Catasart 4 mg Tablets

Land: Irland

Språk: engelska

Källa: HPRA (Health Products Regulatory Authority)

Aktiva substanser:

Candesartan cilexetil

Tillgänglig från:

Rowex Ltd

ATC-kod:

C09CA; C09CA06

INN (International namn):

Candesartan cilexetil

Dos:

4 milligram(s)

Läkemedelsform:

Tablet

Receptbelagda typ:

Product subject to prescription which may be renewed (B)

Terapiområde:

Angiotensin II antagonists, plain; candesartan

Bemyndigande status:

Marketed

Tillstånd datum:

2009-09-04

Bipacksedel

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CATASART 4 MG TABLETS
CATASART 8 MG TABLETS
CATASART 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 Catasart is and what it is used for
2.
What you need to know before you take Catasart
3.
How to take Catasart
4.
Possible side effects
5.
How to store Catasart
6.
Contents of the pack and other information
1. WHAT CATASART IS AND WHAT IT IS USED FOR_ _
The name of your medicine is Catasart. The active substance 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 to:

treat high blood pressure (hypertension) in adult patients and in
children and adolescents aged 6 to
<18 years

treat 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 CATASART_ _
DO NOT TAKE CATASART

if you are allergic to candesartan cilexetil or to any of the
ingredients of this medicine listed in
section 6

if you are more than 3 months pregnant (it is also be

Produktens egenskaper

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Catasart 4 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 4 mg of candesartan cilexetil.
Excipients with known effect
Each tablet contains 70.24 mg lactose (as monohydrate) and up to 0.003
mg (0.0001 mmol) sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
White, round biconvex tablet, debossed with 4 on one side and scored
on the other side.
The tablet can be divided into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Catasart 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 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 Catasart 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.
Catasart 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 Catasart.
_Elderly_
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
d