Atacand 4 mg tablets

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

Wirkstoff:

Candesartan cilexetil

Verfügbar ab:

Imbat Limited

ATC-Code:

C09CA; C09CA06

INN (Internationale Bezeichnung):

Candesartan cilexetil

Dosierung:

4 milligram(s)

Darreichungsform:

Tablet

Verschreibungstyp:

Product subject to prescription which may be renewed (B)

Therapiebereich:

Angiotensin II antagonists, plain; candesartan

Berechtigungsstatus:

Authorised

Berechtigungsdatum:

2012-10-12

Gebrauchsinformation

Page 1 of 2 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ATACAND
® 4MG TABLETS
(candesartan cilexetil)
Your medicine is available using the name Atacand 4mg
tablets but will be referred to as Atacand throughout this
leaflet.
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.

If you get any side effects, talk to your doctor. This
includes any possible side effects not listed in this
leaflet.
WHAT IS IN THIS LEAFLET:
1.
What Atacand is and what it is used for
2.
What you need to know before you take Atacand
3.
How to take Atacand
4.
Possible side effects
5.
How to store Atacand
6.
Contents of the pack and other information
1.
WHAT ATACAND IS AND WHAT IT IS USED FOR
The name of your medicine is Atacand. The active ingredient
is candesartan cilexetil. This belongs to a group of medicines
called angiotensin II receptor antagonists. It works by making
your blood vessels relax and widen. This helps to lower your
blood pressure. It also makes it easier for your heart to pump
blood to all parts of your body.
Atacand can be used to:

treat high blood pressure (hypertension) in adult
patients and in children and adolescents aged 6 to
<18 years.

treat adult heart failure patients with reduced heart
muscle function when Angiotensin Converting Enzyme
(ACE) inhibitors cannot be used or in addition to ACE-
inhibitors when symptoms persist despite treatment and
mineralocorticoid receptor antagonists (MRA) cannot be
used (ACE-inhibitors and MRAs are medicines used to
treat heart failure).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
ATACAND
DO NOT TAKE ATACAND:

if you are allergic to candesartan cilexetil or any of the
other ingredients of this medicine (listed in section 6).

Fachinformation

Health Products Regulatory Authority
23 July 2019
CRN00968R
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Atacand 4 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 4 mg candesartan cilexetil.
Excipient:
Each 4 mg tablet contains 93.4 mg lactose monohydrate
For the full list of excipients, see section 6.1_._
3 PHARMACEUTICAL FORM
Tablets.
_Product imported from UK_
Round, white tablets with a scoreline on each side.
4 CLINICAL PARTICULARS
As per PA1019/004/001.
5 PHARMACOLOGICAL PROPERTIES
As per PA1019/004/001.
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Carmellose calcium
Hydroxypropylcellulose
Lactose monohydrate
Magnesium stearate
Maize starch
Macrogol
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date of this product shall be the date shown on
the blister strips and outer carton of the product as
marketed in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 30°C.
6.5 NATURE AND CONTENTS OF CONTAINER
Cardboard outer carton containing blister strips. Pack size 28
tablets.
Health Products Regulatory Authority
23 July 2019
CRN00968R
Page 2 of 2
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR
WASTE MATERIALS DERIVED FROM SUCH MEDICINAL
PRODUCT AND OTHER HANDLING OF THE PRODUCT
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
Imbat Limited
Unit L2
North Ring Business Park
Santry
Dublin 9
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA1151/109/002
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 12th October 2012
10 DATE OF REVISION OF THE TEXT
July 2019