Candesartan/Hydrochlorothiazide Clonmel 16mg / 12.5mg Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Candesartan cilexetil; Hydrochlorothiazide

Available from:

Clonmel Healthcare Ltd

ATC code:

C09DA; C09DA06

INN (International Name):

Candesartan cilexetil; Hydrochlorothiazide

Dosage:

16/12.5 milligram(s)

Pharmaceutical form:

Tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Angiotensin II antagonists and diuretics; candesartan and diuretics

Authorization status:

Not marketed

Authorization date:

2013-04-05

Patient Information leaflet

Page 1 of 6
PACKAGE LEAFLET: INFORMATION FOR THE USER
CANDESARTAN/HYDROCHLOROTHIAZIDE CLONMEL 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 effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Candesartan/ Hydrochlorothiazide Clonmel is and what it is used
for
2.
What you need to know before you take Candesartan/ Hydrochlorothiazide
Clonmel
3.
How to take Candesartan/ Hydrochlorothiazide Clonmel
4.
Possible side effects
5.
How to store Candesartan/ Hydrochlorothiazide Clonmel
6.
Contents of the pack and further information
1.
WHAT CANDESARTAN/ HYDROCHLOROTHIAZIDE CLONMEL IS AND WHAT IT IS USED
FOR
The name of your medicine is Candesartan/ Hydrochlorothiazide Clonmel
. 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 Clonmel if
your blood pressure has not
been properly controlled by candesartan cilexetil or
hydrochlorothiazide alone.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CANDESART

Summary of Product characteristics

Health Products Regulatory Authority
12 November 2019
CRN008J54
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Candesartan/Hydrochlorothiazide Clonmel 16mg / 12.5mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 16 mg of candesartan cilexetil and 12.5 mg of
hydrochlorothiazide.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
Peach, oval, biconvex (~9.5 x 4.5 mm), uncoated tablets, with a score
line 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 Clonmel 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/Hydrochlorothiazide Clonmel is one
tablet daily.
Dose titration with the individual components (candesartan cilexetil
and hydrochlorothiazide) is recommended. When clinically
appropriate a direct change from monotherapy to
Candesartan/Hydrochlorothiazide Clonmel may be considered. Dose
titration of candesartan cilexetil is recommended when switching from
hydrochlorothiazide monotherapy.
Candesartan/Hydrochlorothiazide Clonmel may be administered in
patients whose blood pressure is not optimally controlled
with candesartan cilexetil or hydrochlorothiazide monotherapy or
Candesartan/Hydrochlorothiazide Clonmel 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
_Older people_
No dose adjustment is necessary in elderly patients.
_Patients with intravascular volume depletion_
Dose titration of candesartan cilexetil is recommended in patients at
risk for hypotension, such as patients with possible
volume depletion (an initial dose of candes