Nurofen Non-Aqua 200mg orally dispersible tablets 12x

Nurofen Non-Aqua 200mg orodispersible tablet is a fast-acting* pain reliever that can be taken without water and is suitable for teenagers with headaches. It contains ibuprofen, which is available without a prescription. - Pain relief - Can be taken without water - Fast absorption How to use: - The starting dose is 2 orodispersible tablets, followed by 1 or 2 orodispersible tablets every 4 hours as needed. - The maximum daily dose is 6 orodispersible tablets, which corresponds to 1200 mg of ibuprofen; do not take more than this! - Not suitable for children under 6 years of age. Marketed by: Reckitt Benckiser (Hungary) Kft. Patient information: Information for the user Nurofen Non-Aqua 200 mg orodispersible tablet ibuprofen Read all of this leaflet carefully before you start 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. · Ask your pharmacist if you need more information or advice. · 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. · You must talk to a doctor if you do not feel better or if you feel worse after 3 days. What is in this leaflet: 1. What Nurofen Non-Aqua 200 mg orodispersible tablet is and what it is used for 2. What you need to know before you take Nurofen Non-Aqua tablet 3. How to take Nurofen Non-Aqua tablet 4. Possible side effects 5. How to store Nurofen Non-Aqua tablet 6. Contents of the pack and other information 1. What Nurofen Non-Aqua tablet is and what it is used for The medicine reduces pain and fever, and relieves inflammation. It quickly and effectively reduces headaches, migraine headaches, menstrual pain, back pain, rheumatic and muscle pain, toothache, neuralgic pain, cold and flu symptoms. It is also an effective fever reducer. Ibuprofen belongs to the group of non-steroidal anti-inflammatory drugs, which can affect the body's chemical response to pain, inflammation and fever. 2. What you need to know before you take Nurofen Non-Aqua tablet Do not take Nurofen Non-Aqua tablet · if you are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6) · if you have experienced shortness of breath, skin rash, skin itching, runny nose, or asthma when taking salicylates or other non-steroidal anti-inflammatory drugs, or independently of taking these medicines · in case of a healed or currently existing peptic ulcer disease or other serious gastrointestinal disease (bleeding) · in case of severe liver, kidney and heart disease · children under 20 kg (under 6 years of age) · in the last 3 months of pregnancy. Warnings and precautions Talk to your doctor before taking Nurofen Non-Aqua tablet: - if you have or have had any gastrointestinal disease, - if you have or have had asthma, - if you have liver, heart, kidney problems, or high blood pressure, - if you have recently had major surgery, - if you have certain immunological diseases (SLE, i.e. systemic lupus erythematosus - a disease that affects the immune system, causing pain, skin lesions and other problems -, and mixed connective tissue disease), - if you are elderly, - if you suffer from phenylketonuria or phenylalanine sensitivity (the product contains aspartame, which corresponds to 14 mg of phenylalanine per tablet), - if you are taking other non-steroidal pain relievers or acetylsalicylic acid. - it is advisable to avoid using Nurofen Non-Aqua tablet during chickenpox (varicella). If the product needs to be used for more than 3 days, or if symptoms worsen, a doctor should be consulted. Very rarely, serious, potentially life-threatening blistering skin rashes, (Stevens-Johnson syndrome, toxic epidermal necrolysis) hypersensitivity reactions involving swelling of the face/tongue/throat (angioedema) have been reported in patients taking ibuprofen. Treatment should be discontinued at the first appearance of skin rash, mucosal lesions or any other sign of hypersensitivity. It can only be taken with caution in inflammatory diseases (Crohn's disease, ulcerative colitis), as the disease may flare up. Life-threatening ulceration, bleeding can occur at any time, even without warning symptoms. In case of gastrointestinal bleeding or ulceration, treatment should be discontinued. Anti-inflammatory/pain-relieving drugs similar to ibuprofen may slightly increase the risk of heart attack or stroke, especially when used in high doses. Do not exceed the recommended dose or duration of treatment. Always talk to your doctor or pharmacist before taking Nurofen Non-Aqua tablet if: - you have heart problems, such as heart failure, angina (chest pain), or if you have had a heart attack, bypass surgery, peripheral artery disease (poor circulation in the legs due to narrowing or blockage of the arteries), or any type of stroke (including "mini-stroke" or transient ischemic attack [TIA]). - you have high blood pressure, diabetes, high cholesterol, or a family history of heart disease or stroke, or if you smoke. Take only the lowest dose necessary for the shortest possible time, as this will reduce the chance of side effects. In case of long-term use, it is necessary to have the examinations recommended by the doctor performed. Do not take more than the recommended dose! Take only the lowest dose necessary for the shortest possible time, as this will reduce the chance of side effects. In case of long-term use, it is necessary to have the examinations recommended by the doctor performed. If you notice visual, hearing disturbances, signs of gastrointestinal bleeding or allergy, discontinue taking the medicine. Side effects are more common in the elderly. Similar to other anti-inflammatory drugs, Nurofen Non-Aqua tablet can mask the usual signs of inflammation. Children and adolescents Dehydrated (dehydrated, dehydrated) children and adolescents are at risk of kidney damage. Other medicines and Nurofen Non-Aqua tablet Always tell your doctor or pharmacist about all medicines the child or adult taking or using, or may take or use. Nurofen Non-Aqua tablet and certain other medicines can affect each other. Such medicines include: - anticoagulants (also known as blood thinners, blood clot prevention medicines, e.g. acetylsalicylic acid, warfarin, ticlopidine) - blood pressure lowering medicines (ACE inhibitors, e.g. captopril, beta-blockers, e.g. atenolol, angiotensin-II receptor antagonists, e.g. losartan) Nurofen Non-Aqua tablet treatment can also be affected by some other medicines, or it can affect them. Therefore, always ask your doctor or pharmacist for advice before taking Nurofen Non-Aqua tablet with other medicines. It is especially important to inform the doctor before taking the product if the child or adult taking the product is taking any of the following medicines: · other pain relievers, especially non-steroidal anti-inflammatory drugs, as well as acetylsalicylic acid, which can increase the risk of stomach ulcers and gastrointestinal bleeding · blood pressure lowering medicines, diuretics · anticoagulants · corticosteroids (for the treatment of allergies and inflammation) · antiplatelet medicines · so-called selective serotonin reuptake inhibitors (SSRIs), which are antidepressants · preparations containing lithium (for depression), methotrexate (for cancer or certain arthritis), zidovudine (for HIV infection) · preparations containing digoxin, phenytoin · oral medicines for diabetes · mifepristone (for termination of pregnancy) · antibiotics belonging to the sulfonamide group · quinolone antibiotics · tacrolimus and ciclosporin (to prevent rejection after organ transplantation). Ibuprofen (the active ingredient in the product) enhances the effect of anticoagulant tablets and heparin. When used together with other non-steroidal anti-inflammatory drugs, corticosteroids, antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs), the risk of gastrointestinal complaints and bleeding increases. It affects the effect of diuretics. Reduces the effect of certain blood pressure lowering medicines and heart rhythm regulators. Enhances the effect of sulfonamides, oral medicines for diabetes, lithium, phenytoin, methotrexate, digoxin. Mifepristone should not be used for 8-12 days after taking it, as it may reduce the effects of mifepristone. As a precaution, it is recommended to check blood sugar levels when used together with sulfonylurea blood sugar lowering medicines. May increase the risk of epileptic seizures associated with quinolone antibiotics. When used together with tacrolimus, the risk of kidney damage increases. In HIV-positive hemophiliac patients treated with zidovudine, ibuprofen therapy increases the possibility of hemarthrosis and joint hemorrhage. Probenecid and sulfinpyrazone can delay the excretion of ibuprofen. Taking Nurofen Non-Aqua tablet with food and drink If the product is taken after a meal, the rate of absorption may decrease. Pregnancy, breastfeeding and fertility If you are pregnant or breastfeeding, or if you think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Pregnancy If you are pregnant, tell your doctor immediately. The product can only be used in the first and second trimester of pregnancy (the first six months of pregnancy) if approved by a doctor. The product should not be used in the third trimester of pregnancy (the last 3 months of pregnancy), as it can increase the risk of complications for both the mother and the child. Female fertility Nurofen Non-Aqua tablet belongs to a group of medicines that can reduce fertility. · Fertility returns to the original level when the product is discontinued. · It is unlikely to affect fertility if the product is used occasionally. · However, if you are planning to become pregnant, tell your doctor before using the product. Breast-feeding Ibuprofen (the active ingredient in the product) and its breakdown products are excreted into breast milk in low concentrations. Since no harmful effects on children have been known to date, it is not necessary to discontinue breastfeeding if the product is used for a short period of time and at the dose prescribed for pain and fever relief. The effects of the product on the ability to drive and use machines Nurofen Non-Aqua 200 mg orodispersible tablet, when used as recommended, does not affect the ability to drive and use machines. Nurofen Non-Aqua tablet contains aspartame Contains a source of phenylalanine. Phenylalanine is formed when the product is broken down (14 mg per tablet), so it can be harmful in phenylketonuria. 3. How to take Nurofen Non-Aqua tablet Always take this medicine exactly as described in this leaflet. Ask your doctor or pharmacist if you are not sure about the dose. For oral short-term use only. Unless otherwise prescribed by your doctor, the recommended dose for adults is: The starting dose is 2 orodispersible tablets, followed by 1 or 2 orodispersible tablets every 4 hours as needed. The maximum daily dose is 6 orodispersible tablets, which corresponds to 1200 mg of ibuprofen; do not take more than this! Use in children and adolescents Not suitable for children under 6 years of age. For children between 6 and 9 years of age (20-29 kg): The starting dose is 1 orodispersible tablet, followed by 1 orodispersible tablet every 8 hours as needed. The maximum daily dose is 3 orodispersible tablets, which corresponds to 600 mg of ibuprofen; do not take more than this! For children between 9 and 12 years of age (30-39 kg) and adolescents: The starting dose is 1 orodispersible tablet, followed by 1 orodispersible tablet every 6 hours as needed. The maximum daily dose is 4 orodispersible tablets, which corresponds to 800 mg of ibuprofen; do not take more than this! For children over 12 years of age (over 40 kg) and adolescents: The dosage is the same as for adults. Due to the dosage form of Nurofen Non-Aqua orodispersible tablet, it is recommended for children, adolescents and patients with swallowing difficulties. Taking the tablet: place the Nurofen Non-Aqua tablet on your tongue, wait for it to dissolve, then swallow. Water is not needed to take the product. If the product needs to be used for more than 3 days, or if symptoms worsen, a doctor should be consulted. If you take more Nurofen Non-Aqua tablets than you should If you have taken more tablets than the maximum daily dose: In this case, see a doctor immediately! Symptoms of overdose: nausea, vomiting, dizziness, low blood pressure, drowsiness, rarely loss of consciousness. If you forget to take Nurofen Non-Aqua tablet Do not take a double dose to make up for a forgotten dose. If you stop taking Nurofen Non-Aqua tablet too early Your symptoms may return. Follow the dosage above. 