Patient leaflet - Ibuprofen 200 mg tablets BP
1. What Ibuprofen is and what it is used for
Ibuprofen 200 mg tablets and Ibuprofen 400 mg tablets (referred to as Ibuprofen in this leaflet) contains the active substance ibuprofen. 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, dental pain and neuralgia and/or fever. In addition, it 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 after soft tissues injuries.
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 section6). - if you have had allergic reactions such as asthma, runny nose, itchy skin rash or swelling of the lips, face, tongue, or throat after you have taken medicines containing acetylsalicylic acid (such as aspirin) or other medicines for pain and inflammation (NSAIDs)
- If you have suffered from gastrointestinal bleeding or perforation related to previous use of drugs for pain and inflammation (NSAIDs)
- If you are suffering from an ulcer or bleeding in the stomach or small intestine (duodenum) or if you have had two or more of these episodes in the past
- If you suffer from severe liver, kidney or heart problems
- If you pregnant, planning to become pregnant or breast feeding
- 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)
Have a condition which increases your tendency to bleeding
Do not give Ibuprofen to children below 20 kg body weight or younger than 6 years
Warnings and precautions
Talk to your doctor before taking Ibuprofen
- if you have Systemic Lupus erythematosus (SLE) or mixed connective tissue diseases - 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 thedigestivetract (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
- 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 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 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
Stop taking ibuprofen with the first sign of skin rash, lesions of the mucous membranes or other signs of allergy since this can be the first sign of serious skin reactions (exfoliative dermatitis, erythema multiforme, Steven-Johnson’s syndrome, Lyell’s syndrome), sometimes with fatal outcome. The highest risk of these reactions is in the first month of treatment.
During varicella it is advisable to avoid use of this medicine.
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.
Talk to 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 high blood pressure, diabetes, high cholesterol, or have a family history of heart disease or stroke, or if you 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 allergic reactions (e.g. anaphylactic shock) have been observed. Stop treatment immediately at the first signs of allergic 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 tell 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 must not be used in children below 20 kilograms of body weight or younger than 6 years of age. Ibuprofen may cause kidney problems in children and adolescents who are dehydrated.
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:
- anticoagulants (against clotting) such as warfarin or heparin, since the effect of the anticoagulant may be enhanced
- platelet aggregation inhibitors (against clotting) such as clopidogrel and ticlopidine - methotrexate (used to treat cancer and rheumatoid arthritis)
- 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, beta-blockers 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
- ciclosporine, tacrolimus (for immuno-suppression after organ transplant) since kidney damage mayoccur - 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 beincreased
- sulphonylureas (to treat type 2 diabetes) since the blood sugar levels can be affected - 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.
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.
Some other medicines may also affect or be affected by the treatment of Ibuprofen. Tell your doctor or pharmacist before you use Ibuprofen with other medicines.
Ibuprofen with alcohol
Avoid alcohol since it may enhance the side effects of Ibuprofen, especially those affecting the stomach, intestines or central nervous system.
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 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.
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.
Ibuprofen 200 mg tablets contain sodium, lactose, sucrose and sodium benzoate (E211)
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’. 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.
This medicine contains 143 mg of sucrose per dose. This should be taken into account in patients with diabetes mellitus.
This medicine contains 0.015 mg sodium benzoate in each tablet. Sodium benzoate (E211) may increase jaundice (yellowing of the skin and eyes) in newborn babies (up to 4 weeks old).
Ibuprofen 400 mg tablets contains sodium, lactose, sucrose and sodium benzoate (E211)
This medicine contains 102.465 mg sodium (main component of cooking/table salt) in each Tablet. This is equivalent to 5.12% of the recommended maximum daily dietary intake of sodium for an adult. Talk to your doctor or pharmacist if you need 4 or more Tablets daily for a prolonged period, especially if you have been advised to follow a low salt (sodium) diet.
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.
This medicine contains 329 mg of sucrose per dose. This should be taken into account in patients with diabetes mellitus.
This medicine contains 0.023mg sodium benzoate in each Tablet. Sodium benzoate (E211) may increase jaundice (yellowing of the skin and eyes) in newborn babies (up to 4 weeks old).
3. How to take Ibuprofen
Always take this medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Side effects may be minimised by taking the lowest effective dose for the shortest duration necessary to control symptoms. If you have an infection, consult a doctor without delay if symptoms (such as fever and pain) persist or worsen.
