Amlodipine/Valsartan/Hydrochlorothiazide Clonmel 10 mg/160 mg/12.5 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Amlodipine besilate; Valsartan; Hydrochlorothiazide

Available from:

Clonmel Healthcare Ltd

ATC code:

C09DX; C09DX01

INN (International Name):

Amlodipine besilate; Valsartan; Hydrochlorothiazide

Dosage:

10 mg/ 160mg/12.5 milligram(s)

Pharmaceutical form:

Film-coated tablet

Therapeutic area:

Angiotensin II antagonists, other combinations; valsartan, amlodipine and hydrochlorothiazide

Authorization status:

Marketed

Authorization date:

2019-05-03

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
5 MG/160 MG/12.5 MG FILM-COATED TABLETS
10 MG/160 MG/12.5 MG FILM-COATED TABLETS
5 MG/160 MG/25 MG FILM-COATED TABLETS
10 MG/160 MG/25 MG FILM-COATED TABLETS
10 MG/320 MG/25 MG FILM-COATED TABLETS
amlodipine/valsartan/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 is and what it is used for
2. What you need to know before you take
3. How to take
4. Possible side effects
5. How to store
6. Contents of the pack and other information
1. WHAT IS AND WHAT IT IS USED FOR

tablets
contain
three
substances
called
amlodipine,
valsartan
and
hydrochlorothiazide. All of these substances help to control high
blood pressure.
•
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.
•
Valsartan belongs to a group of substances called “angiotensin-II
receptor antagonists”.
Angiotensin II is produced by the body and makes the blood vessels
tighten, thus increasing
the blood pressure. Valsartan works by blocking the effect of
angiotensin II.
•
Hydrochlorothiazide belongs to a group of substances called
“thiazide diuretics”.
Hydrochlorothiazide increases urine output, which also lowers blood
pressure.
As a result of all three mecha

Summary of Product characteristics

Health Products Regulatory Authority
14 March 2023
CRN00DC5J
Page 1 of 21
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Amlodipine/Valsartan/Hydrochlorothiazide Clonmel 10 mg/160 mg/12.5 mg
film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10 mg of amlodipine (as amlodipine
besilate), 160 mg of valsartan, and 12.5 mg of
hydrochlorothiazide.
3 PHARMACEUTICAL FORM
Amlodipine/Valsartan/Hydrochlorothiazide Clonmel 10/160/12.5 mg
film-coated tablets are pale yellow, oval, biconvex
film-coated tablets, with a length of approximately 15.6 mm and a
width of approximately 6.2 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of essential hypertension as substitution therapy in adult
patients whose blood pressure is adequately controlled on
the combination of amlodipine, valsartan and hydrochlorothiazide
(HCT), taken either as three single-component formulations
or as a dual-component and a single-component formulation.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose of Amlodipine/Valsartan/Hydrochlorothiazide
Clonmel is one tablet per day, to be taken preferably in
the morning.
Before switching to Amlodipine/Valsartan/Hydrochlorothiazide Clonmel
patients should be controlled on stable doses of the
monocomponents taken at the same time. The dose of
Amlodipine/Valsartan/Hydrochlorothiazide Clonmel should be based
on the doses of the individual components of the combination at the
time of switching.
The maximum recommended dose of
Amlodipine/Valsartan/Hydrochlorothiazide Clonmel is 10 mg/320 mg/25
mg.
_Special populations_
_Renal impairment_
Due to the hydrochlorothiazide component,
Amlodipine/Valsartan/Hydrochlorothiazide Clonmel is contraindicated
for use in
patients with anuria (see section 4.3) and in patients with severe
renal impairment (glomerular filtration rate (GFR)
< 30 ml/min/1.73 m
2
) (see sections 4.3, 4.4 and 5.2).
No adjustment of the initial dose is required for patients with mild
to moderate renal impa