Package leaflet: Information for the user swelling of the legs and may even lead to heart failure or high blood pressure in predisposed Ibuprofen 200 mg film- individuals. coated tablets Ibuprofen may cause kidney damage especially in patients who already have kidney, heart or Ibuprofen 400 mg film- liver problems, or are taking diuretics or ACE inhibitors, as well as in the elderly. Stopping coated tablets Ibuprofen however generally leads to recovery. Always take this medicine exactly as Aseptic meningitis (inflammation of the brain described in this leaflet or as your doctor or membrane without bacterial infection) During treatment with ibuprofen, some cases of pharmacist has told you. meningitis (presenting as stiff neck, headache, - Keep this leaflet. You may need to read it nausea, vomiting, fever or disorientation) again. have been seen. Although it is probably - Ask your pharmacist if you need more more likely to occur in patients with existing information or advice. autoimmune disorders such as systemic lupus - If you get any side effects, talk to your erythematosus or mixed connective tissue doctor or pharmacist. This includes any diseases, it has been reported in patients who possible side effects not listed in this leaflet. do not have an existing long-term disease. See section 4. Other precautions - You must talk to a doctor if you do not feel Very rarely, severe acute hypersensitivity better or if you feel worse reactions (e.g. anaphylactic shock) have been - after 3 days in adolescents observed. Stop treatment immediately at the - after 3 days in migraine headache and fever first signs of hypersensitivity reaction after and after 4 days in pain and period pain in taking Ibuprofen and tell immediately to your adults doctor. What is in this leaflet Ibuprofen can temporarily inhibit blood platelet 1. What Ibuprofen is and what it is used for function (blood platelet aggregation). Patients 2. What you need to know before you take with blood clotting disorders should therefore be Ibuprofen carefully monitored. 3. How to take Ibuprofen Prolonged use of any type of pain killer for 4. Possible side effects headaches can make them worse. If this 5. How to store Ibuprofen situation is experienced or suspected, stop 6. Contents of the pack and other information taking ibuprofen and consult your doctor. The diagnosis of medication overuse headache 1. What Ibuprofen is and what it is used for (MOH) should be suspected in patients who have frequent or daily headaches despite Ibuprofen belongs to a group of medicines (or because of) the regular use of headache called NSAID (non-steroidal anti- inflammatory medications. drugs) which work by reducing pain and fever. The habitual use of painkillers may cause Ibuprofen is used for the short-term permanent damage to the kidneys and a risk of symptomatic treatment of mild to moderate kidney failure.

Half Fold: 340 mm pain such as headache, including migraine Ibuprofen may hide the symptoms or signs headache, dental pain, period pain and/or fever. of an infection (fever, pain and swelling) and temporarily prolong bleeding time. 2. What you need to know before you take Ibuprofen Ibuprofen may decrease your chance of becoming pregnant. You should inform your Do not take Ibuprofen: doctor if you are planning to become pregnant - if you are allergic to ibuprofen or any of the or if you have problems becoming pregnant. other ingredients of this medicine (listed in Children and adolescents section 6). Do not use in children younger than 12 years. - if you have had allergic reactions such as asthma, runny nose, itchy skin rash or Ibuprofen may cause kidney problems in swelling of the lips, face, tongue, or throat adolescents who are dehydrated. after you have taken medicines containing Other medicines and Ibuprofen acetylsalicylic acid (such as aspirin) or other Tell your doctor or pharmacist if you are taking, drugs for pain and inflammation (NSAIDs). have recently taken or might take any other - if you have suffered from an ulcer or medicines. bleeding in the stomach or small intestine Ibuprofen may affect or be affected by some (duodenum) related to previous use of drugs other medicines. for pain and inflammation (NSAIDs) Foe example: - if you are suffering from gastrointestinal - other NSAIDs including COX-2 inhibitors, bleeding or perforation or if you have had since this may increase the risk of two or more