ATACAND 8 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

CANDESARTAN CILEXETIL

Available from:

TZAMAL BIO-PHARMA LTD

ATC code:

C09CA06

Pharmaceutical form:

TABLETS

Composition:

CANDESARTAN CILEXETIL 8 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

CHEPLAPHARM ARZNEIMITTEL GMBH, GERMANY

Therapeutic group:

CANDESARTAN

Therapeutic area:

CANDESARTAN

Therapeutic indications:

Hypertension. Treatment of patients with heart failure and impaired left ventricle systolic function ( left ventricular ejection fraction < or = 40 % ) as add-on therapy to ACE inhibitors or when ACE inhibitors are not tolerated.

Authorization date:

2023-01-31

Patient Information leaflet

PATIENT PACKAGE INSERT IN ACCORDANCE WITH
THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed with a doctor's prescription only
Atacand
®
4 mg
Atacand
®
8 mg
Atacand
®
16 mg
Tablets
Tablets
Tablets
Composition
Each tablet contains:
Candesartan cilexetil 4 mg
Candesartan cilexetil 8 mg
Candesartan cilexetil 16 mg
For inactive ingredients please see section 6 – “Further
information”.
Read this leaflet carefully in its entirety before using this
medicine.
Keep this leaflet; you may need it again.
This leaflet contains concise information about the medicine. If you
have further
questions, refer to the doctor or pharmacist.
This medicine has been prescribed for the treatment of your ailment.
Do not pass it on
to others. It may harm them, even if it seems to you that their
ailment is similar.
The medicine is intended for adults above 18 years of age.
1. WHAT IS THE MEDICINE INTENDED FOR?
For treatment of hypertension and treatment of heart failure.
Therapeutic Group
Angiotensin II receptor antagonist which blocks the effects of the
hormone angiotensin
II, thereby causing the blood vessels to relax, resulting in lowering
of blood pressure. It
also assists the heart with blood flow to all parts of the body.
2. BEFORE USING THE MEDICINE
X Do not use this medicine if:
•
you are more than 3 months pregnant (it is also better to avoid using
the
medicine
in
early
pregnancy,
for
further
information
see
“pregnancy
and
breastfeeding” section below).
•
you have a known sensitivity to the active ingredient - candesartan
cilexetil or to
any of the ingredients of the medicine (see section 6 “Further
Information”
below).
•
you have severe liver function impairment or biliary tract
obstruction.
•
you are taking a medicine to lower blood pressure containing aliskiren
and you
have diabetes.
•
you are taking a medicine to lower blood pressure containing aliskiren
and you
have kidney function problems.
Special warnings regarding use of Atacand
! Before treatment with Atacand, tell your d

Summary of Product characteristics

1 ATA_PI_TZ_06.2021-00
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
ATACAND
® 4 MG, 8 MG AND 16 MG TABLETS.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 4 mg, 8 mg or 16 mg candesartan cilexetil.
Excipient with known effect:
4 mg: Each tablet contains 93.4 mg lactose monohydrate
8 mg: Each tablet contains 89.4 mg lactose monohydrate
16 mg: Each tablet contains 81.4 mg lactose monohydrate
3.
PHARMACEUTICAL FORM
Tablets.
Atacand 4 mg: 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: 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: round (diameter 7 mm), pink tablets with a score and
marked A/CH
on one side and marked 016 on the other side.
The tablet can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
hypertension
Treatment of patients with heart failure and impaired left ventricle
systolic function
(left ventricular ejection fraction

40%) as add-on therapy to ACE inhibitors or
when ACE inhibitors are not tolerated (see section 5.1 Pharmacodynamic
properties).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
2 ATA_PI_TZ_06.2021-00
DOSAGE IN HYPERTENSION
The recommended initial dose and usual maintenance dose is 8 mg once
daily.
Most of the antihypertensive effect is attained within 4 weeks. In
some patients
whose blood pressure is not adequately controlled, the dose can be
increased to a
maximum of 16 mg once daily.
Therapy should be adjusted according to blood pressure response.
Atacand may also be administered with other antihypertensive agents
(see sections
4.3, 4.4, 4.5 and 5.1). Addition of hydrochlorothiazide has been shown
to have an
additive antihypertensive effect with various doses of Atacand.
Use in the elderly
No initial dosage adjustment is necessary in elderly patients.
Use in patients with intravascular volume depletion
An initial dose of 4 mg may be considered in patien