Irprezide 300mg/12.5mg Film-Coated Tablets

Страна: Ирландия

Язык: английский

Источник: HPRA (Health Products Regulatory Authority)

Активный ингредиент:

Irbesartan; Hydrochlorothiazide

Доступна с:

Actavis Group PTC ehf

код АТС:

C09DA; C09DA04

ИНН (Международная Имя):

Irbesartan; Hydrochlorothiazide

дозировка:

300/12.5 milligram(s)

Фармацевтическая форма:

Film-coated tablet

Тип рецепта:

Product subject to prescription which may be renewed (B)

Терапевтические области:

Angiotensin II antagonists and diuretics; irbesartan and diuretics

Статус Авторизация:

Marketed

Дата Авторизация:

2011-02-11

тонкая брошюра

IRPREZIDE 150 MG/12.5 MG FILM-COATED TABLETS
IRPREZIDE 300 MG/12.5 MG FILM-COATED TABLETS
IRPREZIDE 300 MG/25 MG FILM-COATED TABLETS
irbesartan/hydrochlorothiazide
PACKAGE LEAFLET: INFORMATION FOR THE USER
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 IRPREZIDE IS AND WHAT IT IS USED FOR
2
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
IRPREZIDE
3
HOW TO TAKE IRPREZIDE
4
POSSIBLE SIDE EFFECTS
5
HOW TO STORE IRPREZIDE
6 CONTENTS OF THE PACK AND OTHER INFORMATION
1
WHAT IRPREZIDE IS AND WHAT IT IS USED FOR
Irprezide is a combination of two active substances,
irbesartan and hydrochlorothiazide. Irbesartan belongs
to a group of medicines known as angiotensin-II receptor
antagonists. Angiotensin-II is a substance produced in
the body that binds to receptors in blood vessels causing
them to tighten. This results in an increase in blood
pressure. Irbesartan prevents the binding of angiotensin-
II to these receptors, causing the blood vessels to relax
and the blood pressure to lower. Hydrochlorothiazide
is one of a group of medicines (called thiazide diuretics)
that causes increased urine output and so causes a
lowering of blood pressure.
The two active ingredients in Irprezide work together
to lower blood pressure further than if either was given
alone.
Irprezide IS USED IN THE TREATMENT OF HIGH BLOOD
PRESSURE (essential hypertension), when treatment with
irbesartan or hydrochlorothiazide alone did not provide
adequate control of your blood pressure.
2
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
IRPREZIDE
DO NOT TAK

Характеристики продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Irprezide 300mg/12.5mg Film-Coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 300 mg of irbesartan and 12.5 mg of
hydrochlorothiazide.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Irprezide 300 mg/12.5 mg film-coated tablets.
Pink, biconvex, oval-shaped, 8.2 x 16.0 mm film-coated tablet with a H
engraved on one side and I on the other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of essential hypertension.
This fixed dose combination is indicated in adult patients whose blood
pressure is not adequately controlled on
irbesartan or hydrochlorothiazide alone (see section 5.1).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Irprezide can be taken once daily, with or without food.
Dose titration with the individual components (i.e. irbesartan and
hydrochlorothiazide) may be recommended.
When clinically appropriate direct change from monotherapy to the
fixed combinations may be considered:
Irprezide 150 mg/12.5 mg may be administered in patients whose blood
pressure is not adequately controlled
with hydrochlorothiazide or irbesartan 150 mg alone;
Irprezide 300 mg/12.5 mg may be administered in patients
insufficiently controlled by irbesartan 300 mg or by
Irprezide 150 mg/12.5 mg;
Irprezide 300 mg/25 mg may be administered in patients insufficiently
controlled by Irprezide 300 mg/12.5 mg.
Doses higher than 300 mg irbesartan/25 mg hydrochlorothiazide once
daily are not recommended. When necessary,
Irprezide may be administered with another antihypertensive medicinal
product (see sections 4.3, 4.4, 4.5 and 5.1).
Special populations
_Renal impairment_: due to the hydrochlorothiazide component,
Irprezide is not recommended for patients with severe
renal dysfunction (creatinine clearance < 30 ml/min). Loop diuretics
are preferred to thiazides in this population. No
dosage adjustment is necessary in patients with renal impairment whose
renal creatin