Atacand 4 mg tablets

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

Candesartan cilexetil

Dostupné z:

AstraZeneca AB

ATC kód:

C09CA; C09CA06

INN (Medzinárodný Name):

Candesartan cilexetil

Dávkovanie:

4 milligram(s)

Forma lieku:

Tablet

Typ predpisu:

Product subject to prescription which may be renewed (B)

Terapeutické oblasti:

Angiotensin II antagonists, plain; candesartan

Stav Autorizácia:

Not marketed

Dátum Autorizácia:

2002-04-29

Príbalový leták

Page 1 of 7
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Atacand 4 mg tablets
Atacand 8 mg tablets
Atacand 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. This includes any
possible side effects
not listed in this leaflet.
WHAT IS IN THIS LEAFLET:
1.
What Atacand is and what it is used for
2.
What you need to know before you take Atacand
3.
How to take Atacand
4.
Possible side effects
5.
How to store Atacand
6.
Contents of the pack and other information
1.
WHAT ATACAND IS AND WHAT IT IS USED FOR
The name of your medicine is Atacand. 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.
Atacand can be 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 ATACAND
DO NOT TAKE ATACAND:

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 also better to avoid
Atacand in e

Súhrn charakteristických

HealthProductsRegulatoryAuthority
21June2019
CRN009404
Page1of13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Atacand4mgtablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Eachtabletcontains4mgcandesartancilexetil.
Excipientwithknowneffect
Eachtabletcontains93.4mglactosemonohydrate.
For thefulllistofexcipients,seesection6.1_._
3 PHARMACEUTICAL FORM
Tablet.
Round(diameter7mm),whitetabletswithascoreandmarkedA/CFononesideandmarked004ontheotherside.
The tabletcanbedividedintoequaldoses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Atacandisindicatedfor:

-Thetreatmentofprimaryhypertensioninadults.

-The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Atacand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.
Ataca