of these episodes in the past gastrointestinal ulcers and bleeding - if you suffer from severe liver, kidney or - anticoagulants (against clotting) such as heart problems warfarin or heparin, since the effect of the - if you are in the last 3 months of pregnancy anticoagulant may be enhanced - if you are suffering from significant - platelet aggregation inhibitors (against dehydration (caused by vomiting, diarrhoea clotting) such as ticlopidin or clopidogrel - methotrexate (used to treat cancer and or insufficient fluid intake) auto-immune diseases) - if you have any active bleeding (including in - digoxin (for treatment of various heart the brain) conditions) since the effect of digoxin may - if you suffer from a condition of unknown be enhanced origin resulting in abnormal formation of - phenytoin (used in prevention of the blood cells occurrence of epileptic seizures) since the Ibuprofen is contraindicated in children younger effect of phenytoin may be enhanced than 12 years. - lithium (used to treat depression and mania) since the effect of lithium may be enhanced Warnings and precautions - diuretics (water tablets) since the effect of Talk to your doctor before taking Ibuprofen the diuretics may be weakened - if you have Systemic Lupus erythematosus - potassium-sparing diuretics since this may (SLE) or mixed connective tissue diseases lead to hyperkalaemia - if you have inherited a disorder of the red - medicines that reduce high blood pressure blood pigment haemoglobin (porphyria) (ACE-inhibitors such as captopril, beta- - if you have chronic inflammatory intestinal blockers such as atenolol medicines, diseases such as inflammation of the colon angiotensin-II receptor antagonists such as with ulcers (ulcerative colitis), inflammation losartan) - cholestyramine (used in the treatment of affecting the digestive tract (Crohn’s high cholesterol) disease) or other stomach or intestinal - aminoglycosides (medicines against certain diseases types of bacteria) since NSAIDs may - if you have disturbances in the formation of decrease excretion of aminoglycosides blood cells - SSRIs (medicines against depression) - if you have problems with normal blood such as paroxetin, sertralin, citalopram as clotting mechanism these may increase risk of gastrointestinal - if you suffer from allergies, hay bleeding fever, asthma, chronic swelling of - ciclosporine, tacrolimus (for immuno- nasal mucosa, sinuses, adenoids, suppression after organ transplant) since or chronic obstructive disorders of kidney damage may occur the respiratory tract because the - zidovudine or ritanovir (used to treat risk for developing narrowing of the patients with HIV) airways with difficulty in breathing - mifepristone since NSAIDs can reduce the (bronchospasm) is greater effect of mifepristone - if you have liver, kidney, or heart - probenecid or sulfinpyrazone (for treating problems or high blood pressure gout) since the excretion of ibuprofen may - if you have just had major surgery be delayed - quinolone antibiotics since the risk of - if you are in the first six months of convulsions (fits) may be increased pregnancy - sulphonylureas (to treat type 2 diabetes) - if you are breast-feeding since the blood sugar levels can be affected - if you have an infection - please see - glucocorticoids (used against inflammations) heading “Infections” below since this may increase the risk of gastrointestinal ulcers or bleeding Infections - bisphosphonates (used in osteoporosis, Ibuprofen may hide signs of infections such Paget’s disease and to reduce high blood as fever and pain. It is therefore possible that calcium levels) Ibuprofen may delay appropriate treatment of - oxpentifylline ((pentoxifylline) used in the infection, which may lead to an increased risk treatment of circulatory disease of the of complications. This has been observed in arteries of the legs or arms) pneumonia caused by bacteria and bacterial - baclofen (a muscle relaxant) because of skin infections related to chickenpox. If you elevated baclofen toxicity take this medicine while you have an infection - Gingko biloba herbal medicine (there is a and your symptoms of the infection persist or chance you may bleed more easily if you worsen, consult a doctor without delay. are taking this with ibuprofen).voriconazole Elderly and fluconazole (CYP2C9 inhibitors) (used If you are elderly you will be more prone to side for fungal