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.
Dosage:
The ibuprofen dose depends on the patient's age and body weight. The maximum single dose for adults should not exceed 800 mg of ibuprofen.
Adults and children over 12 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 – The usual daily dose is 20 mg per kilogram of bodyweight each day, given in divided doses. Do not give this medicine to children weighing less than 7 kilogram.
In cases of severe juvenile arthritis your doctor may increase the dosage up to 40 mg per kilogram in divided doses.
Method of Administration
Take this medicine with or after food, with a glass of water. If you have a sensitive stomach, take this medicine with food. 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.
Duration of the treatment
Your doctor will decide on the duration of the treatment.
In rheumatic diseases the use of ibuprofen can be required for a longer period.
If you take more Ibuprofen than you should
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 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 blood pressure, hyperkalaemia, metabolic acidosis, increased prothrombin time/INR, acute renal failure, liver damage, respiratory depression, cyanosis, cold body feeling, and breathing problems have been reported.
If you forget to take Ibuprofen
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.
4. Possible side effects
Like all medicines, Ibuprofen tablets can cause side effects, although not everybody gets them.
Stop taking this medicine and talk to your doctor if you experience:
- Signs of aseptic meningitis such as severe headache, high temperature, stiffness of the neck or intolerance to bright light.
Signs of intestinal bleeding such as
- Passing blood in your faeces (stools/motions)
- Passing black tarry stools
- Vomiting any blood or dark particles that look like coffee grounds
Tell your doctor and stop taking this medicine if you experience:
- Unexplained stomach pain (abdominal pain) or other abnormal stomach symptoms, indigestion,heartburn, feeling sick and/or vomiting.
- Unexplained wheezing, shortness of breath, skin rash, itching or bruising (these may be symptoms of an allergic reaction).
Loss of vision, blurred or disturbed vision (visual impairment) or seeing/hearing strange things
(hallucinations).
Severe spreading skin rash (‘Stevens-Johnson Syndrome’, ‘toxic epidermal necrolysis’ and
‘erythema multiforme’, symptoms include severe skin rash, blistering of skin, including inside mouth, nose, and genitals, as well as skin peeling which may be accompanied with symptoms such as aching, headaches, and feverishness)
- 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). Medicines such as Ibuprofen have been associated with a small increased risk of high blood pressure, heart attack (myocardial infarction), stroke or heart failure.
In exceptional cases this medicine has 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, 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.
Ibuprofen has also been shown to sometimes worsen the symptoms of Crohn's disease or colitis.
Chest pain, which can be a sign of a potentially serious allergic reaction called Kounis syndrome
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 (may affect 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 (may affects up to 1 in a 1,000 people):
- feeling depressed or confused
Very rare (may 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 skinfolds, trunk, and upper extremities accompanied by fever at the initiation of treatment (acute generalised exanthematous pustulosis). Stop using Ibuprofen if you develop these symptoms and seek medical attention immediately. See also section 2.
Skin becomes sensitive to light
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 the 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 store above 25°C. Keep the container tightly closed. Store in the original container.
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.
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 substance is ibuprofen.
Each 200 mg tablet contains 200 mg of ibuprofen.
Each 400 mg tablet contains 400 mg of ibuprofen.
The other ingredients are: lactose monohydrate, maize starch, methylcellulose, sodium starch glycolate
(type A), colloidal silicon dioxide (aerosil 200), magnesium stearate, ethyl acetate, calcium carbonate, gum acacia, titanium dioxide, purified talc, sucrose, wincoat WT-TR-05034 (polyvinyl acetate phthalate, stearic acid), winglow WG-02213 pink (sucrose, titanium dioxide, erythrosine aluminium lake, sodium benzoate), opaglos 6000P (shellac, beeswax white, carnauba wax yellow).
What Ibuprofen looks like and contents of the pack
Ibuprofen 200 mg tablets: Pink, circular, sugar coated tablets.
Ibuprofen 400 mg tablets: Pink, circular, sugar coated tablets.
Pack sizes: 48, 84, 100, 250 and 500 tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Medley Pharma Limited,
Unit 2A, Olympic Way,
Sefton Business Park, Bootle,
L30 1RD,
United Kingdom.
Ibuprofen 200 mg Tablets: PL 43870/0021
Ibuprofen 400 mg Tablets: PL43870/0022
The leaflet was last revised in 08/2024