TEVETEN 400 mg, film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Eprosartan mesylate

Available from:

Mylan IRE Healthcare Limited

ATC code:

C09CA; C09CA02

INN (International Name):

Eprosartan mesylate

Dosage:

400 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Angiotensin II antagonists, plain; eprosartan

Authorization status:

Marketed

Authorization date:

1997-09-05

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
TEVETEN 400 MG AND TEVETEN 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 Teveten and what it is used for
2.
What you need to know before you take Teveten
3.
How to take Teveten
4.
Possible side effects
5.
How to store Teveten
6.
Contents of the pack and other information
1.
WHAT TEVETEN IS AND WHAT IT IS USED FOR
Teveten is used:

to treat high blood pressure.
Teveten contains the active ingredient 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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE TEVETEN
DO NOT TAKE TEVETEN IF:

you are allergic (hypersensitive) to eprosartan or any of the other
ingredients in Teveten (listed in
Section 6)

you have
SEVERE
liver disease

you have
SEVERE
problems with the blood flow in your kidneys

you have diabetes or impaired kidney function and you are treated with
a blood pressure lowering
medicine containing aliskiren

you are more than 3 months pregnant (it is also better to avoid
Teveten in early pregnancy – see
pregnancy section.
Do not take Teveten if any of the above apply to you. If you

Summary of Product characteristics

Health Products Regulatory Authority
23 November 2020
CRN00C1PR
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
TEVETEN 400 mg, film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains eprosartan mesylate equivalent to 400
mg eprosartan.
Excipient with known effect:
Each film-coated tablet contains 28.8 mg lactose (as lactose
monohydrate).
This medicine contains less than 1mmol sodium (23mg) per tablet, that
is to say essentially sodium-free.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Oval, light to moderately pink film-coated tablet marked “5044” on
one side and no inscription on the other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Eprosartan is indicated for the treatment of essential hypertension.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
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.
Eprosartan may be taken with or without food.
Duration of treatment is not limited.
GERIATRIC PATIENTS
No dose adjustment is required in the elderly.
DOSAGE IN HEPATICALLY IMPAIRED PATIENTS
There is limited experience in patients with hepatic insufficiency
(see section 4.3).
DOSAGE IN RENALLY IMPAIRED PATIENTS
In patients with moderate or severe renal impairment (creatinine
clearance <60 ml/min), the daily dose should not exceed 600
mg.
PAEDIATRIC PATIENTS
Teveten is not recommended for use in children and adolescents due to
lack of data on safety and efficacy.
Health Products Regulatory Authority
23 November 2020
CRN00C1PR
Page 2 of 8
4.3 CONTRAINDICATIONS
· Known hypersensiti