ATACAND TABLET 16 mg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Candesartan cilexetil

Available from:

ASTRAZENECA SINGAPORE PTE LTD

ATC code:

C09CA06

Dosage:

16 mg

Pharmaceutical form:

TABLET

Composition:

Candesartan cilexetil 16 mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

ASTRAZENECA AB

Authorization status:

ACTIVE

Authorization date:

1999-04-20

Patient Information leaflet

10/AC/SG/CV.000-197-311.8.0  
Page 1/20 
ATACAND® 4 MG, 8 MG, 16 MG TABLETS  
_Candesartan cilexetil _tablets  
FERTILITY, PREGNANCY AND LACTATION  
_Use in pregnancy _ 
The use of Atacand is contraindicated
during pregnancy (see section Contraindications). 
Patients receiving Atacand 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 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 fetal 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).  

_Use in lactation _ 
It is not known whether candesartan is excreted in human milk.
However, candesartan is 
excreted in the milk of lactating rats. Because of the potential
for adverse effects on the 
nursing infant, Atacand should not be given
during breast-feeding (see section 
Contraindications).  

COMPOSITION  
Each tablet contains 4 mg, 8 mg 16 mg candesartan cilexetil.  
For excipients (see list of excipients).  

PHARMACEUTICAL FORM  
Tablets.  
Atacand 4 mg are round (diameter 7 mm), white tablets with
a score and marked A/CF 
on one side and marked 004 on the other side.  
10/AC/SG/CV.000-197-311.8.0  
Page 2/20 
Atacand 8 mg are round (diameter 7 mm), light pink tablets with a
score and marked 
A/CG on one side and marked 008 on the other side.  
Atacand 16 mg are round (diameter 7 mm), pink tablets with
a score and marked A/CH 
on one side and marked 016 on the o

Summary of Product characteristics

1
ATACAND
®
(CANDESARTAN CILEXETIL)
FERTILITY, PREGNANCY AND LACTATION
_USE IN PREGNANCY _
The use of Atacand is contraindicated during pregnancy (see section
Contraindications).
Patients receiving Atacand 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 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 fetal 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).
_USE IN LACTATION _
It is not known whether candesartan is excreted in human milk.
However, candesartan is
excreted in the milk of lactating rats. Because of the potential for
adverse effects on the
nursing
infant,
Atacand
should
not
be
given
during
breast-feeding
(see
section
Contraindications).
1.
NAME OF THE MEDICINAL PRODUCT
Atacand
®
4 mg, 8 mg, 16 mg tablets
_Candesartan cilexetil _
tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 4 mg, 8 mg 16 mg candesartan cilexetil.
For excipients (see list of excipients).
3.
PHARMACEUTICAL FORM
Tablets.
Atacand 4 mg are round (diameter 7 mm), white tablets with a score and
marked A/CF
on one side and marked 004 on the other side.
Atacand 8 mg are round (diameter 7 mm), light pink tablets with a
score and marked
A/CG on one side and marked 008 on the other side.
Atacand 16 mg are round (diameter 7 mm), pink tablets with a score and
marked A/CH
on one side and marked 016 on the other side.
2
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Hypertension.
Treatment of patients with heart failure and impaired left ventricle
systolic function (left
ventricu