Aspirin complex 500 mg/30 mg granules for oral suspension 10x

Water-soluble granules that provide a combined solution for colds and flu-like illnesses, as they contain a combination of active ingredients that treat nasal congestion in addition to fever and pain. Active ingredients: acetylsalicylic acid, pseudoephedrine hydrochloride Distributor: Bayer Hungária Kft., 1123 Budapest, Alkotás u. 50 Patient information: Information for the user Aspirin Complex 500 mg / 30 mg granules for oral suspension acetylsalicylic acid and pseudoephedrine hydrochloride Before you start using this medicine, read the following patient information carefully because it contains important information for you. Always use this medicine exactly as described in the patient information or as directed by your doctor or pharmacist. Keep the patient information. You may need to read it again. For further information or advice, ask your pharmacist. If you experience any side effects, talk to your doctor or pharmacist. This also applies to any possible side effects not listed in this patient information. See section 4. Be sure to tell your doctor if your symptoms do not improve within 3 days or get worse. Contents of the patient information: 1. What is Aspirin Complex 500 mg / 30 mg granules for oral suspension (hereinafter Aspirin Complex granules) and what is it used for? 2. Things to know before using Aspirin Complex granules 3. How to take Aspirin Complex granules? 4. Possible side effects 5. How to store Aspirin Complex granules? 6. Contents of the package and other information 1. What is Aspirin Complex granules and what is it used for? Aspirin Complex granules have analgesic, anti-inflammatory, antipyretic and decongestant effects. The white or yellowish granules contain two active ingredients: acetylsalicylic acid and pseudoephedrine hydrochloride. This medicine is used to relieve nasal congestion and pressure and tension in the face and forehead (rhinosinusitis) in colds and/or flu-like illnesses accompanied by pain and fever, and to relieve pain and fever. If only one of the listed symptoms occurs in your case, it is more advisable to take a medicine that contains only one of the active ingredients. See your doctor if your symptoms do not improve within 3 days or get worse. Aspirin Complex is for use in adults and adolescents aged 16 years and over. 2. Things to know before using Aspirin Complex granules Do not take Aspirin Complex granules: if you are allergic (hypersensitive) to acetylsalicylic acid, pseudoephedrine or any of the other ingredients of this medicine (listed in section 6); if you have previously had asthma that was triggered by taking salicylates or similar substances (non-steroidal anti-inflammatory drugs); if you have a stomach ulcer; if you have an increased tendency to bleed; if you are pregnant or breastfeeding; if you have kidney or liver failure; if you have severe heart failure; if you are taking 15 mg (or more) of methotrexate per week; if you have very high blood pressure or severe coronary artery disease; if you are also taking an antidepressant containing a monoamine oxidase inhibitor (MAO inhibitor) (or have taken one in the past two weeks). Warnings and precautions Talk to your doctor or pharmacist before taking Aspirin Complex granules: if you are allergic (hypersensitive) to other painkillers, antirheumatic or anti-inflammatory medicines; if you suffer from allergies (e.g. skin reactions, itching, hives), asthma, hay fever, nasal swelling (nasal polyps), or chronic respiratory disease; if you are also taking anticoagulant medicines (anticoagulants); if you have ever had a stomach ulcer or gastrointestinal bleeding; if you have kidney or liver damage; if you suffer from cardiovascular damage (for example, when your heart is not pumping blood properly into your body, hypovolemia, major surgery, blood poisoning or an event involving significant bleeding); if you are about to have surgery (including minor surgeries such as tooth extraction), as acetylsalicylic acid increases the risk of bleeding even in small doses; if you have an overactive thyroid gland, mild to moderately severe high blood pressure, diabetes, heart disease, increased eye pressure (glaucoma), an enlarged prostate, or are sensitive to certain active ingredients in cold and flu remedies, e.g. phenylephrine and ephedrine (sympathomimetic medicines); if you regularly take several different painkillers together (especially in the case of combinations of different painkillers). You are at risk of developing chronic kidney disease as a result; if you are prone to gout. In small doses, acetylsalicylic acid reduces the excretion of uric acid in the urine, which can cause a gout attack; if you have a deficiency of glucose-6-phosphate dehydrogenase (an inherited disease affecting red blood cells), as increased doses of acetylsalicylic acid can lead to hemolysis (destruction of red blood cells). If you experience a sudden onset of generalized blistering skin rash, stop using Aspirin Complex and see a doctor immediately. See section 4. During the use of Aspirin Complex, sudden abdominal pain or rectal bleeding may occur, which may be due to inflammation of the colon (ischemic colitis). If you experience these gastrointestinal symptoms, stop using