(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 further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for personally and you should 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.
2.
3.
4.
5.
6.
What Ibuprofen tablets are and what are they used for
Before you take Ibuprofen tablets
How to take Ibuprofen tablets
Possible side effects
How to store Ibuprofen tablets
Further information
1. WHAT IBUPROFEN TABLETS ARE AND WHAT ARE THEY USED FOR
Ibuprofen tablets belong to a group of medicines called non steroidal antiinflammatory drugs (NSAIDs). It is a painkiller and antipyretic (reduces fever).
Ibuprofen works by reducing inflammation and relieving pain, swelling and stiffness
in the joints and muscles. There are number of conditions that can affect your joints
and muscles, which can be helped by taking Ibuprofen. These conditions include:
• rheumatoid arthritis including childhood rheumatoid arthritis
• ankylosing spondylitis (arthritis of the spine)
• inflammation or disease of the joints including osteoarthritis
• soft tissue injuries
• mild to moderate pain
2. BEFORE YOU TAKE IBUPROFEN TABLETS
Do not take this medicine if any of the following apply to you
• You are allergic (hypersensitive) to Ibuprofen or to any of the other ingredients in
these tablets which are listed in section 6 of this leaflet (an allergic reaction may
include rash, itching, swelling of face, lips, or hands/feet, or breathing difficulties)
• You have ever had a stomach ulcer.
• You get symptoms of asthma, inflammation of the nose or blotches on the skin on
taking aspirin or other non-steroidal anti-inflammatory drugs.
• 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.
Please note: 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.
Take special care with Ibuprofen tablets if
• You are pregnant, planning to become pregnant or if you are breast feeding.
• You have kidney, liver or heart problems; you may require a lower dosage or
monitoring of kidney function.
Tell your doctor if any of the above applies to you.
Taking other medicines
Make sure you tell your doctor or pharmacist about any other medicines you are
taking, or have taken recently. This includes medicines bought from a chemist or
another shop without a prescription by a doctor.
Informing your doctor is especially important if you are taking any of these
medicines:
• Medication to help increase urine excretion (water tablets e.g.furosemide).
• Any other painkillers (e.g. aspirin and other non-steroidal anti-inflammatory
drugs)
• Medication to prevent blood clotting (e.g. warfarin)
• Lithium (used in the treatment of certain mental illnesses)
• Corticosteroids (used to treat various illnesses that involve inflammation in the
body e.g. prednisolone, cortisone)
• Antihypertensives (medicines which lower your blood pressure e.g. propranolol,
atenelol, metoprolol, prazosin, alfuzosin, terazosin)
• Methotrexate (medicines for treating cancer)
Taking Ibuprofen tablets with food and drink
You should take these tablets orally, preferably with or after food
Pregnancy
Ibuprofen may make it more difficult to become pregnant. You should inform your
doctor if you are planning to become pregnant or have problems getting pregnant.
Tell your doctor as soon as possible if you are pregnant or think you may be pregnant.
You should not take this medicine when pregnant.
Breast-feeding
If you are breast-feeding, please consult your doctor or pharmacist for advice
before taking any medicine.
Driving and using machines
Ibuprofen should not have any effect on your ability to drive or use machines.
Important information about some of the ingredients of Ibuprofen tablet(s)
Your medicine contains small quantities of an inactive ingredient known as lactose
monohydrate. If you have been told by your doctor that you have intolerance to some
sugars, contact your doctor before taking this medicinal product.
3. HOW TO TAKE IBUPROFEN TABLETS
Take your medicine as instructed by your doctor. Do not take more than the doctor
told you to. Always check the label carefully for how much to take and how often to
take. Your pharmacist or doctor can help if you are not sure.
Dosage: You should take your tablets by mouth.
The following dosage guidelines are only for patients taking this medicine on
prescription from the doctor.
Adults:
The usual dose is 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 2400
mg.
Children:
The dose is worked out depending on the weight of your child. The usual dose is
20mg Ibuprofen/kg body weight daily in divided doses. For children with rheumatoid
arthritis, the usual dose is up to 40mg/kg body weight daily in divided doses.
Children weighing below 30 kg must not receive more than 500 mg daily in total.
Elderly:
If you are elderly the dose you take will be similar to other adults unless you suffer
from kidney or liver problems. If so your doctor may decide to prescribe you a lower
dose.
Note:
Your doctor will prescribe the appropriate strength depending on your dosage
schedule. Always follow your doctor's advice on how to take your medicine; it may
be different to the above.
Do not stop taking your tablets just because you feel better. It is important that you
carry on taking Ibuprofen tablet(s) for as long as your doctor tells you.
Consult your doctor if your symptoms return but do not stop taking Ibuprofen
tablet(s) unless your doctor tells you to.
If you have the impression that the effect of Ibuprofen tablet(s) is too strong or
too weak, talk to your doctor or pharmacist.
