Konverge 20mg/5mg film-coated Tablets

Χώρα: Μάλτα

Γλώσσα: Αγγλικά

Πηγή: Medicines Authority

Δραστική ουσία:

AMLODIPINE, OLMESARTAN MEDOXOMIL

Διαθέσιμο από:

Menarini International Operations Luxembourg S.A 1 Avenue de la Gare, L-1611, Luxembourg

Φαρμακολογική κατηγορία (ATC):

C09DB02

INN (Διεθνής Όνομα):

AMLODIPINE 5 mg OLMESARTAN MEDOXOMIL 20 mg

Φαρμακοτεχνική μορφή:

FILM-COATED TABLET

Σύνθεση:

AMLODIPINE 5 mg OLMESARTAN MEDOXOMIL 20 mg

Τρόπος διάθεσης:

POM

Θεραπευτική περιοχή:

AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2009-08-02

Φύλλο οδηγιών χρήσης

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
KONVERGE 20 MG/5 MG
KONVERGE 40 MG/5 MG
KONVERGE 40 MG/10 MG
FILM-COATED TABLETS
OLMESARTAN MEDOXOMIL/AMLODIPINE
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 Konverge is and what it is used for
2.
What you need to know before you take Konverge
3.
How to take Konverge
4.
Possible side effects
5.
How to store Konverge
6.
Contents of the pack and other information
1.
WHAT KONVERGE IS AND WHAT IT IS USED FOR
Konverge contains two substances called olmesartan medoxomil and
amlodipine (as amlodipine
besilate). Both of these substances help to control high blood
pressure.
•
Olmesartan medoxomil belongs to a group of medicines called
“angiotensin-II receptor
antagonists” which lower blood pressure by relaxing the blood
vessels.
•
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 thereby also reducing blood pressure.
The actions of both these substances contribute to stopping the
tightening of blood vessels, so that
blood vessels relax and blood pressure decreases.
Konverge is used for the treatment of high blood pressure in patients
whose blood pressure is not
controlled enough with either olmesartan medoxomil or amlodipine
alone.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE KONVERGE
DO NOT TAKE KONVERGE
▪
if you are allergic to olmesartan medoxomil or to amlodipine or a
special group of calcium
chann

Αρχείο Π.Χ.Π.

1
1.
NAME OF THE MEDICINAL PRODUCT
Konverge 20 mg/5 mg film-coated tablets
Konverge 40 mg/5 mg film-coated tablets
Konverge 40 mg/10 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Konverge 20 mg/5 mg film-coated tablets:
Each film-coated tablet of Konverge contains 20 mg of olmesartan
medoxomil and 5 mg of amlodipine
(as amlodipine besilate).
Konverge 40 mg/5 mg film-coated tablets:
Each film-coated tablet of Konverge contains 40 mg of olmesartan
medoxomil and 5 mg of amlodipine
(as amlodipine besilate).
Konverge 40 mg/10 mg film-coated tablets:
Each film-coated tablet of Konverge contains 40 mg of olmesartan
medoxomil and 10 mg of amlodipine
(as amlodipine besilate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Konverge 20 mg/5 mg film-coated tablets:
White, round, film-coated tablet of 6 mm with C73 debossed on one
side.
Konverge 40 mg/5 mg film-coated tablets:
Cream, round, film-coated tablet of 8 mm with C75 debossed on one
side.
Konverge 40 mg/10
mg film-coated tablets:
Brownish-red, round, film-coated tablet of 8 mm with C77 debossed on
one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of essential hypertension.
Konverge is indicated in adult patients whose blood pressure is not
adequately controlled on olmesartan
medoxomil or amlodipine monotherapy (see section 4.2 and section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults _
The recommended dosage of Konverge is 1 tablet per day.
Konverge 20 mg/5 mg may be administered in patients whose blood
pressure is not adequately controlled
by 20 mg olmesartan medoxomil or 5 mg amlodipine alone.
2
Konverge 40 mg/5 mg may be administered in patients whose blood
pressure is not adequately controlled
by Konverge 20 mg/5 mg.
Konverge 40 mg/10 mg may be administered in patients whose blood
pressure is not adequately
controlled by Konverge 40 mg/5 mg.
A step-wise titration of the dosage of the individual components is
recommended before changing to the
fixed combinati