Candist 4 mg Tablets

Negara: Irlandia

Bahasa: Inggris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Candesartan cilexetil

Tersedia dari:

Clonmel Healthcare Ltd

Kode ATC:

C09CA; C09CA06

INN (Nama Internasional):

Candesartan cilexetil

Dosis:

4 milligram(s)

Bentuk farmasi:

Tablet

Jenis Resep:

Product subject to prescription which may be renewed (B)

Area terapi:

Angiotensin II antagonists, plain; candesartan

Status otorisasi:

Marketed

Tanggal Otorisasi:

2011-09-23

Selebaran informasi

Page 1 of 6
PACKAGE LEAFLET: INFORMATION FOR THE USER
CANDIST 4MG TABLETS
CANDIST 8MG TABLETS
CANDIST 16MG TABLETS
Candesartan cilexetil
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even
if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Candist is and what it is used for
2. What you need to know before you take Candist
3. How to take Candist
4. Possible side effects
5. How to store Candist
6. Contents of the pack and other information
1. WHAT CANDIST IS AND WHAT IT IS USED FOR
The name of your medicine is Candist. The active ingredient is
candesartan cilexetil. This belongs to a
group of medicines called angiotensin II receptor antagonists. It
works by making your blood vessels
relax and widen. This helps to lower your blood pressure. It also
makes it easier for your heart to pump
blood to all parts of your body.
This medicine is used for
•
treating high blood pressure (hypertension) in adult patients and in
children and adolescents aged 6
to under 18 years.
•
treating adult heart failure patients with reduced heart muscle
function when Angiotensin
Converting Enzyme (ACE) inhibitors cannot be used or in addition to
ACE-inhibitors when
symptoms persist despite treatment and mineralocorticoid receptor
antagonists (MRA) cannot be
used. (ACE-inhibitors and MRAs are medicines used to treat heart
failure).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CANDIST
DO NOT TAKE CANDIST
•
if you are allergic to candesartan cilexetil or any of the other
ingredients of this medicine (listed in
section 6).
•
if you are more than 3 months pregnant (it is

Karakteristik produk

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Candist 4 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 4 mg candesartan cilexetil.
Excipients with known effect:
Each tablet contains 133.80 mg lactose monohydrate
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
White biconvex tablets with a score line on one side and embossing C4
on the same side.
The tablet can be divided into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Candist is indicated for the:
Treatment of primary hypertension in adults.
Treatment of hypertension in children and adolescents aged 6 to < 18
years.
Treatment of adult patients with heart failure and impaired left
ventricular systolic function (left ventricular
ejection fraction
40 %) when Angiotensin Converting Enzyme (ACE)-inhibitors are not
tolerated or as add-on
therapy to ACE-inhibitors in patients with symptomatic heart failure,
despite optimal therapy, when
mineralocorticoid receptor antagonists are not tolerated (see sections
4.2, 4.4, 4.5 and 5.1).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology in hypertension
The recommended initial dose and usual maintenance dose of Candist 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 16 mg once daily and to a
maximum of 32 mg once daily. Therapy should be
adjusted according to blood pressure response.
Candist 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 Candist.
_Elderly population_
No initial dose adjustment is necessary in elderly patients.
_Patients with intravascular volume depletion_
An initial dose of 4 mg may be considered in patients at risk for
hypotension, such as patients with possible volume
depletion (see section 4.4).
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