TELFAST 30MG FILM-COATED TABLETS
Active substance: FEXOFENADINE HYDROCHLORIDE
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PACKAGE LEAFLET: INFORMATION FOR THE USER
4. Possible side effects Taking other medicines Please tell your doctor or pharmacist if your child is taking or has recently taken any other medicines, including medicines obtained without a prescription. Indigestion remedies containing aluminium and magnesium may affect the action of Telfast, by lowering the amount of medicinal product absorbed. It is recommended that 2 hours are left between the time that your child takes Telfast and the indigestion remedy. Pregnancy and breast-feeding This medicine is for use in children 6 - 11 years of age. However, the following information should be noted regarding the safe use of this medicine. Ask your doctor or pharmacist for advice before giving any medicine. Telfast should not be taken during pregnancy, unless necessary. Telfast is not recommended during breast-feeding.
6. Further information
30 mg film-coated tablets
Fexofenadine hydrochloride
Is this leaflet hard to see or read? Phone 01483 505515
Read all of this leaflet carefully before your child starts taking this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for your child. Do not pass it on to others. It may harm them, even if their symptoms are the same as your childs. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1.What Telfast is and what it is used for 2.Before you use Telfast 3.How to use Telfast 4.Possible side effects 5.How to store Telfast 6.Further information 1. What Telfast is and what it is used for Telfast contains fexofenadine hydrochloride, which is an antihistamine. Telfast 30 mg is used in children 6 to 11 years old to relieve the symptoms that occur with hay fever (seasonal allergic rhinitis) such as sneezing, itchy, runny or blocked nose and itchy, red and watery eyes. 2. Before you use Telfast
Driving and using machines Telfast is unlikely to affect ones ability to drive or use machines. However, you should check that these tablets do not make your child feel sleepy or dizzy. Do not let your child drive or operate machinery if they are affected. 3. How to use Telfast Always use Telfast exactly as the doctor has told you. You should check with your doctor or pharmacist if you are not sure. For children 6 to 11 years of age The recommended dose is one tablet (30 mg) twice daily. The tablet should be taken with water. If you use more Telfast than you should If your child takes too many tablets, contact your doctor or the nearest hospital emergency department immediately. Symptoms of an overdose are dizziness, drowsiness, fatigue and dry mouth. If you forget to use Telfast Do not give a double dose to make up for a forgotten tablet. Give the next dose at the usual time as prescribed by the doctor. If you stop using Telfast Tell your doctor if you want your child to stop taking Telfast before the course of treatment has finished. If treatment with Telfast is stopped earlier than planned, the symptoms may return. If you have any further questions on the use of this product, ask your doctor or pharmacist.
Like all medicines, Telfast can cause side effects, although What Telfast 30 mg film-coated tablets contains not everybody gets them. The active substance of Telfast is fexofenadine hydrochloride. Each tablet contains 30 mg of Tell your doctor immediately and stop treatment with Telfast if your child experiences swelling of the face, lips, fexofenadine hydrochloride. tongue or throat and difficulty breathing, as these may The other ingredients are: be signs of a serious allergic reaction. Tablet core: microcrystalline cellulose, pregelatinised In clinical trials in children 6 to 11 years of age, the most starch, croscarmellose sodium, magnesium stearate. common side effect was headache. Film coating: hypromellose, povidone, titanium dioxide (E171), colloidal anhydrous silica, macrogol, pink iron In adults, the following side effects have been reported: oxide (E172) blend and yellow iron oxide (E172) blend. Common side effects (occurring in less than 1 in 10 but What Telfast 30 mg looks like and contents of the pack more than 1 in 100 patients): headache, drowsiness, feeling sick (nausea) and dizziness. Telfast 30 mg film-coated tablets are round and peach coloured, marked with 03 on one side and a scripted Uncommon side effects (occurring in less than 1 in 100 but more than 1 in 1,000 patients): tiredness/sleepiness. e on the other. Telfast is presented in blister packs. Each tablet is blistered. Additional side effects (frequency unknown) which may Telfast is available in packs of 1, 2, 4, 8, 10 or 15 (sample occur are: difficulty sleeping (insomnia), sleeping only), 20, 30, 40, 50, 60, and 100 tablets per package. disorders, bad dreams, nervousness, fast or irregular Not all pack sizes are marketed. heart beat, diarrhoea, skin rash and itching, hives, serious allergic reactions which can cause swelling of the face, lips, tongue or throat, flushing, chest tightness, and Marketing