Atacand 8 mg tablets

Pajjiż: Irlanda

Lingwa: Ingliż

Sors: HPRA (Health Products Regulatory Authority)

Ingredjent attiv:

Candesartan cilexetil

Disponibbli minn:

IMED Healthcare Ltd.

Kodiċi ATC:

C09CA; C09CA06

INN (Isem Internazzjonali):

Candesartan cilexetil

Dożaġġ:

8 milligram(s)

Għamla farmaċewtika:

Tablet

Tip ta 'preskrizzjoni:

Product subject to prescription which may be renewed (B)

Żona terapewtika:

Angiotensin II antagonists, plain; candesartan

L-istatus ta 'awtorizzazzjoni:

Authorised

Data ta 'l-awtorizzazzjoni:

2010-02-05

Fuljett ta 'informazzjoni

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ATACAND
® 8 MG TABLETS
ATACAND
® 16 MG TABLETS
candesartan cilexetil
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).

if you are more than 3 months pregnant (it is also better to avoid
Atacand in early pregnancy – see pre

Karatteristiċi tal-prodott

Health Products Regulatory Authority
25 July 2022
CRN00D0J9
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Atacand 8 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 8 mg candesartan cilexetil.
Excipient(s) with known effect: lactose monohydrate
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Tablets
_Product imported from Italy:_
Round, light pink tablets with a score and marked A/CG on one side and
008 on the other side.
The tablet can be divided in equal doses.
4 CLINICAL PARTICULARS
As per PA2239/010/002
5 PHARMACOLOGICAL PROPERTIES
As per PA2239/010/002
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Carmellose calcium
Hydroxypropyl cellulose
Iron oxide red (E172)
Lactose monohydrate
Magnesium stearate
Maize starch
Macrogol
6.2 INCOMPATIBILITIES
Not applicable
6.3 SHELF LIFE
The shelf life expiry date of the product is the date shown on the
container and outer carton of the product as marketed in the
country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
This medicinal product does not require any special storage
conditions.
Health Products Regulatory Authority
25 July 2022
CRN00D0J9
Page 2 of 2
6.5 NATURE AND CONTENTS OF CONTAINER
Over-labelled cardboard carton containing 2 blister strips (14 tablets
per strip).
Pack size 28 tablets.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING
No special requirements
7 PARALLEL PRODUCT AUTHORISATION HOLDER
IMED Healthcare Ltd.
Unit 625 Kilshane Avenue
Northwest Business Park
Ballycoolin
Dublin 15
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA1463/031/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 5
th
February 2010
10 DATE OF REVISION OF THE TEXT
July 2022