PACKAGE LEAFLET: INFORMATION FOR THE USER <invented name> 500 mg / 30 mg granules for oral suspension Acetylsalicylic acid / pseudoephedrine hydrochloride 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 have 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 <invented name> is and what it is used for 2. What you need to know before you take <invented name> 3. How to take <invented name> 4. Possible side effects 5. How to store <invented name> 6. Contents of the pack and other information 1. WHAT <INVENTED NAME> IS AND WHAT IT IS USED FOR <invented name> has pain-relieving, anti-inflammatory, fever-reducing and nasal decongestant properties. <invented name> contains two active substances: acetylsalicylic acid and pseudoephedrine hydrochloride. <invented name> is used for the symptomatic treatment of nasal congestion and cold-related pain and fever. If you have only one of the symptoms mentioned above it may be more appropriate to take a medicine that contains only one of the active substances. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE <INVENTED NAME> Do not take <invented name> if you: are allergic to acetylsalicylic acid or to salicylates, to pseudoephedrine or to any of the other ingredients of this medicine (listed in section 6). suffer from stomach ulcers. have an increased tendency to bleed. are pregnant or breast feeding. have liver or kidney failure. have severe, unstable heart failure. are also taking 15 mg (or more) of methotrexate per week. have very high blood pressure or severe coronary artery disease. are also taking an antidepressant medicinal product containing a monoamine oxidase (MAO) inhibitor. Page 1 of 5
Warnings and precautions Talk to your doctor or pharmacist before taking <invented name>. if you: are allergic (hypersensitive) to other analgesics, anti-rheumatics or anti-inflammatory medicines. suffer from allergies (e.g. with rash, itching, nettle rash), asthma, hay fever, swelling of the mucous membrane of the nose (nasal polyps) or long-standing lung diseases. have a history of stomach ulcers or gastrointestinal bleeding. are also taking medicines to thin the blood and to prevent its clotting (anticoagulants). are about to have surgery (including minor operations such as tooth extractions). have impaired kidney and liver function. suffer from an overactive thyroid, mild to moderate hypertension, diabetes mellitus, heart diseases, increased pressure in the eye, an enlarged prostate gland, or sensitivity to some ingredients in cough/cold medicines e.g. phenylephrine and ephedrine (sympathomimetic substances). are prone to having gout. At low doses acetylsalicylic acid reduces the excretion of uric acid in urine, which may cause a gout attack. take a number of painkillers together. You are at risk of permanent kidney disease. Athletes must be aware that this medicinal product may cause a positive reaction to anti-doping tests. Use in elderly Elderly patients may be particularly sensitive to pseudoephedrine and may experience sleeplessness or sense things that are not real (hallucinations). Use in children There is a possible association between acetylsalicylic acid and Reye s syndrome when given to children. Reye s syndrome is a very rare disease, which can be fatal. For this reason acetylsalicylic acid should not be given to children and adolescents aged under 16 years, unless on the advice of a doctor. Other medicines and <invented name> Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. The action of the following medicines may be affected if taken together with <invented name>. <invented name> may increase the effectiveness of: medicinal products that thin the blood and help to prevent its clotting, e.g. ticlopidine. medicinal products such as cortisone or prednisolone, when taken by mouth or being injected. digoxin (to treat heart failure or irregular heart beat) by increasing the amount of digoxin that is in your blood. anti-inflammatory and analgesic medicines (non-steroidal analgesics / anti-inflammatory medicines). medicinal products to lower blood sugar (antidiabetics). methotrexate (possibly causing more side effects). valproic acid (medicine for treating epilepsy). salbutamol tablets which may cause your heart to beat irregularly or faster. This should not stop you using an inhaler (containing an aerosol bronchodilator of the adrenergic stimulant type, at the prescribed dose) instead. antidepressants including MAO-inhibitors. other medicinal products containing phenylephrine and ephedrine or other sympathomimetic substances such as those included in nasal decongestants e.g. nose drops. <invented name> may reduce the effectiveness of: medicinal products that treat water retention (aldosterone antagonists and loop diuretics). medicinal products that lower blood pressure (antihypertensives such as guanethidine, methyldopa, -blockers). Page 2 of 5