Authorisation Holder and Manufacturer difficulty breathing. If any of the side effects gets serious, or if you notice any Marketing Authorisation Holder: Sanofi-aventis, One Onslow Street, Guildford, side effects not listed in this leaflet, please tell your Surrey, GU1 4YS, UK doctor or pharmacist. Tel: 01483 505515 Fax: 01483 535432 5. How to store Telfast email:uk-medicalinformation@sanofi-aventis.com Keep out of the reach and sight of children. Manufacturer: Do not use Telfast after the expiry date which is stated on Sanofi-Aventis S.p.A. the carton after EXP. The expiry date refers to the last day S.S 17 Km 22 Scoppito (AQ) ITALY of that month. This medicinal product is authorised in the Member This medicinal product does not require any special States of the EEA under the following names: storage condition. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. Belgium: Telfast 30 mg filmomhulde tabletten Cyprus: Telfast Denmark: Telfast, filmovertrukne tabletter 30 mg Finland: Telfast 30 mg tabletti, kalvopllysteinen Germany: Telfast 30 mg Filmtabletten Iceland: Telfast 30 mg filmuhaar tflur Ireland: Telfast 30 mg film coated tablets Italy: Telfast 30 mg compresse rivestite con film Luxembourg: Telfast 30 mg filmomhulde tabletten Malta: Telfast 30 mg film coated tablets Norway: Telfast 30 mg filmdrasjerte tabletter Poland: Telfast 30 Portugal: Telfast 30, comprimidos revestidos por pelcula Spain: Telfast 30 mg comprimidos recubiertos con pelcula Sweden: Telfast 30 mg filmdragerade tabletter United Kingdom: Telfast 30 mg film coated tablets This leaflet was last approved in 09/2011
Do not use Telfast if your child is allergic (hypersensitive) to fexofenadine or any of the other ingredients of Telfast (see section 6 for a full list of ingredients)
Take special care with Telfast if your child has liver or kidney problems if your child has or ever had heart disease, since this medicine may lead to a fast or irregular heart beat If any of these apply to your child, or if you are not sure, always tell your doctor before giving Telfast to your child.
89024475
4. Possible side effects Taking other medicines Please tell your doctor or pharmacist if your child is taking or has recently taken any other medicines, including medicines obtained without a prescription. Indigestion remedies containing aluminium and magnesium may affect the action of Telfast, by lowering the amount of medicinal product absorbed. It is recommended that 2 hours are left between the time that your child takes Telfast and the indigestion remedy. Pregnancy and breast-feeding This medicine is for use in children 6 - 11 years of age. However, the following information should be noted regarding the safe use of this medicine. Ask your doctor or pharmacist for advice before giving any medicine. Telfast should not be taken during pregnancy, unless necessary. Telfast is not recommended during breast-feeding.
6. Further information
30 mg film-coated tablets
Fexofenadine hydrochloride
Is this leaflet hard to see or read? Phone 01483 505515
Read all of this leaflet carefully before your child starts taking this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for your child. Do not pass it on to others. It may harm them, even if their symptoms are the same as your childs. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1.What Telfast is and what it is used for 2.Before you use Telfast 3.How to use Telfast 4.Possible side effects 5.How to store Telfast 6.Further information 1. What Telfast is and what it is used for Telfast contains fexofenadine hydrochloride, which is an antihistamine. Telfast 30 mg is used in children 6 to 11 years old to relieve the symptoms that occur with hay fever (seasonal allergic rhinitis) such as sneezing, itchy, runny or blocked nose and itchy, red and watery eyes. 2. Before you use Telfast
Driving and using machines Telfast is unlikely to affect ones ability to drive or use machines. However, you should check that these tablets do not make your child feel sleepy or dizzy. Do not let your child drive or operate machinery if they are affected. 3. How to use Telfast Always use Telfast exactly as the doctor has told you. You should check with your doctor or pharmacist if you are not sure. For children 6 to 11 years of age The recommended dose is one tablet (30 mg) twice daily. The tablet should be taken with water. If you use more Telfast than you should If your child takes too many tablets, contact your doctor or the nearest hospital emergency department immediately. Symptoms of an overdose are dizziness, drowsiness, fatigue and dry mouth. If you forget to use Telfast Do not give a double dose to make up for a forgotten tablet. Give the next dose at the usual time as prescribed by the doctor. If you stop using Telfast Tell your doctor if you want your child to stop taking Telfast before the course of treatment has finished. If treatment with Telfast is stopped earlier than planned, the symptoms may return. If you have any further questions on the use of this product, ask your doctor or pharmacist.
