Package leaflet: Information for the user You should discuss your treatment with your doctor or pharmacist before taking Ibuprofen if Ibuprofen 600 mg film- you: • have heart problems including heart failure, coated tablets angina (chest pain), or if you have had a heart attack, bypass surgery, peripheral Read all of this leaflet carefully before artery disease (poor circulation in the legs you start taking this medicine because it or feet due to narrow or blocked arteries), or contains important information for you. any kind of stroke (including ‘mini-stroke’ or - Keep this leaflet. You may need to read it transient ischaemic attack “TIA”). again. • have high blood pressure, diabetes, high - If you have any further questions, ask your cholesterol, or have a family history of heart doctor or pharmacist. disease or stroke, or if you are a smoker. - This medicine has been prescribed for you Effects on the kidneys only. Do not pass it on to others. It may Ibuprofen may cause problems with kidney harm them, even if their signs of illness are function even in patients who have not had the same as yours. kidney problems before. This may result in - If you get any side effects, talk to your swelling of the legs and may even lead to heart doctor or pharmacist. This includes any failure or high blood pressure in predisposed possible side effects not listed in this leaflet. individuals. See section 4. Ibuprofen may cause kidney damage especially What is in this leaflet in patients who already have kidney, heart or 1. What Ibuprofen is and what it is used for liver problems, or are taking diuretics or ACE 2. What you need to know before you take inhibitors, as well as in the elderly. Stopping Ibuprofen however generally leads to recovery. Ibuprofen 3. How to take Ibuprofen Aseptic meningitis (inflammation of the brain 4. Possible side effects membrane without bacterial infection) 5. How to store Ibuprofen During treatment with ibuprofen, some cases of 6. Contents of the pack and other information meningitis (presenting as stiff neck, headache, nausea, vomiting, fever or disorientation) 1. What Ibuprofen is and what it is used for have been seen. Although it is probably more likely to occur in patients with existing Ibuprofen belongs to a group of medicines autoimmune disorders such as systemic lupus called NSAID (non-steroidal anti- inflammatory erythematosus or mixed connective tissue drugs) which work by reducing pain and diseases, it has been reported in patients who inflammation. do not have an existing long-term disease. Ibuprofen is used for the symptomatic treatment Other precautions of pain and inflammation in arthritic diseases Very rarely, severe acute hypersensitivity (e.g. rheumatoid arthritis), degenerative arthritic reactions (e.g. anaphylactic shock) have been Half Fold: 320 mm conditions (e.g. osteoarthritis) and in painful observed. Stop treatment immediately at the swelling and inflammation after soft tissues first signs of hypersensitivity reaction after injuries. taking Ibuprofen and tell immediately to your doctor. 2. What you need to know before you take Ibuprofen Ibuprofen can temporarily inhibit blood platelet function (blood platelet aggregation). Patients Do not take Ibuprofen: with blood clotting disorders should therefore be - if you are allergic to ibuprofen or any of the carefully monitored. other ingredients of this medicine (listed in During long-term, high-dose use of pain killers, section 6). headache may occur which should not be - if you have had allergic reactions such treated with high doses of this medicine. as asthma, runny nose, itchy skin rash or The habitual use of painkillers may cause swelling of the lips, face, tongue, or throat permanent damage to the kidneys and a risk of after you have taken medicines containing kidney failure. acetylsalicylic acid (such as aspirin) or other drugs for pain and inflammation (NSAIDs). Ibuprofen may hide the symptoms or signs - if you have suffered from gastrointestinal of an infection (fever, pain and swelling) and bleeding or perforation related to previous temporarily prolong bleeding time. use of drugs for pain and inflammation Ibuprofen may decrease your chance of (NSAIDs) becoming pregnant. You should inform your - if you are suffering from an ulcer or doctor if you are planning to become pregnant bleeding in the stomach or small intestine or if you have problems becoming pregnant. (duodenum) or if you have had two or more Adolescents of these episodes in the past Ibuprofen is contraindicated in children and - if you suffer from severe liver, kidney or adolescents younger than 15 years of age (See heart problems section 3). - if you are in the last 3 months of pregnancy Ibuprofen may cause kidney problems in - if you are suffering from significant adolescents who are dehydrated. dehydration (caused by vomiting, diarrhoea Other medicines and Ibuprofen or insufficient fluid intake) Tell your doctor or pharmacist if you are taking, - if you