Fexofenadine Bluefish 120 mg Filmdragerad tablett

Country: Шведска

Језик: Шведски

Извор: Läkemedelsverket (Medical Products Agency)

Активни састојак:

fexofenadinhydroklorid

Доступно од:

Bluefish Pharmaceuticals AB

АТЦ код:

R06AX26

INN (Међународно име):

fexofenadine hydrochloride

Дозирање:

120 mg

Фармацеутски облик:

Filmdragerad tablett

Састав:

fexofenadinhydroklorid 120 mg Aktiv substans

Тип рецептора:

Receptbelagt

Резиме производа:

Förpacknings: Blister, 7 tabletter; Blister, 10 tabletter; Blister, 15 tabletter; Blister, 20 tabletter; Blister, 30 tabletter; Blister, 50 tabletter; Blister, 100 tabletter; Blister, 200 (10 x 20) tabletter

Статус ауторизације:

Godkänd

Датум одобрења:

2017-09-25

Информативни летак

1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
FEXOFENADINE BLUEFISH 120 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 or
nurse.
-
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 or
nurse. This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Fexofenadine Bluefish is and what it is used for
2.
What you need to know before you take Fexofenadine Bluefish
3.
How to take Fexofenadine Bluefish
4.
Possible side effects
5.
How to store Fexofenadine Bluefish
6.
Contents of the pack and other information
1.
WHAT FEXOFENADINE BLUEFISH IS AND WHAT IT IS USED FOR
Fexofenadine Bluefish contains fexofenadine hydrochloride, which is a
non-drowsy antihistamine.
Fexofenadine Bluefish 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 FEXOFENADINE BLUEFISH
DO NOT TAKE FEXOFENADINE BLUEFISH
-
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 Bluefish
if:
-
you have or ever had heart disease, since this kind of medicine may
lead to a fast or irregular heart beat
-
you are elderly
-
you have problems with your liver or kidneys.
If any of these apply to you, or if you are not sure, tell your doctor
before taking Fexofenadine Bluefish.
OTHER MEDICINES AND FEXOFENADINE BLUEFISH
Tell your doctor or pharmacist

Карактеристике производа

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Fexofenadine Bluefish 120 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 120 mg fexofenadine hydrochloride, which is
equivalent to 112 mg fexofenadine.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Peach-colored, 15 mm x 6.6 mm capsule-shaped, biconvex, film-coated
tablet.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Fexofenadine Bluefish 120 mg is indicated in adults and children 12
years and older for the relief of
symptoms associated with seasonal allergic rhinitis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults_
The recommended dose of fexofenadine hydrochloride for adults is 120
mg once daily taken before a meal.
Fexofenadine is a pharmacologically active metabolite of terfenadine.
_Paediatric population_
•
Children aged 12 years and over
The recommended dose of fexofenadine hydrochloride for children aged
12 years and over is 120 mg once
daily taken before a meal.
•
Children under 12 years of age
The efficacy and safety of fexofenadine hydrochloride has not been
studied in children under 12 years of
age.
In children from 6 to 11 years of age: fexofenadine hydrochloride 30
mg tablet is the appropriate formulation
for administration and dosing in this population.
_Special populations _
Studies in special risk groups (elderly, renally or hepatically
impaired patients) indicate that it is not
necessary to adjust the dose of fexofenadine hydrochloride in these
patients.
Method of administration
Oral use
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
(listed in section 6.1).
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
There is limited data in the elderly and renally or hepatically
impaired patients. Fexofenadine hydrochloride
should be administered with care in these special groups(see section
4.2).
Patients with a history of or ongoing cardiovascular disease should be
warned that, antihistamin