OLMESARTAN MEDOXOMIL

Country: Ирска

Језик: Енглески

Извор: HPRA (Health Products Regulatory Authority)

Активни састојак:

OLMESARTAN MEDOXOMIL

Доступно од:

Generics (UK) Limited

АТЦ код:

C09CA08

INN (Међународно име):

OLMESARTAN MEDOXOMIL

Дозирање:

40 Milligram

Фармацеутски облик:

Film Coated Tablet

Тип рецептора:

Product subject to prescription which may be renewed (B)

Терапеутска област:

olmesartan medoxomil

Статус ауторизације:

Marketed

Датум одобрења:

2015-01-09

Информативни летак

Page 1 of 7
PACKAGE LEAFLET: INFORMATION FOR THE USER
OLMESARTAN MEDOXOMIL 10 MG FILM-COATED TABLETS
OLMESARTAN MEDOXOMIL 20 MG FILM-COATED TABLETS
OLMESARTAN MEDOXOMIL
40 MG FILM-COATED TABLETS
olmesartan medoxomil
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 is and what it is used for
2.
What you need to know before you take Olmesartan medoxomil
3.
How to take Olmesartan medoxomil
4.
Possible side effects
5.
How to store Olmesartan medoxomil
6.
Contents of the pack and other information
1.
WHAT OLMESARTAN MEDOXOMIL IS AND WHAT IT IS USED FOR
Olmesartan medoxomil belongs to a group of medicines called
angiotensin-II receptor antagonists. They
lower blood pressure by relaxing the blood vessels.
This medicine is used for the treatment of high blood pressure (also
known as ‘hypertension’)
in adults and
in children and adolescents aged 6 to less than 18 years. High blood
pressure can damage blood vessels in
organs such as the heart, kidneys, brain and eyes. In some cases this
may lead to a heart attack, heart or
kidney failure, stroke or blindness. Usually high blood pressure has
no symptoms. It is important to have
your blood pressure checked to prevent damage occurring.
High blood pressure can be controlled with medicines such as
olmesartan medoxomil tablets. Your doctor
has probably also recommended that you make some changes in your
lifestyle to help lower your blood
pressure (for example losing weight, giving up smoking, reducing the
amount of alcohol you drink and

Карактеристике производа

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Olmesartan medoxomil 40mg Film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Olmesartan medoxomil
Each film-coated tablet contains 40 mg of olmesartan medoxomil
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White, film coated, oval, biconvex beveled edge tablets debossed with
'M'
on one side of the tablet and 'O4'
on the
other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of essential hypertension in adults.
Treatment of hypertension in children and adolescents from 6 to less
than 18 years of age.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults_
The recommended starting dose of olmesartan medoxomil is 10 mg once
daily. In patients whose blood pressure is not
adequately controlled at this dose, the dose of olmesartan medoxomil
may be increased to 20 mg once daily as the
optimal dose. If additional blood pressure reduction is required,
olmesartan medoxomil dose may be increased to a
maximum of 40 mg daily or hydrochlorothiazide therapy may be added.
The antihypertensive effect of olmesartan medoxomil is substantially
present within 2 weeks of initiating therapy and is
maximal by about 8 weeks after initiating therapy. This should be
borne in mind when considering changing the dose
regimen for any patient.
_Elderly (65 years or older)_
No adjustment of dosage is generally required in elderly people (see
below for dose recommendations in patients with
renal impairment). If up-titration to the maximum dose of 40 mg daily
is required, blood pressure should be closely
monitored.
_Renal impairment_
The maximum dose in patients with mild to moderate renal impairment
(creatinine clearance of 20 – 60 ml/min) is
20 mg olmesartan medoxomil once daily, owing to limited experience of
higher dosages in this patient group. The use
of olmesartan medoxomil in patients with severe renal impairment
(creatinine clearance < 20 ml/min) is not
recommended, since there is only limit