Package leaflet: Information for the user. < ASPROFLASH and associated names > 500 mg coated tablet Acetylsalicylic acid

Transcription

1 PACKAGE LEAFLET 1

2 Package leaflet: Information for the user < ASPROFLASH and associated names > 500 mg coated tablet Acetylsalicylic acid Read all of this leaflet carefully before you start using this medicine because it contains important information for you. Always use 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. You must talk to a doctor if you do not feel better or if you feel worse after 3 days (for fever) or 3-4 days (for pain). <[legal status to be completed nationally]> What is in this leaflet 1. What ASPROFLASH is and what is it used for 2. What you need to know before you use ASPROFLASH 3. How to use ASPROFLASH 4. Possible side effects 5. How to store ASPROFLASH 6. Contents of the pack and other information. 1. What ASPROFLASH is and what is it used for ASPROFLASH contains acetylsalicylic acid (aspirin). Acetylsalicylic acid is an analgesic (pain-relief) and an antipyretic (fever-reducer). ASPROFLASH is used for the symptomatic treatment for fever and/or mild to moderate pain such as headaches, flu syndrome, dental pain, muscular pain. ASPROFLASH is specifically reserved for adults and adolescents 12 years of age and older (weighing 40 kg or more). Ask your doctor or pharmacist about other forms of acetylsalicylic acid for patients weighing less than 40 kg. You must talk to a doctor if you do not feel better or if you feel worse after 3 days (for fever) or 3-4 days (for pain). 2. What you need to know before you use ASPROFLASH Do not use ASPROFLASH: if you are allergic to acetylsalicylic acid (aspirin) or other salicylates, or any of the other ingredients of this medicine (listed in section 6). if you have a history of asthma or allergic reaction (e.g. urticarial, angioedema, severe rhinitis, shock) caused by the administration of acetylsalicylic acid or to a related medicine (notably non-steroidal antiinflammatory drugs). if you have a stomach or intestinal (including duodenal) ulcer. if you have a hemorrhagic condition or risk of bleeding. if you have severe kidney, liver or heart failure. if you are being treated with methotrexate in doses of more than 20 mg/week. if you are being treated with oral anticoagulants (medicines to thin the blood and to prevent it from clotting). if you are after the 5th month of pregnancy (beyond 24 weeks of amenorrhea). 2

3 If you are in any doubt if this medicine should be used, ask your doctor or pharmacist. Warnings and precautions Talk to your doctor or pharmacist before using ASPROFLASH: if you are being treated with other products containing acetylsalicylic acid (aspirin), to avoid the risk of overdose. if headaches occur while taking strong aspirin doses over a prolonged period, do not increase your dosage, rather seek the advice of your doctor or pharmacist. if you use pain killers regularly, in particular several pain killers in combination, this may lead to reduced kidney function. 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 hemolysis (destruction of redblood cells). if you have a history of stomach or intestinal ulcers, stomach or intestinal haemorrhages or gastritis. if you have impaired kidney or liver function. if you have asthma: the occurrence of asthma attacks, in some patients, may be related to allergic reactions to non-steroidal anti-inflammatory drugs or to acetylsalicylic acid. In this case, the use of this medication is not recommended. in case of heavy menstrual bleeding. if gastrointestinal haemorrhage occur during the treatment (rejection of blood by mouth, blood in feces, black colour of feces); you must stop the treatment and call immediately your doctor or an emergency medical service. if you are also taking medicines to thin the blood and to prevent it clotting (anticoagulants). Acetylsalicylic acid increases hemorrhagic risks even in low doses and even if it is taken several days before. Tell your doctor, surgeon or anesthetist or dentist in case a surgery, even minor, is envisaged. Acetylsalicylic acid modifies the quantity of uric acid in the blood. This has to be taken into account if you take medicines used against gout. It is not recommended to use this medicine during breast-feeding. Children Reye's syndrome (a rare yet very serious disease primarily associated with neurological and liver damage) has been observed in children suffering from viral illnesses and being administered acetylsalicylic acid. As a result: in the case of a viral sickness such as the flu or chicken pox, administration of acetylsalicylic acid to a child should not be done without the prior consultation of a doctor; if signs of dizziness or fainting, altered behavior, or vomiting occur in a child taking acetylsalicylic acid, notify your doctor immediately. Other medicines and ASPROFLASH Tell your doctor or pharmacist if you are using or have recently used or might use any other medicine. In the subsequent text the following definitions are used: Acetylsalicylic acid may be used for the treatment of rheumatic disorders in high doses (called antiinflammatory doses) defined as: 1 g or more as single dose and/or 3 g or more per day. Acetylsalicylic acid may be used for the treatment of pain and fever in doses defined as: 500 mg or more as single dose and/or not more than 3 g per day. Do not take ASPROFLASH: if you are being treated with methotrexate in doses of more than 20 mg per week. In that case acetylsalicylic acid should be avoided when used at high (anti-inflammatory) doses, or for the treatment of pain and fever. 3

