ATACAND PLUS TABLET

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE

Available from:

ASTRAZENECA SINGAPORE PTE LTD

ATC code:

C09DA06

Dosage:

16 mg

Pharmaceutical form:

TABLET

Composition:

CANDESARTAN CILEXETIL 16 mg; HYDROCHLOROTHIAZIDE 12.5 mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

ASTRAZENECA AB

Authorization status:

ACTIVE

Authorization date:

2000-08-26

Patient Information leaflet

04/AD/SG/CV.000-048-340.7.0 
Page 1/17 

ATACAND

 PLUS 16/12.5 MG 
_candesartan cilexetil/hydrochlorothiazide   _
TABLETS 

FERTILITY, PREGNANCY AND LACTATION 
_Use in pregnancy _
The use of Atacand Plus is contraindicated
during pregnancy (see “Contraindications”). Patients 
receiving Atacand Plus should be made aware of that
before contemplating a possibility of 
becoming pregnant so that they can discuss appropriate
options with their treating physician. 
When pregnancy is diagnosed, treatment with Atacand Plus must be
stopped immediately and if 
appropriate, alternative therapy should be started. 
When used in pregnancy, drugs that act directly on the
renin-angiotensin system can cause foetal 
and neonatal injury and death. Exposure to angiotensin
II receptor antagonist therapy is known to 
induce human fetotoxicity (decreased renal function,
oligohydramnios, skull ossification 
retardation) and neonatal toxicity (renal failure, hypotension,
hyperkalaemia) (see “Preclinical 
safety data”).  
There is limited experience with hydrochlorothiazide
during pregnancy, especially during the 
first trimester. Animal studies are insufficient. Hydrochlorothiazide
crosses the placenta. Based 
on the pharmacological mechanism of action of hydrochlorothiazide,
its use during pregnancy 
may compromise foeto-placental perfusion and may cause foetal and
neonatal effects like icterus, 
disturbance of electrolyte balance and thrombocytopenia. 

_Use in lactation_ 
It is not known whether candesartan is excreted in human milk.
However, candesartan is 
excreted in the milk of lactating rats. Hydrochlorothiazide passes
into mother’s milk. Because of 
the potential for adverse effects on the nursing infant, Atacand
Plus should not be given during 
breast-feeding (see “Contraindications”). 

COMPOSITION 
One Atacand Plus tablet contains 16 mg candesartan cilexetil and
12.5 mg hydrochlorothiazide. 
For

Summary of Product characteristics

1
ATACAND
® PLUS
(CANDESARTAN CILEXETIL/HYDROCHLOROTHIAZIDE)
FERTILITY, PREGNANCY AND LACTATION
_USE IN PREGNANCY _
The use of Atacand Plus is contraindicated during pregnancy (see
section Contraindications).
Patients receiving Atacand Plus should be made aware of that before
contemplating a possibility
of becoming pregnant so that they can discuss appropriate options with
their treating physician.
When pregnancy is diagnosed, treatment with Atacand Plus must be
stopped immediately and if
appropriate, alternative therapy should be started.
When used in pregnancy, drugs that act directly on the
renin-angiotensin system can cause foetal
and neonatal injury and death. Exposure to angiotensin II receptor
antagonist therapy is known
to induce human fetotoxicity (decreased renal function,
oligohydramnios, skull ossification
retardation)
and
neonatal
toxicity
(renal
failure,
hypotension,
hyperkalaemia)
(see
section
Preclinical safety data).
There is limited experience with hydrochlorothiazide during pregnancy,
especially during the
first trimester. Animal studies are insufficient. Hydrochlorothiazide
crosses the placenta. Based
on the pharmacological mechanism of action of hydrochlorothiazide, its
use during pregnancy
may compromise foeto-placental perfusion and may cause foetal and
neonatal effects like
icterus, disturbance of electrolyte balance and thrombocytopenia.
_USE IN LACTATION_
It is not known whether candesartan is excreted in human milk.
However, candesartan is
excreted in the milk of lactating rats. Hydrochlorothiazide passes
into mother’s milk. Because of
the potential for adverse effects on the nursing infant, Atacand Plus
should not be given during
breast-feeding (see section Contraindications).
1.
NAME OF THE MEDICINAL PRODUCT
Atacand

Plus 16/12.5 mg
_candesartan cilexetil/hydrochlorothiazide _
tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One Atacand Plus tablet contains 16 mg candesartan cilexetil and 12.5
mg hydrochlorothiazide.
For excipients (see section List of excipients).
3.
PHARMAC