PACKAGE LEAFLET. Page 1 of 5

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1 PACKAGE LEAFLET Page 1 of 5

2 Package leaflet: Information for the user PREST 500 mg orodispersible tablets paracetamol 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. - You must talk to a doctor if you do not feel better or if you feel worse. What is in this leaflet 1. What PREST is and what it is used for 2. What you need to know before you take PREST 3. How to take PREST 4. Possible side effects 5. How to store PREST 6. Contents of the pack and other information 1. What Prest is and what it is used for Paracetamol is a pain relieving, fever reducing medicinal product (analgesic and antipyretic). Paracetamol is used for symptomatic treatment of mild to moderate pain and/or fever. PREST 500 mg orodispersible tablets may be used in adults and adolescents. 2. What you need to know before you take Prest Do not take Prest - if you are allergic to paracetamol or any of the other ingredients of this medicine (listed in section 6). Warnings and precautions Talk to your doctor or pharmacist before taking Prest: - if you have kidney or liver disease; - if you regularly take large amounts of alcohol; - in case of dehydration or chronic malnutrition Do not take paracetamol for longer periods or in higher doses without your doctor s or dentist s advice, since: - the use of high doses of pain-relieving agents (analgesics) for longer periods may cause headache. This headache should never be treated by increasing the dose of paracetamol. - regular use of pain relieving agents, especially combinations of various pain relieving agents, may cause permanent kidney damage including the risk of kidney failure (analgesic nephropathy). - abrupt discontinuation after longer use of high doses of pain relieving agents may lead to headache, tiredness, muscular pain, nervousness and vegetative symptoms. These symptoms fade away in a few Page 2 of 5

3 days. In the meantime do not start using pain relieving agents again without consulting your doctor. If your symptoms get worse, or if complaints do not begin to improve after three days, seek medical advice. Other medicines and Prest Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Please see your doctor before you take paracetamol in case you use one of the following medicines: - metoclopramide or domperidone ( medicines used to treat nausea and vomiting); - colestyramine (used to lower your cholesterol); - anti-coagulants (medicines to thin the blood, e.g. warfarin), in case you need to take a painkiller on a daily basis over a long period. - salicylamide (a pain killer) - probenecide (a medicine used to treat gout) - isoniazid (a medicine used to treat tuberculosis) - lamotrigine (a medicine used to treat epilepsy) If you are going to have any laboratory tests (such as a blood test, urine analysis, skin allergy test, etc.), you should tell your doctor that you are taking this medicine as it could affect the results of these tests. Prest with food and drink Be careful with the use of paracetamol if you frequently take large amounts of alcohol. Pregnancy and breastfeeding 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. Studies with paracetamol do not indicate that there are adverse effects on the pregnancy or on the health of the unborn child. You may take paracetamol in the recommended doses during pregnancy. During pregnancy, paracetamol should not be taken for long periods, at high doses or in combination with other medicinal products. Although paracetamol is excreted in the breast milk in small amounts it has no unwanted effects on the child that is breast fed. Paracetamol may be used by breastfeeding women as long as the recommended dosage is not exceeded. In case of long term use caution should be exercised. Driving and using machines Using paracetamol does not influence your ability to drive or use machines. Prest contains aspartame PREST contains aspartame, which is a source of phenylalanine. The phenylalanine in the tablets may be harmful to people with phenylketonuria. 3. How to take Prest 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. Dosage depends on body weight and age; a single dose ranges from 10 to 15 mg/kg body weight. The maximum daily dose is 60 mg/kg body weight. The usual dose is: Adolescents: Page 3 of 5

4 1 tablet at a time, max 6 tablets per 24 hours. Adults: 1-2 tablets at a time, max 6 tablets per 24 hours. Do not exceed the stated dose. Method of administration: The tablet should be placed in the mouth where it melts on the tongue so it can be easily swallowed. Alternatively, to facilitate the intake, the tablet can be swallowed with a glass of water or dispersed in a spoonful of water. If you take more Prest than you should Immediately contact your doctor or pharmacist in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage. 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. However, occasionally some people may get allergic reactions, such as skin rash or fever. There have been very rare reports of blood disorders. Once you stop taking the medicine these effects should go away. 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 Nederlands Bijwerkingen Centrum Lareb, Website: By reporting side effects you can help provide more information on the safety of this medicine. Met opmaak: Lettertype: 11 pt 5. How to store Prest Keep out of the reach and sight of children. Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month. [PVC/PVDC blisters:] Do not store above 30 C. [PVC/ACLAR blisters:] This medicine 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 protect the environment. 6. Contents of the pack and other information What Prest contains - The active substance is paracetamol. Page 4 of 5

5 - Each orodispersible tablet contains 500 mg of paracetamol. - The other ingredients are ethylcellulose, mannitol (E421), microcrystalline cellulose (E460), crospovidone type B, aspartame (E951), magnesium stearate (E572), strawberry flavour (contains amongst other, maltodextrine, arabic gum (E414)). What Prest looks like and contents of the pack Prest 500 mg orodispersible tablets are white to off-white round, flat face radius edge orodispersible tablets. Prest 500 mg orodispersible tablets are packed in blisters. Each box contains 2, 16 or 20 orodispersible tablets. Marketing Authorisation Holder Olvos Science S.A. 4 Eleftherias Str Kifissia Manufacturer Galenica Pharmaceutical Industry S.A. 3 rd km Old National Road Chalkida-Athens, Glyfa Chalkidas, Eubia This medicinal product is authorised in the Member States of the EEA under the following names: The Netherlands Prest 500 mg orodispergeerbare tabletten Prest διασπειρόμενo στο στόμα δισκίo 500 mg Cyprus Prest διασπειρόμενo στο στόμα δισκίo 500 mg Deze bijsluiter is voor het laatst goedgekeurd in maart 2015 Page 5 of 5