Download the Inflanor Max 400mg leaflet.pdf Product description Package leaflet: information for the patient Inflanor Max, 400 mg, coated tablets Ibuprofen Read this leaflet carefully before taking this medicine because it contains important information for you. Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. - Keep this leaflet. You may need to read it again. - If you need advice or further information, please ask your pharmacist. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. - If you do not feel better or feel worse after 3 days in the case of fever or migraine headache or 5 days in the case of pain, contact your doctor. 1. What is Inflanor Max and what is it used for? Inflanor Max belongs to a group of medications called nonsteroidal anti-inflammatory drugs (NSAIDs). These medications have analgesic, antipyretic, and anti-inflammatory effects. Adults and adolescents (aged 12-18 years, from 40 kg body weight): Inflanor Max is used for short-term, symptomatic treatment of mild to moderate pain, such as: headache (including migraine headache), back pain and muscle and joint pain, toothache, painful menstruation. Inflanor Max is used for acute pain and fever associated with colds. Inflanor Max is recommended for use in adults and adolescents over 40 kg body weight (over 12 years of age). 2. Important information before taking Inflanor Max When not to take Inflanor Max - if you are hypersensitive to ibuprofen or any of the other ingredients of this medicine (listed in section 6). - if you have ever had hypersensitivity reactions such as asthma, runny nose, itchy skin rash or swelling of the lips, face, tongue or throat after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs. - if you have or have ever had recurrent ulcers or bleeding from the stomach or small intestine (duodenum) with two or more such episodes in the past. - if you have had gastrointestinal bleeding or perforation related to previous NSAID treatment. − if you have blood formation or blood clotting disorders. − if you have severe heart, liver or kidney failure. − if you are severely dehydrated (due to vomiting, diarrhea or insufficient fluid intake). − if you have any active bleeding (including in the brain). - if you are in the last 3 months of pregnancy (see section “Pregnancy, breast-feeding and fertility”). Warnings and precautions Talk to your doctor or pharmacist before taking Inflanor Max: − if you have kidney or liver problems. − if you have asthma. − if you have hay fever, nasal polyps or chronic, obstructive respiratory diseases, due to the increased risk of allergic reactions. - if you are also taking medicines that may increase the risk of ulceration or bleeding (see section Other medicines and Inflanor Max below). - if you have heart problems such as heart failure, angina (chest pain), have had a heart attack, bypass surgery, peripheral arterial disease (poor circulation in the arms, legs or feet due to narrow or blocked arteries) or any type of stroke (including mini-stroke or transient ischemic attack). − if you have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you smoke. - if you have systemic lupus erythematosus (immune system disorder) or mixed connective tissue disease (risk of aseptic meningitis). − if you have a stomach ulcer such as Crohns disease or ulcerative colitis. − if you have a problem with the normal blood clotting mechanism. − if the patient has recently undergone extensive surgery. − if you are in the first six months of pregnancy. - if you are breast-feeding (see section “Pregnancy, breast-feeding and fertility”). − if you have an infection - see Infections below. Elderly patients Elderly patients should be aware of the increased risk of adverse reactions, especially gastrointestinal bleeding and perforation, which may be fatal. Ulcers, perforation and bleeding in the stomach or intestines Bleeding, ulceration, or perforation of the stomach or intestines can occur without any warning symptoms, even in patients who have never had such problems before. This can be life-threatening. The risk of stomach or intestinal bleeding, ulceration, or perforation generally increases with high doses of ibuprofen. It is also greater in elderly people; for more information, see the Elderly section in the How to take Inflanor Max section. The risk is also increased if you take certain other medicines at the same time as ibuprofen (see the Other medicines and Inflanor Max section). Patients who have ever had stomach problems, especially the elderly, should be alert to any unusual stomach or intestinal symptoms and report them to their doctor immediately. Treatment should be discontinued if bleeding or ulceration in the gastrointestinal tract occurs during ibuprofen treatment. Effects on the heart and brain Taking anti-inflammatory