Olmesartan/Hydrochlorothiazide STADA Arzneimittel AG 20 mg/12.5 mg film-coated tablets

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

Olmesartan medoxomil; Hydrochlorothiazide

Διαθέσιμο από:

Stada Arzneimittel AG

Φαρμακολογική κατηγορία (ATC):

C09DA; C09DA08

INN (Διεθνής Όνομα):

Olmesartan medoxomil; Hydrochlorothiazide

Δοσολογία:

20 mg/12.5 milligram(s)

Φαρμακοτεχνική μορφή:

Film-coated tablet

Τρόπος διάθεσης:

Product subject to prescription which may be renewed (B)

Θεραπευτική περιοχή:

Angiotensin II antagonists and diuretics; olmesartan medoxomil and diuretics

Καθεστώς αδειοδότησης:

Not marketed

Ημερομηνία της άδειας:

2017-03-10

Φύλλο οδηγιών χρήσης

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

Αρχείο Π.Χ.Π.

HealthProductsRegulatoryAuthority
21May2019
CRN008RFK
Page1of21
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Olmesartan/HydrochlorothiazideSTADAArzneimittelAG20mg/12.5mgfilm-coatedtablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Eachfilm-coatedtabletcontains20
mgolmesartanmedoxomiland12.5 mghydrochlorothiazide.
Excipient(s)withknowneffect
Eachfilm-coatedtabletcontains105.34
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/12.5mgfilm-coatedtabletsarebeige,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com