medicinal products for the treatment of gout that promote excretion of uric acid in the urine (e.g. probenecid, sulphinpyrazone). <invented name> with food and alcohol It does not matter whether the product is taken with or without food. Drinking alcohol while taking acetylsalicylic acid can increase the risk of gastrointestinal bleeding, and impair your ability to react. Pregnancy, breast-feeding and fertiliy If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Pregnancy and breast-feeding Due to lack of experience with the combination of both drug substances in <invented name>, the product must not be used during pregnancy or if you are breast feeding. Ask your doctor or pharmacist for advice before taking any medicinal products. Fertility The product belongs to a group of medicines (NSAIDs) which may impair the fertility in women. This effect is reversible on stopping the intake of the medicinal product. Driving and using machines During treatment with <invented name>, your ability to react may be impaired. The risk may be further increased if you drink alcohol at the same time. This should be taken into consideration when increased attention is required, e.g. when driving. <invented name> contains sucrose This medicinal product contains 2 g of sucrose per sachet. This should be taken into account in patients with diabetes mellitus. If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicinal product. 3. HOW TO TAKE <INVENTED NAME> Always take this medicine exactly as discribed in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The recommended dose is Age Single dose Total daily dose Adults and adolescents (16 years and older) 1-2 sachets (corresponding to 500-1000 mg acetylsalicylic acid / 30-60 mg pseudoephedrine hydrochloride) up to 6 sachets (corresponding to 3000 mg acetylsalicylic acid / 180 mg pseudoephedrine hydrochloride) If necessary, single doses can be taken at intervals of 4 to 8 hours. The total daily dose should not exceed 6 sachets (corresponding to 3000 mg acetylsalicylic acid / 180 mg pseudoephedrine hydrochloride). <invented name> should not be given to children and adolescents under 16 years of age, unless on the advice of a doctor. Page 3 of 5
Due to limited experience a dosage recommendation for children and adolescents cannot be given. Oral use. Pour the contents of one or two sachets of <invented name> in a glass of hot, but not boiling water and stir well. The oral suspension should be cooled down to an adequate drinking temperature before use. The granules do not dissolve completely. Do not take this medicine for more than 3 days without talking to your doctor. If you take more <invented name> than you should In the event of overdose, headache, dizziness, convulsions, being sick, noises in the ears, a fast heartbeat (tachycardia), chest pain, agitation or shortness of breath may occur. If an overdose of this product is suspected, contact a doctor 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. Frequencies: not known: frequency cannot be estimated from the available data Possible side-effects of acetylsalicylic acid: These are all very serious side effects and you may need urgent medical attention or hospitalisation. Tell your doctor immediately or go to your nearest hospital if you notice any of the folllowing: gastrointestinal bleeding that may in isolated cases lead to iron deficiency anaemia. Signs of gastrointestinal bleeding are passing of black stools or vomiting blood. allergic reactions (such as difficulty in breathing, rash possibly with a fall in blood pressure), particularly in asthmatics. stomach ulcers that may in isolated cases lead to perforation. These are all serious side effects and you may need urgent medical attention. Tell your doctor if you notice any of the following: increase in the risk of bleeding. gastrointestinal discomfort such as stomach ache, indigestion and inflammation of the lining of the stomach. increase of liver proteins (enzymes). These are all mild, side effects: nausea, vomiting, diarrhoea. Possible side effects of pseudoephedrine: These are all serious side effects and you may need urgent medical attention. Tell your doctor if you notice any of the below: insomnia, rarely hallucinations and other central nervous system stimulation. cardiac effects (e.g. a fast heartbeat). increase in blood pressure, although not in controlled hypertension. effects on the skin (e.g. rash, nettle rash, itching). urinary retention, especially in patients with prostate hyperplasia. If you experience any of the above side-effects, stop taking the product. Let your doctor know so that Page 4 of 5
your doctor can assess the severity of the reaction and decide on any other necessary action. 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 via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine. 5. HOW TO STORE <INVENTED NAME> Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is printed on the carton and sachets. The expiry date refers to the last day of that month. This medicinal product does not require any special storage conditions. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment. 6. CONTENTS OF THE PACK AND OTHER INFORMATION What <invented name> contains The active substances are acetylsalicylic acid and pseudoephedrine hydrochloride. Each sachet contains 500 mg acetylsalicylic acid and 30 mg pseudoephedrine hydrochloride. The other ingredients are sucrose, hypromellose, sucralose, flavour vanilla and flavour peppermintmenthol-eucalyptus (contains menthol and cineole). What <invented name> looks like and contents of the pack White to yellowish granules for oral suspension. This product is available in packs containing 10 and 20 sachets. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer <to be completed nationally> Name of the product in other Member States Germany Austria Bulgaria Hungary Poland Romania Slovakia Aspirin Complex Heissgetränk 500 mg / 30 mg Granulat zur Herstellung einer Suspension zum Einnehmen Aspirin Complex Heissgetränk 500 mg / 30 mg Granulat zur Herstellung einer Suspension zum Einnehmen Аспирин Комплекс Топла Напитка 500 mg / 30 mg Гранули за перорална суспензия Aspirin Komplex Forró Ital 500 mg / 30 mg granulátum belsőleges szuszpenzióhoz Aspirin Complex Hot 500 mg / 30 mg Granulat do sporządzania zawiesiny doustnej Aspirin Complex Hot Drink 500 mg / 30 mg Granule pentru suspensie orală Aspirin Complex horúci nápoj 500 mg / 30 mg Granulát na perorálnu suspenziu This leaflet was last revised in... [To be completed nationally] Page 5 of 5