Ibuprofen 400 mg film-coated tablets – patient leaflet, side effects, dosage

1. WHAT IBUPROFEN IS AND WHAT IT IS USED FOR

Ibuprofen Tablets contain 400 mg of the active ingredient ibuprofen. Ibuprofen belongs to the class of medicines called non-steroidal anti-inflammatory agents which reduce pain, fever and inflammation. 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 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.

The active ingredient in Ibuprofen Tablets is ibuprofen and each tablet contains 400 mg.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE IBUPROFEN

Do not take Ibuprofen:

• if you are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6).
• If you suffer from asthma or have you ever had an allergic reaction or suffered from wheezing after taking ibuprofen, aspirin or other anti-inflammatory pain killers
• If you suffer from swelling and irritation inside the nose
• If you have, or have you previously had, a stomach ulcer or other gastric complaint
• Do not take Ibuprofen tablets if you 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.
• If you have a condition which increases your tendency to bleeding
• if you suffer from severe liver, kidney or heart problems
• If you are pregnant or planning to become pregnant, or are you breast-feeding? Ibuprofen tablets 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.
• if you are suffering from significant dehydration (caused by vomiting, diarrhoea or insufficient fluid intake)
• if you have any active bleeding (including in the brain)
• if you suffer from a condition of unknown origin resulting in abnormal formation of blood cells
• Do not give Ibuprofen to children below 20 kg body weight or younger than 6 years.

Warnings and precautions

If you are taking ibuprofen 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).

Talk to your doctor before taking Ibuprofen

• If you have chicken pox or shingles
• If you have you been told by your doctor that you have an intolerance to some sugars
• If you have systemic lupus erythematosus (SLE, sometimes known as lupus) or a connective tissue disease (autoimmune diseases affecting connective tissue)
• if you have inherited a disorder of the red blood pigment haemoglobin (porphyria)
• if you have chronic inflammatory intestinal diseases such as inflammation of the colon with ulcers (ulcerative colitis), inflammation affecting the digestive tract (Crohn’s disease) or other stomach or intestinal diseases
• if you have disturbances in the formation of blood cells
• if you have problems with normal blood clotting mechanism
• if you suffer from allergies, hay fever, asthma, chronic swelling of nasal mucosa, sinuses, adenoids, or chronic obstructive disorders of the respiratory tract because the risk for developing narrowing of the airways with difficulty in breathing (bronchospasm) is greater
• if you have liver, kidney, or heart problems or high blood pressure
• if you have just had major surgery - if you are in the first six months of pregnancy
• if you are breast-feeding
• if you are taking more than 75mg of aspirin a day. If you are on low-dose aspirin (up to 75mg daily) speak to your doctor or pharmacist before you take ibuprofen.

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. 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).

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. 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 Tablets and seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions described in section 4. Signs of an allergic reaction to this medicine, including breathing problems, 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. During varicella it is advisable to avoid use of this drug.

Effects on the heart and brain

Any risk is more likely with high doses and prolonged treatment. Anti-inflammatory/pain-killer medicines like ibuprofen may be associated with a small increased risk of heart attack (myocardial Infraction) or stroke, particularly when used at high doses. Do not exceed the recommended dose or duration of treatment (7 days in adults or 3 days in children and adolescents).

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 or feet due to narrow or blocked arteries), or any kind of stroke (including ‘mini-stroke’ or transient ischaemic attack “TIA”).
• have any kind of stroke or think that you might be at risk of these conditions (e.g. if you have a family history of heart disease or stroke, high blood pressure, diabetes, high cholesterol or are a smoker).

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).

Are you or your child dehydrated? As there is a risk of kidney damage in dehydrated children adolescents and the elderly.

Other medicines and Ibuprofen

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:

• steroids (used in the treatment of inflammatory conditions)
• any other anti-inflammatory pain killer, including aspirin
• other NSAIDs including COX-2 inhibitors, since this may increase the risk of gastrointestinal ulcers and bleeding
• anti-coagulants (i.e. thin blood/prevent clotting e.g. aspirin/acetylsalicyclic acid, warfarin, ticlodipine)
• platelet aggregation inhibitors (against clotting) such as ticlopidin or clopidogrel
• methotrexate (used to treat cancer and auto-immune diseases Rheumatoid arthritis)
• cardiac glycosides, such as digoxin (for treatment of various heart conditions) since the effect of digoxin may be enhanced
• phenytoin (used in prevention of the occurrence of epileptic seizures) since the effect of phenytoin may be enhanced
• lithium (used to treat depression and mania) since the effect of lithium may be enhanced
• diuretics (water tablets) since the effect of the diuretics may be weakened
• potassium-sparing diuretics since this may lead to hyperkalaemia
• medicines that reduce high blood pressure (ACE-inhibitors such as captopril, betablockers such as atenolol medicines, angiotensin-II receptor antagonists such as losartan)
• cholestyramine (used in the treatment of high cholesterol)
• aminoglycosides (medicines against certain types of bacteria) since NSAIDs may decrease excretion of aminoglycosides
• SSRIs (medicines against depression) such as paroxetin, sertralin, citalopram as these may increase risk of gastrointestinal bleeding
• medicines known as immunosuppressants such as ciclosporin and tacrolimus (used to dampen down your immune response)
• zidovudine or ritanovir (used to treat patients with HIV)
• mifepristone since NSAIDs can reduce the effect of mifepristone
• probenecid or sulfinpyrazone (for treating gout) since the excretion of ibuprofen may be delayed
• quinolone antibiotics since the risk of convulsions (fits) may be increased e.g. ciprofloxacin
• medicines known as sulphonylureas such as glibenclamide (used to treat diabetes)