Like all medicines, Telfast can cause side effects, although What Telfast 30 mg film-coated tablets contains not everybody gets them. The active substance of Telfast is fexofenadine hydrochloride. Each tablet contains 30 mg of Tell your doctor immediately and stop treatment with Telfast if your child experiences swelling of the face, lips, fexofenadine hydrochloride. tongue or throat and difficulty breathing, as these may The other ingredients are: be signs of a serious allergic reaction. Tablet core: microcrystalline cellulose, pregelatinised In clinical trials in children 6 to 11 years of age, the most starch, croscarmellose sodium, magnesium stearate. common side effect was headache. Film coating: hypromellose, povidone, titanium dioxide (E171), colloidal anhydrous silica, macrogol, pink iron In adults, the following side effects have been reported: oxide (E172) blend and yellow iron oxide (E172) blend. Common side effects (occurring in less than 1 in 10 but What Telfast 30 mg looks like and contents of the pack more than 1 in 100 patients): headache, drowsiness, feeling sick (nausea) and dizziness. Telfast 30 mg film-coated tablets are round and peach coloured, marked with 03 on one side and a scripted Uncommon side effects (occurring in less than 1 in 100 but more than 1 in 1,000 patients): tiredness/sleepiness. e on the other. Telfast is presented in blister packs. Each tablet is blistered. Additional side effects (frequency unknown) which may Telfast is available in packs of 1, 2, 4, 8, 10 or 15 (sample occur are: difficulty sleeping (insomnia), sleeping only), 20, 30, 40, 50, 60, and 100 tablets per package. disorders, bad dreams, nervousness, fast or irregular Not all pack sizes are marketed. heart beat, diarrhoea, skin rash and itching, hives, serious allergic reactions which can cause swelling of the face, lips, tongue or throat, flushing, chest tightness, and Marketing Authorisation Holder and Manufacturer difficulty breathing. If any of the side effects gets serious, or if you notice any Marketing Authorisation Holder: Sanofi-aventis, One Onslow Street, Guildford, side effects not listed in this leaflet, please tell your Surrey, GU1 4YS, UK doctor or pharmacist. Tel: 01483 505515 Fax: 01483 535432 5. How to store Telfast email:uk-medicalinformation@sanofi-aventis.com Keep out of the reach and sight of children. Manufacturer: Do not use Telfast after the expiry date which is stated on Sanofi-Aventis S.p.A. the carton after EXP. The expiry date refers to the last day S.S 17 Km 22 Scoppito (AQ) ITALY of that month. This medicinal product is authorised in the Member This medicinal product does not require any special States of the EEA under the following names: storage condition. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. Belgium: Telfast 30 mg filmomhulde tabletten Cyprus: Telfast Denmark: Telfast, filmovertrukne tabletter 30 mg Finland: Telfast 30 mg tabletti, kalvopllysteinen Germany: Telfast 30 mg Filmtabletten Iceland: Telfast 30 mg filmuhaar tflur Ireland: Telfast 30 mg film coated tablets Italy: Telfast 30 mg compresse rivestite con film Luxembourg: Telfast 30 mg filmomhulde tabletten Malta: Telfast 30 mg film coated tablets Norway: Telfast 30 mg filmdrasjerte tabletter Poland: Telfast 30 Portugal: Telfast 30, comprimidos revestidos por pelcula Spain: Telfast 30 mg comprimidos recubiertos con pelcula Sweden: Telfast 30 mg filmdragerade tabletter United Kingdom: Telfast 30 mg film coated tablets This leaflet was last approved in 09/2011
Do not use Telfast if your child is allergic (hypersensitive) to fexofenadine or any of the other ingredients of Telfast (see section 6 for a full list of ingredients)
Take special care with Telfast if your child has liver or kidney problems if your child has or ever had heart disease, since this medicine may lead to a fast or irregular heart beat If any of these apply to your child, or if you are not sure, always tell your doctor before giving Telfast to your child.
89024475
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
