Patient Leaflet Updated 29-Jun-2026 | Aurobindo Pharma - Milpharm Ltd.
Ibuprofen 200mg & 400mg film-coated tablets
Ibuprofen 200 mg film-coated tablets
Ibuprofen 400 mg film-coated tablets
1. What Ibuprofen is and what it is used for
2. What you need to know before you take Ibuprofen
3. How to take Ibuprofen
4. Possible side effects
5. How to store Ibuprofen
6. Contents of the pack and other information
Ibuprofen belongs to a group of medicines called NSAID (non-steroidal anti- inflammatory drugs) which work by reducing pain, inflammation and fever.
Ibuprofen is used for the symptomatic treatment of mild to moderate pain including migraine headache period pain and/or fever. In addition, Ibuprofen is used for the symptomatic treatment of pain and inflammation in arthritic diseases (e.g. rheumatoid arthritis), degenerative arthritic conditions (e.g. osteoarthritis) and in painful swelling and inflammation aftersoft tissues injuries.
Do not give Ibuprofen to children below 20 kg body weight or younger than 6 years.
Talk to your doctor before taking Ibuprofen
Infections
Ibuprofen may hide signs of infections such as fever and pain. It is therefore possible that Ibuprofen 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.
Elderly
If you are elderly you will be more prone to side effects, especially bleeding and perforation in the digestive tract, which may be fatal.
Ulcers, perforation and bleeding in the stomach or intestines
If you have earlier had an ulcer in the stomach or intestines, especially if this has been complicated by perforation or accompanied by bleeding, you should look out for any unusual symptoms in the abdomen, and report them at once to your doctor, especially if these symptoms occur at the beginning of treatment.
This is because the risk for bleeding or ulceration of the digestive tract is higher in this case, especially in elderly patients. If bleeding or ulceration of the digestive tract occurs, the treatment has to be stopped.
Bleeding, ulceration or perforation in the stomach or intestines may occur without any warning signs even in patients who have never had such problems before. It may also be fatal.
The risk of ulcers, perforation or bleeding in the stomach or intestines generally increases with higher doses of ibuprofen. The risk also increases if certain other medicines are taken at the same time as ibuprofen (see other medicines and ibuprofen, below).
Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms.
Skin reactions
Serious skin reactions have been reported in association with Ibuprofen treatment. You should stop taking Ibuprofen tablet 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.
During varicella it is advisable to avoid use of this drug.
Effects on the heart and brain
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:
Effects on the kidneys
Ibuprofen may cause problems with kidney function even in patients who have not had kidney problems before. This may result in swelling of the legs and may even lead to heart failure or high blood pressure in predisposed individuals.
Ibuprofen may cause kidney damage especially in patients who already have kidney, heart or liver problems, or are taking diuretics or ACE inhibitors, as well as in the elderly. Stopping Ibuprofen however generally leads to recovery.
Aseptic meningitis (inflammation of the brain membrane without bacterial infection)
During treatment with ibuprofen, some cases of meningitis (presenting as stiff neck, headache, nausea, vomiting, fever or disorientation) have been seen. Although it is probably more likely to occur in patients with existing autoimmune disorders such as systemic lupus erythematosus or mixed connective tissue diseases, it has been reported in patients who do not have an existing long-term disease.
Other precautions
Very rarely, severe acute hypersensitivity reactions (e.g. anaphylactic shock) have been observed. Stop treatment immediately at the first signs of hypersensitivity reaction after taking Ibuprofen and tell immediately to your doctor.
Ibuprofen can temporarily inhibit blood platelet function (blood platelet aggregation). Patients with blood clotting disorders should therefore be carefully monitored.
Prolonged use of any type of pain killer for headaches can make them worse. If this situation is experienced or suspected, stop taking ibuprofen and consult your doctor. The diagnosis of medication overuse headache (MOH) should be suspected in patients who have frequent or daily headaches despite (or because of) the regular use of headache medications.
The habitual use of painkillers may cause permanent damage to the kidneys and a risk of kidney failure.
Ibuprofen may hide the symptoms or signs of an infection (fever, pain and swelling) and temporarily prolong bleeding time.
Ibuprofen may decrease your chance of becoming pregnant. You should inform your doctor if you are planning to become pregnant or if you have problems becoming pregnant.
Children and adolescents
Ibuprofen is contraindicated in children below 20 kg body weight or younger than 6 years of age (See section 3).
Ibuprofen may cause kidney problems in children and adolescents who are dehydrated.
Take special care with Ibuprofen film-coated tablets
Serious skin reactions including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP) have been reported in association with ibuprofen treatment. Stop using Ibuprofen film-coated tablets and seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.
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:
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.
Avoid alcohol since it may enhance the side effects of Ibuprofen, especially those affecting the stomach, intestines or central nervous system.
