Amlodipin/Valsartan Actavis 5 mg/160 mg Filmdragerad tablett

Land: Zweden

Taal: Zweeds

Bron: Läkemedelsverket (Medical Products Agency)

Werkstoffen:

amlodipinbesilat; valsartan

Beschikbaar vanaf:

Actavis Group PTC ehf.

ATC-code:

C09DB01

INN (Algemene Internationale Benaming):

amlodipine besylate; valsartan

Dosering:

5 mg/160 mg

farmaceutische vorm:

Filmdragerad tablett

Samenstelling:

amlodipinbesilat 6,95 mg Aktiv substans; valsartan 160 mg Aktiv substans

Prescription-type:

Receptbelagt

Product samenvatting:

Förpacknings: Blister, 7 tabletter; Blister, 14 tabletter; Blister, 28 tabletter; Blister, 30 tabletter; Blister, 56 tabletter; Blister, 60 tabletter; Blister, 90 tabletter; Blister, 98 tabletter; Blister, 280 tabletter

Autorisatie-status:

Godkänd

Autorisatie datum:

2016-11-25

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE USER
AMLODIPIN/VALSARTAN ACTAVIS 5 MG/80 MG FILM-COATED TABLETS
AMLODIPIN/VALSARTAN ACTAVIS 5 MG/160 MG FILM-COATED TABLETS
AMLODIPIN/VALSARTAN ACTAVIS 10 MG/160 MG FILM-COATED TABLETS
amlodipine/valsartan
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 Amlodipin/Valsartan Actavis is and what it is used for
2.
What you need to know before you take Amlodipin/Valsartan Actavis
3.
How to take Amlodipin/Valsartan Actavis
4.
Possible side effects
5.
How to store Amlodipin/Valsartan Actavis
6.
Contents of the pack and other information
1.
WHAT AMLODIPIN/VALSARTAN ACTAVIS IS AND WHAT IT IS USED FOR
Amlodipin/Valsartan Actavis tablets contain two substances called
amlodipine and valsartan. Both
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.
This means that both of these substances help to stop the blood
vessels tightening. As a result,
the blood vessels relax and blood pressure is lowered.
Amlodipin/Valsartan Actavis is used to treat high blood pressure in
adults whose blood pressure is
not controlled

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Amlodipin/Valsartan Actavis 5 mg/80 mg film-coated tablets
Amlodipin/Valsartan Actavis 5 mg/160 mg film-coated tablets
Amlodipin/Valsartan Actavis 10 mg/160 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 5 mg of amlodipine (as amlodipine
besylate) and 80 mg of valsartan.
Each film-coated tablet contains 5 mg of amlodipine (as amlodipine
besylate) and 160 mg of valsartan.
Each film-coated tablet contains 10 mg of amlodipine (as amlodipine
besylate) and 160 mg of
valsartan.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
5mg/80mg
Yellow, 8mm round, biconvex, film-coated tablet, imprinted with
“I” on one side and “LD” on the
other side.
5mg/160mg
Yellow, 13.5 x 7mm oval, biconvex, film-coated tablet, imprinted with
“2” on one side and “LD” on
the other side.
10mg/160mg
White, 13.5 x 7mm oval, biconvex, film-coated tablet, imprinted with
“3” on one side and “LD” on
the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of essential hypertension.
Amlodipin/Valsartan Actavis is indicated in adults whose blood
pressure is not adequately controlled
on amlodipine or valsartan monotherapy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose of Amlodipin/Valsartan Actavis is one tablet per
day.
Amlodipin/Valsartan Actavis 5 mg/80 mg may be administered in patients
whose blood pressure is not
adequately controlled with amlodipine 5 mg or valsartan 80 mg alone.
Amlodipin/Valsartan Actavis 5 mg/160 mg may be administered in
patients whose blood pressure is
not adequately controlled with amlodipine 5 mg or valsartan 160 mg
alone.
Amlodipin/Valsartan Actavis 10 mg/160 mg may be administered in
patients whose blood pressure is
not adequately controlled with amlodipine 10 mg or valsartan 160 mg
alone or with
Amlodipin/Valsartan Actavis 5 mg/160 mg.
Amlodipin/Valsartan Actavis can be used with or without