and/or pain-relieving medicines such as ibuprofen may be associated with a small increased risk of heart attack or stroke, particularly when used in high doses. Do not exceed the recommended dose or duration of treatment. Any risk is more likely with high doses and long-term treatment. Skin reactions Serious skin reactions have been reported in association with ibuprofen. If you develop any skin rash, lesions on the mucous membranes, blisters, or other signs of allergy, stop taking Inflanor Max and seek immediate medical attention, as these may be the first signs of a very serious skin reaction. See section 4. Effect on the kidneys Ibuprofen can cause kidney problems, even in patients without previous kidney disease. This can cause leg swelling and even lead to heart failure or high blood pressure in predisposed individuals. Ibuprofen can cause kidney damage, especially in patients who already have kidney, heart, or liver disease, or who are taking diuretics or ACE inhibitors, and in the elderly. However, stopping ibuprofen usually leads to recovery. Infections Inflanor Max may mask symptoms of infection, such as fever and pain. Therefore, Inflanor Max may delay appropriate treatment of the infection, potentially increasing the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If you are taking this medicine while you have an infection and symptoms persist or worsen, consult your doctor immediately. Other warnings Long-term use of any painkiller for headaches can worsen its effects. If you experience frequent or daily headaches despite (or because of) the regular use of headache medication, consult your doctor before using another painkiller. Treatment should be discontinued if medication overuse headache (MOH) is diagnosed. Do not take Inflanor Max if you are planning a pregnancy. Consult your doctor first. See also the section Pregnancy, breast-feeding, and fertility. Children and youth Do not use Inflanor Max in children under 40 kg body weight (under 12 years of age). You should talk to your doctor before using this medicine if: − the child is seriously ill or has abdominal pain, a stiff neck or back pain. − the child has serious diseases of the ears, throat or trachea. If your child has a fever, you should consult a doctor if: − the child has not drunk any fluids or has lost a large amount of fluids due to persistent vomiting or diarrhea. − the treatment had no effect on pain or fever after the first day. − new symptoms or abdominal pain or stomach problems have become more severe or persist for a longer period of time. Inflanor Max and other medicines Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Inflanor Max may affect the way other medicines work, or other medicines may affect the way Inflanor Max works. For example: - medicines with anticoagulant effects (such as blood thinners/prevention of clots, such as acetylsalicylic acid, warfarin, ticlopidine). - medicines that lower blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol-containing medicines, angiotensin II receptor antagonists such as losartan). - other NSAIDs or acetylsalicylic acid, as these medicines may increase the risk of peptic ulcers or gastrointestinal bleeding. − methotrexate (used to treat cancer and autoimmune diseases) because ibuprofen may increase the effect of this medicine. − digoxin (used to treat various heart conditions), because the effect of digoxin may be enhanced. - phenytoin (used to prevent seizures), as ibuprofen may increase the effects of this medicine. − lithium (used to treat depression and mania), as ibuprofen may increase the effects of this medicine. − potassium-sparing diuretics, as this may lead to hyperkalaemia (increased potassium levels in the blood). − cholestyramine (used to treat high cholesterol), as the effect of ibuprofen may be reduced. The drugs should be administered at least one hour apart. − aminoglycosides (drugs against certain types of bacteria), because ibuprofen may reduce the elimination of aminoglycosides, their concomitant use may increase the risk of toxicity. - SSRIs (antidepressants) such as paroxetine, sertraline, citalopram, as they may increase the risk of gastrointestinal bleeding. − moclobemide (RIMA - a drug used to treat depression or social phobia), as the effect of ibuprofen may be enhanced. - cyclosporine, tacrolimus (to suppress immunity after organ transplantation), as kidney damage may occur. - zidovudine (used to treat HIV-infected patients) since the use of this medicine may result in an increased risk of bleeding into a joint or bleeding that leads to swelling in HIV-positive haemophilia patients. - ritonavir (used to treat HIV-infected patients) because ritonavir may increase the levels of ibuprofen. − mifepristone, because ibuprofen may reduce the effect of this