KONVERGE PLUS

Страна: Ирландия

Язык: английский

Источник: HPRA (Health Products Regulatory Authority)

Активный ингредиент:

OLMESARTAN MEDOXOMIL ; AMLODIPINE AS AMLODIPINE BESILATE; HYDROCHLOROTHIAZIDE

Доступна с:

LTT Pharma Limited

код АТС:

C09DX03

ИНН (Международная Имя):

OLMESARTAN MEDOXOMIL ; AMLODIPINE AS AMLODIPINE BESILATE; HYDROCHLOROTHIAZIDE

дозировка:

40/10/12.5 Milligram

Фармацевтическая форма:

Film Coated Tablet

Тип рецепта:

Product subject to prescription which may be renewed (B)

Терапевтические области:

olmesartan medoxomil, amlodipine and hydrochlorothiazide

Статус Авторизация:

Authorised

Дата Авторизация:

2016-09-02

тонкая брошюра

KONVERGE PLUS 40 MG/10 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 40 mg/10 mg/12.5 mg
Belgium: Forzaten/HCT 40 mg/10 mg/12.5 mg
Bulgaria: Tespadan HCT 40 mg/10 mg/12.5 mg
Cyprus: Orizal plus 40 mg/10 mg/12.5 mg
Czech Republic: Sintonyn Combi 40 mg/10 mg/12.5mg
Denmark: Alea COMP 40 mg/10 mg/12.5 mg
Estonia: Sanoral HCT 40 mg/10 mg/12.5 mg
Finland: Alea COMP 40 mg/10 mg/12.5 mg
France: TRIAXELER 40 mg/10 mg/12.5 mg
Germany: Vocado HCT 40 mg/10 mg/12.5 mg
Greece: Orizal plus 40 mg/10 mg/12.5 mg
Hungary: Duactan HCT 40 mg/10 mg/12.5 mg
Iceland: Alea COMP 40 mg/10 mg/12.5 mg
Ireland: Konverge Plus 40 mg/10 mg/12.5 mg
Italy: Trivis 40 mg/10 mg/12.5 mg
Latvia: Sanoral HCT 40 mg/10 mg/12.5 mg
Lithuania: Sanoral HCT 40 mg/10 mg/12.5 mg
Luxembourg: Forzaten/HCT 40 mg/10 mg/12.5 mg
The Netherlands: Belfor HCT 40 mg/10 mg/12.5 mg
Malta: Konverge Plus 40 mg/10 mg/12.5 mg
Norway: Alea COMP 40 mg/10 mg/12.5 mg
Poland: Elestar HCT 40 mg/10 mg/12.5 mg
Portugal: Zolnor HCT 40 mg/10 mg/12.5 mg
Romania: Inovum HCT 40 mg/10 mg/12.5 mg
Slovak Republic: Folgan HCT 40 mg/10 mg/12.5 mg
Slovenia: Olectan HCT 40 mg/10 mg/12.5 mg
Spain: Balzak plus 40 mg/10 mg/12.5 mg
Konverge Plus is a
DAIICHI SANKYO COMPANY,
LIMITED.
PPA1562/174/003
Revision date: 03/10/2016
Ref: 174/003/031016/1/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.

Характеристики продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Konverge Plus 40 mg/10 mg/12.5 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 40 mg olmesartan medoxomil, 10 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_
Greyish red, round, film-coated tablet of 9.5 mm debossed C55 on one
side.
4 CLINICAL PARTICULARS
As per PA0865/019/003
5 PHARMACOLOGICAL PROPERTIES
As per PA0865/019/003
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)
6.2 INCOMPATIBILITIES
Not applicable.
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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 NATURE AND CONTENTS OF CONTAINER
Lam