ATACAND PLUS

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

CANDESARTAN CILEXETIL ; HYDROCHLOROTHIAZIDE

Available from:

AstraZeneca UK Limited

ATC code:

C09DA06

INN (International Name):

CANDESARTAN CILEXETIL ; HYDROCHLOROTHIAZIDE

Dosage:

8/12.5 Milligram

Pharmaceutical form:

Tablets

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

candesartan and diuretics

Authorization status:

Not Marketed

Authorization date:

1998-11-27

Patient Information leaflet

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

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Atacand Plus 8 mg/12.5 mg tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One Atacand Plus 8mg/12.5 mg tablet contains 8 mg candesartan
cilexetil and 12.5 mg hydrochlorothiazide.
Excipient with known effect: Each tablet contains 77 mg lactose
monohydrate.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Tablet.
Atacand Plus 8 mg/12.5 mg tablets are white, oval, biconvex tablets
with a score on both sides and engraved
on
one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Atacand Plus is indicated for the:
Treatment of primary hypertension in adult patients whose blood
pressure is not optimally controlled with
candesartan cilexetil or hydrochlorothiazide monotherapy.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology in Hypertension
The recommended dose of Atacand Plus is one tablet once daily.
Dose titration with the individual components (candesartan cilexetil
and hydrochlorothiazide) is recommended. When
clinically appropriate a direct change from monotherapy to Atacand
Plus may be considered. Dose titration of
candesartan cilexetil is recommended when switching from
hydrochlorothiazide monotherapy. Atacand Plus may be
administered in patients whose blood pressure is not optimally
controlled with candesartan cilexetil or
hydrochlorothiazide monotherapy or Atacand Plus at lower doses.
Most of the antihypertensive effect is usually attained within 4 weeks
of initiation of treatment.
Special populations
_Elderly population_
No dose adjustment is necessary in elderly patients.
_Patients with intravascular volume depletion_
Dose titration of candesartan cilexetil is recommended in patients at
risk for hypotension, such as patients with possible
volume depletion (an initial dose of candesartan cilexetil of 4 mg may
be considered in these patients).
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
_