Olmesartan Medoxomil 20mg film-coated tablets

Kraj: Irlandia

Język: angielski

Źródło: HPRA (Health Products Regulatory Authority)

Składnik aktywny:

Olmesartan medoxomil

Dostępny od:

Accord Healthcare Limited

Kod ATC:

C09CA; C09CA08

INN (International Nazwa):

Olmesartan medoxomil

Dawkowanie:

20 milligram(s)

Forma farmaceutyczna:

Film-coated tablet

Typ recepty:

Product subject to prescription which may be renewed (B)

Dziedzina terapeutyczna:

Angiotensin II antagonists, plain; olmesartan medoxomil

Status autoryzacji:

Marketed

Data autoryzacji:

2016-01-29

Ulotka dla pacjenta

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 sign of illness are the same as
yours.
-
If you get any side effects, talk to your doctor or
pharmacist or nurse. 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.
Olmesartan Medoxomil are 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. 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 re

Charakterystyka produktu

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Olmesartan Medoxomil 20mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 20 mg Olmesartan Medoxomil.
Excipients- with known effect:
Each 20mg tablet contains 123.96 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
White to off-white, round, biconvex, film coated tablets, debossed
with “IO3” on one side and plain on other side.
Diameter and thickness of the film-coated tablet is 8.5 mm± 0.1 mm
and 3.9 mm ± 0.3 mm respectively.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of essential hypertension.
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 older people (see
below for dose recommendations in patients with
renal impairment). If up-titration to the maximum dose of 40mg 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 u