Vivactra 5mg film-coated tablet

Kraj: Malta

Język: angielski

Źródło: Medicines Authority

Składnik aktywny:

OLMESARTAN MEDOXOMIL

Dostępny od:

Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland

Kod ATC:

C09CA08

INN (International Nazwa):

OLMESARTAN MEDOXOMIL 5 mg

Forma farmaceutyczna:

FILM-COATED TABLET

Skład:

OLMESARTAN MEDOXOMIL 5 mg

Typ recepty:

POM

Dziedzina terapeutyczna:

AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM

Status autoryzacji:

Withdrawn

Data autoryzacji:

2013-09-17

Ulotka dla pacjenta

1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
VIVACTRA 5 MG FILM-COATED TABLETS
VIVACTRA 10 MG FILM-COATED TABLETS
VIVACTRA 20 MG FILM-COATED TABLETS
VIVACTRA 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 Vivactra is and what it is used for
2.
What you need to know before you take Vivactra
3.
How to take Vivactra
4.
Possible side effects
5.
How to store Vivactra
6.
Contents of the pack and other information
1.
WHAT VIVACTRA IS AND WHAT IT IS USED FOR
Vivactra belongs to a group of medicines called angiotensin-II
receptor antagonists. They lower blood
pressure by relaxing the blood vessels.
Vivactra 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 Vivactra
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

Charakterystyka produktu

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Vivactra 5 mg film-coated tablet
Vivactra 10 mg film-coated tablet
Vivactra 20 mg film-coated tablet
Vivactra 40 mg film-coated tablet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Olmesartan medoxomil
Each 5 mg tablet contains 5 mg of olmesartan medoxomil
Each 10 mg tablet contains 10 mg of olmesartan medoxomil
Each 20 mg tablet contains 20 mg of olmesartan medoxomil
Each 40 mg tablet contains 40 mg of olmesartan medoxomil
Excipients with known effect:
Each 5 mg tablet contains 37.365 mg of lactose monohydrate
Each 10 mg tablet contains 75.53 mg of lactose monohydrate
Each 20 mg tablet contains 151.06 mg of lactose monohydrate
Each 40 mg tablet contains 302.12 mg of lactose monohydrate
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Vivactra 5 mg film-coated tablets are white, round, biconvex and 5.5
mm in diameter, with OL
debossed on one side and 5 on the other side.
Vivactra 10 mg film-coated tablets are white, round, biconvex and 6.5
mm in diameter, with OL 10
debossed on one side.
Vivactra 20 mg film-coated tablets are white, round, biconvex and 8.5
mm in diameter, with OL 20
debossed on one side.
Vivactra 40 mg film-coated tablets are white, oval, biconvex and 15x7
mm in diameter, with OL 40
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 antihyper