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. Stop taking the medicine and see a doctor immediately if you notice the following symptoms: swelling of the face, tongue and larynx, difficulty breathing, rapid heartbeat, drop in blood pressure. Side effects are listed according to the following frequency categories: Very common: affects more than 1 in 10 people. Common: affects 1 to 10 people in 100. Uncommon: affects 1 to 10 people in 1000. Rare: affects 1 to 10 people in 10,000. Very rare: Not known affects less than 1 in 10,000 people. the frequency cannot be estimated from the available data. The side effects of Nurofen Non-Aqua tablet may occur with the following frequency: Uncommon side effect: · abdominal pain, indigestion, nausea · headache · skin rashes · hypersensitivity reactions (hives, itching) Rare side effect: · diarrhea, flatulence, constipation, vomiting Very rare side effect: · blood formation disorders (increased bleeding, anemia, decreased white blood cell or platelet count), which can cause the following symptoms: nose and skin bleeding, high fever, sore throat, mouth ulcers, very pale skin, weakness. Decreased hemoglobin level · serious skin and soft tissue infectious complications during chickenpox (varicella) infection · severe hypersensitivity reactions, symptoms of which may include: asthma, difficulty breathing, wheezing, rapid heartbeat, drop in blood pressure, shock (the product can trigger bronchospasm in asthmatic patients sensitive to salicylates), swelling of the face, tongue, larynx, worsening of asthma · edema (dropsy), high blood pressure and heart failure · gastritis, gastrointestinal ulcer disease, gastrointestinal bleeding (symptoms of which may include black stools and vomiting blood), ulcerative stomatitis, worsening of existing gastrointestinal problems (ulcerative colitis, Crohn's disease) · liver function disorders, symptoms of which may include: yellowing of the skin and/or eyes, light-colored stools and dark urine · in some cases, in patients with certain autoimmune diseases (systemic lupus erythematosus, mixed connective tissue diseases) non-infectious meningitis (aseptic meningitis). Symptoms: stiff neck, headache, nausea, vomiting, fever, confusion · more severe skin reactions with exfoliation, such as toxic epidermal necrolysis and Stevens‑Johnson syndrome, an allergic disease characterized by severe, symmetrical, slightly reddish (erythematous), edematous, or blistering rashes on the skin and mucous membranes (erythema multiforme). Bacteria, viruses, fungi, certain medicines, irradiation (radiation) can trigger the disease. · kidney diseases, which can manifest as less or more urine, cloudy or bloody urine, back pain and/or dropsy (especially in the legs). In general, the constant use of pain relievers can lead to serious kidney problems in rare cases, the symptoms of which may include: more or less urine, cloudy urine, blood in the urine, back pain, edematous swelling (especially in the legs) Not known side effect: · respiratory symptoms: asthma and difficulty breathing Medicines similar to Nurofen Non-Aqua 200 mg orodispersible tablet may slightly increase the risk of heart attack ("myocardial infarction") or stroke (stroke) (see section 2). If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. 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 to the authority through the contact details listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine. 5. How to store Nurofen Non-Aqua tablet Keep this medicine out of the sight and reach of children. Store below 25°C. Do not use this medicine after the expiry date (Exp:) printed on the carton. The expiry date refers to the last day of that month. Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. 6. Contents of the pack and other information What Nurofen Non-Aqua tablet contains - The active ingredient of the product: 200 mg ibuprofen per orodispersible tablet. - Other ingredients: ethylcellulose, silicon dioxide, hypromellose 6cPS, mannitol, aspartame (15 mg), croscarmellose sodium, magnesium stearate, lemon flavor E9947900. What Nurofen Non-Aqua tablet looks like and contents of the pack White or almost white, round, with a notch in the center of both sides, lemon-scented tablet. 12 orodispersible tablets in opaque polyamide/aluminum/polyvinyl chloride//aluminum blister pack and box. Marketing Authorization Holder Reckitt Benckiser Healthcare International Ltd. 103-105 Bath Road, Slough, Berkshire SL1 3UH United Kingdom Manufacturer Reckitt Benckiser Healthcare International Ltd. Nottingham Site, Thane Road, Nottingham, NG90 2DB United Kingdom For any further information about this product, please contact the local representative of the marketing authorization holder: Reckitt Benckiser Kft. 1113 Budapest, Bocskai út 134-146. Tel: 06 1 880‑1870 Fax: 06 1 250‑8398 E-mail: gyogyszer@reckittbenckiser.com OGYI-T-6793/84 Date of last revision of the leaflet: September 2016