Aprovel 75mg tablets

দেশ: যুক্তরাজ্য

ভাষা: ইংরেজি

সূত্র: MHRA (Medicines & Healthcare Products Regulatory Agency)

সক্রিয় উপাদান:

Irbesartan

থেকে পাওয়া:

Sanofi

এটিসি কোড:

C09CA04

INN (আন্তর্জাতিক নাম):

Irbesartan

ডোজ:

75mg

ফার্মাসিউটিকাল ফর্ম:

Tablet

প্রশাসন রুট:

Oral

শ্রেণী:

No Controlled Drug Status

প্রেসক্রিপশন টাইপ:

Valid as a prescribable product

পণ্য সারাংশ:

BNF: 02050502; GTIN: 5000283642794

তথ্য লিফলেট

1
PACKAGING ADMINISTRATION : SANOFI AMBARÈS - FRANCE
LIBELLÉ :
NOT APROVEL RM 75 CP DC RL GB
ITEM CODE
647775
CREATION DATE
26/08/2016
COUNTRY
GRANDE BRETAGNE GB
CODE LAETUS 4341
BASED ON
566993
BY
B.VIGUIE
FORMAT
170 X 210 DC
COLOR
1
ARTICLE
NOTICE
MODIFICATION DATE
25/10/2016
COUNTRY REQUIREMENT CRPGB-V1-05/2012
FONTS
OCEAN SANS PRO SAN
PROOF N°
8
BY
B.VIGUIE
SENS D’ENROULEMENT
1A EST/EAST OU 1A-2B
FONT SIZE
10 PT
THIS ARTWORK PROOF INDICATES COLOUR POSITION ONLY.
PLEASE REFER TO PANTONE COLOUR FORMULA
USED COLOR PRINTABLE: PANTONE BLACK + TRAMÉ
RÉF. F.T.
AMBRP-M002188 NOT-DC OU AMBRP-M002189
NOT-DP
NO PRINTABLE COLOR:PLAN
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 i

পণ্য বৈশিষ্ট্য

OBJECT 1
APROVEL 75MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 14-Jul-2016 | SANOFI
1. Name of the medicinal product
Aprovel 75 mg film-coated tablets.
2. Qualitative and quantitative composition
Each film-coated tablet contains 75 mg of irbesartan.
Excipient with known effect: 25.50 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 2871
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, t