Telfast 120 Mg Film-Coated Tablets
650720_NT. TELFAST 120MG RL S1 GB.qxp_FORMAT 210x170^^^ 09/09/16 14:46 Pagel
Package leaflet: Information for the user
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TELFAST 120 mg film-coated tablets
Fexofenadine hydrochloride
SANOFI *5
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In the UK Phone 0845 372 7101 for help In Ireland Phone 01 403 5600 for help
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
- 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 you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- 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.
What is in this leaflet
1. What Telfast is and what it is used for
2. What you need to know before you take Telfast
3. How to take Telfast
4. Possible side effects
5. How to store Telfast
6. Contents of the pack and other information
1. What Telfast is and what it is used for
Telfast contains fexofenadine hydrochloride, which is an antihistamine.
Telfast 120 mg is used in adults and adolescents of 12 years and older 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. What you need to know before you take Telfast
Do not take Telfast
X if you are allergic to fexofenadine or any of the other ingredients of this medicine (listed in section 6)
Other medicines and Telfast
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Indigestion remedies containing aluminium and magnesium may affect the action of Telfast, by lowering the amount of medicinal product absorbed.
It is recommended that you leave about 2 hours between the time that you take Telfast and your indigestion remedy.
Pregnancy and breast-feeding
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.
Do not take Telfast if you are pregnant, unless necessary. Telfast is not recommended during breast-feeding.
Driving and using machines
Telfast is unlikely to affect your ability to drive or operate machinery. However, you should check that these tablets do not make you feel sleepy or dizzy before driving or operating machinery.
3. How to take Telfast
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
For adults and children aged 12 years and over
The recommended dose is one tablet (120 mg) daily.
Take your tablet with water before a meal.
This medicine starts to relieve your symptoms within 1 hour and lasts for 24 hours.
If you take more Telfast than you should
If you take too many tablets, contact your doctor or the nearest hospital emergency department immediately. Symptoms of an overdose in adults are dizziness, drowsiness, fatigue and dry mouth.
If you forget to take Telfast
Do not take a double dose to make up for a forgotten tablet. Take the next dose at the usual time as prescribed by your doctor. If you stop taking Telfast
Tell your doctor if you want to stop taking Telfast before you have finished your course of treatment.
If you stop taking Telfast earlier than planned, your symptoms may return.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Warnings and precautions
Talk to your doctor or pharmacist before taking Telfast if: A you have problems with your liver or kidneys A you have or ever had heart disease, since this kind of medicine may lead to a fast or irregular heart beat A you are elderly
If any of these apply to you, or if you are not sure, tell your doctor before taking Telfast.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor immediately and stop taking Telfast if you experience:
- swelling of the face, lips, tongue or throat and difficulty breathing, as these may be signs of a serious allergic reaction.
650720
Common side effects (may affect up to 1 in 10 people):
- headache
- drowsiness
- feeling sick (nausea)
- dizziness.
Uncommon side effects (may affect up to 1 in 100 people):
- tiredness/sleepiness.
Additional side effects (frequency not known: cannot be estimated from the available data) which may occur are:
- difficulty sleeping (insomnia)
- sleeping disorders
- bad dreams
- nervousness
- fast or irregular 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 difficulty breathing.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
UK:
You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
Ireland:
You can also report side effects directly via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517.
Website: www.hpra.ie; E-mail: medsafety@hpra.ie
Malta:
You can also report side effects directly via ADR Reporting www.medicinesauthority.gov.mt/adrportal
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Telfast
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 after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage condition. 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 Telfast 120 mg contains
• The active substance is fexofenadine hydrochloride. Each tablet contains 120 mg of fexofenadine hydrochloride.
• The other ingredients are: o Tablet core: microcrystalline cellulose, pregelatinised maize starch, croscarmellose sodium, magnesium stearate.
o Film coating: hypromellose, povidone K30, titanium dioxide (E171), colloidal anhydrous silica, macrogol 400, red iron oxide (E172) and yellow iron oxide (E172).
What Telfast 120 mg looks like and contents of the pack
Telfast 120 mg film-coated tablets of 6.1 x 15.8 mm are peach coloured, capsule shaped tablets marked with “012” on one side and a scripted “e” on the other.
Telfast is presented in blister packs. Each tablet is blistered. Telfast is available in packs of 2 (sample only), 7, 10, 15, 20, 30, 50, 100 and 200 (as 10x20) tablets per package.
Not all pack sizes are marketed.
Marketing Authorisation Holder:
In the UK:
Sanofi, One Onslow Street, Guildford, Surrey, GU1 4YS, UK Tel: 0845 372 7101
email: uk-medicalinformation@sanofi.com
In Ireland:
sanofi-aventis Ireland Ltd., T/A SANOFI Citywest Business campus, Dublin 24, Ireland Tel: 00353 (0) 1 403 5600 Fax: 00353 (0) 1 403 5601 email: IEmedinfo@sanofi.com
Manufacturer Sanofi Winthrop industrie, 30-36 Avenue Gustave Eiffel, 37100 Tours, France
This medicinal product is authorised in the Member States of the EEA under the following names:
Austria: Allegra 120 mg Filmtabletten
Belgium: Allegra tab 120 mg filmomhulde tabletten
Croatia: Allegra 120 mg filmom oblozene tablete
Czech Republic: Allegra 120 mg
Denmark: Telfast, filmovertrukne tabletter 120 mg
Estonia: Allegra
Finland: Telfast 120 mg tabletti, kalvopaallysteinen Germany: Telfast 120 mg-Filmtabletten Greece: Allegra
Ireland: Telfast 120 mg film-coated tablets Italy: Telfast 120 mg compresse rivestite con film Latvia: Allegra 120 mg apvalkotas tabletes Lithuania: Allegra 120 mg plevele dengtos tabletes Luxembourg: Allegra tab 120 mg comprimes pellicules Portugal: Telfast 120, comprimidos revestidos por pelfcula Romania: Telfast 120 mg comprimate filmate Slovenia: Telfast 120 mg filmsko oblozene tablete Slovakia: Allegra 120 mg
Spain: Telfast 120 mg comprimidos recubiertos con pelfcula Sweden: Allegra
United Kingdom: Telfast 120 mg film-coated tablets This leaflet was last revised in 09/2016
SANOFI
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Code : |
650720 |
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Update : |
V1 - 09/SEP./2016 |
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Local code : |
N.A. |
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Old PM code: |
619879 |
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Name : |
NT. TELFAST 120MG RL S1 |
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Country : |
GB |
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Plant : |
TOURS |
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Supplier code : |
N.A. |
Format: 210 x 170 mm - Rouleau - Simple Sens de deroulement:
Recto Interieur_4A (Portrait) - Verso Ext. : 4B
Plant barcode : *650720*
Colours : 2
- Noir PMS Black U
- Bleu PMS REFLEX BLUE U
Fonts : OceanSansPRO SAN (8Pt a 100%) - Arial (bullet points o) -L39HrP24Dh (Code 39)
Layout of Cutting : Technical Constraint:
TN_LCG_NTRL_13c PLANTYPE-NTRL-2015_S-DB (CAB/Verso ext.)
Colours may note reproduce accurately on this proof.
You should refer to Pantone references for accurate colour match.
Nature du changement/Reason for change : - Regulatory text:
Add sentence in ’how to take telfast’
Change name of BE and LU product
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