Irbesartan 150mg tablets

Country: Bretland

Tungumál: enska

Heimild: MHRA (Medicines & Healthcare Products Regulatory Agency)

Virkt innihaldsefni:

Irbesartan

Fáanlegur frá:

Milpharm Ltd

ATC númer:

C09CA04

INN (Alþjóðlegt nafn):

Irbesartan

Skammtar:

150mg

Lyfjaform:

Tablet

Stjórnsýsluleið:

Oral

Tegund:

No Controlled Drug Status

Gerð lyfseðils:

Valid as a prescribable product

Vörulýsing:

BNF: 02050502

Upplýsingar fylgiseðill

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 Irbesartan is and what it is used for
2.
What you need to know before you take Irbesartan
3.
How to take Irbesartan
4.
Possible side effects
5.
How to store Irbesartan
6.
Contents of the pack and other information
Irbesartan 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.
Irbesartan prevents the binding of angiotensin-II to these receptors,
causing the blood vessels to relax and the blood pressure to lower.
Irbesartan slows the decrease of kidney function in patients with
high blood pressure and type 2 diabetes.
IRBESARTAN 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.
DO NOT TAKE IRBESARTAN
•
if you are ALLERGIC to irbesartan or any other ingredients of this
medicine (listed in section 6)
•
if you are more than 3 months pregnant. (It is also better to
avoid Irbesartan in early pregnancy – see pregnancy section)
•
if you have diabetes or impaired kidney function and you are
treated with a blood pressure lowering medicine containing
aliskiren.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Irbesartan AND IF
ANY OF THE FOLLOWING APPLY TO YOU:
•
if you get

Vara einkenni

OBJECT 1
IRBESARTAN 150 MG TABLETS.
Summary of Product Characteristics Updated 28-Jul-2017 | Aurobindo
Pharma - Milpharm Ltd.
1. Name of the medicinal product
Irbesartan Milpharm 150 mg tablets.
2. Qualitative and quantitative composition
Each tablet contains 150 mg of irbesartan.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Tablet
White to off-white, biconvex oval shaped uncoated tablets debossed
with 'H 29' on one side and plain on
other side. The size is 13.7 mm X 7.3 mm.
4. Clinical particulars
4.1 Therapeutic indications
Irbesartan Milpharm 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.
Irbesartan Milpharm 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 Irbesartan Milpharm can be
increased to 300 mg, or other antihypertensive agents can be added. In
particular, the addition of a
diuretic such as hydrochlorothiazide has been shown to have an
additive effect with Irbesartan Milpharm
(see sections 4.3, 4.4, 4.5 and 5.1).
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 Irbesartan Milpharm in hypertensive
type 2 diabetic patients is based on
studies where irbesartan was used in addition to other
antihypertensive agents, as needed, to reach target
blood pressur