OLMESARTAN HYDROCHLOROTHIAZIDE ACTAVIS 20mg/25 Milligram Film Coated Tablet

Држава: Ирска

Језик: Енглески

Извор: HPRA (Health Products Regulatory Authority)

Активни састојак:

HYDROCHLOROTHIAZIDE, OLMESARTAN MEDOXOMIL

Доступно од:

Actavis Group PTC ehf

АТЦ код:

C09CA08

INN (Међународно име):

HYDROCHLOROTHIAZIDE, OLMESARTAN MEDOXOMIL

Дозирање:

20mg/25 Milligram

Фармацеутски облик:

Film Coated Tablet

Тип рецептора:

Product subject to prescription which may be renewed (B)

Терапеутска област:

Angiotensin II antagonists, plain

Статус ауторизације:

Authorised

Датум одобрења:

2016-12-16

Информативни летак

29 
PACKAGE LEAFLET: INFORMATION FOR THE USER 

/…/ 20 MG/12.5 MG FILM-COATED TABLETS 
/…/ 20 MG/25 MG FILM-COATED TABLETS 
/…/ 40 MG/12.5 MG FILM-COATED TABLETS 
/…/ 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 /…/ is and what it is used for 
2. 
What you need to know before you take /…/ 
3. 
How to take /…/ 
4. 
Possible side effects 
5. 
How to store /…/ 
6. 
Contents of the pack and other information 

1. 
WHAT /…/ IS AND WHAT IT IS USED FOR 

/…/ 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 /…/ if olmesartan medoxomil alone has not
adequately controlled your blood 
pressure. When given together, the two active substances in /…/ help
to lower blood pressure more 
than if either of them were given alone. 

You may already be taking medicines to treat your high blood
pressure, but your doctor may wa

Карактеристике производа

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Olmesartan Hydrochlorothiazide Actavis 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.
Excipient with known effect:
Each film-coated tablet contains 127.44 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablets.
Olmesartan Hydrochlorothiazide 20 mg/25 mg film-coated tablets are
pink, round, biconvex, 8.5 mm in diameter and
with OH 22 debossed on one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of essential hypertension.
Olmesartan Hydrochlorothiazide Actavis 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 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 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:
_Elderly (age 65 years or older)_
In elderly people the same dosage of the combination is recommended as
for adults.
_Renal impairment_
When Olmesartan Hydrochlorothiazide is used in patients with mild to
moderate renal impairment (creatinine clearance
of 30
-
60 ml/min) periodic monitoring of renal function is advised (see
section 4.4). Olmesartan Hydrochlorothiazide
is contraindicated in patients with severe renal impairment
(creatinine clearance < 30 mL/min) (see section 4.3).
The maximum dose of olmesartan medoxomil i