Blopress 4 mg Tablets

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Candesartan cilexetil

Tilgjengelig fra:

Takeda Products Ireland Ltd

ATC-kode:

C09CA; C09CA06

INN (International Name):

Candesartan cilexetil

Dosering :

4 milligram(s)

Legemiddelform:

Tablet

Resept typen:

Product subject to prescription which may be renewed (B)

Terapeutisk område:

Angiotensin II antagonists, plain; candesartan

Autorisasjon status:

Marketed

Autorisasjon dato:

1997-11-14

Informasjon til brukeren

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Blopress 2 mg Tablets
Blopress 4 mg Tablets
Blopress 8 mg Tablets
Blopress 16 mg Tablets
Blopress 32 mg Tablets
candesartan cilexetil
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 is and what it is used for
2.
What you need to know before you take Blopress
3.
How to take Blopress
4.
Possible side effects
5.
How to store Blopress
6.
Contents of the pack and other information
1. WHAT BLOPRESS IS AND WHAT IT IS USED FOR
The name of your medicine is Blopress. The active ingredient is
candesartan cilexetil. This belongs to
a group of medicines called angiotensin II receptor antagonists. It
works by making your blood vessels
relax and widen. This helps to lower your blood pressure. It also
makes it easier for your heart to
pump blood to all parts of your body.
This medicine is used for:

treating high blood pressure (hypertension) in adult patients and in
children and adolescents
aged 6 to under 18 years.

treating adult heart failure patients with reduced heart muscle
function, when Angiotensin
Converting Enzyme (ACE) inhibitors cannot be used or in addition to
ACE inhibitors when
symptoms persist despite treatment and mineralocorticoid receptor
antagonists (MRA) cannot
be used (ACE inhibitors and MRAs are medicines used to treat heart
failure).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BLOPRESS
DO NOT TAKE BLOPRESS

if you are allergic to candesartan cilexetil or any of the other
ingredients of this medicine (listed in
section 6).

if you

Preparatomtale

Health Products Regulatory Authority
02 February 2021
CRN00C4VG
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Blopress 4 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 4 mg candesartan cilexetil.
Each tablet contains 93.4 mg lactose monohydrate.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
Blopress 4 mg Tablets are round white tablets with a single score line
on both sides.
The tablet can be divided into equal doses
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Blopress is indicated for the:
• Treatment of essential hypertension in adults.
• Treatment of hypertension in children and adolescents aged 6 to
<18 years.
• Treatment of adult patients with heart failure and impaired left
ventricular systolic function (left ventricular ejection fraction
≤ 40%) when Angiotensin Converting Enzyme (ACE) inhibitors are not
tolerated or as add-on therapy to ACE inhibitors in
patients with symptomatic heart failure, despite optimal therapy, when
mineralocorticoid receptor antagonists are not
tolerated (see sections 4.2, 4.4, 4.5, and 5.1)
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology in Hypertension
The recommended initial dose and usual maintenance dose of Blopress is
8 mg once daily. Most of the antihypertensive effect
is attained within 4 weeks. In some patients whose blood pressure is
not adequately controlled, the dose can be increased to
16 mg once daily and to a maximum of 32 mg once daily. Therapy should
be adjusted according to blood pressure response.
Blopress may also be administered with other antihypertensive agents
(see sections 4.3, 4.4, 4.5 and 5.1). Addition of
hydrochlorothiazide has been shown to have an additive
antihypertensive effect with various doses of Blopress.
_Older people_
No initial dose adjustment is necessary in elderly patients.
_Patients with intravascular volume depletion_
An initial dose of 4 mg may be considered in patients at risk for
hypotension, such as patients with possible