infections), since the effect of effects, especially bleeding and perforation in ibuprofen may increase. Reduction of the the digestive tract, which may be fatal. ibuprofen dose should be considered, particularly when high-dose ibuprofen is Ulcers, perforation and bleeding in the stomach used with either voriconazole or fluconazole. or intestines If you have earlier had an ulcer in the stomach Some other medicines may also affect or be or intestines, especially if this has been affected by the treatment of Ibuprofen. You complicated by perforation or accompanied by should therefore always seek the advice of your bleeding, you should look out for any unusual doctor or pharmacist before you use Ibuprofen symptoms in the abdomen, and report them with other medicines. at once to your doctor, especially if these Ibuprofen with alcohol symptoms occur at the beginning of treatment. This is because the risk for bleeding or Avoid alcohol since it may enhance the side ulceration of the digestive tract is higher in this effects of Ibuprofen, especially those affecting case, especially in elderly patients. If bleeding the stomach, intestines or central nervous or ulceration of the digestive tract occurs, the system. treatment has to be stopped. Pregnancy, breast-feeding and fertility Bleeding, ulceration or perforation in the If you are pregnant or breast-feeding, think stomach or intestines may occur without any you may be pregnant or are planning to have a warning signs even in patients who have never baby, ask your doctor or pharmacist for advice had such problems before. It may also be fatal. before taking this medicine. Ibuprofen must not be taken in the last 3 The risk of ulcers, perforation or bleeding in months of pregnancy since it may cause major the stomach or intestines generally increases heart, lung and kidney disorders in the unborn with higher doses of ibuprofen. The risk also child. If used at the end of pregnancy, it may increases if certain other medicines are taken cause bleeding tendencies in both mother at the same time as ibuprofen (see other and child and weaken the strength of uterine medicines and Ibuprofen, below). contractions delaying the onset of delivery. Undesirable effects may be minimised by You should only use Ibuprofen in the first 6 using the lowest effective dose for the shortest months of pregnancy after consulting your duration necessary to control symptoms. doctor and only when clearly necessary. Skin reactions The product belongs to a group of medicines Serious skin reactions have been reported (NSAIDs) which may impair the fertility in in association with Ibuprofen treatment. women. This effect is reversible on stopping the You should stop taking Ibuprofen tablet and medicine. seek medical attention immediately, if you develop any skin rash, lesions of the mucous Ibuprofen appears in breast milk in a very small membranes, blisters or other signs of allergy amount and breastfeeding will usually not need since this can be the first signs of a very serious to be stopped during short-term treatments. If, skin reaction. See section 4. however, longer treatment is prescribed, early weaning should be considered. During varicella it is advisable to avoid use of this drug. Driving and using machines Ibuprofen generally has no adverse effects Effects on the heart and brain on the ability to drive or operate machinery. Anti-inflammatory/pain-killer medicines like However since at high dosage side effects such ibuprofen may be associated with a small as fatigue, somnolence, vertigo (reported as increased risk of heart attack or stroke, common) and visual disturbances (reported as particularly when used at high doses. Do not uncommon) may be experienced, the ability exceed the recommended dose or duration of to take part actively in road traffic or operate treatment (7 days in adults or 3 days in children machinery may be impaired in individual cases. and adolescents). This effect is potentiated by simultaneous You should discuss your treatment with your consumption of alcohol. doctor or pharmacist before taking Ibuprofen if you: Ibuprofen contain Sodium: This medicine - have heart problems including heart failure, contains less than 1 mmol sodium (23 mg) per angina (chest pain), or if you have had a 200 mg/ 400 mg film-coated tablets, that is to heart attack, bypass surgery, peripheral say essentially ‘sodium-free’. artery disease (poor circulation in the legs or feet due to narrow or blocked arteries), or 3. How to take Ibuprofen any kind of stroke (including ‘mini-stroke’ or transient ischaemic attack “TIA”). Always take this medicine exactly as your - have high blood pressure, diabetes, high doctor has told you. Check with your doctor or cholesterol, or have a family history of heart pharmacist if you are not sure. disease or stroke, or if you are a smoker. Undesirable effects may be minimised Effects on the kidneys by using the lowest effective dose for the Ibuprofen may cause problems with kidney shortest duration necessary to control function even in patients who have not had symptoms. kidney problems before. This may result in P15XXXXX

Black The lowest effective dose should be used - photosensitivity (increased sensitivity to for the shortest duration necessary to relieve sunlight) symptoms. If you have an infection, consult a Rare: doctor without delay if symptoms (such as fever - vision loss and pain) persist or worsen (see section 2). For short-term use only. Very rare: The ibuprofen dose depends on the patient’s - sudden filling of lungs with water resulting age and body weight. The recommended dose in difficulty to breathe, high blood pressure, is: water retention and weight gain Mild to moderate pain and fever Other possible side effects with Ibuprofen are: Adults and adolescents ≥40 kg body weight (12 Very common: years and above): - Disturbances in the digestive tract, such 1-2 tablets given as a single dose or 3-4 times a as diarrhoea, feeling sick, vomiting, wind, day with an interval of 6 hours as required. constipation ½ to 1 tablet given as a single dose or 3‑4 times a day with an interval of 6 hours as Common: required. - Digestive tract ulcer with or without The maximum daily dose should not exceed 6 perforation tablets (1200 mg). - Bowel inflammation and worsening of The maximum daily dose should not exceed 3 inflammation of the colon (colitis) and tablets (1200 mg). digestive tract (Crohn’s disease) and complications of diverticula of the large Migraine headache bowel (perforation or fistula) Adults and adolescents ≥40 kgbody weight (12 - Microscopic bleeding from the intestine years and above): which may result in anemia 2 tablets given as a single dose, if necessary 2 - Mouth ulcers and inflammation (ulcerative tablets with intervals of 6 hours. stomatitis) 1 tablet given as a single dose, if necessary 1 - Headache, sleepiness, vertigo, dizziness, tablet with intervals of 6 hours. fatigue, agitation, insomnia and irritability The maximum daily dose should not exceed 6 tablets (1200 mg). Uncommon: The maximum daily dose should not exceed 3 - Inflammation of the stomach lining tablets (1200 mg). - Kidney problems including development of oedema, inflammation of the kidneys and Period pain Adults and adolescents ≥ 40 kg body weight (12 kidney failure years of age and above): - Runny nose 1-2 tablets 1-3 times a day, with an interval of - Difficulty breathing (bronchospasm) 4-6 hours, as needed. The maximum daily dose Rare: should not be more than 6 tablets (1200 mg). - Depression, confusion, hallucinations ½ to 1 tablet 1‑3 times a day, with an interval of - Lupus erythematosus syndrome 4‑6 hours, as needed. The maximum daily dose - Increase of blood urea nitrogen, serum should not be more than 3 tablets (1200 mg). transaminases and alkaline phosphatase, Half Fold: 340 mm The tablet should be swallowed with a glass - decrease in haemoglobin and haematocrit of water during or after a meal. Patients with values, inhibition of platelet aggregation and sensitive stomach are recommended to take prolonged bleeding time, decrease of serum Ibuprofen during a meal.For the ease of calcium and increase in serum uric acid swallowing or adjusting of doses the tablets can values be divided in equal halves. - Damage of the kidney tissue If you are an adult and your condition has Very rare: worsened or has not improved within 3 days in - Unpleasant awareness of heart beat, heart migraine headache or fever and within 4 days in failure, or heart attack pain and period, you should contact a doctor. - Disorders of blood cell formation If a child or adolescent requires this medicine (anaemia, leucopenia, thrombocytopenia, for more than 3 days, or if symptoms worsen, a pancytopenia, agranulocytosis, neutropenia) doctor should be consulted. The first symptoms or signs may include