Candesartan Krka 4 mg tablets

Country: Irlanda

Lingwa: Ingliż

Sors: HPRA (Health Products Regulatory Authority)

Ingredjent attiv:

Candesartan cilexetil

Disponibbli minn:

KRKA, d.d., Novo mesto

Kodiċi ATC:

C09CA; C09CA06

INN (Isem Internazzjonali):

Candesartan cilexetil

Dożaġġ:

4 milligram(s)

Għamla farmaċewtika:

Tablet

Tip ta 'preskrizzjoni:

Product subject to prescription which may be renewed (B)

Żona terapewtika:

Angiotensin II antagonists, plain; candesartan

L-istatus ta 'awtorizzazzjoni:

Marketed

Data ta 'l-awtorizzazzjoni:

2012-03-09

Fuljett ta 'informazzjoni

PACKAGE LEAFLET: INFORMATION FOR THE USER
CANDESARTAN KRKA 4 MG TABLETS
CANDESARTAN KRKA 8 MG TABLETS
CANDESARTAN KRKA 16 MG TABLETS
CANDESARTAN KRKA 32 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 Krka is and what it is used for
2.
What you need to know before you take Candesartan Krka
3.
How to take Candesartan Krka
4.
Possible side effects
5.
How to store Candesartan Krka
6.
Contents of the pack and other information
1.
WHAT CANDESARTAN KRKA IS AND WHAT IT IS USED FOR
The name of your medicine is Candesartan Krka. 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 is medicine is used for
-
treating high blood pressure (hypertension) in adult patients and in
children and adolescents
aged 6 to under 18 years.
-
Candesartan Krka can be used to 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 CANDESARTAN KRKA
DO NOT TAKE CANDESARTAN KRKA
-
if you are allergic to can

Karatteristiċi tal-prodott

Health Products Regulatory Authority
11 July 2023
CRN00DJ4H
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Candesartan Krka 4 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 4 mg candesartan cilexetil.
Excipient with known effect:
4 mg tablets
Lactose monohydrate
94.050 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
Round, white, biconvex tablets, scored on one side, engraved with mark
4.
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
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
ventricle 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
Krka 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 Krka may also be administered with other antihypertensive
agents. Addition of hydrochlorothiazide has been
shown to have an additive antihypertensive effect with various doses
of Candesartan Krka.
_Older people_
No initial dosage adjustment is necessary in older people.
_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