EPROSARTAN NICHE

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

EPROSARTAN MESYLATE

Available from:

Niche Generics Limited

ATC code:

C09CA02

INN (International Name):

EPROSARTAN MESYLATE

Dosage:

400 Milligram

Pharmaceutical form:

Film Coated Tablet

Administration route:

Oral use

Units in package:

Pack sizes of 4, 7, 14, 28, 50, 56, 98 and 280 film-coated tablets.

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic group:

Angiotensin II antagonists, plain.

Therapeutic area:

eprosartan

Therapeutic indications:

It is indicated in adults for the treatment of essential hypertension.

Authorization status:

Not Marketed

Authorization date:

2015-05-29

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
EPROSARTAN NICHE 300 MG FILM-COATED TABLETS
EPROSARTAN NICHE 400 MG FILM-COATED TABLETS
EPROSARTAN NICHE 600 MG FILM-COATED TABLETS
Eprosartan
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 Eprosartan Nicheis and what it is used for
2.
What you need to know before you take Eprosartan Niche
3.
How to take Eprosartan Niche
4.
Possible side effects
5.
How to store Eprosartan Niche
6.
Contents of the pack and other information
1.
WHAT EPROSARTAN NICHE IS AND WHAT IT IS USED FOR
Eprosartan Niche contains the active substance eprosartan.
Eprosartan belongs to a group of medicines called ‘angiotensin II
receptor antagonists’. It blocks the action
of a substance in your body called ‘angiotensin II’. This
substance causes your blood vessels to narrow.
This makes it more difficult for the blood to flow through the vessels
and so your blood pressure increases.
By blocking this substance, the vessels relax and your blood pressure
decreases.
Eprosartan is used to treat high blood pressure (hypertension).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE EPROSARTAN NICHE
_ _
DO NOT TAKE EPROSARTAN NICHE:
-
if you are allergic to eprosartan or any of the other ingredients of
this medicine (listed in Section 6)
-
if you have
SEVERE
liver disease
-
if you have
SEVERE
problems with the blood flow in your kidneys
or serious restriction to blood flow
in a single functioning kidney
-
if you are more than 3 months pregnant (it is also better to avoid
eprosartan in early pregn

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Eprosartan Niche 400 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 490.56 mg eprosartan mesilate
equivalent to 400 mg eprosartan.
Excipient with known effect:
28 mg lactose monohydrate per tablet.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Peached coloured, oval shaped, biconvex film-coated tablets. Tablets
are approximately 18 x 7 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Eprosartan is indicated in adults for the treatment of essential
hypertension.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose is 600 mg eprosartan once daily.
Achievement of maximal blood pressure reduction in most patients may
take 2 to 3 weeks of treatment.
Eprosartan may be used alone or in combination with other
anti-hypertensives (see sections 4.3, 4.4, 4.5 and 5.1).
In
particular, addition of a thiazide-type diuretic such as
hydrochlorothiazide or a calcium channel blocker such as
sustained release nifedipine has been shown to have an additive effect
with eprosartan.
Duration of treatment is not limited.
_Older people_
No dose adjustment is required in older people.
_Patients with Hepatic impairment_
There is limited experience in patients with hepatic insufficiency_
(see section 4.3, Contraindications)_.
_Patients with Renal impairment_
In patients with moderate or severe renal impairment (creatinine
clearance <60 ml/min), the daily dose should not
exceed 600 mg.
_Paediatric population_
Eprosartan Niche 400mg Film-coated Tablets are not recommended for use
in children and adolescents. The safety and
efficacy of eprosartan in children and adolescents under 18 years have
not been established. No data are available.
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