• glucocorticoids (used against inflammations) since this may increase the risk of

  gastrointestinal ulcers or bleeding

• bisphosphonates (used in osteoporosis, Paget’s disease and to reduce high blood calcium levels)
• oxpentifylline ((pentoxifylline) used in the treatment of circulatory disease of the arteries of the legs or arms)

• baclofen (a muscle relaxant) because of elevated baclofen toxicity

  • Gingko biloba herbal medicine (there is a chance you may bleed more easily if you are taking this with ibuprofen).voriconazole and fluconazole (CYP2C9 inhibitors) (used for fungal infections), since the effect of ibuprofen may increase. Reduction of the ibuprofen dose should be considered, particularly when high-dose ibuprofen is used with either voriconazole or fluconazole.

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.

Ibuprofen with alcohol

Ibuprofen may cause some side effects including dizziness, drowsiness and stomach problems such as bleeding in the stomach. Drinking excessive alcohol with Ibuprofen might make these side effects worse.

Pregnancy, breast-feeding and fertility

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 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 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. Female fertility

Ibuprofen belongs to a group of medicines which may affect fertility in women. Fertility goes back to normal when you stop taking the medicine. It is unlikely that if you only take ibuprofen occasionally it will affect your chances of becoming pregnant. If you have problems becoming pregnant talk to your doctor before taking this medicine..

Driving and using machines

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 400 mg film-coated tablets, that is to say essentially ‘sodium-free’.

3. HOW TO TAKE IBUPROFEN

ALWAYS take Ibuprofen 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. 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.

For oral use. This product is intended for short term use only. 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). You must contact a doctor if your symptoms worsen or do not improve after 3 days for children and adolescents between 12 and 18 years and after 10 days for adults.

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.

They will tell you if it is safe to carry on taking the medicine.

For adults and children & adolescents between 12 and 18 years:

The usual dosage is 600 to 1800 mg spread throughout the day. Your doctor may choose to increase this depending on what you are being treated for; but no more than 2400 mg should be taken in one day.

Children under 12 years:

The usual daily dose is 20 mg per kg of bodyweight each day, given in divided doses.

Ibuprofen tablets should NOT be taken by children weighing less than 7 kg. The 600 mg tablets should not be given to children under the age of 12 years. In cases of severe juvenile arthritis your doctor my increase the dosage up to 40 mg/kg in divided doses.

If you have taken more medicine 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 your Ibuprofen tablets 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.

You should avoid excessive use of painkillers. If you usually take painkillers, especially combinations of different painkillers, you may damage your kidneys, tell your doctor if you are already taking another painkiller before taking this medicine and your doctor will decide whether you should take this medicine. This risk may be increased if you are dehydrated. The use of painkillers for a long period of time has in some patients been linked to headaches, a condition called medication overuse headache (MOH). Patients who have frequent or daily headaches despite (or because of) the regular use of pain killers should not be treated with increased doses of Ibuprofen. Tell your doctor if you have been having headaches while taking this medicine. 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).

4. POSSIBLE SIDE EFFECTS

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. The elderly are more likely to suffer such effects. If you suffer from any of the following at any time during your treatment STOP TAKING the medicine and seek immediate medical help:

• Passing blood in your faeces (stools/motions).
• Passing black tarry stools.
• Vomiting any blood or dark particles that look like coffee grounds.

• Allergic reactions, which can include the following: bruising or facial swelling; swelling of the lips, throat and tongue causing difficulty swallowing or breathing; breathing problems, e.g. unexplained wheezing, shortness of breath, asthma or worsening of asthma; skin reactions, e.g. skin rashes, itching, urticaria (hives) which can be severe with blistering and peeling of the skin; rapid heart rate/palpitations, collapsing or low blood pressure. Seek medical help immediately.

  • Severe skin reaction known as DRESS syndrome. 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 the skin and blisters mainly localised on the skin folds, trunk, and upper extremities accompanied by fever at the initiation of treatment (acute generalised exanthematous pustulosis). See also section 2.
  • Chest pain, which can be a sign of a potentially serious allergic reaction called Kounis syndrome
  • 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].