medicine. - probenecid or sulfinpyrazone (for the treatment of gout), as the excretion of ibuprofen may be delayed. − quinolone antibiotics, as there may be an increased risk of seizures. − sulfonylureas (for the treatment of type 2 diabetes), as the effect of these drugs may be enhanced. − corticosteroids (used for inflammation), as these drugs may increase the risk of gastrointestinal ulcers or bleeding. - bisphosphonates (used for osteoporosis, Pagets disease and to reduce high calcium levels in the blood) as they may increase the risk of ulcers or bleeding. − oxpentifylline (pentoxifylline) (used to treat circulatory diseases in the arteries of the legs or arms), as it may increase the risk of peptic ulcers or bleeding. − baclofen (a muscle relaxant), because the toxicity of baclofen may be increased. - CYP2C9 inhibitors, since concomitant administration of ibuprofen with CYP2C9 inhibitors (voriconazole, fluconazole) may increase the exposure to ibuprofen (CYP2C9 substrate). Inflanor Max with food, drink and alcohol If you have a sensitive stomach, it is recommended to take this medicine with food. Alcohol should be avoided as it may increase the side effects of this medicine, especially those affecting the stomach, intestines or brain. Pregnancy, breastfeeding and fertility If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Pregnancy Do not use Inflanor Max during the last three months of pregnancy, as it may harm your unborn baby or cause problems during delivery. It may cause kidney and heart problems in your unborn baby. It may increase your and your babys bleeding tendency and cause a delay or prolongation of labor. Do not use Inflanor Max during the first six months of pregnancy unless your doctor considers it absolutely necessary. If treatment is necessary during this period or while trying to conceive, use the lowest possible dose for the shortest possible time. From the 20th week of pregnancy, Inflanor Max may cause kidney problems in your unborn baby if taken for more than a few days. This could lead to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of the blood vessel (ductus arteriosus) in the babys heart. If treatment is required for more than a few days, your doctor may recommend additional monitoring. Breast-feeding Ibuprofen passes into breast milk, but is unlikely to affect the breastfed infant when used for short-term treatment. However, if longer-term treatment is recommended, early discontinuation of breastfeeding should be considered. Fertility Inflanor Max may make it more difficult to become pregnant. Tell your doctor if you plan to become pregnant or if you have problems getting pregnant. This medication belongs to a group of drugs (NSAIDs) that may impair female fertility. This effect is reversible upon discontinuation of the medication. Driving and operating machinery Ibuprofen generally has no effect on the ability to drive or use machines. However, because side effects caused by high doses can occur, such as fatigue and dizziness, the ability to drive or operate machinery may be impaired. This is especially important if you consume alcohol concomitantly. Inflanor Max contains sodium This medicine contains less than 1 mmol sodium (23 mg) per tablet, i.e. it is essentially sodium-free. 3. How to take Inflanor Max Always use this medicine exactly as described in the package leaflet or as directed by your doctor or pharmacist. If you have any questions, ask your doctor or pharmacist. How to take Inflanor Max Swallow the tablet with a glass of water. Do not crush, chew, or suck the tablet to avoid irritating your stomach or throat. If you have a sensitive stomach, it is recommended to take this medicine with food. How much to take Inflanor Max The lowest effective dose should be used for the shortest time necessary to relieve your symptoms. If you have an infection, contact your doctor immediately if symptoms (such as fever and pain) persist or worsen (see section 2). Adults: If you do not feel better or if you feel worse after 3 days in the case of fever or migraine headache or after 5 days in the case of pain, you should consult a doctor. Children and adolescents: If this medicine is required for more than 3 days, or if symptoms worsen, consult a doctor. The dose of ibuprofen in children and adolescents depends on the patients age and weight. Do not use Inflanor Max in adolescents weighing less than 40 kg or younger than 12 years of age. Higher doses than recommended may pose a serious risk. Do not use different types of pain relievers at the same time without consulting your doctor. Mild to moderate pain and severe pain and fever associated with a cold For pediatric doses, Inflanor 200 mg should be used. Adults and adolescents weighing 40 kg or more (over 12 years of age): Maximum daily dose: 1200 mg. The