Atacand Plus 16 mg/12.5 mg tablets

Country: আয়ার্লণ্ড

ভাষা: ইংরেজি

সূত্র: HPRA (Health Products Regulatory Authority)

সক্রিয় উপাদান:

Candesartan cilexetil; Hydrochlorothiazide

থেকে পাওয়া:

PCO Manufacturing Ltd.

এটিসি কোড:

C09DA06

INN (International Name):

Candesartan cilexetil; Hydrochlorothiazide

ডোজ:

16 mg/12.5 milligram(s)

ফার্মাসিউটিকাল ফর্ম:

Tablet

প্রেসক্রিপশন টাইপ:

Product subject to prescription which may be renewed (B)

Therapeutic area:

candesartan and diuretics

অনুমোদন অবস্থা:

Authorised

অনুমোদন তারিখ:

2004-01-26

তথ্য লিফলেট

_ _
_ _
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 m

পণ্য বৈশিষ্ট্য

Health Products Regulatory Authority
11 April 2022
CRN00CVK8
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
One Atacand Plus 16 mg/12.5 mg tablet contains 16 mg candesartan
cilexetil and 12.5 mg hydrochlorothiazide.
Excipient(s) with known effect: lactose monohydrate
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
_Product imported from the Netherlands:_
Peach, oval, biconvex tablets marked ‘A/CS’ on one side and scored
on both sides.
_Product imported from Italy:_
Peach, oval, biconvex tablets marked A/CS on one side and scored on
both sides or 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
Hyprolose
Lactose monohydrate
Magnesium stearate
Maize starch
Macrogol
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
blister and outer carton of the product on the market in the
country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 30 °C.
Health Products Regulatory Authority
11 April 2022
CRN00CVK8
Page 2 of 2
6.5 NATURE AND CONTENTS OF CONTAINER
Product imported from Italy presented as 28 tablets in a blister pack
contained in an outer cardboard carton.
Product imported from The Netherlands presented as 30 tablets in a
blister pack contained in an overlabelled outer carton.
Not all pack sizes may be marketed.
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
PPA0465/117/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 26
th
January 2004
Date of last renewal: