Byblok 5 mg, filmomhulde tabletten

Χώρα: Ολλανδία

Γλώσσα: Ολλανδικά

Πηγή: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Δραστική ουσία:

BISOPROLOLFUMARAAT SAMENSTELLING overeenkomend met ; BISOPROLOL

Διαθέσιμο από:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

Φαρμακολογική κατηγορία (ATC):

C07AB07

INN (Διεθνής Όνομα):

BISOPROLOLFUMARAAT COMPOSITION corresponding to ; BISOPROLOL

Φαρμακοτεχνική μορφή:

Filmomhulde tablet

Σύνθεση:

CALCIUMDIWATERSTOFFOSTAAT 0-WATER ; CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSPOVIDON (E 1202) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE ROOD (E 172) ; MACROGOL 6000 ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL, GEPREGELATINEERD ; POLYSORBAAT 80 (E 433) ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171),

Οδός χορήγησης:

Oraal gebruik

Θεραπευτική περιοχή:

Bisoprolol

Περίληψη προϊόντος:

Hulpstoffen: CALCIUMDIWATERSTOFFOSTAAT 0-WATER; CELLULOSE, MICROKRISTALLIJN (E 460); CROSPOVIDON (E 1202); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); IJZEROXIDE ROOD (E 172); MACROGOL 6000; MAGNESIUMSTEARAAT (E 470b); MAÏSZETMEEL, GEPREGELATINEERD; POLYSORBAAT 80 (E 433); SILICIUMDIOXIDE (E 551); TITAANDIOXIDE (E 171);

Ημερομηνία της άδειας:

2017-01-16

Φύλλο οδηγιών χρήσης

Sandoz B.V.
Byblok 5 mg, 10 mg filmomhulde tabletten
Page 1/9
RVG 118309-13
1313-v2
1.3.1.3 Package Leaflet
Augustus 2021
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
BYBLOK 5 MG, FILMOMHULDE TABLETTEN
BYBLOK 10 MG, FILMOMHULDE TABLETTEN
bisoprolol fumarate
_ _
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 [Nationally completed name] is and what it is used for
2. What you need to know before you take [Nationally completed name]
3. How to take [Nationally completed name]
4. Possible side effects
5. How to store [Nationally completed name]
6. Contents of the pack and other information
1. WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR
The active substance in [Nationally completed name] is bisoprolol.
Bisoprolol belongs to a group of medicines called beta-blockers. They
protect the heart against too
much activity.
[Nationally completed name] is used in combination with other
medicines to treat stable heart failure.
[Nationally completed name] is also used to treat high blood pressure
(hypertension) and angina
pectoris (chest pain caused by blockages in the arteries that supply
the heart muscle).
Heart failure occurs when the heart muscle is too weak to pump blood
around the body adequately.
This results in breathlessness and swelling. Bisoprolol slows down the
heart rate and makes the heart
more efficient at pumping blood around the body. It is used in
combination with other medicines
suitable for this condition (such as ACE-inhibitors, diuretics, and
heart glycosides).
2. WHAT YOU NEE

Αρχείο Π.Χ.Π.

Sandoz B.V.
Page 1/14
Byblok 5 mg, 10 mg, filmomhulde tabletten
RVG 118309-13
1311-v3
1.3.1.1 Summary of Product Characteristics
Augustus 2021
_ _
1.
NAME OF THE MEDICINAL PRODUCT
Byblok 5 mg, filmomhulde tabletten
Byblok 10 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_5 mg film-coated tablets: _
Each film-coated tablet contains 5 mg of bisoprolol fumarate.
_10 mg film-coated tablets: _
Each film-coated tablet contains 10 mg of bisoprolol fumarate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
_5 mg film-coated tablets: _
Pink coloured, round, biconvex, film-coated tablets of approximately
6.1 x 2.80 mm with “U5”
debossed on one side and scored notch on other side.
The tablet can be divided into equal doses.
_10 mg film-coated tablets: _
White to off-white coloured, round, biconvex, film-coated tablets of
approximately 7.1 x 4.10 mm
with “U10” debossed on one side and scored notch on other side
The tablet can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of hypertension
Treatment of angina pectoris
Treatment of stable chronic heart failure with reduced systolic left
ventricular function in addition to
ACE inhibitors, and diuretics, and optionally cardiac glycosides (for
additional information see section
5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Sandoz B.V.
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Byblok 5 mg, 10 mg, filmomhulde tabletten
RVG 118309-13
1311-v3
1.3.1.1 Summary of Product Characteristics
Augustus 2021
Hypertension/Angina pectoris
_Adults _
The dosage should be individually adjusted, in particular according to
the pulse rate and therapeutic
success. It is recommended to start with 5 mg per day. The usual dose
is 10 mg once daily with a
maximum recommended dose of 20 mg once daily.
_Elderly _
It is recommended to start with the lowest possible dose.
_Renal or hepatic impairment _
In patients with liver or kidney function disorders of mild to
moderate severity, no dosage adjustment
is normally