ACERYCAL 10mg/10mg tablets

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

Perindopril arginine; Amlodipine besylate

Disponibil de la:

Primecrown 2010 Limited

Codul ATC:

C09BB; C09BB04

INN (nume internaţional):

Perindopril arginine; Amlodipine besylate

Dozare:

10/10 milligram(s)

Forma farmaceutică:

Tablet

Tip de prescriptie medicala:

Product subject to prescription which may be renewed (B)

Zonă Terapeutică:

ACE inhibitors and calcium channel blockers; perindopril and amlodipine

Statutul autorizaţiei:

Authorised

Data de autorizare:

2015-01-30

Prospect

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ACERYCAL
 5MG / 5MG TABLETS
ACERYCAL
 10MG / 5MG TABLETS
ACERYCAL
 5MG / 10MG TABLETS
ACERYCAL
 10MG / 10MG TABLETS
perindopril arginine / amlodipine
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 medicine (listed in Section 6),
-
if you are more than 3 months pregnant (It is also better to avoid
Acerycal in early pregnancy - see pregnancy section),
-
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
these
symptoms in any other circumstances (a condition called angioedema),
-
if you have diabetes or impaired kidney function and you are treated
with
a blood pressure lowering medicine containing aliskiren,

Caracteristicilor produsului

Health Products Regulatory Authority
05 October 2018
CRN008K9F
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
ACERYCAL 10mg/10mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains 6.790 mg perindopril equivalent to 10 mg
perindopril arginine
and 13.870 mg amlodipine besilate equivalent to 10 mg amlodipine
Excipient: lactose monohydrate.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
_Product imported from Poland:_
White, round tablet engraved with 10/10 on one face and
on the other face.
4 CLINICAL PARTICULARS
As per PA0568/018/004
5 PHARMACOLOGICAL PROPERTIES
As per PA0568/018/004
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
Health Products Regulatory Authority
05 October 2018
CRN008K9F
Page 2 of 2
The shelf life expiry date of 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 an overlabelled polypropylene container equipped with a
low density
polyethylene flow reducer and a low density polyethylene stopper
containing a
desiccant gel repackaged in an outer cardboard carton.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
Primecrown 2010 Limited
4/5 Northolt Trading Estate,
Belvue Road,
Northolt,
Middlesex UB5 5QS,
United Kingdom
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA1633/035/004
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 30
th
January 2015.
10 DATE OF REVISION OF THE TEXT
October 2018