IBUPROFEN TABLETS BP 200mg – patient leaflet, side effects, dosage

1. What Ibuprofen Tablets are and what they are used for

Ibuprofen Tablets contain the active ingredient ibuprofen, which belongs to a group of medicines called Non-Steroidal Anti-Inflammatory Drugs (known as NSAIDs) which relieve pain, reduce inflammation and lower temperature when you have a fever.

This medicine is used for the relief of rheumatic and muscular pain, pain of non-serious arthritic conditions, backache, neuralgia, migraine, headache, dental pain and period pains. Also for the relief of feverishness, and the symptoms of colds and influenza.

2. What you need to know before you take Ibuprofen Tablets

Do not take Ibuprofen Tablets if you:

• are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6), to aspirin or to any other painkillers.
• have ever had a stomach ulcer, perforation or bleeding
• have had a worsening of asthma, skin rash, itchy runny nose or facial swelling when previously taking ibuprofen, aspirin or similar medicines
• have had gastrointestinal bleeding or perforation when previously taking NSAID painkillers
• are taking other NSAID painkillers,
• are taking aspirin with a daily dose above 75mg. If you are on low-dose aspirin (upto 75mg daily) speak to your doctor or pharmacist before you take this medicine
• have severe liver or kidney problems
• have heart problems, high blood pressure or blood coagulation disorder
• have breathing difficulties
• are in the last 3 months of pregnancy.
• are under 12 years old.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Ibuprofen Tablets if you:

• have or have had asthma
• suffer from kidney, heart, liver or bowel problems
• have high cholesterol or previously have had a heart attack or stroke
• are elderly, as you may be more likely to suffer from side effects (see section 4)
• suffer from systemic lupus erythematosus (SLE) or another connective tissue disorder
• have a history of gastrointestinal diseases (such as Crohn’s disease, ulcerative colitis)
• are in the first 6 months of pregnancy or you are breast-feeding.
• you have an infection - please see heading “Infections” below.
• are a smoker

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.

If you are taking Ibuprofen tablets for longer than the recommended time or at higher than recommended doses you are at risk of serious harms. These include serious harms to the stomach/gut and kidneys, as well as very low levels of potassium in your blood. These can be fatal (see section 4). Signs of allergic reaction to this medicine including breathing problem, swelling of the face and neck region (angioedema), chest pain have been reported with ibuprofen. Stop immediately Ibuprofen tablets and contact immediately your doctor or medical emergencies if you notice any of these signs. You should discuss your treatment with your doctor or pharmacist before taking Ibuprofen Tablets 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 or 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. Skin reactions

Serious skin reactions including exfoliative dermatitis, erythema multiforme, stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic syndrome (DRESS), acute generalized exanthematous pustulosis (AGEP) have been reported in association with Ibuprofen treatment. You should stop taking Ibuprofen Tablets and seek medical attention immediately, if you develop any skin rash, lesions of the mucous membranes, blisters or other signs of allergy since this can be the first signs of a very serious skin reaction. See section 4. Infections

Ibuprofen Tablets may hide signs of infections such as fever and pain. It is therefore possible that Ibuprofen Tablets may delay appropriate treatment of infection, which may lead to an increased risk of complications. This has been observed in pneumonia caused by bacteria and bacterial skin infections related to chickenpox. If you take this medicine while you have an infection and your symptoms of the infection persist or worsen, consult a doctor without delay.

Children and adolescents

There is a risk of renal impairment in dehydrated children and adolescents.

Other medicines and Ibuprofen Tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

For example:

• aspirin (low dose up to 75 mg daily) or any other NSAID painkiller
• medicines that are anti-coagulants (i.e. thin blood/prevent clotting e.g. aspirin/acetylsalicylic acid, warfarin, ticlopidine)
• medicines that reduce high blood pressure (ACE-inhibitors such as captopril, beta-blockers such as atenolol medicines, angiotensin-11 receptor antagonists such as losartan)
• digoxin (for heart problems)
• water tablets (diuretics)
• corticosteroids (e.g. hydrocortisone, prednisolone)
• lithium or a selective serotonin reuptake inhibitor (SSRI) drug (for treating depression), e.g. citalopram, fluoxetine, sertraline
• for the temporary suppression of your immune system ( e.g. methotrexate, ciclosporin, tacrolimus)
• colestyramine (to lower cholesterol)
• medicines known as sulfonylureas such as glibenclamide (for treating diabetes)
• voriconazole or fluconazole (anti-fungal drugs)
• aminoglycosides (a type of antibiotic)
• ginko biloba (a herbal medicine)
• zidovudine (an anti-viral)
• mifepristone (to terminate a pregnancy)
• a quinolone antibiotic for treating infection (e.g. ciprofloxacin, ofloxacin).

