Teveten 600mg, film-coated Tablets

Krajina: Malta

Jazyk: angličtina

Zdroj: Medicines Authority

Dostupné z:

Viatris Healthcare Limited Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN , Ireland

ATC kód:

C09CA02

INN (Medzinárodný Name):

EPROSARTAN 600 mg

Forma lieku:

FILM-COATED TABLET

Zloženie:

EPROSARTAN 600 mg

Typ predpisu:

POM

Terapeutické oblasti:

AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM

Stav Autorizácia:

Authorised

Dátum Autorizácia:

2007-05-16

Príbalový leták

PACKAGE 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

Súhrn charakteristických

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.
Excipient with known effect:
Each film-coated tablet contains 43.3 mg lactose (as lactose
monohydrate).
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Teveten Mono 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 (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.
•
Second and third trimester of pregnancy (see sections 4.4 and 4.6).
•
Hemodynamically significant bilateral renovascular disease or severe
stenosis of a solitary
functioning k