OLMESARTAN ACTAVIS 10 Milligram Film Coated Tablet

البلد: أيرلندا

اللغة: الإنجليزية

المصدر: HPRA (Health Products Regulatory Authority)

العنصر النشط:

OLMESARTAN MEDOXOMIL

متاح من:

Actavis Group PTC ehf

ATC رمز:

C09CA08

INN (الاسم الدولي):

OLMESARTAN MEDOXOMIL

جرعة:

10 Milligram

الشكل الصيدلاني:

Film Coated Tablet

نوع الوصفة الطبية :

Product subject to prescription which may be renewed (B)

المجال العلاجي:

Angiotensin II antagonists, plain

الوضع إذن:

Authorised

تاريخ الترخيص:

2016-09-23

نشرة المعلومات

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
OLMESARTAN ACTAVIS 5, 10, 20, 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 Actavis is and what it is used for
2.
What you need to know before you take Olmesartan Actavis
3.
How to take Olmesartan Actavis
4.
Possible side effects
5.
How to store Olmesartan Actavis
6.
Contents of the pack and other information
1.
WHAT OLMESARTAN ACTAVIS IS AND WHAT IT IS USED FOR
Olmesartan Actavis belongs to a group of medicines called
angiotensin-II receptor antagonists. They
lower blood pressure by relaxing the blood vessels.
Olmesartan Actavis 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 Actavis 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 reducing the amount of salt in your diet). Your doctor
may also have urged you to take
regular exercise

خصائص المنتج

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Olmesartan Actavis 10 mg Film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Olmesartan medoxomil
Each 10 mg tablet contains 10 mg of olmesartan medoxomil
Excipients with known effect: Each 10 mg tablet contains 75.53 mg of
lactose monohydrate
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-coated tablet.
Olmesartan Actavis 10 mg film-coated tablets are white, round,
biconvex and 6.5 mm in diameter, with OL 10
debossed on one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
_Adults_
Treatment of essential hypertension.
_Paediatric population_
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 people (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
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