Amlodipine/Valsartan Clonmel 5 mg/160 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Amlodipine; Valsartan

Available from:

Clonmel Healthcare Ltd

ATC code:

C09DB; C09DB01

INN (International Name):

Amlodipine; Valsartan

Dosage:

5/160 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; valsartan and amlodipine

Authorization status:

Marketed

Authorization date:

2016-09-09

Patient Information leaflet

Page 1 of 8
PACKAGE LEAFLET: INFORMATION FOR THE USER
AMLODIPINE/VALSARTAN CLONMEL 5MG/80MG FILM-COATED TABLETS
AMLODIPINE/VALSARTAN CLONMEL 5MG/160MG FILM-COATED TABLETS
AMLODIPINE/VALSARTAN CLONMEL 10MG/160MG FILM-COATED TABLETS
AMLODIPINE/VALSARTAN
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 Amlodipine/Valsartan Clonmel
is and what it is used for
2. What you need to know before you take Amlodipine/Valsartan Clonmel
3. How to take Amlodipine/Valsartan Clonmel
4. Possible side effects
5. How to store Amlodipine/Valsartan Clonmel
6. Contents of the pack and other information
1. WHAT AMLODIPINE/VALSARTAN CLONMEL IS AND WHAT IT IS USED FOR
Amlodipine/Valsartan Clonmel
tablets contain two substances called
AMLODIPINE
and
VALSARTAN
. Both
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.
This means that both of these substances help to stop the blood
vessels tightening. As a result, the
blood vessels relax and blood pressure is lowered.
Amlodipine/Valsartan Clonmel
is used to treat high blood pressure in adults whose blood pressure

Summary of Product characteristics

Health Products Regulatory Authority
08 August 2022
CRN00CZSC
Page 1 of 16
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Amlodipine/Valsartan Clonmel 5 mg/160 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 5 mg amlodipine (as amlodipine
besilate) and 160 mg valsartan
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Dark yellow, oval, biconvex film-coated tablets with length of
14.6±0.2mm and width 6.8±0.2mm
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of essential hypertension.
Amlodipine/valsartan is indicated in adults whose blood pressure is
not adequately controlled on amlodipine or valsartan
monotherapy.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
The recommended dose of Amlodipine/Valsartan Clonmel is one tablet per
day.
Amlodipine/valsartan 5 mg/ 160 mg may be administered in patients
whose blood pressure is not adequately controlled with
amlodipine 5 mg or valsartan 160 mg alone.
Amlodipine/Valsartan Clonmel can be used with or without food.
Individual dose titration with the components (i.e. amlodipine and
valsartan) is recommended before changing to the fixed
dose combination. When clinically appropriate, direct change from
monotherapy to the fixed-dose combination may be
considered.
For convenience, patients receiving valsartan and amlodipine from
separate tablets/capsules may be switched to
Amlodipine/Valsartan Clonmel containing the same component doses.
RENAL IMPAIRMENT
There are no available clinical data in severely renally impaired
patients. No dosage adjustment is required for patients with
mild to moderate renal impairment. Monitoring of potassium levels and
creatinine is advised in moderate renal impairment.
HEPATIC IMPAIRMENT
Amlodipine/valsartan is contraindicated in patients with severe
hepatic impairment (see section 4.3).
Caution should be exercised when administering amlodipine/valsartan to
patients with hepatic impairment or biliary
obstructive dis