have any active bleeding (including in have recently taken or might take any other the brain) medicines. - if you suffer from a condition of unknown origin resulting in abnormal formation of The side effects of Ibuprofen may be increased blood cells if certain medicines are taken at the same time. On the other hand, Ibuprofen may increase Do not give Ibuprofen 600 mg and film-coated or decrease the effect of other medicines or tablets to children and adolescents younger increase their side effects when taken at the than 15 years. same time. Warnings and precautions Ibuprofen may affect or be affected by some Talk to your doctor before taking Ibuprofen other medicines. - if you have Systemic Lupus erythematosus For example: (SLE) or mixed connective tissue diseases - other NSAIDs including COX-2 inhibitors, - if you have inherited a disorder of the red since this may increase the risk of blood pigment haemoglobin (porphyria) gastrointestinal ulcers and bleeding - if you have chronic inflammatory intestinal - anticoagulants (against clotting) such as diseases such as inflammation of the colon warfarin or heparin, since the effect of the with ulcers (ulcerative colitis), inflammation anticoagulant may be enhanced affecting the digestive tract (Crohn’s - platelet aggregation inhibitors (against disease) or other stomach or intestinal clotting) such as clopidogrel and ticlopidine diseases - methotrexate (used to treat cancer and auto-immune diseases) - if you have disturbances in the - digoxin (for treatment of various heart formation of blood cells conditions) ) since the effect of digoxin may - if you have problems with normal be enhanced blood clotting mechanism - phenytoin (used in prevention of the - if you suffer from allergies, hay occurrence of epileptic seizures) since the fever, asthma, chronic swelling of effect of phenytoin may be enhanced nasal mucosa, sinuses, adenoids, - lithium (used to treat depression and mania) or chronic obstructive disorders of since the effect of lithium may be enhanced the respiratory tract because the - diuretics (water tablets) since the effect of risk for developing narrowing of the the diuretics may be weakened, airways with difficulty in breathing - potassium-sparing diuretics since this may (bronchospasm) is greater lead to hyperkalaemia - if you have liver, kidney or heart problems - medicines that reduce high blood pressure - if you have just had major surgery (ACE-inhibitors such as captopril, beta- - if you are in the first six months of blockers such as atenolol medicines, pregnancy angiotensi-II receptor antagonists such as - if you are breast-feeding losartan) - if you have an infection - please see - cholestyramine (used in the treatment of heading “Infections” below high cholesterol) - aminoglycosides (medicines against certain Infections types of bacteria) since NSAIDs may Ibuprofen may hide signs of infections such decrease excretion of aminoglycosides as fever and pain. It is therefore possible that - SSRIs (medicines against depression) Ibuprofen may delay appropriate treatment of such as paroxetin, sertralin, citalopram as infection, which may lead to an increased risk these may increase risk of gastrointestinal of complications. This has been observed in bleeding pneumonia caused by bacteria and bacterial - ciclosporine, tacrolimus (for immuno- skin infections related to chickenpox. If you suppression after organ transplant) since take this medicine while you have an infection kidney damage may occur and your symptoms of the infection persist or - zidovudine or ritanovir (used to treat worsen, consult a doctor without delay. patients with HIV) Elderly - mifepristone since NSAIDs can reduce the If you are elderly you will be more prone to side effect of mifepristone - probenecid or sulfinpyrazone (for treating effects, especially bleeding and perforation in gout) since the excretion of ibuprofen may the digestive tract, which may be fatal. be delayed Ulcers, perforation and bleeding in the stomach - quinolone antibiotics since the risk of or intestines convulsions (fits) may be increased If you have earlier had an ulcer in the stomach - sulphonylureas (to treat type 2 diabetes) or intestines, especially if this has been since the blood sugar levels can be affected complicated by perforation or accompanied by - glucocorticoids (used against inflammations) bleeding, you should look out for any unusual since this may increase the risk of symptoms in the abdomen, and report them gastrointestinal ulcers or bleeding at once to your doctor, especially if these - bisphosphonates (used in osteoporosis, symptoms occur at the beginning of treatment. Paget’s disease and to reduce high blood This is because the risk for bleeding or calcium levels) ulceration of the digestive tract is higher in this - oxpentifylline ((pentoxifylline) used in the case, especially in elderly patients. If bleeding treatment of circulatory disease of the or ulceration of the digestive tract