dose should be taken as follows: 400 mg tablets: One tablet taken as a single dose or up to three times daily. Leave at least 4 to 6 hours between doses. The maximum daily dose should not exceed three tablets. A single dose greater than 400 mg does not provide better pain relief. Migraine headache Adults and adolescents weighing 40 kg or more (over 12 years of age): Maximum daily dose: 1200 mg. The dose should be taken as follows: One 400 mg tablet taken as needed, 1 to 3 times daily. Leave at least 4 to 6 hours between doses. A single dose greater than 400 mg does not provide better pain relief. Menstrual pain Adults and adolescents weighing 40 kg or more (over 12 years of age): Maximum daily dose: 1200 mg. The dose should be taken as follows: One 400 mg tablet at the first symptoms of menstruation, 1 to 3 times daily. Leave at least 4 to 6 hours between doses. A single dose greater than 400 mg does not provide better pain relief. Elderly people If you are elderly, you should always consult your doctor before taking Inflanor Max. If you are elderly, you will be more susceptible to side effects, especially gastrointestinal bleeding and perforation, which can be fatal. Your doctor will advise you accordingly. Liver or kidney dysfunction If you have kidney or liver problems, always consult your doctor before using Inflanor Max. Taking more Inflanor Max than recommended If you have taken a larger dose of Inflanor Max than recommended, or if a child has accidentally taken the medicine, always contact your doctor or go to the nearest hospital to get an opinion on the possible risk to your health and advice on the actions to be taken in such a case. Symptoms may include nausea, stomach pain, vomiting (may be blood streaked), headache, ringing in the ears, confusion, and nystagmus. Loss of consciousness, seizures (mainly in children), slow heart rate, weakness and dizziness (low blood pressure), blood in the urine, feeling cold, and difficulty breathing have been reported after taking large doses. If you forget to take Inflanor Max Do not take a double dose to make up for a missed 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, this medicine can cause side effects, although not everybody gets them. Side effects are more likely with high doses and long-term treatment. Stop taking Inflanor Max and contact your doctor immediately if you experience any of the following side effects: − Angioedema (may affect up to 1 in 10,000 people) with symptoms such as: • swelling of the face, tongue or throat • difficulty swallowing • rash and difficulty breathing. − Black, tarry stools or vomit containing blood (may affect up to 1 in 10 people). - Severe skin and mucous membrane lesions, such as epidermal necrolysis and/or erythema multiforme (very rare side effect). In addition, a severe skin reaction known as DRESS syndrome may occur. Symptoms of DRESS syndrome include skin rash, fever, swollen lymph nodes, and an increase in eosinophils (a type of white blood cell). Frequency not known (frequency cannot be estimated from the available data). − Red, scaly rash with bumps under the skin and blisters, mostly located in the skin folds, on the trunk and upper limbs, accompanied by fever at the initiation of treatment (acute generalized exanthematous pustulosis). Frequency unknown (frequency cannot be estimated from the available data). − Blurred vision or other eye problems such as sensitivity to light, vision loss (may affect up to 1 in 1,000 people). Other side effects that may occur are listed below in groups according to their frequency: Very common (may affect more than 1 in 10 people): − Heartburn, stomach pain, indigestion. − Digestive disorders such as diarrhea, malaise, vomiting, wind, constipation. Common (may affect up to 1 in 10 people): − Gastrointestinal ulcer with or without perforation. − Inflammation of the intestine and exacerbation of inflammation of the large intestine (colitis) and the digestive tract (Crohns disease) and complications of diverticula of the large intestine (perforation or fistula). − Microscopic intestinal bleeding that may cause anemia. − Ulcers and inflammation of the oral cavity. − Headache, drowsiness, vertigo, fatigue, agitation, insomnia and irritability. Uncommon (may affect up to 1 in 100 people): − Inflammation of the gastric mucosa. − Kidney diseases, including the development of edema, nephritis and kidney failure. − Runny nose, asthma. − Rash, increased skin sensitivity to the sun. − Hypersensitivity reaction such as hives, itching. Rare (may affect up to 1 in 1,000 patients): − Depression, confusion, hallucinations. − Lupus erythematosus syndrome. - Increased blood urea nitrogen and other liver enzymes, decreased hemoglobin and hematocrit values, inhibition of platelet aggregation and prolonged