Amlodipine/Valsartan Genericon 10 mg/160 mg Filmdragerad tablett

Country: Шведска

Језик: Шведски

Извор: Läkemedelsverket (Medical Products Agency)

Активни састојак:

amlodipinbesilat; valsartan

Доступно од:

Genericon Pharma Ges.m.b.H.

АТЦ код:

C09DB01

INN (Међународно име):

amlodipine besylate; valsartan

Дозирање:

10 mg/160 mg

Фармацеутски облик:

Filmdragerad tablett

Састав:

valsartan 160 mg Aktiv substans; amlodipinbesilat 13,9 mg Aktiv substans

Тип рецептора:

Receptbelagt

Резиме производа:

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

Статус ауторизације:

Avregistrerad

Датум одобрења:

2017-01-27

Информативни летак

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
AMLODIPINE/VALSARTAN GENERICON 5 MG/80 MG FILM-COATED TABLETS
AMLODIPINE/VALSARTAN GENERICON 5 MG/160 MG FILM-COATED TABLETS
AMLODIPINE/VALSARTAN GENERICON 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 Amlodipine/Valsartan Genericon is and what it is used for
2.
What you need to know before you take Amlodipine/Valsartan Genericon
3.
How to take Amlodipine/Valsartan Genericon
4.
Possible side effects
5.
How to store Amlodipine/Valsartan Genericon
6.
Contents of the pack and other information
1.
WHAT AMLODIPINE/VALSARTAN GENERICON IS AND WHAT IT IS USED FOR
Amlodipine/Valsartan Genericon 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.
Amlodipine/Valsartan Genericon is used to treat high blood

Карактеристике производа

1
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Amlodipine/Valsartan Genericon 5 mg/80 mg film-coated tablets
Amlodipine/Valsartan Genericon 5 mg/160 mg film-coated tablets
Amlodipine/Valsartan Genericon 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.
Amlodipine/Valsartan Genericon 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 Amlodipine/Valsartan Genericon is one tablet
per day.
Amlodipine/Valsartan Genericon 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.
Amlodipine/Valsartan Genericon 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.
3
Amlodipine/Valsartan Genericon 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
Amlodipine/Valsartan Genericon 5 mg/160 mg.
Amlodipine/Valsartan G