Candestar

Страна: Нова Зеландия

Език: английски

Източник: Medsafe (Medicines Safety Authority)

Активна съставка:

Candesartan cilexetil 16mg;  

Предлага се от:

Viatris Limited

INN (Международно Name):

Candesartan cilexetil 16 mg

дозиране:

16 mg

Лекарствена форма:

Tablet

Композиция:

Active: Candesartan cilexetil 16mg   Excipient: Carmellose calcium Hyprolose Lactose monohydrate Magnesium stearate Mannitol

Броя в опаковка:

Blister pack, cold form, OPA/Al/PVC, hard tempered Al foil, 30 tablets

Клас:

Prescription

Вид предписание :

Prescription

Произведено от:

Zhejiang Huahai Pharmaceutical Co Ltd

Терапевтични показания:

Hypertension

Каталог на резюме:

Package - Contents - Shelf Life: Blister pack, cold form, OPA/Al/PVC, hard tempered Al foil - 30 tablets - 24 months from date of manufacture stored at or below 25°C - Blister pack, cold form, OPA/Al/PVC, hard tempered Al foil - 90 tablets - 24 months from date of manufacture stored at or below 25°C - Bottle, HDPE, white, with opaque screw, absorbent cotton and desiccant - 30 tablets - 24 months from date of manufacture stored at or below 25°C - Bottle, HDPE, white, with opaque screw, absorbent cotton and desiccant - 90 tablets - 24 months from date of manufacture stored at or below 25°C

Дата Оторизация:

2010-05-27

Листовка

Page 1 of 4
NEW ZEALAND CONSUMER MEDICINE INFORMATION
CANDESTAR
_CANDESARTAN CILEXETIL _
_4 MG, 8 MG, 16 MG AND 32 MG TABLETS _
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you start taking Candestar.
This leaflet answers some common
questions about Candestar.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor will have
weighed the risks of you taking
Candestar against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE. You may need to read it
again.
WHAT CANDESTAR IS
TAKEN FOR
Candestar contains the active
ingredient candesartan cilexetil. It
belongs to a group of medicines
called angiotensin II receptor
blockers, or ARBs.
Candestar is taken to treat:

high blood pressure
(hypertension)

heart failure patients with
reduced heart muscle
function
Candestar works by blocking the
effects of the hormone, angiotensin
II. This causes relaxation or
widening of the blood vessels which
results in a lowering of the blood
pressure.
It also helps with heart failure by
widening the blood vessels, so that
the heart does not have to pump as
hard to move the blood around the
body. This also means that when
you place extra demands on your
heart, such as during exercise, the
heart may cope better so you may
not get short of breath as easily.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED FOR
YOU.
Your doctor may have prescribed it
for another reason.
This medicine is available only with
a doctor’s prescription.
BEFORE YOU TAKE
CANDESTAR
_WHEN YOU MUST NOT TAKE IT:_
DO NOT TAKE CANDESTAR IF YOU
HAVE AN ALLERGY TO:

any medicine containing
candesartan

any of the ingredients listed
at the end of this leaflet
Some of the symptoms of an
allergic reaction may include:
shortness of breath; wheezing or
difficulty breathing; swelling o

Данни за продукта

Page 1 of 12
NEW ZEALAND DATA SHEET
CANDESTAR
1. PRODUCT NAME
Candestar, 4 mg, 8 mg, 16 mg and 32 mg tablets.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 4 mg, 8 mg, 16 mg or 32 mg of candesartan
cilexetil.
Excipients with known effect: Contains sugars as lactose.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Candestar 4 mg: White to off white, round, biconvex tablet debossed
with “M” over “C1” on one side,
and plain with a break line on the other side.
Candestar 8 mg: White to off white, round, biconvex tablet debossed
with “M” over “C5” on one side,
and plain with a break line on the other side.
Candestar 16 mg: White to off white, round, biconvex tablet debossed
with “M” over “C6” on one
side, and plain with a break line on the other side.
Candestar 32 mg: White to off white, round, biconvex tablet debossed
with “M” over “C7” on one
side, and plain with a break line 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 left ventricular systolic
dysfunction. Treatment
with candesartan cilexetil reduces mortality, reduces hospitalisation
due to heart failure,
and improves symptoms.
_4.2_
_DOSE AND METHOD OF ADMINISTRATION_
DOSAGE IN HYPERTENSION
The recommended initial and maintenance dose of Candestar is 8 mg once
daily. The dose may be
increased to 16 mg once daily. In patients who require further blood
pressure reduction, the dose
may be increased to 32 mg once daily.
Therapy should be adjusted according to blood pressure response. The
maximal antihypertensive
effect is attained within 4 weeks after initiation of treatment.
Page 2 of 12
In patients with less than optimal blood pressure reduction on
Candestar, combination with a thiazide
diuretic is recommended.
USE IN THE ELDERLY
No initial dosage adjustment is necessary for elderly patients.
USE IN IMPAIRED RENAL FUNCTION
No initial dosage adjustment