Aspirin Complex and see a doctor immediately (see section 4). Ask your doctor or pharmacist if you are unsure whether you can use this medicine. Elderly: The elderly are particularly sensitive to pseudoephedrine and may experience sleep disturbances or hallucinations. Children and adolescents: There may be a link between acetylsalicylic acid and Reye's syndrome when given to children or adolescents. Reye's syndrome is very rare but can be fatal. Therefore, acetylsalicylic acid should not be given to children and adolescents under 16 years of age unless otherwise directed by a doctor. Other medicines and Aspirin Complex granules Always tell your doctor or pharmacist about all medicines you are taking, have recently taken or might take. The effects of the following medicines may change if taken together with Aspirin Complex granules. Please discuss with your doctor, as it may be necessary to change the dosage of the following medicines. Aspirin Complex granules may increase the effects of the following medicines: blood thinners and anticoagulants, e.g. ticlopidine; medicines containing cortisone or prednisolone taken by mouth or injected into the body; the concentration of digoxin (a medicine used to treat heart failure or irregular heartbeat) in the blood increases; anti-inflammatory and painkillers (non-steroidal painkillers/anti-inflammatories). blood sugar lowering medicines (antidiabetics); methotrexate (a medicine used for epilepsy); antidepressants, including MAO inhibitors; salbutamol tablets, which can cause rapid and irregular heartbeat. There is no objection to using an inhaler instead (at the prescribed dose); other medicines containing phenylephrine and ephedrine or other sympathomimetic substances found in other nasal decongestants (e.g. nasal drops). Aspirin Complex granules may reduce the effects of the following medicines: medicines used to remove excess water from the body and increase the amount of urine (aldosterone antagonists and loop diuretics); medicines to lower blood pressure (antihypertensives, e.g. guanethidine, methyldopa, beta-blockers); medicines for the treatment of gout, which promote the excretion of uric acid in the urine (e.g. probenecid, sulfinpyrazone). Taking Aspirin Complex granules with food, drink and alcohol The product can be taken with or without food. However, the granules should be sprinkled into a glass of water and stirred well before taking. Drinking alcohol while taking acetylsalicylic acid can increase the risk of gastrointestinal bleeding and impair responsiveness. Pregnancy, breastfeeding and fertility As there is no experience with the combination of the two active ingredients in Aspirin Complex granules, the product should not be used during pregnancy or breastfeeding. If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. The product belongs to a group of non-steroidal anti-inflammatory drugs that can potentially reduce fertility in women. This process is reversible by stopping the medicine. Effects of the product on the ability to drive and use machines Treatment with this product may impair responsiveness. The risk may be further increased if alcohol is consumed at the same time. This should be taken into account in cases where increased attention is required, e.g. when driving. Aspirin Complex granules contain sucrose and benzyl alcohol This medicine contains 2 g of sucrose (sugar) per sachet (equivalent to 0.17 bread units). This should be taken into account in patients with diabetes. If you have been told by your doctor that you have an intolerance to certain sugars, contact your doctor before taking this medicine. This medicine contains 3.78 mg benzyl alcohol per sachet. Benzyl alcohol can cause allergic reactions. Ask your doctor or pharmacist for advice if you have liver or kidney disease. This is because benzyl alcohol used in large amounts can accumulate in your body and cause side effects (so-called metabolic acidosis). 3. How to take Aspirin Complex granules? Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure about the dosage. Unless otherwise prescribed by your doctor, the recommended dosage for adults and adolescents aged 16 years and over is shown in the following table: Age Single dose Total daily dose Adults and adolescents 1-2 sachets Maximum 6 sachets If necessary, the individual doses can be taken at intervals of 4-8 hours. The total daily dose should not exceed 6 sachets. Sprinkle the contents of one or two sachets of Aspirin Complex granules into a glass of water and stir well. The resulting suspension has an orange flavor. Drink the whole thing immediately. Note: the granules do not dissolve completely. Do not take the medicine for more than 3 days unless otherwise directed by your doctor. Use in children and adolescents Aspirin Complex is for use in adults and adolescents aged 16 years and over. Aspirin Complex granules should not be given to children or adolescents under 16 years of age unless otherwise directed by a doctor. Due to the limited experience, no dosage recommendations can be given for children and adolescents. If you take more Aspirin Complex granules than you should In case of overdose, the following symptoms may occur: headache, dizziness, seizures, nausea, tinnitus, rapid heartbeat (tachycardia), chest pain, restlessness or shortness of breath. If an overdose is suspected, seek medical attention immediately. 