Atenolol Sandoz 25, tabletten 25 mg

Land: Nederland

Taal: Nederlands

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

Koop het nu

Bijsluiter Bijsluiter (PIL)
21-09-2022
Productkenmerken Productkenmerken (SPC)
24-03-2021

Werkstoffen:

ATENOLOL 25 mg/stuk

Beschikbaar vanaf:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

ATC-code:

C07AB03

INN (Algemene Internationale Benaming):

ATENOLOL 25 mg/stuk

farmaceutische vorm:

Tablet

Samenstelling:

CELLULOSE, MICROKRISTALLIJN (E 460) ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL ; NATRIUMZETMEELGLYCOLAAT ; POVIDON K 25 (E 1201) ; SILICIUMDIOXIDE (E 551), CELLULOSE, MICROKRISTALLIJN (E 460) ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL ; NATRIUMZETMEELGLYCOLAAT (E468) ; POVIDON K 25 (E 1201) ; SILICIUMDIOXIDE (E 551),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Atenolol

Product samenvatting:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); MAGNESIUMSTEARAAT (E 470b); MAÏSZETMEEL; NATRIUMZETMEELGLYCOLAAT (E468); POVIDON K 25 (E 1201); SILICIUMDIOXIDE (E 551);

Autorisatie datum:

2000-07-17

Bijsluiter

                                Sandoz B.V.
Page 1/9
Atenolol Sandoz
®
25/50/100, tabletten 25/50/100 mg
RVG 24399-14705-14706
1313-V13
1.3.1.3 Bijsluiter
Maart 2021
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ATENOLOL SANDOZ
® 25, TABLETTEN 25 MG
ATENOLOL SANDOZ
® 50, TABLETTEN 50 MG
ATENOLOL SANDOZ
® 100, TABLETTEN 100 MG
ATENOLOL
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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
[Nationally completed name] contains a medicine called atenolol. This
belongs to a group of
medicines called beta-blockers.
[Nationally completed name] is used to:
•
treat high blood pressure (hypertension)
•
treat chest pain caused by “chronic stable angina pectoris”
•
treat some types of uneven heart beats (arrhythmias)
•
help prevent another heart attack from happening.
It works by making your heart beat more slowly and with less force.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE [NATIONALLY COMPLETED NAME]
DO NOT TAKE [NATIONALLY COMPLETED NAME]
IF:
•
You are allergic to atenolol or any of the other ingredients of this
medicine (listed in section 6).
•
You have ever had any of the following heart problems:
o
heart failure which is not under control (this usually makes you
breathless and caus
                                
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Productkenmerken

                                Sandoz B.V.
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Atenolol Sandoz 25/50/100, tabletten 25/50/100 mg
RVG 24399-14705-14706
1311-V12
1.3.1.1 Samenvatting van de Productkenmerken
Maart 2021
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Atenolol Sandoz 25, tabletten 25 mg
Atenolol Sandoz 50, tabletten 50 mg
Atenolol Sandoz 100, tabletten 100 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 25 mg atenolol.
Each tablet contains 50 mg atenolol.
Each tablet contains 100 mg atenolol.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
_25 mg tablets: _
White, round biconvex tablets, on one side an inscription ‘25’
and` on the other side a score.
Diameter: 7 mm.
_50 mg tablets: _
White, round biconvex tablets, on one side an inscription ‘50’ and
on the other side a score.
Diameter: 8 mm.
_100 mg tablets: _
White, round biconvex tablets, on one side an inscription ‘100’
and on the other side a score.
Diameter: 10 mm.
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal
doses.
4. CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
•
Hypertension
•
Chronic stable angina pectoris
•
Secondary prevention after acute myocardial infarction
•
Supraventricular arrhythmias:
-
paroxysmal supraventricular tachycardia (in therapeutic or
prophylactic treatment)
-
atrial fibrillation and atrial flutter: in case of inadequate response
to maximum doses of cardiac glycosides; in cases where cardiac
glycosides may be contra-indicated or may be associated with an
unfavourable risk/benefit ratio.
•
Ventricular arrhythmias:
-
ventricular extrasystoles (prophylactic or therapeutic treatment), if
the extrasystoles are
Sandoz B.V.
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Atenolol Sandoz 25/50/100, tabletten 25/50/100 mg
RVG 24399-14705-14706
1311-V12
1.3.1.1 Samenvatting van de Productkenmerken
Maart 2021
the result of increased sympathetic activity
-
ventricular tachycardias and ventricular fibrillation (prophylactic
treatment), especially
when the ventricular abnormality i
                                
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