Catasart Plus 16mg/12.5mg tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Candesartan cilexetil; Hydrochlorothiazide

Available from:

Rowex Ltd

ATC code:

C09DA; C09DA06

INN (International Name):

Candesartan cilexetil; Hydrochlorothiazide

Dosage:

16 mg/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:

Marketed

Authorization date:

2010-07-02

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CATASART PLUS 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 Catasart Plus is and what it is used for
2.
What you need to know before you take Catasart Plus
3.
How to take Catasart Plus
4.
Possible side effects
5.
How to store Catasart Plus
6.
Contents of the pack and other information
1. WHAT CATASART PLUS IS AND WHAT IT IS USED FOR
The name of your medicine is Catasart Plus. It is used for treating
high blood pressure (hypertension)
in adult patients. It contains two active substances: candesartan
cilexetil and hydrochlorothiazide.
These work together to lower your blood pressure.

Candesartan
cilexetil
belongs
to
a
group
of
medicines
known
as
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 Catasart Plus if your blood pressure has not
been properly controlled by
candesartan cilexetil or hydrochlorothiazide alone.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CATASART PLUS
DO NOT TAKE CATASART PLUS IF:

you are
ALLERGIC
to candesartan cilexetil or hydrochlorothiazide or any of the other
ingredients of
this medicine (listed in section 6)

you are allergic to sulphonamide me

Summary of Product characteristics

Health Products Regulatory Authority
01 March 2022
CRN00CR3D
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Catasart Plus 16mg/12.5mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 16 mg of candesartan cilexetil and 12.5 mg of
hydrochlorotiazide.
Excipient with known effect
Each tablet contains 72.1 mg lactose (as lactose monohydrate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
Apricot, mottled, oval biconvex tablet, scored on both sides.
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
Catasart Plus is indicated for the:
• Treatment of primary 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 Catasart Plus 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 Catasart Plus may be
considered. Dose titration of candesartan cilexetil is
recommended when switching from hydrochlorothiazide monotherapy.
Catasart Plus may be administered in patients whose
blood pressure is not optimally controlled with candesartan cilexetil
or hydrochlorothiazide monotherapy or Catasart Plus 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 initial dose of candesartan cilexetil of 4 mg may
be considered in these patients).
_Renal impairment_
In patients with mild to moderate renal impairment (creatinine
clea