Olmesartan Medoxomil/Hydrochlorothiazide 20 mg/12.5 mg film-coated tablets

国: アイルランド

言語: 英語

ソース: HPRA (Health Products Regulatory Authority)

有効成分:

Olmesartan medoxomil; Hydrochlorothiazide

から入手可能:

Accord Healthcare Ireland Ltd.

ATCコード:

C09DA; C09DA08

INN（国際名）:

Olmesartan medoxomil; Hydrochlorothiazide

投薬量:

20 mg/12.5 milligram(s)

医薬品形態:

Film-coated tablet

治療領域:

Angiotensin II antagonists and diuretics; olmesartan medoxomil and diuretics

認証ステータス:

Not marketed

承認日:

2017-08-18

情報リーフレット

NL/H/3765/001-004/IA/013, version 01, 10/2023
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT OLMESARTAN MEDOXOMIL/HYDROCHLOROTHIAZIDE 20 MG/12.5 MG FILM-COATED
TABLETS
OLMESARTAN MEDOXOMIL/HYDROCHLOROTHIAZIDE 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 Medoxomil/Hydrochlorothiazide tablets
are and what they are used for
2.
What you need to know before you take Olmesartan
Medoxomil/Hydrochlorothiazide tablets
3.
How to take Olmesartan Medoxomil/Hydrochlorothiazide tablets
4.
Possible side effects
5.
How to store Olmesartan Medoxomil/Hydrochlorothiazide tablets
6.
Contents of the pack and other information
1.
WHAT OLMESARTAN MEDOXOMIL/HYDROCHLOROTHIAZIDE TABLETS ARE AND WHAT
THEY ARE USED
FOR
Olmesartan Medoxomil/Hydrochlorothiazide tablets 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 Medoxomil/Hydrochlorothiazide
tablets if olmesartan medoxomil
alone has not adequately controlled your blood pressure. When given
to

製品の特徴

Health Products Regulatory Authority
16 August 2022
CRN00CV39
Page 1 of 17
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Olmesartan Medoxomil/Hydrochlorothiazide 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.
Excipients- with known effect:
Each 20 mg olmesartan medoxomil and 12.5 mg hydrochlorothiazide
film-coated tablet contains 111 mg of lactose
monohydrate.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-coated tablet.
FOR THE 20/12.5 MGFILM-COATED TABLET:Reddish-Yellow, round,
film-coated tablets; debossed with “OH1” on one side and
plain on other side.
Dimension: Diameter approximately 8.6 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of essential hypertension.
Olmesartan Medoxomil/Hydrochlorothiazide tablets 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 Medoxomil/Hydrochlorothiazide tablets is not for use as
initial therapy, but in patients whose blood pressure is not
adequately controlled by 20 mg olmesartan medoxomil alone. Olmesartan
Medoxomil/Hydrochlorothiazide tablets 20 mg/12.5
mg 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
components is recommended:
20 mg olmesartan medoxomil/12.5 mg hydrochlorothiazide may be
administered in patients whose blood pressure is not
adequately controlled by the optimal monotherapy olmesartan medoxomil
20 mg alone.
20 mg olmesartan medoxomil/ 25 mg hydrochlorothiazide may be
administered in patients whose