Atacand 16 mg tablets

Ülke: İrlanda

Dil: İngilizce

Kaynak: HPRA (Health Products Regulatory Authority)

Aktif bileşen:

Candesartan cilexetil

Mevcut itibaren:

PCO Manufacturing Ltd.

ATC kodu:

C09CA; C09CA06

INN (International Adı):

Candesartan cilexetil

Doz:

16 milligram(s)

Farmasötik formu:

Tablet

Reçete türü:

Product subject to prescription which may be renewed (B)

Terapötik alanı:

Angiotensin II antagonists, plain; candesartan

Yetkilendirme durumu:

Authorised

Yetkilendirme tarihi:

2004-02-06

Bilgilendirme broşürü

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ATACAND
® 4 MG TABLETS
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 a

Ürün özellikleri

Health Products Regulatory Authority
21 September 2022
CRN00D5MJ
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Atacand 16 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 16 mg candesartan cilexetil.
Excipient(s) with known effect: lactose monohydrate
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
_Product imported from Italy, Portugal and Poland:_
Pink, round tablets with a score and marked 'A/CH' on one side and
'016' on the other side.
_Product imported from Italy:_
Light pink tablets with one convex side and one scored flat side,
embossed '16' on the convex side.
The tablet can be divided into equal doses.
4 CLINICAL PARTICULARS
As per PA2239/010/003
5 PHARMACOLOGICAL PROPERTIES
As per PA2239/010/003
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
The product imported from Italy contains:
Carmellose calcium
Hyprolose
Lactose monohydrate
Magnesium stearate
Maize starch
Macrogol
Iron oxide red (E172)
The product imported from Portugal and Poland contains:
Carmellose calcium
Hydroxypropyl cellulose
Lactose monohydrate
Magnesium stearate
Maize starch
Macrogol
Iron oxide (E172)
Health Products Regulatory Authority
21 September 2022
CRN00D5MJ
Page 2 of 2
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 30 °C.
6.5 NATURE AND CONTENTS OF CONTAINER
Blister pack containing 28 tablets.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
PCO Manufacturing Ltd.
Unit 10, Ashbourne Business Park
Rath
Ashbourne
Co. Meath
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA0465/116/002
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 6
th
February 2004
Date of last renewal: 6
th
February 2009
10 DATE OF REVISION OF THE