Olmesartan Hydrochlorothiazide Rowex 20 mg/25 mg film-coated tablets

Pajjiż: Irlanda

Lingwa: Ingliż

Sors: HPRA (Health Products Regulatory Authority)

Ingredjent attiv:

Olmesartan medoxomil; Hydrochlorothiazide

Disponibbli minn:

Rowex Ltd

Kodiċi ATC:

C09DA

INN (Isem Internazzjonali):

Olmesartan medoxomil; Hydrochlorothiazide

Dożaġġ:

20 mg/25 milligram(s)

Għamla farmaċewtika:

Film-coated tablet

Tip ta 'preskrizzjoni:

Product subject to prescription which may be renewed (B)

Żona terapewtika:

Angiotensin II antagonists and diuretics

L-istatus ta 'awtorizzazzjoni:

Not marketed

Data ta 'l-awtorizzazzjoni:

2015-08-13

Fuljett ta 'informazzjoni

PACKAGE LEAFLET: INFORMATION FOR THE USER
OLMESARTAN HYDROCHLOROTHIAZIDE ROWEX 20MG/12.5MG FILM-COATED TABLETS
OLMESARTAN HYDROCHLOROTHIAZIDE ROWEX 20MG/25MG 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 Rowex is and what it is used
for
2. What you need to know before you take Olmesartan
Hydrochlorothiazide Rowex
3. How to take Olmesartan Hydrochlorothiazide Rowex
4. Possible side effects
5. How to store Olmesartan Hydrochlorothiazide Rowex
6. Contents of the pack and other information
1. WHAT OLMESARTAN HYDROCHLOROTHIAZIDE ROWEX IS AND WHAT IT IS USED
FOR
Olmesartan Hydrochlorothiazide Rowex contains two active substances,
olmesartan
medoxomil and hydrochlorothiazide, that are used to treat high blood
pressure (hypertension) in
adults:
•
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 Rowex if
olmesartan medoxomil alone has
not adequately controlled your blood pressure. When given together,
the two active substances in
Olmesartan Hydrochlorothiazide Rowex help to lower blood pressure more
than if either of them
were given alone.
Yo

Karatteristiċi tal-prodott

Health Products Regulatory Authority
23 August 2019
CRN008S87
Page 1 of 17
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Olmesartan Hydrochlorothiazide Rowex 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 film-coated tablet contains 298.2 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Yellow film coated, oval shape, biconvex tablets debossed with
‘L400’ on one side and plain on other side.
Dimension: 16mm x 7.5mm
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of essential hypertension.
Olmesartan Hydrochlorothiazide Rowex 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 Rowex 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 Rowex 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 YEARS OR OLDER)
In elderly patients the same do