Use in children fever, sore throat, surface mouth ulcers, flu- Ibuprofen should not be given to children like symptoms, severe fatigue, nasal and younger than 12 years. skin bleeding) - Ringing or buzzing in the ears Elderly - Inflammation of the oesophagus or If you are elderly you should always consult pancreas your doctor before using ibuprofen since you - Narrowing of the bowel will be more prone to side effects, especially - Acute inflammation of the liver, yellowish bleeding, ulceration and perforation in the discolouration of the skin or whites of digestive tract, which may be fatal. Your doctor the eyes, liver dysfunction, liver damage will advise you accordingly. especially in long-term use or liver failure Reduced kidney or liver function - Hair loss If you suffer from reduced kidney or liver - Inflammation of the brain membrane without function, always consult your doctor before bacterial infection (aseptic meningitis) using Ibuprofen. your doctor will advise you Not known: accordingly. - Tingling of the hands and feet If you take more Ibuprofen than you should - Anxiety If you have taken more ibuprofen than you - Impaired hearing should, or if children have taken this medicine - General feeling of being unwell by accident always contact a doctor or nearest - Inflammation of the optic nerve which may hospital to get an opinion of the risk and advice cause vision problems on action to be taken. - A severe skin reaction known as DRESS The symptoms can include nausea, stomach syndrome can occur. Symptoms of DRESS pain, vomiting (may be blood streaked), or include: skin rash, fever, swelling of lymph more rarely diarrhoea. In addition, headache, nodes and an increase of eosinophils (a gastrointestinal bleeding, blurred vision, ringing type of white blood cells). in the ears, confusion and shaky eye movement - A red, scaly widespread rash with bumps and exacerbation of asthma in asthmatics. under the skin and blisters mainly localized At high doses, drowsiness, excitation, on the skin folds, trunk, and upper disorientation, chest pain, palpitations, loss of extremities accompanied by fever at the consciousness, convulsions (mainly in children), initiation of treatment (acute generalised vertigo, weakness and dizziness, blood in urine, exanthematous pustulosis). Stop using low blood pressure, hyperkalaemia, metabolic Ibuprofen tablets if you develop these acidosis, increased prothrombin time/INR, symptoms and seek medical attention acute renal failure, liver damage, respiratory immediately. See also section 2. depression, cyanosis, cold body feeling, and Ibuprofen may cause a reduction in the number breathing problems have been reported. of white blood cells and your resistance to If you forget to take Ibuprofen infection may be decreased. If you experience Do not take a double dose to make up an infection with symptoms such as fever and for a forgotten dose. serious deterioration of your general condition, If you have any further questions on the or fever with local infection symptoms such as use of this medicine, ask your doctor or sore throat/pharynx/mouth or urinary problems pharmacist. you should see your doctor immediately. A blood test will be taken to check possible 4. Possible side effects reduction of white blood cells (agranulocytosis). It is important to inform your doctor about your Like all medicines, this medicine medicine. can cause side effects, although not everybody gets them. Reporting of side effects If you get any side effects, talk to your doctor With regard to the following side effects, it must or pharmacist. This includes any possible side be considered that they are largely dependent effects not listed in this leaflet. You can also on the dose and that they vary from patient to report side effects directly via the national patient. reporting system listed in Yellow Card Scheme The most commonly observed side effects Website: www.mhra.gov.uk/yellowcard or are gastrointestinal in nature. Peptic ulcers, search for MHRA Yellow Card in the Google perforation or gastrointestinal bleeding, Play or Apple App Store. By reporting side sometimes fatal, particularly in the elderly, may effects you can help provide more information occur. Nausea, vomiting, diarrhoea, flatulence, on the safety of this medicine. constipation, indigestion, abdominal pain, melaena, heamatemesis, ulcerative stomatits, 5. How to store Ibuprofen