Teveten Plus 600 mg/12.5 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Eprosartan; Hydrochlorothiazide

Available from:

Mylan IRE Healthcare Limited

ATC code:

C09DA; C09DA02

INN (International Name):

Eprosartan; Hydrochlorothiazide

Dosage:

600/12.5 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Angiotensin II antagonists and diuretics; eprosartan and diuretics

Authorization status:

Marketed

Authorization date:

2005-01-28

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
TEVETEN PLUS 600 MG/12.5 MG, FILM-COATED TABLETS
Eprosartan and hydrochlorothiazide
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.
The full name of your medicine is Teveten Plus 600 mg/12.5 mg,
film-coated tablets. In this leaflet the
shorter name Teveten Plus is used.
WHAT IS IN THIS LEAFLET
1.
What Teveten Plus is and what it is used for
2.
What you need to know before you take Teveten Plus
3.
How to take Teveten Plus
4.
Possible side effects
5.
How to store Teveten Plus
6.
Contents of the pack and other information
1.
WHAT TEVETEN PLUS IS AND WHAT IT IS USED FOR
Teveten Plus is used:

to treat high blood pressure.
Teveten Plus contains two active ingredients: eprosartan and
hydrochlorothiazide.

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.

HYDROCHLOROTHIAZIDE
belongs to a group of medicines called “thiazide diuretics”. It
increases how
often and how much urine you pass. This decreases your blood pressure
You will only be given Teveten Plus if your blood pressure is not
lowered enough by eprosartan on its
own.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE TEVETEN PLUS
DO NOT TAKE TEVETEN PLUS IF:

you are alle

Summary of Product characteristics

Health Products Regulatory Authority
06 June 2023
CRN00DGZ3
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Teveten Plus 600 mg/12.5 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains eprosartan mesylate equivalent to 600
mg eprosartan and 12.5 mg hydrochlorothiazide.
Excipients with known effect:
Each film-coated tablet contains 43.3 mg lactose (as lactose
monohydrate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Butterscotch-coloured, capsule-shaped film-coated tablets.
The inscription of the tablet is “5147” on one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Essential hypertension. Teveten Plus 600 mg/12.5 mg is indicated in
patients whose blood pressure is not adequately
controlled on eprosartan alone.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The recommended dose is one tablet Teveten Plus 600 mg/12.5 mg once
daily, which should be taken in the morning. The
switch from eprosartan monotherapy to the fixed combination can be
considered after 8 weeks of blood pressure stabilization.
Teveten Plus 600 mg/12.5 mg can be taken with or without food.
ELDERLY
No dose adjustment is required in the elderly, although limited
information is available in this population.
PAEDIATRIC POPULATION
As safety and efficacy of administration to children have not been
established, treatment of children and adolescents < 18
years with Teveten Plus 600 mg/12.5 mg is not recommended.
HEPATIC IMPAIRMENT
The use of Teveten Plus in patients with mild to moderate hepatic
impairment is not recommended since there is currently only
limited experience of eprosartan mesylate in this patient group. In
patients with severe hepatic impairment Teveten Plus is
contraindicated (see section 4.3).
RENAL IMPAIRMENT
In patients with mild to moderate renal impairment (creatinine
clearance ≥ 30 ml/min) dose adjustment is not necessary.
Teveten Plus is contraindicated in patients with severe renal
impairment (se