Atenolol/Chloortalidon Sandoz 50/12,5, filmomhulde tabletten 50/12,5 mg

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

ATENOLOL ; CHLOORTALIDON

Beschikbaar vanaf:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

ATC-code:

C07CB03

INN (Algemene Internationale Benaming):

ATENOLOL ; CHLOORTALIDON

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

GELATINE (E 441) ; HYPROMELLOSE (E 464) ; MACROGOL 6000 ; MAGNESIUMCARBONAAT, ZWAAR (E 504 (II)) ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL ; NATRIUMLAURILSULFAAT (E 487) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Atenolol And Other Diuretics

Product samenvatting:

Hulpstoffen: GELATINE (E 441); HYPROMELLOSE (E 464); MACROGOL 6000; MAGNESIUMCARBONAAT, ZWAAR (E 504 (II)); MAGNESIUMSTEARAAT (E 470b); MAÏSZETMEEL; NATRIUMLAURILSULFAAT (E 487); TALK (E 553 B); TITAANDIOXIDE (E 171);

Autorisatie datum:

1993-05-24

Bijsluiter

Sandoz B.V.
Page 1/8
Atenolol/chloortalidon Sandoz 50/12,5, 100/25, filmomhulde tabletten
50/12,5
mg, 100/25 mg
RVG 15842-15843
V12
1.3.1.3 Bijsluiter
Mei 2020
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ATENOLOL/CHLOORTALIDON SANDOZ 50/12,5, FILMOMHULDE TABLETTEN 50/12,5
MG
ATENOLOL/CHLOORTALIDON SANDOZ 100/25, FILMOMHULDE TABLETTEN 100/25 MG
atenolol, chlortalidone
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. Content of the pack and other information
1. WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR_ _
[Nationally completed name] is used to treat high blood pressure
(hypertension). It contains
two different medicines called atenolol and chlortalidone.

Atenolol belongs to a group of medicines called ‘beta-blockers’.
It works by slowing
down your heartbeat and making it beat with less force.

Chlortalidone belongs to a group of medicines called water tablets
(diuretics). It works by
increasing the amount of urine made by your kidneys.
These medicines work together to lower your blood pressure.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE [NATIONALLY COMPLETED NAME]
DO NOT TAKE [NATIONALLY COMPLETED NAME] IF:

you are allergic to active substances or any of the other ingredients
of this medicine (listed
in section 6).

yo

Productkenmerken

Sandoz B.V.
Page 1/10
Atenolol/Chloortalidon Sandoz
®
50/12,5, 100/25,
V14
filmomhulde tabletten 50/12,5 mg, 100/25 mg
RVG 15842-15843
1.3.1.3 Bijsluiter
Mei 2020
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
ATENOLOL/CHLOORTALIDON SANDOZ 50/12,5, FILMOMHULDE TABLETTEN 50/12,5
MG
ATENOLOL/CHLOORTALIDON SANDOZ 100/25, FILMOMHULDE TABLETTEN 100/25 MG
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 50 mg atenolol and 12.5 mg
chlortalidone.
Each film-coated tablet contains 100 mg atenolol and 25 mg
chlortalidone.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
50/12.5 mg film-coated tablets
White, round, film-coated tablets with the inscription A50 C12.5
100/25 mg film-coated tablets
White, round, film-coated tablets with the inscription A100 C25
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Hypertension that has not responded satisfactorily to treatment with a
beta blocker or diuretic alone.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
One tablet daily. The clinical effect is achieved rapidly and lasts
for at least 24 hours after
administration of one single oral dose. [Nationally completed name] as
fixed dosage combination is
particularly utilized in maintenance therapy after the required dose
has been established.
USE IN THE ELDERLY
Dosage requirements are often lower in this age group.
USE IN CHILDREN AND ADOLESCENTS (< 18 YEARS)
There is no experience with [nationally completed name] in children
and adolescents. Therefore
[nationally completed name] should not be administered to children and
adolescents.
USE IN PATIENTS WITH RENAL FAILURE
Sandoz B.V.
Page 2/10
Atenolol/Chloortalidon Sandoz
®
50/12,5, 100/25,
V14
filmomhulde tabletten 50/12,5 mg, 100/25 mg
RVG 15842-15843
1.3.1.3 Bijsluiter
Mei 2020
Due to the properties of the chlorthalidone component, [nationally
completed name] has reduced
efficacy in the presence of renal insufficiency. This fixed dose
combination should thus not be
administrated to patients wi