bleeding time, decreased serum calcium levels and increased serum uric acid levels. Very rare (may affect up to 1 in 10,000 patients): − Unpleasant feeling of heartbeat, heart failure or heart attack or high blood pressure. - Blood cell formation disorders (with symptoms such as fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe fatigue, nose and skin bleeding). − Ringing or buzzing in the ears. − Inflammation of the esophagus or pancreas. − Intestinal stenosis. − Liver damage causing yellowish discoloration of the skin or whites of the eyes and fluid retention in the body. − Inflammation of the brain membrane (without bacterial infection). − Kidney tissue damage. − Baldness. − Psychotic reactions. − Inflammation of blood vessels. − Ibuprofen may mask the symptoms of an infection, worsen the infection, or cause complications of the infection. If you are taking this medicine while you have an infection and symptoms persist or worsen, consult your doctor immediately. Frequency unknown (frequency cannot be estimated from the available data): - Tingling in hands and feet. - Anxiety. - Impaired hearing. − General malaise. − Inflammation of the optic nerve, which may cause visual disturbances. − Low neutrophil count (a type of white blood cell). Taking medicines like Inflanor Max may slightly increase your risk of heart attack or stroke. Fluid retention (edema), high blood pressure, and heart failure have been reported in association with NSAID use. Inflanor Max may cause a decrease in white blood cells, and resistance to infection may be reduced. If you experience an infection with symptoms such as fever and a serious deterioration of your general condition, or fever with symptoms of a local infection, such as a sore throat or mouth, or difficulty urinating, you should see a doctor immediately. A blood test will be performed to check for a possible decrease in white blood cells (agranulocytosis). It is important to inform your doctor about your treatment. A few cases of meningitis (symptoms include stiff neck, headache, nausea, vomiting, fever or disorientation) have been observed during treatment with ibuprofen in patients with existing autoimmune disorders such as systemic lupus erythematosus or mixed connective tissue disease. Reporting adverse reactions If you experience any side effects, including any side effects not listed in this leaflet, talk to your doctor or pharmacist. You can report side effects directly to the Department of Monitoring Adverse Reactions of Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309, website: https://smz.ezdrowie.gov.pl You can also report side effects to the Marketing Authorisation Holder (MAH) or the MAHs representative in Poland. By reporting side effects, you can help gather more information on the safety of this medicine. 5. How to store Inflanor Max Keep the medicine out of the sight and reach of children. Store below 25°C. Store in the original packaging to protect from moisture. Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. Doing so will help protect the environment. 6. Package contents and other information What does Inflanor Max contain? The active substance of the drug is ibuprofen. Each tablet of Inflanor Max contains 400 mg of ibuprofen. The other ingredients are: Tablet core: microcrystalline cellulose, croscarmellose sodium, hypromellose 2910/5, stearic acid, colloidal anhydrous silica, magnesium stearate. Tablet coating: hypromellose 2910/5, macrogol 300, talc, titanium dioxide (E 171). What does Inflanor Max look like and what does the package contain? White to almost white, round, film-coated tablets, 12 mm in diameter. The tablets are packed in PVC/Aluminum blisters. Package sizes: 10, 12, 20, 24, 30, 36, 40, 48, 50, 100, 250 film-coated tablets Not all pack sizes may be marketed. Responsible entity Zentiva, Fr., U kabelovny 130 Dolní Měcholupy 102 37 Prague 10 Czech Republic Manufacturer Zentiva, Fr., U kabelovny 130 Dolní Měcholupy 102 37 Prague 10 Czech Republic SC Zentiva SA B flat major Theodor Pallady no. 50, sector 3, 032266 Bucharest Romania This medicinal product is authorised in the member states of the European Economic Area under the following names: Austria, Estonia, Lithuania, Latvia, Czech Republic, Slovakia - Ibuprofen Zentiva Bulgaria - Zentidol Finland, Iceland, Sweden - Ibetin Spain - Ibuprofeno Zentiva Poland - Inflanor Max Romania - Inflanor For more detailed information about the medicine, please contact the representative of the marketing authorisation holder in Poland: Zentiva Polska Sp. z o. o. Bonifraterska Street 17 00-203 Warsaw phone: +48 22 375 92 00 Important information about the drug This is a medicine. For safety, use it according to the package leaflet. Do not exceed the maximum dose. If in doubt, consult your doctor or pharmacist.