Acerycal 5 mg/5 mg tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Perindopril arginine; Amlodipine besylate

Available from:

PCO Manufacturing Ltd.

ATC code:

C09BB; C09BB04

INN (International Name):

Perindopril arginine; Amlodipine besylate

Dosage:

5mg/5 milligram(s)

Pharmaceutical form:

Tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

ACE inhibitors and calcium channel blockers; perindopril and amlodipine

Authorization status:

Authorised

Authorization date:

2012-04-20

Patient Information leaflet

_ _
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ACERYCAL
® 5 MG/5 MG TABLETS
ACERYCAL
® 5 MG/10 MG TABLETS
ACERYCAL
® 10 MG/10 MG TABLETS
ACERYCAL
® 10 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 you get any 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 Acerycal is and what it is used for
2.
What you need to know before you take Acerycal
3.
How to take Acerycal
4.
Possible side effects
5.
How to store Acerycal
6.
Content of the pack and other information
1.
WHAT ACERYCAL IS AND WHAT IT IS USED FOR
Acerycal is prescribed for treatment of high blood pressure
(hypertension) and/or treatment of
stable coronary artery disease (a condition where the blood supply to
the heart is reduced or
blocked).
Patients already taking perindopril and amlodipine from separate
tablets may instead receive
one tablet of Acerycal which contains both ingredients.
Acerycal is a combination of two active ingredients, perindopril and
amlodipine. 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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ACERYCAL
DO NOT TAKE ACERYCAL

if you are allergic to perindopril or any other ACE inhibitor, or to
amlodipine or any other
calcium antagonists, or any of the other ingredients of this med

Summary of Product characteristics

Health Products Regulatory Authority
18 November 2021
CRN00CN12
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Acerycal 5 mg/5 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains 3.395 mg perindopril equivalent to 5 mg
perindopril arginine and 6.935 mg amlodipine besilate equivalent
to 5 mg amlodipine
Excipient : lactose monohydrate.
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Tablet.
_Product imported from Hungary and Poland:_
White, rod-shaped tablet engraved with 5/5 on one face and the Servier
Company Logo on the other face.
4 CLINICAL PARTICULARS
As per PA0568/018/001
5 PHARMACOLOGICAL PROPERTIES
As per PA0568/018/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Lactose monohydrate
Cellulose, microcrystalline (E460)
Silica, colloidal anhydrous (E551)
Magnesium stearate (E470B)
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date for this product shall be the date shown on
the container and outer package of the product on the
market in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Keep the container tightly closed in order to protect from moisture.
Store in the original package.
6.5 NATURE AND CONTENTS OF CONTAINER
30 tablets in polypropylene container equipped with a low density
polyethylene flow reducer and a low density polyethylene
stopper containing a desiccant gel.
Box of 1 container of 30 tablets.
Health Products Regulatory Authority
18 November 2021
CRN00CN12
Page 2 of 2
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
PCO Manufacturing Ltd.
Unit 10, Ashbourne Business Park
Rath
Ashbourne
Co. Meath
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA0465/283/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 20th April 2012
10 DATE OF REVISION OF THE TEXT
November 2021