Amlodipin/Valsartan/HCT beta 5 mg/160 mg/12,5 mg Filmtabletten

Land: Deutschland

Sprache: Deutsch

Quelle: BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte)

Wirkstoff:

Amlodipinbesilat; Valsartan; Hydrochlorothiazid

Verfügbar ab:

betapharm Arzneimittel GmbH (3364323)

ATC-Code:

C09DX01

INN (Internationale Bezeichnung):

Amlodipine Besylate, Valsartan, Hydrochlorothiazide

Darreichungsform:

Filmtablette

Zusammensetzung:

Teil 1 - Filmtablette; Amlodipinbesilat (24866) 6,935 Milligramm; Valsartan (26826) 160 Milligramm; Hydrochlorothiazid (00512) 12,5 Milligramm

Verabreichungsweg:

zum Einnehmen

Berechtigungsstatus:

zugelassen

Berechtigungsdatum:

2019-10-17

Gebrauchsinformation

_ _
PACKAGE LEAFLET: INFORMATION FOR THE USER
[INVENTED NAME] 5 MG/160 MG/12.5 MG FILM-COATED TABLETS
[INVENTED NAME] 10 MG/160 MG/12.5 MG FILM-COATED TABLETS
[INVENTED NAME] 5 MG/160 MG/25 MG FILM-COATED TABLETS
[INVENTED NAME] 10 MG/160 MG/25 MG FILM-COATED TABLETS
[INVENTED NAME] 10 MG/320 MG/25 MG FILM-COATED TABLETS
amlodipine/valsartan/hydrochlorothiazide
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 [Invented Name] is and what it is used for
2.
What you need to know before you take [Invented Name]
3.
How to take [Invented Name]
4.
Possible side effects
5.
How to store [Invented Name]
6.
Contents of the pack and other information
1.
WHAT [INVENTED NAME] IS AND WHAT IT IS USED FOR
[Invented Name] contains three substances called amlodipine, valsartan
and hydrochlorothiazide.
All of these substances help to control high blood pressure.
-
Amlodipine belongs to a group of substances called “calcium channel
blockers”. Amlodipine
stops calcium from moving into the blood vessel wall, which stops the
blood vessels from
tightening.
-
Valsartan belongs to a group of substances called “angiotensin-II
receptor antagonists”.
Angiotensin II is produced by the body and makes the blood vessels
tighten, thus increasing
the blood pressure. Valsartan works by blocking the effect of
angiotensin II.
-
Hydrochlorothiazide belongs to a group of substances called
“thiazide diuretics”.
Hydrochlorothiazide increases urine output, which also lowers blood
pressure.
As a result of all three mechanisms, t

Fachinformation

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
[Invented Name] 5 mg/160 mg/12.5mg film-coated Tablets
[Invented Name] 10 mg/160 mg/12.5mg film-coated Tablets
[Invented Name] 5 mg/160 mg/25mg film-coated Tablets
[Invented Name] 10 mg/160 mg/25mg film-coated Tablets
[Invented Name] 10 mg/320 mg/25mg film-coated Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
[Invented Name] 5 mg/160 mg/12.5mg film-coated Tablets
Each film-coated tablet contains 5 mg of Amlodipine (as Amlodipine
besilate), 160 mg of
Valsartan and 12.5 mg of Hydrochlorothiazide.
[Invented Name] 10 mg/160 mg/12.5mg film-coated Tablets
Each film-coated tablet contains 10 mg of Amlodipine (as Amlodipine
besilate), 160 mg of
Valsartan and 12.5 mg of Hydrochlorothiazide.
[Invented Name] 5 mg/160 mg/25mg film-coated Tablets
Each film-coated tablet contains 5 mg of Amlodipine (as Amlodipine
besilate), 160 mg of
Valsartan and 25 mg of Hydrochlorothiazide.
[Invented Name] 10 mg/160 mg/25mg film-coated Tablets Each film-coated
tablet contains 10
mg
of
Amlodipine
(as
Amlodipine
besilate),
160
mg
of
Valsartan
and
25
mg
of
Hydrochlorothiazide.
[Invented Name] 10 mg/320 mg/25mg film-coated Tablets Each film-coated
tablet contains 10
mg
of
Amlodipine
(as
Amlodipine
besilate),
320
mg
of
Valsartan
and
25
mg
of
Hydrochlorothiazide.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL
FORM
Film-coated tablet.
[Invented Name] 5 mg/160 mg/12.5mg film-coated Tablets
White, oval shaped, biconvex, film-coated tablets debossed with
“T23” on one side and plain on
other side. (Dimension - 15.1± 0.3 mm X 7.1± 0.3 mm)
[Invented Name] 10 mg/160 mg/12.5mg film-coated Tablets
Pale yellow, oval shaped, biconvex, film-coated tablets debossed with
“C96” on one side and
plain on other side. (Dimension - 15.6 ± 0.3 mm X 6.6 ± 0.3 mm)
[Invented Name] 5 mg/160 mg/25mg film-coated Tablets
Yellow, oval shaped, biconvex, film-coated tablets debossed with
“T25” on one side and plain on
other side. (Dimension- 15.1± 0.3 mm X 7.1± 0.3