Teveten 600mg, film-coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

eprosartan 600 mg

Available from:

Abbott Healthcare Products Limited

ATC code:

C09CA02

INN (International Name):

eprosartan

Pharmaceutical form:

film-coated tablet

Authorization status:

Authorised

Authorization date:

2007-05-16

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. 
  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 any of the side effects gets serious, or if you notice
any side effects not listed in this leaflet, please tell 
your doctor or pharmacist. 

IN THIS LEAFLET:  
1.  What Teveten is and what it is used for 
2.  Before you take Teveten 
3.  How to take Teveten 
4.  Possible side effects 
5.  How to store Teveten 
6.  Further 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 in 
Section 6) 
  you have SEVERE liver disease 
  you have SEVERE problems with the
blood 

Summary of Product characteristics

 
SUMMARY OF PRODUCT CHARACTERISTICS 

1. 
NAME OF THE MEDICINAL PRODUCT 
TEVETEN 600 mg, film-coated tablets 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
Each film-coated tablet contains eprosartan mesylate equivalent
to 600 mg eprosartan.  

For a full list of excipients, see section 6.1. 

3. 
PHARMACEUTICAL FORM 
Film-coated tablet 
Teveten 600 mg is a capsule-shaped, white, film-coated tablet
marked “5046” on one 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. 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. 
Second and third trimester of pregnancy (see sections 4.4
and 4.6). 
Hemodynamically significant bilateral renovascular disease or severe
stenosis of a s