Konverge Plus 40mg/10mg/25mg film coated tablets

Land: Irland

Sprog: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv bestanddel:

Olmesartan medoxomil; Amlodipine; Hydrochlorothiazide

Tilgængelig fra:

Menarini International Operations Luxembourg S.A.

ATC-kode:

C09DX; C09DX03

INN (International Name):

Olmesartan medoxomil; Amlodipine; Hydrochlorothiazide

Dosering:

40 mg/10 mg/25 milligram(s)

Lægemiddelform:

Film-coated tablet

Recept type:

Product subject to prescription which may be renewed (B)

Terapeutisk område:

Angiotensin II antagonists, other combinations; olmesartan medoxomil, amlodipine and hydrochlorothiazide

Autorisation status:

Marketed

Autorisation dato:

2011-09-23

Indlægsseddel

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
KONVERGE PLUS 20 MG/5 MG/12.5 MG FILM-COATED TABLETS
KONVERGE PLUS 40 MG/5 MG/12.5 MG FILM-COATED TABLETS
KONVERGE PLUS 40 MG/10 MG/12.5 MG FILM-COATED TABLETS
KONVERGE PLUS 40 MG/5 MG/25 MG FILM-COATED TABLETS
KONVERGE PLUS 40 MG/10 MG/25 MG FILM-COATED TABLETS
OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE
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 Plus is and what it is used for
2.
What you need to know before you take Konverge Plus
3.
How to take Konverge Plus
4.
Possible side effects
5.
How to store Konverge Plus
6.
Contents of the pack and other information
1.
WHAT KONVERGE PLUS IS AND WHAT IT IS USED FOR
Konverge Plus contains three active substances called olmesartan
medoxomil, amlodipine (as
amlodipine besilate) and hydrochlorothiazide. All three substances
help to control high blood
pressure.

Olmesartan
medoxomil
belongs
to
a
group
of
medicines
called
“angiotensin-II
receptor antagonists”, which lowers blood pressure by relaxing the
blood vessels.

Amlodipine belongs to a group of substances called “calcium channel
blockers”.
Amlodipine also lowers blood pressure by relaxing blood vessels.

Hydrochlorothiazide is one of a group of medicines called thiazide
diuretics (“water
tablets”). It lowers blood pressure by helping the body to get rid
of extra fluid by
making your kidneys produce more urine.
The actions of these substances contribute to decrease your blood
pressure.
Konverge Plus is used f

Produktets egenskaber

Health Products Regulatory Authority
21 June 2023
CRN00DHYF
Page 1 of 24
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Konverge Plus 40mg/10mg/25mg film coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 40 mg olmesartan medoxomil, 10 mg
amlodipine (as amlodipine besilate) and 25 mg
hydrochlorothiazide.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Greyish red, oval, film-coated tablet of 15 x 7 mm debossed C57 on one
side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of essential hypertension.
_ADD-ON THERAPY _
Konverge Plus is indicated in adult patients whose blood pressure is
not adequately controlled on the combination of
olmesartan medoxomil and amlodipine taken as dual-component
formulation.
_SUBSTITUTION THERAPY_
Konverge Plus is indicated as substitution therapy in adult patients
whose blood pressure is adequately controlled on the
combination of olmesartan medoxomil, amlodipine and
hydrochlorothiazide, taken as a dual-component (olmesartan
medoxomil and amlodipine or olmesartan medoxomil and
hydrochlorothiazide) and a single-component formulation
(hydrochlorothiazide or amlodipine).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
ADULTS
The recommended dose of Konverge Plus is 1 tablet per day.
_ADD-ON THERAPY_
Konverge Plus 40 mg/10 mg/25 mg may be administered in patients whose
blood pressure is not adequately controlled on
Konverge Plus 40 mg/10 mg/12.5 mg or by Konverge Plus 40 mg/5 mg/25
mg.
A step-wise titration of the dosage of the individual components is
recommended before changing to the triple-component
combination. When clinically appropriate, direct change from
dual-component combination to the triple-component
combination may be considered.
_SUBSTITUTION THERAPY_
Patients controlled on stable doses of olmesartan medoxomil,
amlodipine and hydrochlorothiazide taken at the same time as a
dual-component (olmesartan medoxomil and amlodipine or olmesartan
medoxomil and hy