Olmesartan/Vocate 10mg film-coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

OLMESARTAN MEDOXOMIL

Available from:

Vocate Pharmaceuticals S.A 150, Gounari str, 166 74 Glyfada, Athens, Greece

ATC code:

C09CA08

INN (International Name):

OLMESARTAN MEDOXOMIL 10 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

OLMESARTAN MEDOXOMIL 10 mg

Prescription type:

POM

Therapeutic area:

AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM

Authorization status:

Authorised

Authorization date:

2019-08-07

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
OLMESARTAN/ VOCATE 10 MG, 20MG AND 40MG 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/ VOCATE
is and what it is used for
2.
What you need to know before you take OLMESARTAN/ VOCATE
3.
How to take OLMESARTAN/ VOCATE
4.
Possible side effects
5.
How to store OLMESARTAN/ VOCATE
6.
Contents of the pack and other information
1.
WHAT OLMESARTAN/ VOCATE IS AND WHAT IT IS USED FOR
OLMESARTAN/ VOCATE
belongs to a group of medicines called angiotensin-II receptor
antagonists. They lower blood pressure by relaxing the blood vessels.
The tablets 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/ VOCATE. 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
regula

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
OLMESARTAN/ VOCATE 10 mg film-coated tablets
OLMESARTAN/ VOCATE 20 mg film-coated tablets
OLMESARTAN/ VOCATE 40 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Olmesartan medoxomil
Each film-coated tablet contains 10 mg olmesartan medoxomil
Each film-coated tablet contains 20 mg olmesartan medoxomil
Each film-coated tablet contains 40 mg olmesartan medoxomil
Excipient with known effect:
OLMESARTAN/ VOCATE 10 mg film-coated tablets: each film-coated tablet
contains 75.41 mg lactose
monohydrate
OLMESARTAN/ VOCATE 20 mg film-coated tablets: each film-coated tablet
contains 150.82 mg lactose
monohydrate
OLMESARTAN/ VOCATE 40 mg film-coated tablets: each film-coated tablet
contains 301.65mg lactose
monohydrate
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Film-coated tablet.
OLMESARTAN/ VOCATE 10 mg are white to off-white, round film-coated
tablets, debossed with 476 on
one side and plain on the other side with a characteristic odour,
approx. 6.3 mm in diameter.
OLMESARTAN/ VOCATE 20 mg are white to off-white, round film-coated
tablets, debossed with 437 on
one side and plain on the other side with a characteristic odour,
approx. 8.6 mm in diameter.
OLMESARTAN/ VOCATE 40 mg are white to off-white, oval-shaped
film-coated tablets debossed with
438 on one side and plain on the other side with a characteristic
odour, approx.15.3 mm in length and 7.2
mm in breadth.
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.
_ _
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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
redu