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 ibuprofen 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, lung 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 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 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 appears in breast milk in a very small amount and breastfeeding will usually not need to be stopped during short-term treatments. If, however, longer treatment is prescribed, early weaning should be considered.
Ibuprofen generally has no adverse effects on the ability to drive or operate machinery. However since at high dosage side effects such as fatigue, somnolence, vertigo (reported as common) and visual disturbances (reported as uncommon) may be experienced, the ability to take part actively in road traffic or operate machinery may be impaired in individual cases. This effect is potentiated by simultaneous consumption of alcohol.
Ibuprofen contain Sodium: This medicine contains less than 1 mmol sodium (23 mg) per 200 mg/ 400 mg film-coated tablets, that is to say essentially ‘sodium-free’.
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms.
The lowest effective dose should be used for the shortest duration necessary to relieve symptoms. If you have an infection, consult a doctor without delay if symptoms (such as fever and pain) persist or worsen (see section 2).
The treating physician decides on the duration of treatment.
In rheumatic diseases the use of Ibuprofen can be required for a longer period.
Ibuprofen is contraindicated in children below 20 kg body weight or younger than 6 years of age. (See section 2).
Ibuprofen 200 mg film-coated tablets
The ibuprofen dose depends on the patient’s age and body weight. The maximum single dose for adults should not be greater than 800 mg of ibuprofen (4 tablets).
The recommended dose is:
Mild to moderate pain and fever
Adults and adolescents older than 12 years (≥40 kg):
1-2 tablets given as a single dose or 3-4 times a day with an interval of 6 hours. The maximum daily dose should not exceed 6 tablets (1200 mg).
Children 6-12 years (>20 kg):
Children 6-9 years (20-29 kg): 1 tablet 1-3 times a day with intervals of 4 to 6 hours as required.
The maximum number of tablets should not exceed 3 tablets in one day.
Children 10-12 years (30-40 kg): 1 tablet 1-4 times a day with intervals of 4 to 6 hours as required. The maximum number of tablets should not exceed 4 tablets in one day.
Migraine headache
Adults and adolescents older than 12 years (>40 kg):
2 tablets given as a single dose, if necessary 2 tablets with intervals of 4 to 6 hours.
The maximum daily dose should not exceed 6 tablets (1200 mg).
Period pain
Adults and adolescents over 12 years of age:
1-2 tablets 1-3 times a day, with an interval of 4-6 hours, as needed. The maximum daily dose should not be more than 6 tablets (1200 mg).
Rheumatic diseases
Adults:
The recommended dose is 2-3 tablets daily in divided doses. Lower doses may be prescribed by your doctor. Due to the nature and severity of your condition, the doctor may increase your medication to a maximum of 12 tablets (2400 mg) daily, taken in 3 or 4 divided doses.
Adolescents from 15 to 17 years of age:
The recommended dose is 20 mg/kg to a maximum of 40 mg/kg body weight daily (max 2400 mg daily) in 3 to 4 divided doses.
The tablet should be swallowed with a glass of water, preferably after a meal. Patients with sensitive stomach are recommended to take Ibuprofen during a meal. For the ease of swallowing or adjusting of doses the tablets can be divided in equal halves.
If a child or adolescent requires this medicine for more than 3 days, or if symptoms worsen, a doctor should be consulted.
Ibuprofen 400 mg film-coated tablets
The ibuprofen dose depends on the patient’s age and body weight. The maximum single daily dose for adults should not be greater than 800 mg of ibuprofen (2 tablets).The recommended dose is:
Mild to moderate pain and fever
Adults and adolescents ≥40 kg (12 years and above):
½ (half tablet) to 1 tablet given as a single dose or 3-4 times a day with an interval of 6 hours as required. The maximum daily dose should not exceed 3 tablets (1200 mg).
Paediatric population
Children ≥20 kg body weight (6-11 years):
Other preparations may be more suitable for this age group. Your doctor will advise you accordingly.
Children 20-29 kg (6-9 years): ½ half tablet 1-3 times a day with intervals of 6 hours as required. The maximum number of tablets should not exceed 1½ (one and half) tablet in one day.
Children 30-39 kg body weight (10-11 years): ½ half tablet 1-4 times a day with intervals of 6 hours as required. The maximum number of tablets should not exceed 2 tablets in one day.
Migraine headache
Adults and adolescents ≥40 kg body weight (12 years and above):
1 tablet given as a single dose, if necessary 1 tablet with intervals of 6 hours.
The maximum daily dose should not exceed 3 tablets (1200 mg).
Period pain
Adults and adolescents >40 kg body weight (12 years of age and above):
½ (half tablet) -1 tablet 1-3 times a day, with an interval of 6 hours as needed.
The maximum daily dose should not be more than 3 tablets (1200 mg).
