Telfast 30mg tablets

Kraj: Wielka Brytania

Język: angielski

Źródło: MHRA (Medicines & Healthcare Products Regulatory Agency)

Składnik aktywny:

Fexofenadine hydrochloride

Dostępny od:

Sanofi Consumer Healthcare

Kod ATC:

R06AX26

INN (International Nazwa):

Fexofenadine hydrochloride

Dawkowanie:

30mg

Forma farmaceutyczna:

Oral tablet

Droga podania:

Oral

Klasa:

No Controlled Drug Status

Typ recepty:

Valid as a prescribable product

Podsumowanie produktu:

BNF: 03040100; GTIN: 5013011005884

Ulotka dla pacjenta

PACKAGE LEAFLET: INFORMATION FOR THE USER
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOUR CHILD STARTS
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 your child only. Do
not pass it on to others. It may harm them, even if their
signs of illness are the same as your child’s.
• If your child gets 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 your child uses Telfast
3. How to use Telfast
4. Possible side effects
5. How to store Telfast
6. Content 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 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. WHAT YOU NEED TO KNOW BEFORE YOUR CHILD USES TELFAST
DO NOT USE TELFAST
if your child is allergic to fexofenadine or any of the other
ingredients of this medicine (listed in section 6)
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using Telfast if:
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.
OTHER MEDICINES AND TELFAST
Tell your doctor or pharmacist if your child is taking, has
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 2 hours

Charakterystyka produktu

OBJECT 1
TELFAST 30MG TABLETS
Summary of Product Characteristics Updated 12-Sep-2019 | SANOFI
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Fertility, pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
•
6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
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 the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet.
Peach round film-coated tablet debossed with “03” on one side and
a scripted “e” on the other side.
4. Clinical particulars
4.1 Therapeutic indications
Telfast 30 mg is indicated in children aged 6 to 11 years for the
relief of symptoms associated with seasonal
allergic rhinitis.
4.2 Posology and method of administration
Posology
_Paediatric population_
• _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