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. Frequency: unknown: frequency cannot be estimated from the available data Possible side effects of acetylsalicylic acid: These are all very serious side effects that may require urgent medical attention or hospitalization. See your doctor or go to the nearest hospital immediately if you notice any of the following: stomach ulcer, which in isolated cases can lead to perforation of the stomach; gastrointestinal bleeding, which in isolated cases can lead to iron deficiency anemia. Signs of gastrointestinal bleeding: black stools, vomiting blood; allergic reactions (e.g. difficulty breathing, skin reactions, possibly with a drop in blood pressure), especially in asthmatic patients; hemolysis (destruction of red blood cells) in severe cases of G6PD (glucose-6-phosphate dehydrogenase) deficiency; kidney damage, kidney failure. These are all serious side effects that may require immediate medical attention. See your doctor if you notice any of the following: increased bleeding tendency; gastrointestinal disorders such as stomach pain, indigestion and inflammation of the stomach lining; elevated liver enzymes (proteins); dizziness, tinnitus (ringing in the ears). These are all mild side effects: nausea, vomiting, diarrhea. Possible side effects of pseudoephedrine: These are all serious side effects that may require immediate medical attention. See your doctor if you notice any of the following: effects on the heart (e.g. rapid or irregular heartbeat); difficulty urinating, especially in patients with an enlarged prostate; increased blood pressure, although this does not occur if high blood pressure is being treated; insomnia, rarely hallucinations and other effects that stimulate the central nervous system; effects on the skin (e.g. rash, hives, itching); Sudden onset of fever, redness of the skin or multiple, small, pus-filled skin rashes (possible symptoms of acute generalized exanthematous pustulosis) may appear within the first two days of Aspirin Complex treatment. See section 2. Stop taking Aspirin Complex if you experience these symptoms and see your doctor or seek medical help immediately. Inflammation of the colon (ischemic colitis) due to impaired blood supply If any of the above side effects occur, stop taking the medicine! See your doctor so that your doctor can assess the severity of the reaction and decide if any other intervention is necessary. Reporting of side effects If you experience any side effects, talk to your doctor or pharmacist. This also applies to any possible side effects not listed in this patient information. You can also report side effects directly to the authority via the contact details provided in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine. 5. How to store Aspirin Complex granules? Keep this medicine out of the reach of children! Do not use this medicine after the expiry date (EXP) stated on the carton and sachet. The expiry date refers to the last day of that month. Store at a maximum of 30 °C. Do not throw any medicines into wastewater or household waste. Ask your pharmacist what to do with any unused medicines. These measures will help protect the environment. 6. Contents of the package and other information What Aspirin Complex granules contain? The active ingredients (500 mg) acetylsalicylic acid and (30 mg) pseudoephedrine hydrochloride per sachet. Other ingredients: citric acid, sucrose, hypromellose, saccharin, orange flavor (which contains benzyl alcohol, acetic acid, alpha-tocopherol, modified starch (E1450) and maltodextrin). What Aspirin Complex granules look like and contents of the pack? White or yellowish granules for oral suspension. This product is marketed in packs of 10 or 20 sachets. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: Bayer Hungária Kft. 1123 Budapest, Alkotás u. 50. Hungary Manufacturer: Bayer Bitterfeld GmbH Ortsteil Greppin, Salegaster Chaussee 1., 06803 Bitterfeld-Wolfen Germany This medicine is authorised in the Member States of the European Economic Area under the following names: Although the product is registered in other Member States, it may not be marketed. Austria: ASPIRIN Complex Granulat zur Herstellung einer Suspension zum Einnehmen Bulgaria: Аспирин Комплекс 500 mg / 30 mg Гранули за перорална суспензия Cyprus Aspirin Complex Cold & Flu Greece Aspirin Complex Cold & Flu Croatia Asprin Complex 500 mg/30 mg granula za oralnu suspenziju Poland: Aspirin Complex Zatoki500 mg / 30 mg Granulat do sporządzania zawiesiny doustnej Hungary: Aspirin Complex 500 mg / 30 mg granulátum belsőleges szuszpenzióhoz Germany: ASPIRIN COMPLEX 500 mg / 30 mg Granulat zur Herstellung einer Suspension zum Einnehmen Italy “Aspirina influenza e naso chiuso” 500mg/30mg granulato per sospensione orale Portugal Asprina Complex 500 mg/30 mg granulado para suspensão oral Romania Aspirin Complex 500 mg/30 mg granule pentru suspensie orală Slovenia: Aspirin Complex 500 mg / 30 mg zrnca za peroralno suspenzijo Slovakia: ASPIRIN COMPLEX 500 mg / 30 mg Granulát na perorálnu suspenziu OGYI-T-20613/01 (10 db) OGYI-T-20613/02 (20 db) Date of last revision of the patient information: September 2019.