Olmesartan Medoxomil/Hydrochlorothiazide 40 mg/12.5 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Olmesartan medoxomil; Hydrochlorothiazide

Available from:

Accord Healthcare Ireland Ltd.

ATC code:

C09DA; C09DA08

INN (International Name):

Olmesartan medoxomil; Hydrochlorothiazide

Dosage:

40 mg/12.5 milligram(s)

Pharmaceutical form:

Film-coated tablet

Therapeutic area:

Angiotensin II antagonists and diuretics; olmesartan medoxomil and diuretics

Authorization status:

Not marketed

Authorization date:

2017-08-18

Patient Information leaflet

NL/H/3765/001-004/IA/013, version 01, 10/2023
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
OLMESARTAN MEDOXOMIL/HYDROCHLOROTHIAZIDE 40 MG/12.5 MG FILM-COATED
TABLETS OLMESARTAN MEDOXOMIL/HYDROCHLOROTHIAZIDE 40 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

Summary of Product characteristics

Health Products Regulatory Authority
16 August 2022
CRN00CV39
Page 1 of 19
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Olmesartan Medoxomil/Hydrochlorothiazide 40 mg/12.5 mg film-coated
tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 40 mg olmesartan medoxomil and 12.5
mg hydrochlorothiazide.
Excipients- with known effect:
Each 40 mg olmesartan medoxomil and 12.5 mg hydrochlorothiazide
film-coated tablet contains 234 mg of lactose
monohydrate.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-coated tablet.
Reddish-Yellow, oval film-coated tablets; debossed with “OH2” on
one side and plain on other side.
Approximate dimensions: Length 15.3 mm, width 7.1 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of essential hypertension.
Olmesartan Medoxomil/Hydrochlorothiazide tablets 40 mg/12.5 mg fixed
dose combinations are indicated in adult patients
whose blood pressure is not adequately controlled on olmesartan
medoxomil 40 mg alone.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults_
The recommended dose of Olmesartan Medoxomil/Hydrochlorothiazide
tablets 40 mg/12.5 mg is 1 tablet per day.
Olmesartan Medoxomil/Hydrochlorothiazide tablets 40 mg/12.5 mg may be
administered in patients whose blood pressure is
not adequately controlled by olmesartan medoxomil 40 mg alone.
Olmesartan Medoxomil/Hydrochlorothiazide tablets 40 mg /25 mg may be
administered in patients whose blood pressure is
not adequately controlled on Olmesartan Medoxomil/Hydrochlorothiazide
tablets 40 mg/12.5 mg fixed dose combination.
For convenience, patients receiving olmesartan medoxomil and
hydrochlorothiazide from separate tablets may be switched to
Olmesartan Medoxomil/Hydrochlorothiazide tablets 40 mg/12.5 mg and 40
mg/25 mg tablets containing the same component
doses.
Olmesartan Medoxomil/Hydrochlorothiazide tablets 40 mg/12.5 mg and 40
mg/25 mg can be taken with or without food.
_Older people (age 65 years or over)_
In older people t