Valtensam 5 mg/160 mg Filmdragerad tablett

Nazione: Svezia

Lingua: svedese

Fonte: Läkemedelsverket (Medical Products Agency)

Principio attivo:

amlodipinbesilat; valsartan

Commercializzato da:

Teva B.V.

Codice ATC:

C09DB01

INN (Nome Internazionale):

amlodipine besylate; valsartan

Dosaggio:

5 mg/160 mg

Forma farmaceutica:

Filmdragerad tablett

Composizione:

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

Tipo di ricetta:

Receptbelagt

Dettagli prodotto:

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

Stato dell'autorizzazione:

Godkänd

Data dell'autorizzazione:

2016-11-25

Foglio illustrativo

PACKAGE LEAFLET: INFORMATION FOR THE USER
VALTENSAM 5 MG/160 MG FILM-COATED TABLETS
VALTENSAM 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 Valtensam is and what it is used for
2.
What you need to know before you take Valtensam
3.
How to take Valtensam
4.
Possible side effects
5.
How to store Valtensam
6.
Contents of the pack and other information
1.
WHAT VALTENSAM IS AND WHAT IT IS USED FOR
Valtensam 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.
Valtensam is used to treat high blood pressure in adults whose blood
pressure is not controlled
enough with either amlodipine or valsartan on its own.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE VALTENSAM
DO NOT TAKE VALTENSAM
−
if you are allergic to amlodipine or to any other calcium channel
blockers. This may
inv

Scheda tecnica

1.
NAME OF THE MEDICINAL PRODUCT
Valtensam 5 mg/160 mg film-coated tablets
Valtensam 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 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/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.
Valtensam 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 Valtensam is one tablet per day.
Valtensam 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.
Valtensam 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
Valtensam 5 mg/160 mg.
Valtensam can be used with or without food.
Individual dose titration with the components (i.e. amlodipine and
valsartan) is recommended before
changing to the fixed dose combination. When clinically appropriate,
direct change from monotherapy
to the fixed-dose combination may be considered.
For convenience, patients receiving valsartan and amlodipine from
separate tablets/capsules may be
switched to Valtensam containing the same component doses.
_Renal impairment_
There are no available clinical data in severely renally impaired
patients. No dosage adjustment is
required for patients with mild to moderate renal impairment.
Monitoring of potassium levels and
cr