Konverge 40 mg/10 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Olmesartan medoxomil; Amlodipine

Available from:

Menarini International Operations Luxembourg S.A.

ATC code:

C09DB; C09DB02

INN (International Name):

Olmesartan medoxomil; Amlodipine

Dosage:

40mg/10 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Angiotensin II antagonists and calcium channel blockers; olmesartan medoxomil and amlodipine

Authorization status:

Marketed

Authorization date:

2009-06-19

Patient Information leaflet

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 B
EFORE YOU TAKE KONVERGE
DO NOT TAKE KONVERGE
▪
if you are allergic to olmesartan medoxomil or to amlodipine or a
special group of
calcium channel

Summary of Product characteristics

Health Products Regulatory Authority
06 September 2022
CRN00D0CV
Page 1 of 18
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Konverge 40 mg/10 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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
Brownish-red, round, film-coated tablet of 8mm 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 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 combination.
When clinically appropriate, direct change from monotherapy to the
fixed combination may be considered.
For convenience, patients receiving olmesartan medoxomil and
amlodipine from separate tablets may be switched to Konverge
tablets containing the same component doses.
Konverge can be taken with or without food.
Elderly (age 65 years or over)
No adjustment of the recommended dose is generally required for
elderly people but increase of the dosage should take place
with care (see sections 4.4 and 5.2).
If up-titration to the maximum dose of 40 mg olmesartan medoxomil
daily is required, blood pressure should be closely
monitored.
Renal impairment
Health Products Regulatory Authority
06 September 2022
CRN00D0CV
Page 2 of 18
The maximum dose of olmesartan medoxomil in patients with mild to
moderate renal impairment (creatinine clearance of 20 –
60