Some other medicines may also affect or be affected by the treatment of Ibuprofen Tablets. You should therefore always seek the advice of your doctor or pharmacist before you use Ibuprofen Tablets with other medicines.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Do not take this medicine if you are in the last 3 months of pregnancy as it could harm your unborn child or cause problems at delivery. It can cause kidney and heart problems in your unborn baby. It may affect your and your baby’s tendency to bleed and cause labour to be later or longer than expected. You should not take Ibuprofen tablets during the first 6 months of pregnancy unless absolutely necessary and advised by your doctor. If you need treatment during this period or while you are trying to get pregnant, the lowest dose for the shortest time possible should be used. If taken for more than a few days from 20 weeks of pregnancy onward, Ibuprofen tablets can cause kidney problems in your unborn baby that may lead to low levels of amniotic fluid that surrounds the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the heart of the baby. If you need treatment for longer than a few days, your doctor may recommend additional monitoring.

Ibuprofen belongs to a group of medicines which may impair fertility in women. This effect is reversible on stopping the medicine. 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.

Driving and using machines

Ibuprofen Tablets contains Sucrose

If you have been told by your doctor that you have an intolerance to some sugars, check with your doctor before taking this medicine. Ibuprofen Tablets contains Sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet that is to say essentially ‘sodium-free’.

3. How to take Ibuprofen Tablets

Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse have told you. Check with your doctor, pharmacist or nurse if you are not sure.

The tablets should be swallowed with a drink of water.

This medicine is intended for short term use only. You should take the lowest dose for the shortest time necessary to relieve your symptoms. If you have an infection, consult a doctor without delay if symptoms (such as fever and pain) persist or worsen (see section 2). You should not take Ibuprofen for longer than 10 days unless your doctor tells you. If symptoms persist or worsen consult your doctor.

In adults:

You should not take Ibuprofen for longer than 10 days unless your doctor tells you to. If symptoms persist or the pain or fever worsen, or if any new symptoms occur, consult your doctor or pharmacist.

Use in children and adolescents

In adolescents (age range > 12 years to < 18 years):

If in adolescents this medicinal product is required for more than 3 days, or if symptoms worsen a doctor should be consulted. Adults, the elderly and children & adolescents between 12 and 18 years: Take one or two tablets up to 3 times a day. Leave at least 4 hours between doses, and do not take more than 6 tablets in any 24 hour period. Do not give to children under 12 years of age. If you take more Ibuprofen Tablets than you should

Contact your doctor straight away or go to the nearest hospital casualty department. Take with you any remaining tablets and the pack so that the medicine can be identified.

If you have taken more Ibuprofen Tablets than you should, or if children have taken this medicine by accident always contact a doctor or nearest hospital to get an opinion of the risk and advice on action to be taken.

The symptoms can include nausea, stomach pain, vomiting (may be blood streaked), headache, ringing in the ears, confusion and shaky eye movement. At high doses, drowsiness, chest pain, palpitations, loss of consciousness, convulsions (mainly in children), weakness and dizziness, blood in urine, cold body feeling, and breathing problems have been reported.

If you forget to take Ibuprofen Tablets

Do not take a double dose to make up for a forgotten dose

If you stop taking Ibuprofen Tablets

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Ibuprofen is usually well tolerated, however, ibuprofen can cause side effects, although not everybody gets them. The elderly may be more at risk of developing problems due to side effects.

