Olmesartan/Hydrochlorothiazide STADA Arzneimittel AG 20 mg/25 mg film-coated tablets

国家: 爱尔兰

语言: 英文

来源: HPRA (Health Products Regulatory Authority)

有效成分:

Olmesartan medoxomil; Hydrochlorothiazide

可用日期:

Stada Arzneimittel AG

ATC代码:

C09DA; C09DA08

INN（国际名称）:

Olmesartan medoxomil; Hydrochlorothiazide

剂量:

20 mg/25 milligram(s)

药物剂型:

Film-coated tablet

处方类型:

Product subject to prescription which may be renewed (B)

治疗领域:

Angiotensin II antagonists and diuretics; olmesartan medoxomil and diuretics

授权状态:

Not marketed

授权日期:

2017-03-10

资料单张

Olmesartan/HCT, PIL-IE
Var. 006 - EMA/PRAC/595691/2018
2018-11-21
Page 1 of 9
PACKAGE LEAFLET: INFORMATION FOR THE USER
OLMESARTAN/HYDROCHLOROTHIAZIDE STADA ARZNEIMITTEL AG 20 MG/12.5 MG
FILM-COATED
TABLETS
OLMESARTAN/HYDROCHLOROTHIAZIDE STADA ARZNEIMITTEL AG 20 MG/25 MG
FILM-COATED
TABLETS
Olmesartan medoxomil/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.
WHAT IS IN THIS LEAFLET
1. What Olmesartan/Hydrochlorothiazide STADA Arzneimittel AG is and
what it is used for
2. What
you
need
to
know
before
you
take
Olmesartan/Hydrochlorothiazide
STADA
Arzneimittel AG
3. How to take Olmesartan/Hydrochlorothiazide STADA Arzneimittel AG
4. Possible side effects
5. How to store Olmesartan/Hydrochlorothiazide STADA Arzneimittel AG
6. Contents of the pack and other information
1. WHAT OLMESARTAN/HYDROCHLOROTHIAZIDE STADA ARZNEIMITTEL AG IS AND
WHAT IT IS USED
FOR
Olmesartan/Hydrochlorothiazide STADA Arzneimittel AG contains two
active substances,
olmesartan medoxomil and hydrochlorothiazide, that are used to treat
high blood pressure
(hypertension):

Olmesartan medoxomil is one of a group of medicines called angiotensin
II-receptor
antagonists. It lowers blood pressure by relaxing the blood vessels.

Hydrochlorothiazide is one of a group of medicines called thiazide
diuretics (“water tablets”).
It lowers blood pressure by helping the body to get rid of extra fluid
by making your kidneys
produce more urine.
You will only be given Olmesartan/Hydrochlorothiazide STADA
Arzneimittel AG if olmesartan
medoxomil alone

产品特点

HealthProductsRegulatoryAuthority
21May2019
CRN008RFK
Page1of20
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Olmesartan/HydrochlorothiazideSTADAArzneimittelAG20mg/25mgfilm-coatedtablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Eachfilm-coatedtabletcontains20
mgolmesartanmedoxomiland25 mghydrochlorothiazide.
Excipient(s)withknowneffect
Eachfilm-coatedtabletcontains92.84
mglactosemonohydrate.
Forthefulllistofexcipients,seesection6.1.
3 PHARMACEUTICAL FORM
Film-coatedtablet.
Olmesartan/HydrochlorothiazideSTADAArzneimittelAG20mg/25mgfilm-coatedtabletsaresalmon,round,biconvex
film-coatedtabletswithadiameterof8mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatmentofessentialhypertension.
Olmesartan/HydrochlorothiazideSTADAArzneimittelAG20mg/12.5mgand20mg/25mgfixeddosecombinationis
indicatedinadultpatientswhosebloodpressureisnotadequatelycontrolledonolmesartanmedoxomilalone.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
ADULTS
Olmesartan/HydrochlorothiazideSTADAArzneimittelAGisnotforuseasinitialtherapy,butinpatientswhosebloodpressure
isnotadequatelycontrolledby20mgolmesartanmedoxomilalone.Olmesartan/HydrochlorothiazideSTADAArzneimittelAG
isadministeredoncedaily,withorwithoutfood.
Whenclinicallyappropriate,directchangefrommonotherapywith20mgolmesartanmedoxomiltothefixedcombinationmay
beconsidered,takingintoaccountthattheantihypertensiveeffectofolmesartanmedoxomilismaximalbyabout8weeksafter
initiatingtherapy(seesection5.1).Dosetitrationoftheindividualcomponent