Candesartan Hydrochlorothiazide Krka 32mg/12.5mg tablets

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

Candesartan cilexetil; Hydrochlorothiazide

Dostupné z:

KRKA, d.d., Novo mesto

ATC kód:

C09DA; C09DA06

INN (Medzinárodný Name):

Candesartan cilexetil; Hydrochlorothiazide

Dávkovanie:

32 mg/12.5 milligram(s)

Forma lieku:

Tablet

Typ predpisu:

Product subject to prescription which may be renewed (B)

Terapeutické oblasti:

Angiotensin II antagonists and diuretics; candesartan and diuretics

Stav Autorizácia:

Not marketed

Dátum Autorizácia:

2011-08-12

Príbalový leták

PACKAGE LEAFLET: INFORMATION FOR THE USER
CANDESARTAN HYDROCHLOROTHIAZIDE KRKA 8 MG/12.5 MG TABLETS
CANDESARTAN HYDROCHLOROTHIAZIDE KRKA 16 MG/12.5 MG TABLETS
CANDESARTAN HYDROCHLOROTHIAZIDE KRKA 32 MG/12.5 MG TABLETS
CANDESARTAN HYDROCHLOROTHIAZIDE KRKA 32 MG/25 MG TABLETS
candesartan cilexetil/hydrochlorothiazide
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 Hydrochlorothiazide Krka is and what it is used for
2.
What you need to know before you take Candesartan Hydrochlorothiazide
Krka
3.
How to take Candesartan Hydrochlorothiazide Krka
4.
Possible side effects
5.
How to store Candesartan Hydrochlorothiazide Krka
6.
Contents of the pack and other information
1.
WHAT CANDESARTAN HYDROCHLOROTHIAZIDE KRKA IS AND WHAT IT IS USED FOR
The name of your medicine is Candesartan Hydrochlorothiazide Krka. It
is used for treating high
blood pressure (hypertension) in adult patients. It contains two
active ingredients: candesartan cilexetil
and hydrochlorothiazide.
These work together to lower your blood pressure.
Candesartan cilexetil belongs to a group of medicines called
angiotensin II receptor antagonists. It
makes your blood vessels relax and widen. This helps to lower your
blood pressure.
Hydrochlorothiazide belongs to a group of medicines called diuretics
(water tablets). It helps your
body to get rid of water and salts like sodium in your urine. This
helps to lower your blood pressure.
Your doctor may prescribe Candesartan Hydrochlorothiazide Krka if your
blood pressure has not been
p

Súhrn charakteristických

Health Products Regulatory Authority
16 January 2024
CRN00DPGQ
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Candesartan Hydrochlorothiazide Krka 32mg/12.5mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 32 mg candesartan cilexetil and 12.5 mg
hydrochlorothiazide.
Excipient with known effect: Lactose 142.79 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
Candesartan Hydrochlorothiazide Krka 32 mg/12.5 mg tablets are
yellowish white, biconvex, oval, with a score on one side.
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
Candesartan Hydrochlorothiazide Krka is indicated for the:
Treatment of essential hypertension in adult patients whose blood
pressure is not optimally controlled with candesartan
cilexetil or hydrochlorothiazide monotherapy.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology in hypertension
The recommended dose of Candesartan Hydrochlorothiazide Krka is one
tablet once daily.
Dose titration with the individual components (candesartan cilexetil
and hydrochlorothiazide) is recommended. When clinically
appropriate a direct change from monotherapy to Candesartan
Hydrochlorothiazide Krka may be considered. Dose titration of
candesartan cilexetil is recommended when switching from
hydrochlorothiazide monotherapy. Candesartan
Hydrochlorothiazide Krka may be administered in patients whose blood
pressure is not optimally controlled with candesartan
cilexetil or hydrochlorothiazide monotherapy or Candesartan
Hydrochlorothiazide Krka at lower doses.
Most of the antihypertensive effect is usually attained within 4 weeks
of initiation of treatment.
_ _
Special populations
_Elderly_
No dose adjustment is necessary in elderly patients.
_Intravascular volume depletion_
Dose titration of candesartan cilexetil is recommended in patients at
risk for hypotension such as patients with possible volume
depletion (an init