Atacand Plus 16 mg/12.5 mg tablets

Negara: Irlandia

Bahasa: Inggris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Candesartan cilexetil; Hydrochlorothiazide

Tersedia dari:

IMED Healthcare Ltd.

Kode ATC:

C09DA06

INN (Nama Internasional):

Candesartan cilexetil; Hydrochlorothiazide

Dosis:

16 mg/12.5 milligram(s)

Bentuk farmasi:

Tablet

Jenis Resep:

Product subject to prescription which may be renewed (B)

Area terapi:

candesartan and diuretics

Status otorisasi:

Authorised

Tanggal Otorisasi:

2011-10-07

Selebaran informasi

PACKAGE LEAFLET: INFORMATION FOR THE USER
ATACAND
® PLUS 16 MG/12.5 MG TABLETS
candesartan cilexetil/hydrochlorothiazide
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 or
pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Atacand Plus is and what it is used for
2. What you need to know before you take
Atacand Plus
3. How to take Atacand Plus
4. Possible side effects
5. How to store Atacand Plus
6. Contents of the pack and other information
1. WHAT ATACAND PLUS IS AND WHAT IT IS USED FOR
The name of your medicine is Atacand Plus. It is
used for treating high blood pressure
(hypertension) in adult patients. It contains two
active ingredients: candesartan cilexetil and
hydrochlorothiazide. These work together to lower
your blood pressure.
• Candesartan cilexetil belongs to a group of
medicines called angiotensin II receptor
antagonists. It makes your blood vessels relax
and widen. This helps to lower your blood
pressure.
• Hydrochlorothiazide belongs to a group of
medicines called diuretics (water tablets). It
helps your body to get rid of water and salts like
sodium in your urine. This helps to lower your
blood pressure.
Your doctor may prescribe Atacand Plus if your
blood pressure has not been properly controlled
by candesartan cilexetil or hydrochlorothiazide
alone.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
ATACAND PLUS
DO NOT TAKE ATACAND PLUS:
-
if you are allergic to candesartan cilexetil or
hydrochlorothiazide or any of the other
ingredients of this medicine (listed in section 6).
-
if you are allergic to sulphonamide medicines. If
you are

Karakteristik produk

Health Products Regulatory Authority
01 March 2021
CRN00C5K8
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Atacand Plus 16 mg/12.5 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 16 mg candesartan cilexetil and 12.5 mg
hydrochlorothiazide.
Excipient with known effect
Lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
_Product imported from Italy_
Pink, oval tablets marked 16/C and scored on both sides.
4 CLINICAL PARTICULARS
As per PA2239/011/002
5 PHARMACOLOGICAL PROPERTIES
As per PA2239/011/002
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Carmellose calcium
Hydroxypropylcellulose
Iron oxide (E172)
Lactose monohydrate
Magnesium stearate
Maize starch
Macrogol
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date of this pack 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
This medicinal product does not require any special temperature
storage conditions.
Health Products Regulatory Authority
01 March 2021
CRN00C5K8
Page 2 of 2
6.5 NATURE AND CONTENTS OF CONTAINER
Blisters of 28 tablets.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
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
PPA1463/053/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 7
th
October 2011
10 DATE OF REVISION OF THE TEXT
March 2021