Amlodipine/Valsartan Denk 5 mg/160 mg Filmdragerad tablett

देश: स्वीडन

भाषा: स्वीडिश

स्रोत: Läkemedelsverket (Medical Products Agency)

सक्रिय संघटक:

amlodipinbesilat; valsartan

थमां उपलब्ध:

Denk Pharma GmbH & Co KG

ए.टी.सी कोड:

C09DB01

INN (इंटरनेशनल नाम):

amlodipine besylate; valsartan

डोज़:

5 mg/160 mg

फार्मास्यूटिकल फॉर्म:

Filmdragerad tablett

रचना:

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

प्रिस्क्रिप्शन प्रकार:

Receptbelagt

उत्पाद समीक्षा:

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

प्राधिकरण का दर्जा:

Godkänd

प्राधिकरण की तारीख:

2017-01-27

सूचना पत्रक

PACKAGE LEAFLET: INFORMATION FOR THE USER
AMLODIPINE/VALSARTAN DENK 5 MG/80 MG FILM-COATED TABLETS
AMLODIPINE/VALSARTAN DENK 5 MG/160 MG FILM-COATED TABLETS
AMLODIPINE/VALSARTAN DENK 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 Denk is and what it is used for
2.
What you need to know before you take Amlodipine/Valsartan Denk
3.
How to take Amlodipine/Valsartan Denk
4.
Possible side effects
5.
How to store Amlodipine/Valsartan Denk
6.
Contents of the pack and other information
1.
WHAT AMLODIPINE/VALSARTAN DENK IS AND WHAT IT IS USED FOR
Amlodipine/Valsartan Denk 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 Denk is used to treat high blood pressure in
adults whose blood pressure is not
controlled enough with either

उत्पाद विशेषताएं

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Amlodipine/Valsartan Denk 5 mg/80 mg film-coated tablets
Amlodipine/Valsartan Denk 5 mg/160 mg film-coated tablets
Amlodipine/Valsartan Denk 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 Denk 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 Denk is one tablet per
day.
Amlodipine/Valsartan Denk 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 Denk 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.
Amlodipine/Valsartan Denk 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
Denk 5 mg/160 mg.
Amlodipine/Valsartan Denk can be used with or without food.
Individual