Aprovel 150mg tablets

País: Reino Unido

Língua: inglês

Origem: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredientes ativos:

Irbesartan

Disponível em:

Sanofi

Código ATC:

C09CA04

DCI (Denominação Comum Internacional):

Irbesartan

Dosagem:

150mg

Forma farmacêutica:

Tablet

Via de administração:

Oral

Classe:

No Controlled Drug Status

Tipo de prescrição:

Valid as a prescribable product

Resumo do produto:

BNF: 02050502; GTIN: 5000283642800

Folheto informativo - Bula

Code :
688021-G620686
Update :
V4- 21/09/2017
PA code :
194507
Product/Item type :
PRO APROVEL 150MG
Country :
GB
Artwork by :
M.PACHO
Format :
170 x 310 mm
(Plegado 170 X 34,5 mm)
Laetus Code :
947
Colours :
1
BLACK
Fonts :
Ocean Sans Pro San (9pt)
Assembly Card :
M-B421
Reason of change:
TRANSFER
SANOFI-AVENTIS
RIELLS PACKAGING TEAM
688021-G620686
170 x 310 mm
PACKAGE LEAFLET: INFORMATION FOR THE USER
FILM-COATED TABLETS
irbesartan
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 Aprovel is and what it is used for
2. What you need to know before you take Aprovel
3. How to take Aprovel
4. Possible side effects
5. How to store Aprovel
6. Contents of the pack and other information
1. WHAT APROVEL IS AND WHAT IT IS USED FOR
Aprovel
belongs
to
a
group
of
medicines
known
as
angiotensin-II
receptor
antagonists.
Angiotensin-II
is
a
substance produced in the body which binds to receptors
in blood vessels causing them to tighten. This results in an
increase in blood pressure. Aprovel prevents the binding of
angiotensin-II to these receptors, causing the blood vessels
to relax and the blood pressure to lower. Aprovel slows the
decrease of kidney function in patients with high blood
pressure and type 2 diabetes.
Aprovel is used in adult patients
• to treat high blood pressure (_essential hypertension_)
• to
protect
the
kidney
in
patients
with
high
blood
pressure, type 2 diabetes and laboratory evidence of
impaired kidney function.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE APROVEL
DO NOT TAKE APR

Características técnicas

OBJECT 1
APROVEL 150MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 14-Jul-2016 | SANOFI
1. Name of the medicinal product
Aprovel 150 mg film-coated tablets.
2. Qualitative and quantitative composition
Each film-coated tablet contains 150 mg of irbesartan.
Excipient with known effect: 51.00 mg of lactose monohydrate per
film-coated tablet.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet.
White to off-white, biconvex, and oval-shaped with a heart debossed on
one side and the number 2872
engraved on the other side.
4. Clinical particulars
4.1 Therapeutic indications
Aprovel is indicated in adults for the treatment of essential
hypertension.
It is also indicated for the treatment of renal disease in adult
patients with hypertension and type 2
diabetes mellitus as part of an antihypertensive medicinal product
regimen (see sections 4.3, 4.4, 4.5 and
5.1).
4.2 Posology and method of administration
Posology
The usual recommended initial and maintenance dose is 150 mg once
daily, with or without food.
Aprovel at a dose of 150 mg once daily generally provides a better 24
hour blood pressure control than 75
mg. However, initiation of therapy with 75 mg could be considered,
particularly in haemodialysed
patients and in the elderly over 75 years.
In patients insufficiently controlled with 150 mg once daily, the dose
of Aprovel can be increased to 300
mg, or other antihypertensive agents can be added (see sections 4.3,
4.4, 4.5 and 5.1). In particular, the
addition of a diuretic such as hydrochlorothiazide has been shown to
have an additive effect with Aprovel
(see section 4.5).
In hypertensive type 2 diabetic patients, therapy should be initiated
at 150 mg irbesartan once daily and
titrated up to 300 mg once daily as the preferred maintenance dose for
treatment of renal disease.
The demonstration of renal benefit of Aprovel in hypertensive type 2
diabetic patients is based on studies
where irbesartan was used in addition to other antihypertensive
agents, as needed