TEVETEN 400 Milligram Film Coated Tablet

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

EPROSARTAN MESYLATE

Available from:

BGP Products Ltd

ATC code:

C09CA02

INN (International Name):

EPROSARTAN MESYLATE

Dosage:

400 Milligram

Pharmaceutical form:

Film Coated Tablet

Administration route:

Oral use

Units in package:

Blister packs: 4,7,14, 28, 50, 56, 98, 280

Prescription type:

Product subject to prescription which may be renewed (B)

Manufactured by:

Mylan Laboratories SAS

Therapeutic group:

Angiotensin-II antagonists, plain C

Therapeutic area:

Angiotensin II antagonists, plain

Therapeutic indications:

Eprosartan is indicated for the treatment of essential hypertension.

Authorization status:

Authorised

Authorization date:

2015-03-27

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. Do not pass it on to
others. It may harm them, even if their 
symptoms 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. 

IN THIS LEAFLET:  
1. 
What Teveten is 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 

The full name of your medicine is either Teveten 400
mg or Teveten 600 mg film-coated tablets. In this 
leaflet the shorter name Teveten is used and applies to both
of these different strength tablets. 

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. 
BEFORE YOU TAKE TEVETEN 

DO NOT TAKE TEVETEN IF: 

  you are allergic (hypersensitive) to
eprosartan or any of the other ingredients in Teveten (listed

Summary of Product characteristics

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.
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.
4.3 CONTRAINDICATIONS
•
Known hypersensitivity to eprosartan or to any of the excipients.
•
Severe hepatic impairment.
HEALTH PRODUCTS REGULATORY AUTHORITY
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