Viacoram 3.5mg/2.5mg Tablets
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
17-08-2022
Summary of Product characteristics
(SPC)
17-08-2022
Active ingredient:
Perindopril arginine; Amlodipine
Available from:
Les Laboratoires Servier
ATC code:
C09BB; C09BB04
INN (International Name):
Perindopril arginine; Amlodipine
Dosage:
3.5 mg/2.5 milligram(s)
Pharmaceutical form:
Tablet
Administration route:
Oral use
Units in package:
30 or 100 tablets
Prescription type:
Product subject to prescription which may be renewed (B)
Manufactured by:
Servier (Ireland) Industries Ltd
Therapeutic group:
Agents acting on the renin-angiotensin system, ACE inhibitors and calcium channel blockers
Therapeutic area:
ACE inhibitors and calcium channel blockers; perindopril and amlodipine
Therapeutic indications:
It is indicated for the treatment of essential hypertension in adults
Authorization status:
Marketed
Authorization date:
2015-05-22
Patient Information leaflet
PACKAGE LEAFLET: INFORMATION FOR THE USER
VIACORAM 3.5 MG/2.5MG TABLETS
VIACORAM 7 MG/5 MG TABLETS
perindopril arginine / 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, pharmacist or
nurse.
-
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 any of the side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Viacoram is and what it is used for
2.
What you need to know before you take Viacoram
3.
How to take Viacoram
4.
Possible side effects
5.
How to store Viacoram
6.
Contents of the pack and other information
1.
WHAT VIACORAM IS AND WHAT IT IS USED FOR
Viacoram is a combination of two active ingredients, perindopril and
amlodipine. Both of these substances
help to control your high blood pressure.
Perindopril is an ACE (Angiotensin Converting Enzyme) inhibitor.
Amlodipine is a calcium antagonist (which
belongs to a class of medicines called dihydropyridines). Together
they work to widen and relax the blood
vessels so that blood passes through them more easily and makes it
easier for your heart to maintain a good
blood flow.
Viacoram is used to treat high blood pressure (hypertension) in
adults.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE VIACORAM
DO NOT TAKE VIACORAM
-
if you are allergic (hypersensitive) to perindopril or any other ACE
inhibitor, or to amlodipine or any other
calcium antagonists, or any of the other ingredients of this medicine
(listed in section 6),
-
if you have severe kidney problems,
-
if you have experienced symptoms such as wheezing, swelling of the
face or tongue, intense itching or
severe skin rashes with previous ACE inhibitor treatment or if you or
a member of your family have had
Read the complete document
Summary of Product characteristics
Health Products Regulatory Authority
15 August 2022
CRN00D0GH
Page 1 of 17
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Viacoram 3.5mg/2.5mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains 2.378 mg perindopril equivalent to 3.5 mg
perindopril arginine and 3.4675 mg amlodipine besilate
equivalent to 2.5 mg amlodipine.
Excipient with known effect: 31.62 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
White, round tablet, 5 mm diameter.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Viacoram is indicated for the treatment of essential hypertension in
adults.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Oral use.
Viacoram 3.5 mg/2.5 mg is intended for first line therapy in patients
with arterial hypertension.
The recommended starting dose of Viacoram is 3.5 mg/2.5 mg once daily.
After at least four weeks of treatment, the dose may be increased to 7
mg/5 mg once daily in patients whose blood pressure is
not adequately controlled with Viacoram 3.5 mg/2.5 mg.
_SPECIAL POPULATIONS_
_Patients with renal impairment (see sections 4.3, 4.4 and 5.2)_
Viacoram is contraindicated in patients with severe renal impairment
(Creatinine clearance below 30 ml/min) (see section 4.3).
In patients with moderate renal impairment (Creatinine clearance
between 30 ml/min to 60 ml/min), the initial recommended
dose of Viacoram is3.5 mg/2.5 mg every other day. In patients whose
blood pressure is not adequately controlled, the dose
of Viacoram 3.5 mg/2.5 mg may be taken once daily. If necessary, the
dose may be increased in patients insufficiently
controlled.The usual medical follow-up includes monitoring of
creatinine and potassium (see sections 4.4 and 5.2).
_Patients with hepatic impairment (see sections 4.4 and 5.2)_
Caution should be exercised when prescribing Viacoram to patients with
severe hepatic impairment.
_Older people (see sections 4.4 and 5.2)_
The efficacy and safety of Viacoram have been established in older
people. Ca
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