Telfast 30mg film-coated Tablets

Land: Malta

Språk: engelsk

Kilde: Malta Medicines Authority

Aktiv ingrediens:

FEXOFENADINE HYDROCHLORIDE

Tilgjengelig fra:

Sanofi Malta Limited Level2, Fort Business Centre, Mriehel Bypass, Birkirkara, Malta

ATC-kode:

R06AX26

INN (International Name):

FEXOFENADINE HYDROCHLORIDE 30 mg

Legemiddelform:

FILM-COATED TABLET

Sammensetning:

FEXOFENADINE HYDROCHLORIDE 30 mg

Resept typen:

POM

Terapeutisk område:

ANTIHISTAMINES FOR SYSTEMIC USE

Autorisasjon status:

Withdrawn

Autorisasjon dato:

2010-03-25

Informasjon til brukeren

07/11/2008 12:43 - VISTAlink folder 246701 - Page 1/3
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 child’s.
• 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  
DO NOT USE TELFAST 
ⴛ 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
䊱
if your child has liver or kidneys problems 
䊱
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.
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 drug absorbed.
It is recommended that 2 hours are left between the
time that your child takes Telfast and the indigestion
remedy.
PREGNANCY AND

Preparatomtale

 
Page 1 of 6 
SUMMARY OF PRODUCT CHARACTERISTICS 

1. 
NAME OF THE MEDICINAL PRODUCT 

Telfast 30 mg film-coated tablets 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Each tablet contains 30 mg of fexofenadine hydrochloride, which is equivalent to 28 mg of 
fexofenadine. 
For a full list of excipients, see section 6.1. 

3. 
PHARMACEUTICAL FORM 

Film-coated tablet. 
Peach round film-coated tablet marked with “03” on one side and “e” on the other side. 

4. 
CLINICAL PARTICULARS 

4.1 
THERAPEUTIC INDICATIONS 

Relief of symptoms associated with seasonal allergic rhinitis. 

4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 

_Children 6 to 11 years of age_ 
The recommended dose of fexofenadine hydrochloride in children aged 6 to 11 years is 30 mg twice 
daily. 

_Children under 6 years of age_ 
The efficacy of fexofenadine hydrochloride has not been established in children under 6 years of 
age. 

_Special risk groups_ 
The safety and efficacy of fexofenadine hydrochloride in renally or hepatically impaired children 
have not been established (see section 4.4). Studies conducted in adults in special risk groups 
(renally or hepatically impaired patients) indicate that it is not necessary to adjust the dose of 
fexofenadine hydrochloride in adults. 

4.3 
CONTRAINDICATIONS 

Hypersensitivity to the active substance or to any of the excipients. 

4.4 
SPECIAL WARNINGS AND PRECAUTIONS FOR USE 

The safety and efficacy of fexofenadine hydrochloride in renally or hepatically impaired children 
have not been established (see section 4.2). Fexofenadine hydrochloride should be administered 
with caution in these patients. 

Patients with a history of or ongoing cardiovascular disease should be warned that, antihist