PACKAGE LEAFLET: INFORMATION FOR THE USER ASPIRIN COMPLEX 500 mg / 30 mg Granules for Oral Suspension Acetylsalicylic Acid 500 mg, Pseudoephedrine Hydrochloride 30 mg 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 ASPIRIN Complex is and what it is used for 2. What you need to know before you take ASPIRIN Complex 3. How to take ASPIRIN Complex 4. Possible side effects 5. How to store ASPIRIN Complex 6. Contents of the pack and other information 1. What ASPIRIN COMPLEX is and what it is used for ASPIRIN Complex has pain-relieving, anti-inflammatory, fever-reducing and nasal decongestant properties. The white to yellowish granules contain two drug substances, Acetylsalicylic acid (Aspirin) and Pseudoephedrine hydrochloride. This medicine is used for the treatment of the symptoms of nasal/sinus congestion (rhinosinusitis) and pain and fever associated with the common cold and/or flu-like symptoms. If you have only one of the symptoms above it may be more appropriate to take a medicine that contains only one of the drug substances. You must talk to a doctor if you do not feel better or if you feel worse after 3 days. 2. What you need to know before you take ASPIRIN COMPLEX Do not take ASPIRIN Complex: 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 a history of asthma induced by administration of salicylates or substances with a similar action (namely non-steroidal anti-inflammatory drugs); if you suffer from stomach ulcers; if you have an increased tendency to bleed; if you are pregnant or breast feeding; if you have liver or kidney failure; if you have severe, heart failure; if you are also 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 medicine containing a monoamine oxidase (MAO) inhibitor (or were taking within the previous two weeks). Warnings and precautions Talk to your doctor or pharmacist before taking ASPIRIN COMPLEX: if you are allergic (hypersensitive) to other analgesics, anti-rheumatics or anti-inflammatory - 1-1.3.1 1
medicines; if you 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; if you are also taking medicines to thin the blood and to prevent it clotting (anticoagulants); if you have a history of stomach ulcers or gastrointestinal bleeding; if you have impaired kidney and liver function; if you have impaired cardiovascular function (for example when the heart inadequately pumps blood through the body, volume depletion, major surgery, blood infection or major haemorrhagic event); if you are about to have surgery (including minor operations such as tooth extractions) as acetylsalicylic acid increases haemorrhagic risks even in low doses; if you suffer from an overactive thyroid, mild to moderate hypertension, diabetes mellitus, heart diseases, increased pressure in the eye (glaucoma), an enlarged prostate gland, or sensitivity to some ingredients in cough/cold medicines e.g. phenylephrine and ephedrine (sympathomimetic substances); if you take a number of painkillers together, habitually,(particularly combinations of different analgesic drugs). You are at risk of permanent kidney disease; if you are prone to having gout. At low doses acetylsalicylic acid reduces the excretion of uric acid in urine, which may cause a gout attack. if you have a G6PD (Glucose-6-phosphate dehydrogenase) deficiency (a hereditary disease affecting red-blood cells), since elevated doses of acetylsalicylic acid could lead to haemolysis (destruction of red-blood cells) if you have a history of a form of a severe skin reaction called acute generalized exanthematous pustulosis (AGEP) (with symptoms and signs such as fever, erythema, or small generalized pustules) with pseudoephedrine-containing products. If you are unsure whether you should take this medicine, consult your doctor or pharmacist. Athletes must be aware that this medicinal product may cause a positive reaction to anti-doping tests. Use in the elderly Elderly patients may be particularly sensitive to pseudoephedrine and may experience sleeplessness or sense things that are not real (hallucinations). Children and adolescents There is a possible association between acetylsalicylic acid and Reye s syndrome when given to children and adolescents. 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 ASPIRIN Complex Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. The action of the following medicines may be affected if taken together with ASPIRIN Complex. Please tell your doctor because he/she may need to adjust the dose of these below medicines. ASPIRIN Complex may increase the effect of: Medicines that thin the blood and help to prevent it clotting so easily, e.g. ticlopidine; Medicines such as cortisone or prednisolone, when taken by mouth or by injection; 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). Medicine to lower blood sugar (antidiabetics); Methotrexate (possibly increase the risk for side effects); - 2-1.3.1 2