4 if you are being treated with oral anticoagulants and in case of history of gastroduodenal ulcer. In that case acetylsalicylic acid should be avoided when used at high (anti-inflammatory) doses, or for the treatment of pain and fever. Talk to your doctor or pharmacist before taking acetylsalicylic acid with any of the following: oral anticoagulants when acetylsalicylic acid is used for the treatment of pain and fever and with no history of gastro-duodenal ulcers. non-steroidal anti-inflammatory drugs when acetylsalicylic acid is used at high (anti-inflammatory) doses, or for the treatment of pain and fever. heparins used at curative doses, or in elderly patients ( 65 years) when acetylsalicylic acid is used at high (anti-inflammatory) doses notably for the treatmernt of rheumatic disorders, or for the treatment of pain and fever. thrombolytics clopidogrel ticlopidine uricosuric medications used in the treatment of gout (example: benzobromarone, probenecid) glucocorticoids (excluding hydrocortisone replacement therapy) when acetylsalicylic acid is used at high (anti-inflammatory) doses. pemetrexed in patients with a mild to moderate kidney impairment anagrelide medicines that treat water retention (diuretics) angiotensin converting enzyme inhibitors, angiotensin II receptor antagonists methotrexate used at doses of 20 mg or less per week gastrointestinal topicals, antacids and charcoal deferasirox selective serotonin re-uptake inhibitors (example: citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline) To avoid any interaction effects between medications, you should alert your doctor or pharmacist to any other medications that you take. ASPROFLASH with alcohol Do not take ASPROFLASH with alcohol. Pregnancy, breast-feeding and fertiliy If you are pregnant or breast-feeding, suspect you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this or any other medicine. Pregnancy In the first five months of pregnancy you should consult your doctor before taking this medicine or other products containing acetylsalicylic acid. From the beginning of the 6 th month of pregnancy (beyond 24 weeks of amenorrhea), on no account you should take this medicine as this may cause serious harm to you or your child. If you have taken this medicine during pregnancy, you should immediately contact your doctor. Breast-feeding This medicine can pass into the mother's breast milk. As a precaution, ASPROFLASH is not recommended during breast-feeding. Fertility The product belongs to a group of medicines which may impair the fertility in women. This effect is reversible on stopping the medicine. Driving and using machines 4

5 Acetylsalicylic acid has no influence on the ability to drive and use machines. 3. How to use ASPROFLASH Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. Check with your doctor or pharmacist if you are not sure. Dosage For oral use only. Take tablet(s) with plenty of liquid. For adults and adolescents (aged 16 and older) The recommended single dose is 1 tablet, and can be taken again if needed after a minimum of 4 hours. For more intense fever or pain, the recommended single dose is 2 tablets, and can be taken again if needed after a minimum of 4 hours. The total daily dose should not exceed 6 tablets. For older patients (aged 65 and older) The recommended single dose is 1 tablet, and can be taken again if needed after a minimum of 4 hours. The total daily dose should not exceed 4 tablets. For adolescents aged years (weighing kg): The dosage depends on the weight of the adolescent; the age referenced is for informational purposes only. The recommended single dose is 1 tablet, and can be taken again if needed after a minimum of 4 hours. The total daily dose should not exceed 6 tablets. For special populations Patients with abnormal hepatic or renal function or circulation problems (e.g., with heart failure or major bleeding events): Seek the advice of your doctor or pharmacist. Children under 12 years of age (weighing less than 40 kg): do not use without a prescription. Do not take this medicine for more than 3 days (for fever) to 3-4 days (for pain) unless directed by a physician. If you use more ASPROFLASH than you should During treatment, it is possible that you experience ringing of the ears, a sensation of hearing loss, headaches, dizziness these are signs typical of an overdose. If overdosage with this product is suspected, stop treatment and contact a doctor immediately. If you forget to use ASPROFLASH Do not take a double dose to make up for a forgotten dose. 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 the nearest hospital if you notice any of the following: bleeding (nose bleed, bleeding gums, red spots under the skin, etc.) allergic reactions such as a cutaneous eruption, asthma attack or facial swelling accompanied with difficulty breathing 5

6 headache, dizziness, sensation of hearing loss, tinnitus (ringing in the ears), which are usually indicative of an overdose cerebral bleeding stomach ache gastrointestinal bleeding. See section Warnings and precautions. These occur more frequently when taking high doses increase of liver enzymes mainley reversible when the treatment is stopped, liver impairment (mainly liver cells) urticaria, skin reactions Reye s syndrome (disturbance of consciousness or abnormal behaviour, or vomiting) in a child presenting a viral disease and taking acetylsalicylic acid (see section 2. What you need to know before you use ASPROFLASH) 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 ASPROFLASH 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 label. The expiry date refers to the last day of that month. Do not store above 30 C. Do not use if you notice visible signs of deterioration. 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 other information What ASPROFLASH contains The active substance is acetylsalicylic acid. Each coated tablet contains 500 mg acetylsalicylic acid. The other ingredients are: Colloidal silicon dioxide, Sodium carbonate anhydrous Coating: Carnauba wax, Hypromellose, Zinc stearate What ASPROFLASH looks like and contents of the pack This medicinal product is presented as white to off-white round biconvex coated tablet of 12 mm. The tablets are embossed on one side with BA 500 and the other side with the Bayer cross. Strips (paper - PE - aluminium - copolymer foil) containing 8, 12, 20, 24, 40, 60, 80 tablets are packed into cardboard packs <Not all pack sizes may be marketed.> Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: Bayer [To be completed nationally] {Name and address} {tel} {fax} 6

7 { } Manufactured by: Bayer Bitterfeld GmbH Salegaster Chausee Bitterfeld-Wolfen Germany [Names of the product to be completed nationally] This leaflet was last revised in <month YYYY> 7