KONVERGE PLUS

מדינה: אירלנד

שפה: אנגלית

מקור: HPRA (Health Products Regulatory Authority)

מרכיב פעיל:

OLMESARTAN MEDOXOMIL ; AMLODIPINE AS AMLODIPINE BESILATE; HYDROCHLOROTHIAZIDE

זמין מ:

LTT Pharma Limited

קוד ATC:

C09DX03

INN (שם בינלאומי):

OLMESARTAN MEDOXOMIL ; AMLODIPINE AS AMLODIPINE BESILATE; HYDROCHLOROTHIAZIDE

כמות:

20/5/12.5 Milligram

טופס פרצבטיות:

Film Coated Tablet

סוג מרשם:

Product subject to prescription which may be renewed (B)

איזור תרפויטי:

olmesartan medoxomil, amlodipine and hydrochlorothiazide

מצב אישור:

Authorised

תאריך אישור:

2016-09-02

עלון מידע

KONVERGE PLUS 20 MG/5 MG/12.5 MG FILM-COATED TABLETS
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
THIS MEDICINAL PRODUCT IS AUTHORISED IN THE MEMBER STATES OF THE EEA
UNDER THE FOLLOWING NAMES:
Austria: Amelior plus HCT 20 mg/5 mg/12.5 mg
Belgium: Forzaten/HCT 20 mg/5 mg/12.5 mg
Bulgaria: Tespadan HCT 20 mg/5 mg/12.5 mg
Cyprus: Orizal plus 20 mg/5 mg/12.5 mg
Czech Republic: Sintonyn Combi 20 mg/5 mg/12.5mg
Denmark: Alea COMP 20 mg/5 mg/12.5 mg
Estonia: Sanoral HCT 20 mg/5 mg/12.5 mg
Finland: Alea COMP 20 mg/5 mg/12.5 mg
France: TRIAXELER 20 mg/5 mg/12.5 mg
Germany: Vocado HCT 20 mg/5 mg/12.5 mg
Greece: Orizal plus 20 mg/5 mg/12.5 mg
Hungary: Duactan HCT 20 mg/5 mg/12.5 mg
Iceland: Alea COMP 20 mg/5 mg/12.5 mg
Ireland: Konverge Plus 20 mg/5 mg/12.5 mg
Italy: Trivis 20 mg/5 mg/12.5 mg
Latvia: Sanoral HCT 20 mg/5 mg/12.5 mg
Lithuania: Sanoral HCT 20 mg/5 mg/12.5 mg
Luxembourg: Forzaten/HCT 20 mg/5 mg/12.5 mg
The Netherlands: Belfor HCT 20 mg/5 mg/12.5 mg
Malta: Konverge Plus 20 mg/5 mg/12.5 mg
Norway: Alea COMP 20 mg/5 mg/12.5 mg
Poland: Elestar HCT 20 mg/5 mg/12.5 mg
Portugal: Zolnor HCT 20 mg/5 mg/12.5 mg
Romania: Inovum HCT 20 mg/5 mg/12.5 mg
Slovak Republic: Folgan HCT 20 mg/5 mg/12.5 mg
Slovenia: Olectan HCT 20 mg/5 mg/12.5 mg
Spain: Balzak plus 20 mg/5 mg/12.5 mg
Konverge Plus is a
DAIICHI SANKYO COMPANY,
LIMITED.
PPA1562/174/001
Revision date: 03/10/2016
Ref: 174/001/031016/1/F
®
(OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE)
Page 1
Page 4
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
What

מאפייני מוצר

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Konverge Plus 20 mg/5 mg/12.5 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 20 mg olmesartan medoxomil, 5 mg
amlodipine (as amlodipine besilate) and 12.5 mg
hydrochlorothiazide.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
_Product imported from Greece_
Light orange, round, film-coated tablet of 8 mm debossed C51 on one
side.
4 CLINICAL PARTICULARS
As per PA0865/019/001
5 PHARMACOLOGICAL PROPERTIES
As per PA0865/019/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Tablet core:
Pregelatinized maize starch,
Silicified microcrystalline cellulose (microcrystalline cellulose and
silica colloidal anhydrous),
Croscarmellose sodium,
Magnesium stearate
Film coat:
Polyvinyl alcohol,
Macrogol 3350,
Talc,
Titanium dioxide (E 171),
Yellow iron oxide (E 172)
Red iron oxide (III) (E 172)
Black iron oxide (II, III) (E 172)
6.2 INCOMPATIBILITIES
Not applicable.
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
_D_
_a_
_t_
_e_
_ _
_P_
_r_
_i_
_n_
_t_
_e_
_d_
_ _
_2_
_9_
_/_
_1_
_1_
_/_
_2_
_0_
_1_
_6_
_C_
_R_
_N_
_ _
_2_
_1_
_8_
_4_
_4_
_7_
_4_
_p_
_a_
_g_
_e_
_ _
_n_
_u_
_m_
_b_
_e_
_r_
_:_
_ _
_1_
6.3 SHELF LIFE
The shelf life expiry date for this product shall be 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 NATUR