Telfast 180mg tablets

Država: Velika Britanija

Jezik: angleščina

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

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Prenos Navodilo za uporabo (PIL)
01-08-2019
Prenos Lastnosti izdelka (SPC)
18-10-2019

Aktivna sestavina:

Fexofenadine hydrochloride

Dostopno od:

Sanofi Consumer Healthcare

Koda artikla:

R06AX26

INN (mednarodno ime):

Fexofenadine hydrochloride

Odmerek:

180mg

Farmacevtska oblika:

Oral tablet

Pot uporabe:

Oral

Razred:

No Controlled Drug Status

Tip zastaranja:

Valid as a prescribable product

Povzetek izdelek:

BNF: 03040100; GTIN: 5015265300333

Navodilo za uporabo

                                04/10/2019 10:04 - VISTAlink folder 103826549 - Page 1/4
PACKAGE LEAFLET:
INFORMATION FOR THE USER
TELFAST 180 MG
FILM-COATED TABLETS
Fexofenadine hydrochloride
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 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 fexofenadine is and what it is used for
2. What you need to know before you take
fexofenadine
3. How to take fexofenadine
4. Possible side effects
5. How to store fexofenadine
6. Contents of the pack and other information
1. WHAT FEXOFENADINE IS AND WHAT IT IS
USED FOR
The name of this medicine is Telfast 180 mg film
coated tablets, referred to as Fexofenadine
throughout this leaflet.
Fexofenadine is an antihistamine.
Fexofenadine 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 FEXOFENADINE
DO NOT TAKE FEXOFENADINE
• if you are 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 taking
fexofenadine if:
• you have problems with your liver or kidneys.
• you have or ever had heart disease, since this
kind of medicine may lead to a fast or irregular
heartbeat
• you are elderly.
If any of these apply to you, or you are not sure,
tell your doctor before taking fexofenadine.
OTHER MEDICINES AND FEXOFENADINE
Tell your doctor or pharmacist if you are taking,
have recently taken or might t
                                
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Lastnosti izdelka

                                OBJECT 1
TELFAST 180MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 25-Oct-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 180 mg film-coated tablets
2. Qualitative and quantitative composition
Each tablet contains 180 mg of fexofenadine hydrochloride, which is
equivalent to 168 mg of fexofenadine.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet
Peach, capsule-shaped, film-coated tablet debossed with “018” on
one side and a scripted “e” on the other
side.
4. Clinical particulars
4.1 Therapeutic indications
Telfast 180 mg is indicated in adults and children 12 years and older
for the relief of symptoms associated
with chronic idiopathic urticaria.
4.2 Posology and method of administration
Posology
_Adults_
The recommended dose of fexofenadine hydrochloride for adults is 180
mg once daily taken before a meal.
Fexofenadine is a pharmacologically active metabolite of terfenadine.
_Paed
                                
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