Olmesartan medoxomil/Amlodipine/Hydrochlorothiazide Clonmel 20 mg/5 mg/12.5 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Olmesartan medoxomil; Amlodipine; Hydrochlorothiazide

Available from:

Clonmel Healthcare Ltd

ATC code:

C09DX03

INN (International Name):

Olmesartan medoxomil; Amlodipine; Hydrochlorothiazide

Dosage:

20 mg/5 mg/12.5 milligram(s)

Pharmaceutical form:

Film-coated tablet

Therapeutic area:

olmesartan medoxomil, amlodipine and hydrochlorothiazide

Authorization status:

Marketed

Authorization date:

2020-07-24

Patient Information leaflet

Page 1 of 13
PACKAGE LEAFLET: INFORMATION FOR THE USER
OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE CLONMEL 20 MG/5
MG/12.5 MG FILM-
COATED TABLETS
OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE CLONMEL 40 MG/5
MG/12.5 MG FILM-
COATED TABLETS
OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE CLONMEL 40 MG/10
MG/12.5 MG FILM-
COATED TABLETS
OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE CLONMEL 40 MG/5
MG/25 MG FILM-
COATED TABLETS
OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE CLONMEL 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 Olmesartan medoxomil/Amlodipine/Hydrochlorothiazide Clonmel is
and what it is used for
2. What you need to know before you take Olmesartan
medoxomil/Amlodipine/Hydrochlorothiazide
Clonmel
3. How to take Olmesartan medoxomil/Amlodipine/Hydrochlorothiazide
Clonmel
4. Possible side effects
5. How to store Olmesartan medoxomil/Amlodipine/Hydrochlorothiazide
Clonmel
6. Contents of the pack and other information
1. WHAT OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE CLONMEL IS
AND WHAT IT IS USED
FOR
Olmesartan medoxomil/Amlodipine/Hydrochlorothiazide Clonmel 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

Summary of Product characteristics

Health Products Regulatory Authority
22 August 2022
CRN00CZCP
Page 1 of 24
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Olmesartan medoxomil/Amlodipine/Hydrochlorothiazide Clonmel 20 mg/5
mg/12.5 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 20 mg olmesartan medoxomil, 5 mg
amlodipine (as amlodipine besilate) and 12.5 mg
hydrochlorothiazide.
Excipient with known effect
One film-coated tablet contains 99.30 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet (tablet)
Orange white, round, biconvex film-coated tablets with a diameter of
8.1 ± 0.2 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of essential hypertension.
_ADD-ON THERAPY_
Olmesartan medoxomil/Amlodipine/Hydrochlorothiazide Clonmel 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_
Olmesartan medoxomil/Amlodipine/Hydrochlorothiazide Clonmel 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 Olmesartan
medoxomil/Amlodipine/Hydrochlorothiazide Clonmel is 1 tablet per day.
_ADD-ON THERAPY_
Olmesartan medoxomil/Amlodipine/Hydrochlorothiazide Clonmel 20 mg/5
mg/12.5 mg may be administered in patients
whose blood pressure is not adequately controlled on olmesartan
medoxomil 20 mg and amlodipine 5 mg taken as
dual-component combination.
A step-wise titration of the dosage of the individual components is
recommended before changing to the triple-component
combination.