Accupro 20 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Quinapril

Available from:

PCO Manufacturing Ltd.

ATC code:

C09AA; C09AA06

INN (International Name):

Quinapril

Dosage:

20 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

ACE inhibitors, plain; quinapril

Authorization status:

Authorised

Authorization date:

2004-11-12

Patient Information leaflet

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PACKAGE LEAFLET : INFORMATION FOR THE USER
ACCUPRO
® 5MG, 10 MG & 20MG FILM-COATED TABLETS
Quinapril Hydrochloride
Important things that you SHOULD know about your medicine:

Accupro is a treatment for high blood pressure and to help treat heart
failure.

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.

You should take Accupro regularly to get the maximum benefit, even if
you are feeling
well.

Most people do not have serious problems when taking Accupro but side
effects can
occur – see Section 4 for details. If you experience swelling of the
face, tongue or throat,
see your doctor immediately. If any of the side effects gets serious,
or if you notice any
side effects not listed in this leaflet, please tell your doctor or
pharmacist.

Taking other medicines may sometimes cause problems. Check with your
doctor or
pharmacist before taking this or any other medicines.

If you think you are (or might become) pregnant, you must tell your
doctor. Do not take
Accupro if you are more than 3 months pregnant.
WHAT IS IN THIS LEAFLET:
1.
What Accupro is and what it is used for
2.
What you need to know before you take Accupro
3.
How to take Accupro
4.
Possible side effects
5.
How to store Accupro
6.
Contents of the pack and other information
1.
WHAT ACCUPRO IS AND WHAT IT IS USED FOR
Accupro is one of a group of medicines called angiotensin converting
enzyme (ACE) inhibitors.
ACE inhibitors work by widening blood vessels in the body, which can
reduce the pressure in
the vessels. It is used to treat high blood pressure, or to help treat
heart failure.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ACCUPRO

DO NOT TAKE ACCUPRO:

If you have had an a

Summary of Product characteristics

Health Products Regulatory Authority
17 December 2018
CRN008NFR
Page 1 of 3
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Accupro 20 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains: quinapril hydrochloride 21.664mg (equivalent to
20mg quinapril
base).
Excipient(s) with known effect: Contains lactose monohydrate
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-coated tablets
_Product imported from Greece and The Netherlands:_
Brown, film-coated, round tablets with a score line on one side and
‘20’ on the other
side. The score line is only to facilitate breaking for ease of
swallowing and not to
divide into equal doses.
_Product imported from Germany:_
White, film-coated, round tablets with a score line on one side and
‘20’ on the other
side. The score line is only to facilitate breaking for ease of
swallowing and not to
divide into equal doses.
_Product imported from Romania:_
White, film-coated, round tablets with a score line on one side and a
score-line and
‘20’ on the other side. The score line is only to facilitate
breaking for ease of
swallowing and not to divide into equal doses.
4 CLINICAL PARTICULARS
As per PA 0822/007/003.
5 PHARMACOLOGICAL PROPERTIES
As per PA 0822/007/003.
Health Products Regulatory Authority
17 December 2018
CRN008NFR
Page 2 of 3
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Heavy magnesium carbonate
Lactose monohydrate
Gelatine
Crospovidone
Magnesium stearate
Candelilla
Hypromellose
Hyprolose
Titanium dioxide (E171)
Macrogol 400
Product imported from Greece and the Netherlands also contains red
iron oxide
(E172).
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf-life expiry date of this product is 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
Do not store above 25°C.
Store in the original package.
6.5 NATURE AND CONTENTS OF CONTAINER
Blister packs of 14 (Greece), 28 (Greece