Amlodipine / Valsartan Mylan

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

Amlodipine besilate, valsartan

Available from:

Mylan Pharmaceuticals Limited

ATC code:

C09DB01

INN (International Name):

amlodipine, valsartan

Therapeutic group:

Agents acting on the renin-angiotensin system

Therapeutic area:

Hypertension

Therapeutic indications:

Treatment of essential hypertension.Amlodipine/Valsartan Mylan is indicated in adults whose blood pressure is not adequately controlled on amlodipine or valsartan monotherapy.

Product summary:

Revision: 11

Authorization status:

Authorised

Authorization date:

2016-03-22

Patient Information leaflet

45
B. PACKAGE LEAFLET
46
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
AMLODIPINE/VALSARTAN MYLAN 5 MG/80 MG FILM-COATED TABLETS
AMLODIPINE/VALSARTAN MYLAN 5 MG/160 MG FILM-COATED TABLETS
AMLODIPINE/VALSARTAN MYLAN 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 Mylan is and what it is used for
2.
What you need to know before you take Amlodipine/Valsartan Mylan
3.
How to take Amlodipine/Valsartan Mylan
4.
Possible side effects
5.
How to store Amlodipine/Valsartan Mylan
6.
Contents of the pack and other information
1.
WHAT AMLODIPINE/VALSARTAN MYLAN IS AND WHAT IT IS USED FOR
Amlodipine/Valsartan Mylan tablets contain two active 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 Mylan is used to treat high blood pressure in
adults whose blood p

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Amlodipine/Valsartan Mylan 5 mg/80 mg film-coated tablets
Amlodipine/Valsartan Mylan 5 mg/160 mg film-coated tablets
Amlodipine/Valsartan Mylan 10 mg/160 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Amlodipine/Valsartan Mylan 5 mg/80 mg film-coated tablets
Each film-coated tablet contains 5 mg of amlodipine (as amlodipine
besilate) and 80 mg of valsartan.
Amlodipine/Valsartan Mylan 5 mg/160 mg film-coated tablets
Each film-coated tablet contains 5 mg of amlodipine (as amlodipine
besilate) and 160 mg of valsartan.
Amlodipine/Valsartan Mylan 10 mg/160 mg film-coated tablets
Each film-coated tablet contains 10 mg of amlodipine (as amlodipine
besilate) and 160 mg of
valsartan.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Amlodipine/Valsartan Mylan 5 mg/80 mg film-coated tablets
Light yellow, round, approximately 9 mm diameter, biconvex film-coated
tablet debossed with “AV1”
on one side and “M” on the other side.
Amlodipine/Valsartan Mylan 5 mg/160 mg film-coated tablets
Yellow, oval, approximately 15.6 mm × 7.8 mm, biconvex film-coated
tablet debossed with “AV2” on
one side and “M” on the other side.
Amlodipine/Valsartan Mylan 10 mg/160 mg film-coated tablets
Light brown, oval, approximately 15.6 mm × 7.8 mm, biconvex
film-coated tablet debossed with
“AV3” on one side and “M” on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of essential hypertension.
Amlodipine/Valsartan Mylan is indicated in adults whose blood pressure
is not adequately controlled
on amlodipine or valsartan monotherapy.
_ _
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
3
The recommended dose of Amlodipine/Valsartan Mylan is one tablet per
day.
_Amlodipine/Valsartan Mylan 5 mg/80 mg film-coated tablets _
Amlodipine/Valsartan Mylan 5 mg/80 mg may be administered in patients
whose blood pressure is not
adequately controlled with amlodipine 5 mg