ATACAND PLUS

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE

Available from:

TZAMAL BIO-PHARMA LTD

ATC code:

C09DA06

Pharmaceutical form:

TABLETS

Composition:

CANDESARTAN CILEXETIL 16 MG; HYDROCHLOROTHIAZIDE 12.5 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

CHEPLAPHARM ARZNEIMITTEL GMBH, GERMANY

Therapeutic group:

CANDESARTAN AND DIURETICS

Therapeutic area:

CANDESARTAN AND DIURETICS

Therapeutic indications:

Essential hypertension, where monotherapy with candesartan cilexetil or hydrochlorothiazide is not sufficient.

Authorization date:

2023-01-31

Patient Information leaflet

PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
This medicine is dispensed with a doctor's prescription only
ATACAND PLUS
®
Tablets
ACTIVE INGREDIENT
Each tablet contains:
candesartan cilexetil 16 mg
hydrochlorothiazide 12.5 mg
Inactive ingredients and allergens in this medicine - see section 2
‘Important information about some of this
medicine’s ingredients’, and section 6 ‘Additional information'.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
This leaflet contains concise information about this medicine. If you
have any further questions, consult
your doctor or pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to others. It may harm them, even
if it seems to you that their illness is similar to yours.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
Atacand Plus is intended for the treatment of hypertension, where
monotherapy with candesartan cilexetil or
hydrochlorothiazide is not sufficient.
THERAPEUTIC GROUP
Candesartan cilexetil belongs to a group of medicines called
angiotensin II receptor antagonists, which
works by blocking the effects of the hormone, angiotensin II. It makes
your blood vessels relax and widen,
which contributes to lowering your blood pressure.
Hydrochlorothiazide - belongs to a group of medicines called
diuretics. It works to get rid of water and salts,
such as sodium, through the urinary tract, and this helps lower your
blood pressure.
2.
BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:
•
You are sensitive (allergic) to the active ingredients candesartan
cilexetil or hydrochlorothiazide or to
any of the other ingredients in this medicine (see section 6).
•
You are more than three months pregnant (even at the beginning of
pregnancy, it is better to avoid
use of the medicine. For more information, see the 'Pregnancy and
breastfeeding' section.
•
You have a known sensitivity to medicines in the sulphonamide class.
If you are unsure whether this
applies to you, consult your doct

Summary of Product characteristics

1
1.
NAME OF THE MEDICINAL PRODUCT
Atacand Plus 16/12.5 mg tablets.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One Atacand Plus tablet contains 16 mg candesartan cilexetil and 12.5
mg
hydrochlorothiazide.
Excipient(s) with known effect
Each tablet contains 68 mg lactose monohydrate.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablets.
Atacand Plus 16/12.5 mg tablets are peach, oval, biconvex tablets with
a score on both
sides and engraved A/CS on one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Essential hypertension, where monotherapy with candesartan cilexetil
or
hydrochlorothiazide is not sufficient.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Dosage _
IN HYPERTENSION_ _
The recommended dose of Atacand Plus is 1 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 can be considered. The dose of candesartan
cilexetil
should be titrated before switching to Atacand Plus. Atacand Plus can
be administered
in patients whose blood pressure is not optimally controlled with
candesartan cilexetil or
hydrochlorothiazide monotherapy.
Most of the antihypertensive effect is usually achieved within 4 weeks
after starting
treatment.
Method of administration:
Oral use.
Atacand Plus can be taken with or without food.
The bioavailability of candesartan is not affected by food.
There is no clinically significant interaction between
hydrochlorothiazide and food.
SPECIAL POPULATIONS
_Elderly population _
No dosage adjustment is needed in elderly patients.
_Patients with reduced blood volume _
Dose
titration
of
candesartan
cilexetil
is
recommended
for
patients
with
risk
for
hypotension, such as patients with possible volume loss (an initial
dose of candesartan
cilexetil 4 mg may be considered in these patients).
_Patients with impaired renal function _
Dose titration is recommended in patients with mild to moderate renal
impairment
(creatinin