occurs, the arteries of the legs or arms) treatment has to be stopped. - baclofen (a muscle relaxant) because of elevated baclofen toxicity Bleeding, ulceration or perforation in the - Gingko biloba herbal medicine (there is a stomach or intestines may occur without any chance you may bleed more easily if you warning signs even in patients who have never are taking this with ibuprofen). had such problems before. It may also be fatal. - voriconazole and fluconazole (CYP2C9 inhibitors) (used for fungal infections), The risk of ulcers, perforation or bleeding in since the effect of ibuprofen may increase. the stomach or intestines generally increases Reduction of the ibuprofen dose should be with higher doses of ibuprofen. The risk also considered, particularly when high-dose increases if certain other medicines are taken ibuprofen is used with either voriconazole or at the same time as ibuprofen (see other fluconazole. medicines and Ibuprofen, below). Some other medicines may also affect or be Undesirable effects may be minimised by affected by the treatment of Ibuprofen. You using the lowest effective dose for the shortest should therefore always seek the advice of your duration necessary to control symptoms. doctor or pharmacist before you use Ibuprofen Skin reactions with other medicines. Serious skin reactions have been reported Ibuprofen with alcohol in association with Ibuprofen treatment. Avoid alcohol since it may enhance the side You should stop taking Ibuprofen tablet and effects of Ibuprofen, especially those affecting seek medical attention immediately, if you the stomach, intestines or central nervous develop any skin rash, lesions of the mucous system. membranes, blisters or other signs of allergy Pregnancy, breast-feeding and fertility since this can be the first signs of a very serious If you are pregnant or breast-feeding, think skin reaction. See section 4. you may be pregnant or are planning to have a During varicella it is advisable to avoid use of baby, ask your doctor or pharmacist for advice this drug. before taking this medicine. Effects on the heart and brain Ibuprofen must not be taken in the last 3 Anti-inflammatory/pain-killer medicines like months of pregnancy since it may cause major ibuprofen may be associated with a small heart, lung and kidney disorders in the unborn increased risk of heart attack or stroke, child. If used at the end of pregnancy, it particularly when used at high doses. Do not may cause bleeding tendencies in both exceed the recommended dose or duration of mother and child and weaken the strength treatment. of uterine contractions delaying the onset of delivery. P15XXXXX

Black Treatment during the first 6 months of You should stop taking the medicine and pregnancy will only be prescribed by your contact your doctor as soon as possible if you doctor if clearly necessary. develop the following side effects: Ibuprofen may make it more difficult to become Very common: pregnant. You should inform your doctor if you - heartburn, abdominal pain, indigestion are planning to become pregnant or if you have Uncommon: problems becoming pregnant. - visual distrubances Ibuprofen appears in breast milk in a very small - hypersensitivity reactions such as skin rash, amount and breastfeeding will usually not need itching, asthma attacks (sometimes with low to be stopped during short-term treatments. If, blood pressure) however, longer treatment is prescribed, early - photosensitivity (increased sensitivity to weaning should be considered. sunlight) Driving and using machines Rare: Ibuprofen generally has no adverse effects - vision loss on the ability to drive or operate machinery. Very rare: However since at high dosage side effects such - sudden filling of lungs with water resulting as fatigue, somnolence, vertigo (reported as in difficulty to breathe, high blood pressure, common) and visual disturbances (reported as water retention and weight gain uncommon) may be experienced, the ability Other possible side effects with Ibuprofen are: to take part actively in road traffic or operate machinery may be impaired in individual cases. Very common: This effect is potentiated by simultaneous - Disturbances in the digestive tract, such consumption of alcohol. as diarrhoea, feeling sick, vomiting, wind, constipation Ibuprofen contain Sodium: This medicine contains less than 1 mmol sodium (23 mg) Common: per 600 mg film-coated tablets, that is to say - Digestive tract ulcer with or without perforation essentially ‘sodium-free’. - Bowel inflammation and worsening of 3. How to take Ibuprofen inflammation of the colon (colitis) and digestive tract (Crohn’s disease) and Always take this medicine exactly as your complications of diverticula of the large doctor has told you. Check with your doctor or bowel (perforation or fistula) pharmacist if you are not sure. - Microscopic bleeding from the intestine which may result in anemia Undesirable effects may be minimised by - Mouth ulcers and inflammation (ulcerative using the lowest effective dose for the shortest stomatitis) duration necessary to control symptoms. - Headache, sleepiness, vertigo, dizziness, The lowest effective dose should be used fatigue, agitation, insomnia and irritability for the shortest duration necessary to relieve symptoms. If you have an infection, consult a Uncommon: Half Fold: 320 mm doctor without delay if symptoms (such as fever - Inflammation of the stomach lining and pain) persist or worsen (see section 2). - Kidney problems including development of The treating physician decides on the duration oedema, inflammation of the kidneys and of treatment. kidney failure In rheumatic diseases the use of Ibuprofen can - Runny nose - Difficulty breathing (bronchospasm) be required for a longer period. Rare: Ibuprofen is contraindicated in children and - Depression, confusion, hallucinations adolescents younger than 15 years of age (See - Lupus erythematosus syndrome section 2). - Increase of blood urea nitrogen, serum The ibuprofen dose depends on the patient’s transaminases and alkaline phosphatase age and body weight. The maximum single daily decrease in haemoglobin and haematocrit dose for adults should not be greater than values, inhibition of platelet aggregation and 800 mg of ibuprofen. The recommended dose is: prolonged bleeding time, decrease of serum calcium and increase in serum uric acid Rheumatic diseases values Adults: - Damage of the kidney tissue The recommended dose is 1200 mg-1800 mg daily in divided doses. Lower doses may be Very rare: prescribed by your doctor. Due to the nature - Unpleasant awareness of heart beat, heart and severity of your condition, the doctor may failure or heart attack increase your medication to a maximum of - Disorders of blood cell formation 2400 mg daily, taken in 3 or 4 divided doses. (anaemia, leucopenia, thrombocytopenia, pancytopenia, agranulocytosis, neutropenia) Adolescents 15 to 17 years of age: The first symptoms or signs may include The recommended dose is 20 mg/kg to a fever, sore throat, surface mouth ulcers, flu- maximum of 40 mg/kg body weight daily (max like symptoms, severe fatigue, nasal and 2400 mg daily) in 3 to 4 divided doses. Your skin bleeding) doctor will advise you accordingly. - Ringing or buzzing in the ears - Inflammation of the oesophagus or The tablet should be swallowed with a glass pancreas of water, preferably after a meal. Patients - Narrowing of the bowel with sensitive stomach are recommended to - Acute inflammation of the liver, yellowish take Ibuprofen during a meal. For the ease of discolouration of the skin or whites of the swallowing or adjusting of doses the tablets can eyes, liver dysfunction, damage or failure be divided in equal halves. - liver damage especially in long-term use or Elderly liver failure If you are elderly you will be more prone to - Hair loss side effects, especially bleeding, ulceration and - Inflammation of the brain membrane without perforation in the digestive tract, which may be bacterial infection (aseptic meningitis) fatal. Your doctor will advise you accordingly. Not known: Reduced kidney or liver function - Tingling of the hands and feet If you suffer from reduced kidney or liver - Anxiety function, your doctor will advise you - Impaired hearing accordingly. - General feeling of being unwell - Inflammation of the optic nerve which may If you take more Ibuprofen than you should cause vision problems If you have taken more ibuprofen than you - A severe skin reaction known as DRESS should, or if children have taken this medicine syndrome can occur. Symptoms of DRESS by accident always contact a doctor or nearest include: skin rash, fever, swelling of lymph hospital to get an opinion of the risk and advice nodes and an increase of eosinophils (a on action to be taken. type of white blood cells). - A red, scaly widespread rash with bumps The symptoms can include nausea, under the skin and blisters mainly localized stomach pain, vomiting (may be blood on the skin folds, trunk, and upper streaked), or more rarely diarrhoea. In extremities accompanied by fever at the addition, headache, gastrointestinal initiation of treatment (acute generalised bleeding, blurred vision, ringing in exanthematous pustulosis). Stop using the ears, confusion and shaky eye Ibuprofen tablets if you develop these movement, and exacerbation of symptoms and seek medical attention asthma in asthmatics. At high doses, immediately. See also section 2. drowsiness, excitation, disorientation, Ibuprofen may cause a reduction in the number chest pain, palpitations, loss of of white blood cells and your resistance to consciousness, convulsions (mainly infection may be decreased. If you experience in children), vertigo, weakness and an infection with symptoms such as fever and dizziness, blood in urine, low blood serious deterioration of your general condition, pressure, hyperkalaemia, metabolic or fever with local infection symptoms such as acidosis, increased prothrombin time/ sore throat/pharynx/mouth or urinary problems INR, acute renal failure, liver damage, you should see your doctor immediately. A respiratory depression, cyanosis, cold blood test will be taken to check possible body feeling, and breathing problems reduction of white blood cells (agranulocytosis). have been reported. It is important to inform your doctor about your medicine. If you forget to take Ibuprofen Do not take a double dose to make up for a Reporting of side effects If you get any side effects, talk to your doctor forgotten dose. or pharmacist. This includes any possible side If you have any further questions on the effects not listed in this leaflet. You can also use of this medicine, ask your doctor or report side effects directly via the national pharmacist. reporting system listed in Yellow Card Scheme 4. Possible side effects Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Like all medicines, this medicine can cause side Play or Apple App Store. By reporting side effects, although not everybody gets them. effects you can help provide more information With regard to the following side effects, it must on the safety of this medicine. be considered that they are largely dependent 5. How to store Ibuprofen on the dose and that they vary from patient to patient. Keep this medicine out of the sight and reach of The most commonly observed side effects children. are gastrointestinal in nature. Peptic ulcers, Do not use this medicine after the expiry date perforation or gastrointestinal bleeding, which is stated on the carton after EXP. The sometimes fatal, particularly in the elderly, may expiry date refers to the last day of that month. occur. Nausea, vomiting, diarrhoea, flatulence, This medicine does not require any special constipation, indigestion, abdominal pain, storage conditions. melaena, heamatemesis, ulcerative stomatits, exacerbation of colitis and Crohn’s disease Do not throw away any medicines via have been reported following administration. wastewater or household waste. Ask your Less frequently, inflammation of the stomach pharmacist how to throw away medicines you lining (gastritis) has been observed. no longer use. These measures will help protect the environment. Medicines such as Ibuprofen may be associated with a small increased risk of heart 6. Contents of the pack and other attack (myocardial infraction) or stroke. Water information retention (oedema), high blood pressure and heart failure have been reported in association What Ibuprofen contains with NSAIDs. - The active substances isIbuprofen. Each film-coated tablet contains 600 mg The side effects are stated according to the ibuprofen. frequency they occur. The following convention has been used: - The other ingredients are: Very common: may affect more than 1 in 10 Tablet core: Maize starch, starch, people pregelatinised (maize starch), silica, Common: may affect up to 1 in 10 people colloidal anhydrous, croscarmellose sodium, Uncommon: may affect up to 1 in 100 people talc, stearic acid. Rare: may affect up to 1 in 1,000 people Film coating: Talc (E553b), polyvinyl Very rare: may affect up to 1 in 10,000 people alcohol, macrogol 3350 (E1521), titanium Not known: frequency cannot be estimated from dioxide (E171). the available data What Ibuprofen looks like and contents of The following side effects are important and the pack will require immediate action if you experience Film-coated tablet. them. You should stop taking Ibuprofen and Ibuprofen 600 mg film-coated tablet see your doctor immediately if the following White to off-white, oval shaped, film-coated symptoms occur: tablets with break line on one side and plain on Common: the other side. The tablet can be divided into - black tarry stools or blood-stained vomit equal doses. (digestive tract ulcer with bleeding) Ibuprofen film-coated tablets are available in Very rare: blister packs - swelling of the face, tongue or throat (larynx) Pack sizes: 10, 20, 24, 30, 40, 50, 56, 60, 84 which can cause great difficulty in breathing and 100 film-coated tablets (angioedema), rapid heartbeat, severe fall in blood pressure or life threatening shock Not all pack sizes may be marketed. - a sudden allergic reaction with shortness Marketing Authorisation Holder and of breath, wheezing and drop of blood Manufacturer pressure - severe rash with blisters on the skin Milpharm Limited especially on the legs, arms, hands and Ares Block, Odyssey Business Park feet which can also involve the face and lips West End Road (erythema multiforme, Stevens-Johnson´s Ruislip HA4 6QD syndrome). This can get even more severe, United Kingdom the blisters get larger and spread out and or parts of the skin may slough off (Lyell´s syndrome). There may also be severe Generis Farmacêutica, S.A. infection with destruction (necrosis) of Rua João de Deus, 19, Amadora, 2700- skin, subcutaneous tissue and muscle 487, Portugal (necrotizing fasciitis) This leaflet was last revised in 06/2020. P15XXXXX