Blopress Plus 8 mg/12.5 mg tablets

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

Candesartan cilexetil; Hydrochlorothiazide

Disponibil de la:

CHEPLAPHARM Arzneimittel GmbH

Codul ATC:

C09DA; C09DA06

INN (nume internaţional):

Candesartan cilexetil; Hydrochlorothiazide

Dozare:

8/12.5 milligram(s)

Forma farmaceutică:

Tablet

Zonă Terapeutică:

Angiotensin II antagonists and diuretics; candesartan and diuretics

Statutul autorizaţiei:

Not marketed

Data de autorizare:

1998-12-10

Prospect

Page 1 of 8
PACKAGE LEAFLET: INFORMATION FOR THE USER
BLOPRESS PLUS 8 MG/12.5 MG_ _TABLETS
BLOPRESS PLUS 16 MG/12.5 MG_ _TABLETS
BLOPRESS PLUS 32 MG/12.5 MG_ _TABLETS
BLOPRESS PLUS 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. This includes any
possible side effects not listed
in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Blopress Plus is and what it is used for
2.
What you need to know before you take Blopress Plus
3.
How to take Blopress Plus
4.
Possible side effects
5.
How to store Blopress Plus
6.
Contents of the pack and other information
1. WHAT BLOPRESS PLUS IS AND WHAT IT IS USED FOR
The name of your medicine is Blopress Plus. 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 Blopress 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 BLOPRESS PLUS
DO NOT TAKE BLOPRESS PLUS:
-
if you are allergic to candesartan cilexetil or hydrochlorothiazide or
any of th

Caracteristicilor produsului

Health Products Regulatory Authority
02 February 2024
CRN00DZ7M
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Blopress Plus 8 mg/12.5 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One Blopress Plus tablet contains 8 mg candesartan cilexetil and 12.5
mg hydrochlorothiazide.
Excipients with known effect: lactose (as monohydrate).
Each tablet contains 76.9 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
Blopress Plus 8 mg/12.5 mg are white to off white, oval, flat tablets
approximately 8.5 mm x 5.1 mm with a score
and debossing 8 | C on both sides.
The tablet can be divided into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Blopress Plus 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 Blopress 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 Blopress Plus may be
considered. Dose titration of candesartan cilexetil is
recommended when switching from hydrochlorothiazide monotherapy.
Blopress Plus may be administered in patients whose
blood pressure is not optimally controlled with candesartan cilexetil
or hydrochlorothiazide monotherapy or Blopress Plus at
lower doses.
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_
Health Products Regulatory Authority
02 February 2024
CRN00DZ7M
Page 2 of 13
Dose titration of candesartan cilexetil is recommended in patients at
risk for hypotension, such as patients with possible
volume depletion (an initial dose of candesar