Betaxolol HCl Mylan 20 mg, filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

BETAXOLOLHYDROCHLORIDE SAMENSTELLING overeenkomend met ; BETAXOLOL

Beschikbaar vanaf:

Mylan B.V.

ATC-code:

C07AB05

INN (Algemene Internationale Benaming):

BETAXOLOLHYDROCHLORIDE COMPOSITION corresponding to ; BETAXOLOL

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

CELLULOSE, MICROKRISTALLIJN (E 460) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; LACTOSE 1-WATER ; MACROGOL 400 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; LACTOSE 1-WATER ; MACROGOL 400 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT (E468) ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Betaxolol

Product samenvatting:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); LACTOSE 1-WATER; MACROGOL 400; MAGNESIUMSTEARAAT (E 470b); NATRIUMZETMEELGLYCOLAAT (E468); SILICIUMDIOXIDE (E 551); TITAANDIOXIDE (E 171);

Autorisatie datum:

2016-10-19

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
BETAXOLOL HCL MYLAN 20 MG, FILMOMHULDE TABLETTEN
_ _
betaxolol 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 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 Betaxolol hydrochloride is and what it is used for
2.
What you need to know before you take Betaxolol hydrochloride
3.
How to take Betaxolol hydrochloride
4.
Possible side effects
5.
How to store Betaxolol hydrochloride
6.
Contents of the pack and other information
1.
WHAT BETAXOLOL HYDROCHLORIDE IS AND WHAT IT IS USED FOR
Betaxolol hydrochloride belongs to a group of medicines called
beta-blockers. These medicines lower
blood pressure, slow heart rate and reduce the heart oxygen
consumption.
Betaxolol hydrochloride is used for the treatment of high blood
pressure (hypertension) in adults, of mild
to moderate forms.
It is also used for long-term treatment of attacks of stable angina
pectoris (chest pain resulting from
insufficient blood supply to the heart muscle due to exertion or
stress) in adults.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE BETAXOLOL HYDROCHLORIDE
DO NOT TAKE BETAXOLOL HYDROCHLORIDE IF YOU:

are allergic to betaxolol or any of the other ingredients of this
medicine (listed in section 6)

have severe asthma and another serious breathing problem called
chronic obstructive lung disease
(COPD), which makes you breathless when active with a cough with
phlegm and suffer from
frequent chest infections

have severe heart failure

have cardiogenic shock (failure of the heart to pump effectively)

have hear

Productkenmerken

1.
NAME OF THE MEDICINAL PRODUCT
Betaxolol HCl Mylan 20 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 20 mg betaxolol hydrochloride
(equivalent to 17.88 mg betaxolol).
Excipient with known effect
Each film-coated tablet contains 100.00 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
White, round, biconvex film-coated tablets with a break-line on one
face.
The tablet can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Betaxolol Hydrochloride is indicated in adults for:
Treatment of essential hypertension.
Chronic, stable angina pectoris.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults _
_Essential hypertension_
_ _
The initial dose is 10 mg once daily. In case of insufficient effect
this dosage can be increased to 20 mg
per day.
In moderate hypertension the standard dose is 20 mg once daily.
In certain cases it could be necessary to increase the daily dose to
40 mg.
_Stable angina pectoris _
The dosage should be adjusted individually. The starting dose is 10 mg
a day, which can be increased to
the usual dose of 20 mg once daily. In certain cases it could be
necessary to increase the daily dose to 40
mg.
_Patients with impaired renal or liver function _
In patients with renal impairment (creatinine clearance up to 20
ml/minute) there is no need to adjust the
daily dose, however, clinical monitoring at the beginning of the
treatment until steady plasma levels of the
medicinal product are attained (over 4 days on average) is
recommended.
In patients with severe renal impairment (creatinine clearance below
20 ml/minute) and in patients with
haemo- or peritoneal dialysis the dose of 10 mg/day should not be
exceeded. In patients on dialysis the
daily dose can be given independent of the time of dialysis.
In patients with liver failure there is no need to adjust the dose.
Careful clinical monitoring is
recommended at the beginning of the treatment.
_Elder