Telfast 180 Mg Film-Coated Tablets
650816_NT. TELFAST 180MG RL S1 GB.qxp_FORMAT 210x170^^^ 09/09/16 14:01 Pagel
650816_NT. TELFAST 180MG RL S1 GB.qxp_FORMAT 210x170^^^ 09/09/16 14:01 Pagel
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Package leaflet: Information for the user
TELFAST 180 mg film-coated tablets
Fexofenadine hydrochloride
SANOFI *5
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In the UK Phone0845 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 180 mg is used in adults and adolescents of 12 years and older to relieve the symptoms that occur with long term allergic skin reactions (chronic idiopathic urticaria) such as itching, swelling and rashes.
2. What you need to know before you take Telfast
^3 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
Ask your doctor or pharmacist for advice before taking any 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 (180 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.
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:
ADR Reporting
Website: 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 180 mg contains
• The active substance is fexofenadine hydrochloride. Each tablet contains 180 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, titanium dioxide (E171), colloidal anhydrous silica, macrogol 400 and iron oxide (E172).
What Telfast 180 mg looks like and contents of the pack
Telfast 180 mg film-coated tablets are peach coloured,
capsule shaped tablets marked with “018” 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), 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 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:
Belgium: Telfast 180 mg filmomhulde tabletten Denmark: Telfast, filmovertrukne tabletter 180 mg Finland: Telfast 180 mg tabletti, kalvopaallysteinen Germany: Telfast 180 mg Ireland: Telfast 180 mg film coated tablets Italy: Telfast 180 mg compresse rivestite con film Luxembourg: Telfast 180 mg filmomhulde tabletten Portugal: Telfast 180, comprimidos revestidos por pelfcula Spain: Fexofenadina Sanofi 180 mg comprimidos recubiertos con pelfcula
Sweden: Telfast 180 mg filmdragerade tabletter United Kingdom: Telfast 180 mg film coated tablets This leaflet was last revised in 09/2016
© Sanofi, 1996 - 2016
650816
SANOFlO
Plant PM code : Update :
Local code :
Old PM code :
Name :
650816
V1 - 09/SEP/2016 N.A.
597812
NT. TELFAST 180 MG RL S1
Country : Plant :
GB
Tours TN
Supplier code : N.A.
Format: 210 x 170 mm - Rouleau - Simple Sens de deroulement:
Recto Interieur_4A (Portrait) - Verso Ext. : 4B
Plant barcode : *650816*
Colors: 2
- Noir PMS Black U
- Bleu PMS REFLEX BLUE U
Fonts: OceanSansPro SAN - L39HrP24Dh Arial (•)
Size mini :8 Pts
Layout of Cutting : TN_LCG_NTRL_13c Technical Constraint: PLANTYPE-NTRL-2015_S-DB
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'
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