Acerycal 5mg/10mg Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Perindopril arginine; Amlodipine besylate

Available from:

LTT Pharma Limited

ATC code:

C09BB; C09BB04

INN (International Name):

Perindopril arginine; Amlodipine besylate

Dosage:

5/10 mg/mg

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:

2011-11-11

Patient Information leaflet

ACERYCAL 5MG/5MG TABLETS
ACERYCAL 5MG/10MG TABLETS
ACERYCAL 10MG/5MG TABLETS
ACERYCAL 10MG/10MG 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:
What Acerycal is and what it is used for
What you need to know before you take Acerycal
How to take Acerycal
Possible side effects
How to store Acerycal
Content of the pack and other information
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.
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 medicine (listed in Section 6),
*
if you are more than 3 months pregnant. (It is also better to avoid
A

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Acerycal 5mg/10mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains 3.395 mg perindopril equivalent to 5 mg
perindopril arginine and 13.870 mg amlodipine equivalent
to 10 mg amlodipine.
Excipient with known effect: lactose monohydrate.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Tablet
_Product imported from Hungary:_
White square shaped tablet engraved with 5/10 on one face and
on the other face.
4 CLINICAL PARTICULARS
As per PA0568/018/002
5 PHARMACOLOGICAL PROPERTIES
As per PA0568/018/002
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.
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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