exacerbation of colitis and Crohn’s disease Keep this medicine out of the sight and reach of have been reported following administration. children. Less frequently, inflammation of the stomach lining (gastritis) has been observed. Do not use this medicine after the expiry date Medicines such as Ibuprofen may be which is stated on the carton after EXP. The associated with a small increased risk of heart expiry date refers to the last day of that month. attack (myocardial infraction) or stroke. Water This medicine does not require any special retention (oedema), high blood pressure and storage conditions. heart failure have been reported in association Do not throw away any medicines via with NSAIDs. wastewater or household waste. Ask your The list of the following side effects comprises pharmacist how to throw away medicines you all side effects that have become known under no longer use. These measures will help protect treatment with ibuprofen, also those under high- the environment. dose long-term therapy in rheumatism patients. The stated frequencies, which extend beyond 6. Contents of the pack and other very rare reports, refer to the short-term use information of daily doses up to a maximum of 1,200 mg What Ibuprofen contains ibuprofen for oral dosage forms and a maximum - The active substances isIbuprofen. of 1,800 mg for suppositories. Each film-coated tablet contains 200 mg The side effects are stated according to the ibuprofen. frequency they occur. The following convention Each film-coated tablet contains 400 mg has been used: ibuprofen. Very common: may affect more than 1 in 10 people - The other ingredients are: Common: may affect up to 1 in 10 people Tablet core: Maize starch, starch, Uncommon: may affect up to 1 in 100 people pregelatinised (maize starch), silica, Rare: may affect up to 1 in 1,000 people colloidal anhydrous, croscarmellose sodium, Very rare: may affect up to 1 in 10,000 people talc, stearic acid. Not known: frequency cannot be estimated from Film coating: Talc (E553b), polyvinyl the available data alcohol, macrogol 3350 (E1521), titanium dioxide (E171). The following side effects are important and What Ibuprofen looks like and contents of will require immediate action if you experience the pack them. You should stop taking Ibuprofen and Film-coated tablet. see your doctor immediately if the following symptoms occur: Ibuprofen 200 mg film-coated tablets White to off-white, round shaped (diameter is Common: 9.8 mm), film coated tablets with break line on - black tarry stools or blood-stained vomit one side and plain on the other side. The tablet (digestive tract ulcer with bleeding) can be divided into equal doses. Very rare: Ibuprofen 400 mg film-coated tablet - swelling of the face, tongue or throat (larynx) White to off-white, round shaped, film-coated which can cause great difficulty in breathing tablets with break line on one side and plain on (angioedema), rapid heartbeat, severe fall in the other side. The tablet can be divided into blood pressure or life threatening shock equal doses. - a sudden allergic reaction with shortness of breath, wheezing and drop of blood Ibuprofen film-coated tablets are available in pressure blister packs. - severe rash with blisters on the skin Pack sizes: especially on the legs, arms, hands and Blisters: feet which can also involve the face and lips 200 mg: 10, 20, 24, 56, 60 & 84 film-coated (erythema multiforme, Stevens-Johnson´s tablets. syndrome). This can get even more severe, 400 mg 10, 20, 24, 50, 56, 84 & 100 film- the blisters get larger and spread out and : parts of the skin may slough off (Lyell´s coated tablets. syndrome). There may also be severe Not all pack sizes may be marketed. infection with destruction (necrosis) of Marketing Authorisation Holder and skin, subcutaneous tissue and muscle Manufacturer (necrotizing fasciitis). Milpharm Limited You should stop taking the medicine and Ares Block, Odyssey Business Park contact your doctor as soon as possible if you West End Road develop the following side effects: Ruislip HA4 6QD Very common: United Kingdom - heartburn, abdominal pain, indigestion or Uncommon: Generis Farmacêutica, S.A. - visual disturbances Rua João de Deus, 19, Amadora - hypersensitivity reactions such as hives, 2700-487, Portugal itching, purpura, exanthema, asthma attacks (sometimes with low blood pressure) This leaflet was last revised in 06/2020. P15XXXXX