Candesartan Hydrochlorothiazide 16 mg/12.5 mg Tablets

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

Hydrochlorothiazide; Candesartan cilexetil

Commercializzato da:

Actavis Group PTC ehf

Codice ATC:

C09DA; C09DA06

INN (Nome Internazionale):

Hydrochlorothiazide; Candesartan cilexetil

Dosaggio:

16/12.5 milligram(s)

Forma farmaceutica:

Tablet

Tipo di ricetta:

Product subject to prescription which may be renewed (B)

Area terapeutica:

Angiotensin II antagonists and diuretics; candesartan and diuretics

Stato dell'autorizzazione:

Marketed

Data dell'autorizzazione:

2012-04-20

Foglio illustrativo

1
PACKAGE LEAFLET: INFORMATION FOR THE USER CANDESARTAN
HYDROCHLOROTHIAZIDE 16 MG/12.5 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 16 mg/12.5 mg tablets is and what
it is used for
2.
What you need to know before you take Candesartan Hydrochlorothiazide
16 mg/12.5 mg
tablets
3.
How to take Candesartan Hydrochlorothiazide 16 mg/12.5 mg tablets
4.
Possible side effects
5.
How to store Candesartan Hydrochlorothiazide 16 mg/12.5 mg tablets
6.
Contents of the pack and other information
1.
WHAT CANDESARTAN HYDROCHLOROTHIAZIDE 16 MG/12.5 MG TABLETS IS AND WHAT
IT IS USED FOR
The name of your medicine is Candesartan Hydrochlorothiazide 16
mg/12.5 mg tablets. 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 16 mg/12.5
mg tablets if your blood pressure
has not been properly controlled by candesartan cilexetil or
hydroch

Scheda tecnica

Health Products Regulatory Authority
23 January 2019
CRN008RJH
Page 1 of 20
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Candesartan Hydrochlorothiazide 16 mg/12.5 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One Candesartan Hydrochlorothiazide 16 mg/12.5 mg tablet contains 16
mg
candesartan cilexetil and 12.5 mg hydrochlorothiazide.
Excipients with known effect:
Each tablet contains 109.30 mg lactose monohydrate.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Tablet.
Candesartan Hydrochlorotiazide 16 mg/12.5 mg Tablets are white, round,
biconvex
tablets with a score line on one side and an embossing CH16 on the
same side.
The tablet can be divided into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Candesartan Hydrochlorothiazide 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
The recommended dose of Candesartan Hydrochlorotiazide 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 Hydrochlorotiazide may be considered.
Dose
titration of candesartan cilexetil is recommended when switching from
Health Products Regulatory Authority
23 January 2019
CRN008RJH
Page 2 of 20
hydrochlorothiazide monotherapy. Candesartan Hydrochlorotiazide may be
administered in patients whose blood pressure is not optimally
controlled with
candesartan cilexetil or hydrochlorothiazide monotherapy or
Candesartan
Hydrochlorotiazide at lower doses (see sections 4.3, 4.4, 4.5 and
5.1).
Most of the antihypertensive effect is usually attained within 4 weeks
of initiation of
treatment.
Special populations
_Elderly population _
No dose adjustment is necessary in elderly patients.
_Patients with intravascular volume depletion _
Do