If you suffer from any of the following at any time while you are taking these tablets, STOP TAKING them and seek IMMEDIATE medical help:

• pass blood in your faeces (stools/motions), pass black tarry stools, or vomit any blood or dark particles that look like coffee granules (these may be signs of a stomach ulcer or bleeding)
• worsening of asthma, unexplained wheezing, shortness of breath, swelling of the face, tongue or throat, collapse (these may be signs of a severe allergic reaction)
• dizziness or faster heartbeat
• reddish non-elevated, target-like or circular patches on the trunk, often with central blisters, skin peeling, ulcers of mouth, throat, nose, genitals and eyes. These serious skin rashes can be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis]
• indigestion or heartburn
• pains in your stomach, feeling sick or other abnormal stomach symptoms
• allergic skin reactions such as rashes, itching, hives.
• a severe skin reaction known as DRESS syndrome can occur. Symptoms of DRESS include: skin rash, fever, swelling of lymph nodes and an increase of eosinophils (a type of white blood cells).

• a red, scaly widespread rash with bumps under skin and blisters accompanied by fever. The symptoms usually appear at the initiation of treatment

  (acute generalized exanthematous pustulosis).

• chest pain, which can be a sign of a potentially serious allergic reaction called Kounis syndrome.

Tell your doctor, pharmacist or nurse if you suffer from any of the following effects:

Uncommon: may affect up to 1 in 100 people

• headache
• allergic reactions, such as skin rashes (urticaria), itching, peeling

Rare: may affect up to 1 in 1,000 people

• diarrhoea, constipation, vomiting, flatulence (wind).

Very rare: may affect up to 1 in 10,000 people

• changes in blood (symptoms may include fever, sore throat, mouth ulcers, flu-like symptoms, tiredness or unexplained bleeding or bruising)
• drop in blood pressure or irregular heart beat
• mouth ulcers

• kidney damage or kidney failure (symptoms include passing more or less urine than usual, cloudy or blood in urine, back pain and/or swelling

  (particularly in the legs))

• stomach or intestinal ulcers, sometimes with bleeding and perforation, inflammation of the lining of the mouth with ulceration (ulcerative stomatitis), inflammation of the stomach (gastritis), pancreatitis
• liver problems (symptoms include yellowing of the skin and eyes)
• aseptic meningitis, especially in people with existing immune disorders (such as “SLE”, mixed connective-tissue diseases); symptoms are fever or consciousness, headache, stiff neck, nausea, vomiting, feeling sick, being sick and skin rash.

Not known: frequency cannot be estimated from the available data

• worsening of asthma or bronchospasm
• swelling (oedema), high blood pressure, heart failure or attack
• worsening of colitis and Crohn’s disease
• skin becomes sensitive to light.

Medicines such as ibuprofen may be associated with a small increased risk of heart attack (“myocardial infarction”) or stroke. Ibuprofen tablets, especially when taken at higher than recommended doses or for a prolonged period of time, can cause damage to your kidneys and affect them removing acids properly from your blood into the urine (renal tubular acidosis). It can also cause very low levels of potassium in your blood (see section 2). This is a very serious condition and will require immediate treatment. Signs and symptoms include muscle weakness and light-headedness.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. 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 or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Ibuprofen Tablets

Keep this medicine in the pack provided and protect from heat, light and moisture.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month. Do not throw away 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 contains

The active substance is Ibuprofen. Each tablet contains 200mg of Ibuprofen as the active ingredient.

The other ingredients are: colloidal anhydrous silica, microcrystalline cellulose, pregelatinised maize starch, purified talc, sodium starch glycolate, magnesium stearate, sucrose, gum acacia, erythrosine (E127), titanium dioxide (E171), shellac, beeswax and carnauba wax. What Ibuprofen Tablets looks like and contents of the pack

Ibuprofen Tablets are pink sugar-coated, biconvex tablets. Each pack contains 84 tablets.

Marketing Authorisation Holder:

Crescent Pharma Ltd., Key House, Sarum Hill, Basingstoke, RG21 8SR, UK.

Manufacturer:

Crescent Pharma Ltd., Units 3 & 4, Quidhampton Business Units, Polhampton Lane, Overton, Hants, RG25 3ED, UK. This leaflet was last revised in March 2026.

If you would like this leaflet in a different format please contact the licence holder at the above address.