Rheumatic diseases
Adults:
The recommended dose is 3-4½ (four and half) tablets (1200 mg- 1800 mg) daily in divided doses. Lower doses may be prescribed by your doctor.
Due to the severity of your condition, the doctor may increase your medication to a maximum of 6 tablets (2400 mg) daily, taken in 3 or 4 divided doses.
Adolescents from 15 to 17 years of age:
The recommended dose is 20 mg/kg to a maximum of 40 mg/kg body weight daily (max 2400 mg daily)in 3 to 4 divided doses. Your doctor will advise you accordingly.
The tablet should be swallowed with a glass of water, preferably after a meal. Patients with sensitive stomach are recommended to take Ibuprofen during a meal. For the ease of swallowing or adjusting of doses the tablets can be divided in equal halves.
Elderly
If you are elderly you will be more prone to side effects, especially bleeding ulceration and perforation in the digestive tract, which may be fatal. Your doctor will advise you accordingly.
Reduced kidney or liver function
If you suffer from reduced kidney or liver function, your doctor will advise you accordingly.
If you have taken more ibuprofen 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 of overdose can include nausea, stomach pain, vomiting (may be blood streaked), or more rarely diarrhoea. In addition, headache, gastrointestinal bleeding, blurred vision, ringing in the ears, confusion and shaky eye movement, and exacerbation of asthma in asthmatics. At high doses, drowsiness, excitation, disorientation, chest pain, palpitations, loss of consciousness, convulsions (mainly in children), vertigo, weakness and dizziness, blood in urine, low levels of potassium in your blood, hyperkalaemia, metabolic acidosis, increased prothrombin time/INR, acute renal failure, liver damage, respiratory depression, cyanosis, cold body feeling, and breathing problems have been reported. Also agitation, somnolence or coma may occur. Furthermore, there may be low blood pressure and reduced breathing.
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.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
With regard to the following side effects, it must be considered that they are largely dependent on the dose and that they vary from patient to patient.
The most commonly observed side effects are gastrointestinal in nature. Peptic ulcers, perforation or gastrointestinal bleeding, sometimes fatal, particularly in the elderly, may occur. Nausea, vomiting, diarrhoea, flatulence, constipation, indigestion, abdominal pain, melaena, heamatemesis, ulcerative stomatits, exacerbation of colitis and Crohn’s disease have been reported following administration. Less frequently, inflammation of the stomach lining (gastritis) has been observed.
Medicines such as Ibuprofen may be associated with a small increased risk of heart attack (myocardial infraction) or stroke. Water retention (oedema), high blood pressure and heart failure have been reported in association with NSAIDs.
Ibuprofen, 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.
Stop using ibuprofen and seek medical attention immediately if you notice any of the following symptoms:
The side effects are stated according to the frequency they occur. The following convention has been used:
Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Rare: may affect up to 1 in 1,000 people
Very rare: may affect up to 1 in 10,000 people
Not known: frequency cannot be estimated from the available data
The following side effects are important and will require immediate action if you experience them. You should stop taking Ibuprofen and see your doctor immediately if the following symptoms occur:
Common:
Very rare:
You should stop taking the medicine and contact your doctor as soon as possible if you develop the following side effects:
Very common:
Uncommon:
Rare:
Very rare:
Not known:
Other possible side effects with Ibuprofen are:
Very common:
Common:
Uncommon:
Rare:
Very rare:
Not known:
Ibuprofen may cause a reduction in the number of white blood cells and your resistance to infection may be decreased. If you experience an infection with symptoms such as fever and serious deterioration of your general condition, or fever with local infection symptoms such as sore throat/pharynx/mouth or urinary problems you should see your doctor immediately. A blood test will be taken to check possible reduction of white blood cells (agranulocytosis). It is important to inform your doctor about your medicine.
Chest pain, which can be a sign of a potentially serious allergic reaction called Kounis syndrome.
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 the national reporting system listed in 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.
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 after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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.
Film-coated tablet.
Ibuprofen 200 mg film-coated tablet
White to off-white, round shaped, film-coated tablets with break line on one side and plain on the other side. The tablet can be divided into equal doses.
Ibuprofen 400 mg film-coated tablet
White to off-white, round shaped, film-coated tablets with break line on one side and plain on the other side. The tablet can be divided into equal doses.
Ibuprofen film-coated tablets are available in blister packs
Pack sizes: 10, 20, 24, 30, 40, 50, 56, 60, 84 and 100 film-coated tablets
Not all pack sizes may be marketed.
or
This leaflet was last revised in 10/2025.
P1540138
Milpharm Limited, 1 Roundwood Avenue, Stockley Park, Uxbridge, UB11 1AF, UK
+ 44 (0)208 845 8811
+44 (0)208 845 8811
http://www.aurobindo.com
+44 (0)208 845 8795