If you have taken more Ibuprofen tablet(s) than you should, consult your doctor
or go to the nearest hospital casualty department immediately. Patients, who have
taken more Ibuprofen tablets than they should have taken, have experienced the
following symptoms: nausea (feeling sick), vomiting (being sick), epigastric pain
(pain in the belly) or more rarely diarrhoea (loose motions). Take this leaflet or some
tablets with you so that your doctor will know what you have taken.
If you forget to take Ibuprofen tablet(s) at the right time, take them as soon as you
remember. However, if it is almost time for your next dose, skip the missed dose and
go back to your regular dosing schedule. Do not take a double dose to make up for a
forgotten dose.
If you stop taking Ibuprofen tablet(s)
Take your Ibuprofen tablet(s) as directed and for as long as directed; do not stop
them, even if you feel better, as otherwise the symptoms may return. It is important to
take the full course of Ibuprofen prescribed by your doctor.
If you have any further questions on the use of this medicine, ask your doctor or
pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Ibuprofen tablet(s) can cause side effects, although not
everybody gets them.
If any undesirable effects occur, they are likely to be mild and temporary. However,
some effects may be serious and require medical attention.
Very Serious Side Effects
If any of the following happens, stop taking Ibuprofen tablet(s) and tell your doctor
immediately and go to the casualty department at your nearest hospital:
ƒ Rashes, hives, itching, chest constriction, shortness of breath or swelling of face,
lips, hands / feet, fever, fainting. Severe skin reactions such as blisters, sores or
ulceration. If you have them you may have had a serious allergic reaction to
Ibuprofen. You may need urgent medical attention or hospitalization.
ƒ If you have severe stomach pain
ƒ If you pass black, tarry stools
ƒ If you vomit any blood or dark particles that look like coffee grounds
Other Side Effects
ƒ Upset stomach
ƒ Skin rashes
ƒ Headache
ƒ Dizziness
ƒ Nervousness
ƒ Drowsiness
ƒ Sleeplessness
ƒ Blurred vision
ƒ Yellowing of the skin and whites of eyes with decreased appetite and/or
abdominal pain (these may be manifestations of a liver problem)
ƒ
ƒ
Kidney problems (symptoms may include swelling of face, ankles or other parts
of the body, with sudden increase or decrease in the amount of urine passed blood
in urine.
Thrombocytopenia (decrease in platelet count which may cause unusual bruising
or bleeding)
Some anti-inflammatory/pain relieving medicines such as Ibuprofen
(particularly at high doses and in long term treatment) may be associated with a
small increased risk of heart attack (“myocardial infarction”) or stroke.
If any side effect 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 sight and reach of children.
Do not take after the expiry date that is printed on the packaging
Store in the original package and in a dry place at or below 25°C.
If your doctor tells you to stop taking the tablets, please take them back to the
pharmacist to be destroyed. Do not throw them away with your normal household
water or waste. This will help to protect the environment.
6. FURTHER INFORMATION
If you would like more information on your disease or treatment, you should ask your
doctor or pharmacist.
What Ibuprofen tablet contains:
Each tablet contains the active ingredient Ibuprofen.
The tablets are available in 200mg, 400mg and 600mg strengths.
Each tablet also contains Povidone, Lactose, Starch Maize, Microcrystalline Cellulose
(E460 (i)), Sodium Starch Glycollate, Colloidal Anhydrous Silica, Sugar, Erythrosin
(E127), Titanium Dioxide (E171), Talc (E553(b)) and Sodium Benzoate (E211).
The 200mg and 400mg strengths also contain Acacia (E414), Beeswax (E901),
Carnauba Wax (E903), Calcium Carbonate and Shellac (E904). The ink is composed
of Ferric Oxide Black, Isopropyl Alcohol, Ethyl Alcohol and Shellac (E904).
The 600mg strength also contains Triethyl Citrate, Polyethylene Glycol and
Methacrylate Copolymer.
What Ibuprofen looks like and contents of pack:
Ibuprofen 200mg tablets are round pink sugar coated tablets, plain on one side, IB2
on the other side.
Ibuprofen 400mg tablets are round pink sugar coated tablets, plain on one side, IB4
on the other side.
Ibuprofen 600mg tablets are pink oval shaped film coated tablets, embossed R111 or
with IBP 600 on one side and R on the reverse.
The tablets are available in containers of 14, 15, 21, 28, 42, 50, 56, 70, 84, 100, 250
and 500 tablets and are available in blister packs of 14, 15, 21, 28, 42, 56, 70 and 84
tablets. The 200mg strength is also available in blister packs of 24 and 48 pack sizes.
The 400mg strength is also available in blister packs of 24 pack size.
Marketing Authorisation Holder and Manufacturer
Ranbaxy Ireland Ltd., Spafield, Cork Road, Cashel, Co. Tipperary, Ireland
This leaflet was prepared in December 2008.