Like all medicines, this medicine can cause side-effects, although not everybody gets them. Tell your doctor or pharmacist if you notice any of the following:

• Liver, kidney problems or difficulty urinating This medicine, 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 TAKING the medicine and tell your doctor if you experience:

• Indigestion or heartburn.
• Unexplained stomach pain (abdominal pain) or other abnormal stomach symptoms, indigestion, heartburn, feeling sick and/or vomiting.
• Blood disorders such as anaemia, low white blood cells, low platelet count, suppressed bone marrow function or reduction in granulocytes (a type of white blood cell) which could result in the following symptoms: unexplained bruising or bleeding, sore throat, mouth ulcers, fever, extreme paleness, weakness or exhaustion.
• Very rarely may cause blood in urine, kidney damage or kidney failure or liver problems such as hepatitis or jaundice (yellowing of the skin).
• There have been rare reports of aseptic meningitis, which can include symptoms such as headache, stiff neck, disorientation, fever and eye sensitivity to light, particularly in patients with existing auto-immune disorders such as Lupus. Seek medical help immediately.
• Loss of vision, blurred or disturbed vision (visual impairment) or seeing/hearing strange things (hallucinations).
• Medicines such as Ibuprofen Tablets have been associated with a small increased risk of high blood pressure, heart attack (myocardial infarction), stroke or heart failure.
• Medicines such as Ibuprofen Tablets have in exceptional cases been associated with severe skin problems for patients with chicken pox or shingles Blood disorders such as reduction in blood cells and platelet counts – the first signs are: high temperature, sore throat, mouth ulcers, flu-like symptoms, bleeding from the mouth, nose, ear and the skin. Kidney problems such as reduced kidney function, fluid retention (oedema), inflammation of the kidney and kidney failure. Liver problems such as inflammation of the liver, reduced liver function and yellowing of the eyes and/or skin (jaundice) or severe skin reactions may occur rarely with ibuprofen.
• Ibuprofen tablets has also been shown to sometimes worsen the symptoms of Crohn’s disease or colitis.

The following side effects could also occur; tell your doctor if you experience these effects:

Other side effects

Common: may affect up to 1 in 10 people:

• feeling dizzy or tired
• diarrhoea, wind, constipation

• headache - if this happens while you are taking this medicine it is important not to take any other medicines for pain to help with this.

  Uncommon (affects up to 1 in a 100 people):

  • feeling drowsy
  • feeling anxious
  • feeling a tingling sensation or ‘pins and needles’
  • difficulty sleeping
  • hives
  • skin becomes sensitive to light
  • hearing problems
  • sneezing, blocked, itchy or runny nose (rhinitis)
  • stomach or gut ulcer, hole in the wall of the digestive tract
  • inflammation of your stomach lining
  • ringing in ears (tinnitus)
  • sensation of spinning (vertigo)
  • mouth ulcers

Rare (affects up to 1 in a 1000 people):

• feeling depressed or confused

Very rare (affects up to 1 in 10,000 people):

• inflammation of the pancreas

Not known (cannot be estimated from the available data):

• A red, scaly widespread rash with bumps under the skin and blisters mainly localized on the skin folds, trunk, and upper extremities accompanied by fever at the initiation of treatment (acute generalised exanthematous pustulosis). Stop using Ibuprofen Tablets if you develop these symptoms and seek medical attention immediately. See also section 2.
• Skin reactions that often occur at the same body site after repeated intake of the drug.

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 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.

5. HOW TO STORE IBUPROFEN

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 blister and carton after EXP. The expiry date refers to the last day of that month. Do not store above 25°C. Store in the original pack. 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 CONTAINS

The active substances is Ibuprofen.

Each film-coated tablet contains 400 mg ibuprofen.

The other ingredients are:

Maize Starch B, Sodium lauryl sulfate, Colloidal silicon dioxide, Croscarmellose sodium, Povidone, Microcrystalline Cellulose, Talc, Stearic acid, Opadry White (macrogol (peg) polyvinyl alcohol graft copolymer, talc, titanium dioxide, gmcc type 1 /mono/diglycerides/glycerol of FA, polyvinyl alcohol-part. hydrolyzed)

What Ibuprofen looks like and contents of the pack

Film-coated tablet.

Ibuprofen 400 mg film-coated tablets White coloured, capsule shaped coated tablets plain on one side and debossed “400” on other side.

Pack sizes: Blisters:

400 mg: film-coated tablets: 24, 48, 84 and 96 film- coated tablets Not all pack sizes may be marketed.

Marketing Authorisation Holder

RxFarma Limited, Colonial Way, Watford, Hertfordshire, WD24 4YR, United Kingdom.

Manufacturer:

Rx Farma Limited, Unit 3, Colonial Way, Watford, Hertfordshire, WD24 4YR, UK.

This leaflet was last revised in April 2026