Candesartan 4 mg Tablets

Country: Իռլանդիա

language: անգլերեն

source: HPRA (Health Products Regulatory Authority)

active_ingredient:

Candesartan cilexetil

MAH:

Actavis Group PTC ehf

ATC_code:

C09CA; C09CA06

INN:

Candesartan cilexetil

dosage:

4 milligram(s)

pharmaceutical_form:

Tablet

prescription_type:

Product subject to prescription which may be renewed (B)

therapeutic_area:

Angiotensin II antagonists, plain; candesartan

authorization_status:

Marketed

authorization_date:

2011-04-15

PIL

PACKAGE LEAFLET: INFORMATION FOR THE USER
CANDESARTAN 4 MG TABLETS
CANDESARTAN 8 MG TABLETS
CANDESARTAN 16 MG 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 or pharmacist.
This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1 WHAT CANDESARTAN IS AND WHAT IT IS USED FOR
2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE CANDESARTAN
3 HOW TO TAKE CANDESARTAN
4 POSSIBLE SIDE EFFECTS
5 HOW TO STORE CANDESARTAN
6 CONTENTS OF THE PACK AND OTHER INFORMATION
1
WHAT CANDESARTAN IS AND WHAT IT IS USED FOR
The name of your medicine is Candesartan. 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 < 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 CANDESARTAN
DO NOT TAKE CANDESARTAN:
•
if you are allergic to candesartan cilexetil or any of the other
ingredients of this medicine
(listed in section 6).
•
if you are more tha

SPC

Health Products Regulatory Authority
21 May 2019
CRN008WW5
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Candesartan 4 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 4 mg candesartan cilexetil.
Each tablet contains 133.80 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
Candesartan 4 mg tablets are white biconex tablets, 8 x 3mm 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
Candesartan is indicated for the:
- Treatment of essential hypertension in adults.
- Treatment of hypertension in children and adolescents aged 6 to <18
years.
- The treatment of adult patients with heart failure and impaired left
ventricular systolic function (left ventricular ejection
fraction ≤ 40%) when 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 Candesartan
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.
Candesartan 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 Candesartan.
_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