Olmesartan/Amlodipine Clonmel 20 mg/5 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Olmesartan medoxomil; Amlodipine besilate

Available from:

Clonmel Healthcare Ltd

ATC code:

C09DB; C09DB02

INN (International Name):

Olmesartan medoxomil; Amlodipine besilate

Dosage:

20 mg/5 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:

2017-12-15

Patient Information leaflet

Page 1 of 9
PACKAGE LEAFLET: INFORMATION FOR THE USER
OLMESARTAN/AMLODIPINE CLONMEL 20MG/5MG FILM-COATED TABLETS
OLMESARTAN/AMLODIPINE CLONMEL 40MG/5MG FILM-COATED TABLETS
OLMESARTAN/AMLODIPINE CLONMEL 40MG/10MG 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 Olmesartan/Amlodipine Clonmel is and what it is used for
2. What you need to know before you take Olmesartan/Amlodipine Clonmel
3. How to take Olmesartan/Amlodipine Clonmel
4. Possible side effects
5. How to store Olmesartan/Amlodipine Clonmel
6. Contents of the pack and other information
1. WHAT OLMESARTAN/AMLODIPINE CLONMEL IS AND WHAT IT IS USED FOR
Olmesartan/Amlodipine Clonmel 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 them from
tightening thereby also
reducing blood pressure
The actions of both these substances contribute to stopping the
tightening of blood vessels, so that they
relax and blood pressure decreases.
Olmesartan/Amlodipine Clonmel is used for the treatment of high blood
pressure in patients whose
blood pressure is not controlled enough

Summary of Product characteristics

Health Products Regulatory Authority
14 September 2022
CRN00D0Q4
Page 1 of 18
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Olmesartan/Amlodipine Clonmel 20 mg/5 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet of Olmesartan/Amlodipine Clonmel contains 20
mg of olmesartan medoxomil and 5 mg of amlodipine
(as amlodipine besilate).
Excipient(s) with known effect
One film-coated tablet of Olmesartan/Amlodipine Clonmel 20 mg/5 mg
contains 31.22 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White, round biconvex film-coated tablets.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of essential hypertension.
Olmesartan/Amlodipine Clonmel is indicated in adult patients whose
blood pressure is not adequately controlled on
olmesartan medoxomil or amlodipine monotherapy (see sections 4.2 and
5.1).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults_
The recommended dosage of Olmesartan/Amlodipine Clonmel is 1 tablet
per day.
Olmesartan/Amlodipine Clonmel 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.
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
Olmesartan/Amlodipine Clonmel tablets containing the same component
doses.
Olmesartan/Amlodipine Clonmel can be taken with or without food.
_Elderly (aged 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 clos