OLMESARTAN MEDOXOMIL/HYDROCHLOROTHIAZIDE ACCORD

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

OLMESARTAN MEDOXOMIL ; HYDROCHLOROTHIAZIDE EP

Available from:

Accord Healthcare Limited

ATC code:

C09DA08

INN (International Name):

OLMESARTAN MEDOXOMIL ; HYDROCHLOROTHIAZIDE EP

Dosage:

20/25 Milligram

Pharmaceutical form:

Film Coated Tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

olmesartan medoxomil and diuretics

Authorization status:

Authorised

Authorization date:

2017-08-18

Patient Information leaflet

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
together, the two active
substances in Olmesarta

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Olmesartan Medoxomil/Hydrochlorothiazide 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.
Excipients- with known effect:
Each 20 mg olmesartan medoxomil and 25 mg hydrochlorothiazide
film-coated tablet contains 98 mg of lactose
monohydrate.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film coated tablet.
Pinkish, round, film-coated tablets; debossed with “OH4” 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 20mg/25 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 blood pressure is not
adequately controlled by 20 mg olmesartan medoxomil/ 12.5 mg
hydrochlorothiazide.
_Older people (age 65 ye