Teveten Plus 600 mg/12.5 mg film-coated tablets

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

유효 성분:

Hydrochlorothiazide; Eprosartan

제공처:

PCO Manufacturing Ltd.

ATC 코드:

C09DA02

INN (국제 이름):

Hydrochlorothiazide; Eprosartan

복용량:

600 mg/12.5 milligram(s)

약제 형태:

Film-coated tablet

치료 영역:

eprosartan and diuretics

승인 날짜:

2019-05-24

환자 정보 전단

_ _
_ _
PACKAGE LEAFLET: INFORMATION FOR THE USER
TEVETEN
® PLUS 600 MG/12.5 MG FILM-COATED TABLETS
eprosartan/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:
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제품 특성 요약

Health Products Regulatory Authority
27 May 2019
CRN008ZV5
Page 1 of 2
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.
Excipient with known effect
Lactose (as monohydrate)
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-coated tablet
_Product imported from Greece_
Butterscotch-coloured, capsule-shaped film-coated tablets
The inscription of the tablet is "5147" on one side.
4 CLINICAL PARTICULARS
As per PA2010/018/001
5 PHARMACOLOGICAL PROPERTIES
As per PA2010/018/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
TABLET CORE:
Lactose monohydrate
Microcrystalline cellulose
Pregelatinised starch (from maize)
Crospovidone
Magnesium stearate
Purified water
FILM COAT:
Polyvinyl alcohol
Talc
Titanium dioxide (E171)
Macrogol 3350
Iron oxide yellow (E172)
Iron oxide black (E172)
6.2 INCOMPATIBILITIES
Not applicable.
Health Products Regulatory Authority
27 May 2019
CRN008ZV5
Page 2 of 2
6.3 SHELF LIFE
The shelf-life expiry date of this product is the date shown on the
blister and outer package of the product on the market in
the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
This medicinal product does not require any special storage
conditions.
6.5 NATURE AND CONTENTS OF CONTAINER
Blister packs of 28 tablets contained in an outer cardboard carton.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR
WASTE MATERIALS DERIVED FROM SUCH MEDICINAL
PRODUCT AND OTHER HANDLING OF THE PRODUCT
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
PCO Manufacturing Ltd.
Unit 10, Ashbourne Business Park
Rath
Ashbourne
Co. Meath
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA0465/448/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 24
th
May 2019
10 DATE OF REVISION OF THE TEXT