TELMISARTAN - HYDROCHLOROTHIAZIDE TEVA 80/25 mg/mg Tablets

Negara: Irlandia

Bahasa: Inggris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

TELMISARTAN, HYDROCHLOROTHIAZIDE

Tersedia dari:

Teva Pharma B.V.

Kode ATC:

C09DA07

INN (Nama Internasional):

TELMISARTAN, HYDROCHLOROTHIAZIDE

Dosis:

80/25 mg/mg

Bentuk farmasi:

Tablets

Jenis Resep:

Product subject to prescription which may be renewed (B)

Area terapi:

Angiotensin II antagonists and diuretics

Status otorisasi:

Authorised

Tanggal Otorisasi:

2014-05-30

Selebaran informasi

PRODUCT
:
AMENDS:
APPROVAL:
• SUBJECT TO REG. AGENCY APPROVAL
• APPROVED BY REG. DEPT. FOR PRINT 
DESIGN DEPARTMENT
 Harlow
Signed
Signed
33027
TELMISARTAN/HCTZ TEVA 
80MG+ 12.5MG/80MG+25MG 
TABS ALL TEI (ZAR) 
27-2-14
180 x 600mm
4
27-5-14
YS
WA
Leafl
 et
CUTTER GUIDE
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Artwork, text and content must NOT be altered. The only exceptions to
this are: bleeds, 
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purposes only. If you have any diffi
 culties 
please contact the Teva Artwork Team. We must receive a copy of the
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approval can be made. 
Body: Univers 55 Roman/

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Subhead: Univers 65 Bld 11pts
Header: Univers 65 Bld 13pts
TELMISARTAN/
HYDROCHLOROTHIAZIDE TEVA 
80 MG/12.5 MG TABLETS
TELMISARTAN/
HYDROCHLOROTHIAZIDE TEVA 
80 MG/25 MG TABLETS
TELMISARTAN/HYDROCHLOROTHIAZIDE
PACKAGE LEAFLET: INFORMATION FOR THE USER
READ ALL OF THIS LEAFL ET CAREFULLY BEFORE YOU START 
TAKING THIS MEDICINE BECAUSE IT CONTAINS 
IMPORTANT INFORMATION FOR YOU.
•  Keep this leafl et. 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 leafl et. See section 4.
WHAT IS IN THIS LEAFLET
1.  WHAT TELMISARTAN/HYDROCHLOROTHIAZIDE TEVA 
TABLETS IS AND WHAT IT IS USED FOR
2.  WHAT YOU NEED TO KNOW BEFORE YOU TAKE 
TELMISARTAN/HYDROCHLOROTHIAZIDE TEVA TABLETS
3.  HOW TO TAKE TELMISARTAN/HYDROCHLOROTHIAZIDE 
TEVA TABLETS
4.  POSSIBLE SIDE EFFECTS
5.  HOW TO STORE TELMISARTAN/HYDROCHLOROTHIAZIDE 
TEVA TABLETS
6.  CONTENTS OF THE PACK AND OTHER INFORMATION
  WHAT TELMISARTAN/
HYDROCHLOROTHIAZIDE TEVA 
TABLE

Karakteristik produk

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Telmisartan-hydrochlorothiazide Teva 80mg/25mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 80 mg telmisartan and 25 mg hydrochlorothiazide.
Excipients with known effect:
Each tablet contains 354.20 mg of lactose monohydrate and 56.74 mg
sorbitol (E420).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
Yellow and white to off white coloured capsule shaped bilayer tablet
with a breakline on the yellow coloured side
(dimension: approx. 18.0 x 8.0 mm).
The tablet can be divided into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of essential hypertension.
Telmisartan/Hydrochlorothiazide 80 mg/25 mg tablets fixed dose
combination is indicated in adults whose blood
pressure is not adequately controlled on
Telmisartan/Hydrochlorothiazide 80 mg/12.5 mg tablets (80 mg
telmisartan/12.5 mg hydrochlorothiazide) or adults who have been
previously stabilised on telmisartan and
hydrochlorothiazide given separately.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Telmisartan/Hydrochlorothiazide tablets should be taken in patients
whose blood pressure is not adequately controlled
by telmisartan alone. Individual dose titration with each of the two
components is recommended before changing to the
fixed dose combination. When clinically appropriate, direct change
from monotherapy to the fixed combination may be
considered.
Telmisartan/Hydrochlorothiazide 80 mg/25 mg tablets may be
administered once daily in patients whose blood
pressure is not adequately controlled by
Telmisartan/Hydrochlorothiazide 80 mg/12.5 mg tablets or in patients
who have been previously stabilised on telmisartan and
hydrochlorothiazide given separately.
Telmisartan/Hydrochlorothiazide tablets is also available at the dose
strength 80 mg/ 12.5 mg
_Special populations:_
Patients with renal impairment
Periodic monitoring of renal function is advised (see section 4.4).
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