Eprosartan Teva 400 mg Film-coated Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Eprosartan mesylate

Available from:

Teva B.V.

ATC code:

C09CA; C09CA02

INN (International Name):

Eprosartan mesylate

Dosage:

400 milligram(s)

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:

Angiotensin II antagonists, plain; 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 TEVA 300 MG FILM-COATED TABLETS
EPROSARTAN TEVA 400 MG FILM-COATED TABLETS
EPROSARTAN TEVA 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 Teva is and what it is used for
2.
What you need to know before you take Eprosartan Teva
3.
How to take Eprosartan Teva
4.
Possible side effects
5.
How to store Eprosartan Teva
6.
Contents of the pack and other information
1.
WHAT EPROSARTAN TEVA IS AND WHAT IT IS USED FOR
Eprosartan Teva 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 TEVA
_ _
DO NOT TAKE EPROSARTAN TEVA:
-
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 pregnancy

Summary of Product characteristics

Health Products Regulatory Authority
02 November 2020
CRN00C0GD
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Eprosartan Teva 400 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 490.56 mg eprosartan mesylate
equivalent to 400 mg eprosartan.
Excipient(s) 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.
Peach 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 Teva 400 mg Film-coated Tablets is not recommended for use
in children and adolescents. The safety and efficacy
of eprosartanin children and adolescents under 18 years have not been
established. No data are available.
Method of administration
Oral use. Eprosartan may be taken with or without food.
Health Products Regulatory Authority
02 November 2020
CRN00C0GD
Page 2