Valproic acid (medicine for treating epilepsy); Antidepressants including MAO-inhibitors; Salbutamol tablets which may cause your heart to beat irregularly or faster. This should not stop you using an inhaler instead (at the prescribed dose); Other medicines containing phenylephrine and ephedrine or other sympathomimetic substances such as those included in nasal decongestants e.g. nose drops. ASPIRIN Complex may reduce the effect of: Medicines used to get excess water out of the body and increase urine (aldosterone antagonists and loop diuretics); Medicines that lower blood pressure (antihypertensives such as guanethidine, methyldopa, β- blockers); Medicines for the treatment of gout that promote excretion of uric acid in the urine (e.g. probenecid, sulphinpyrazone); ASPIRIN Complex with food, drink and alcohol It does not matter whether the product is taken with or without food. However the granules must be added to a glass of water and stirred well before taking. Drinking alcohol while taking acetylsalicylic acid can increase the risk of gastrointestinal bleeding, and impair your ability to react. Pregnancy, breast-feeding and fertility Due to lack of experience with the combination of drugs in ASPIRIN Complex, the product must not be used during pregnancy or if you are breast feeding. If you think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking the medicine. The product belongs to a group of medicines (NSAID) which may impair the fertility in women. This effect is reversible on stopping the medicine. Driving and using machines During treatment with this medicine, 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. ASPIRIN Complex contains sucrose This medicinal product contains 2 g of sucrose (sugar) per sachet (equivalent to 0.17 bread exchange BE). This should be taken into account in patient 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 ASPIRIN COMPLEX Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Unless otherwise prescribed, the dosage is as shown in the following table: Age Single dose Total daily dose Adults 1-2 sachets Up to 6 sachets If necessary, single doses can be taken at intervals of 4 to 8 hours. The total daily dose should not exceed 6 sachets. - 3-1.3.1 3
Pour the contents of one or two sachets of ASPIRIN Complex in a glass of water and stir well. Drink the entire content of the glass immediately. NB: the granules do not dissolve completely. Do not take this medicine for more than 3 days without talking to your doctor. Use in children and adolescents Do not give to children and adolescents under 16 years of age, unless on the advice of a doctor. Due to limited experience a dosage recommendation for adolescents can not be given. If you take more ASPIRIN Complex than you should Headaches, dizziness, convulsions, being sick, noises in the ears, a fast heartbeat (tachycardia), chest pain, agitation or shortness of breath may occur in the event of overdose. If overdose with 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 due to acetylsalicylic acid are: 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: Stomach ulcers that may in isolated cases lead to perforation; 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; Haemolysis (destruction of red-blood cells) in case of severe forms of G6PD (Glucose-6-phosphate dehydrogenase) deficiency; Kidney impairment, kidney failure. 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); Feeling dizzy, ringing in the ears (tinnitus). These are all mild, side effects: Nausea, vomiting, diarrhoea. Possible side effects due to pseudoephedrine are: These are all serious side effects and you may need urgent medical attention. Tell your doctor if you notice any of the below: Cardiac effects (e.g. a fast or irregular heartbeat); Urinary retention, especially in patients with prostate hyperplasia; Increase in blood pressure, although not in controlled hypertension; Insomnia, rarely hallucinations and other central nervous system stimulation; - 4-1.3.1 4
Effects on the skin (e.g. rash, nettle rash, itching). Acute generalized exanthematous pustulosis (a form of severe skin reaction signs and symptoms such as fever, erythema, small (generalized) pustules) If you experience any of the above side-effects, stop taking the product. Let your doctor know so that he/she 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 ASPIRIN COMPLEX Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton and sachets. The expiry date refers to the last day of that month. Do not store above 30 C. 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 protect the environment. 6. Contents of the pack and otherinformations What ASPIRIN Complex contains The active substances are acetylsalicylic acid (500 mg) and pseudoephedrine hydrochloride (30 mg). The other ingredients are citric acid anhydrous, sucrose, hypromellose, saccharin, orange flavour (including benzyl alcohol, alpha tocopherol, modified starch and maltodextrin). What ASPIRIN Complex looks like and contents of the pack White to yellowish granules for oral suspension. This product is available in packs containing 10 or 20 sachets. Not all pack size may be marketed. Marketing Authorisation Holder and Manufacturer [To be completed nationally] This medicinal product is authorised in the Member States of the EEA under the following names: Although the product is approved in other Member States it may not always be marketed. Germany: Austria: Bulgaria: Hungary: Poland: Slovenia: Slovakia: ASPIRIN COMPLEX 500 mg / 30 mg Granulat zur Herstellung einer Suspension zum Einnehmen Aspirin Complex Granulat zur Herstellung einer Suspension zum Einnehmen Аспирин Комплекс 500 mg / 30 mg Гранули за перорална суспензия Aspirin Complex 500 mg / 30 mg granulátum belsőleges szuszpenzióhoz Aspirin Complex Zatoki 500 mg / 30 mg Granulat do sporządzania zawiesiny doustnej Aspirin Complex 500 mg/30 mg zrnca za peroralno suspenzijo ASPIRIN COMPLEX 500 mg / 30 mg Granulát na perorálnu suspenziu - 5-1.3.1 5
This leaflet was last approved in MM/YYYY [To be completed nationally] - 6-1.3.1 6