Omesar Plus 40mg/25mg film-coated Tablets

Nazione: Malta

Lingua: inglese

Fonte: Medicines Authority

Principio attivo:

HYDROCHLOROTHIAZIDE, OLMESARTAN MEDOXOMIL

Commercializzato da:

Menarini International Operations Luxembourg S.A 1 Avenue de la Gare, L-1611, Luxembourg

Codice ATC:

C09DA08

INN (Nome Internazionale):

HYDROCHLOROTHIAZIDE 25 mg OLMESARTAN MEDOXOMIL 40 mg

Forma farmaceutica:

FILM-COATED TABLET

Composizione:

HYDROCHLOROTHIAZIDE 25 mg OLMESARTAN MEDOXOMIL 40 mg

Tipo di ricetta:

POM

Area terapeutica:

AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM

Stato dell'autorizzazione:

Authorised

Data dell'autorizzazione:

2011-05-06

Foglio illustrativo

Page 1 of 9
PACKAGE LEAFLET: INFORMATION FOR THE USER
OMESAR PLUS 40 MG/12.5 MG
OMESAR PLUS 40 MG/25 MG
FILM-COATED TABLETS
OLMESARTAN MEDOXOMIL/HYDROCHLOROTHIAZIDE
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 IN THIS LEAFLET
1. What Omesar Plus is and what it is used for
2. What you need to know before you take Omesar Plus
3. How to take Omesar Plus
4. Possible side effects
5. How to store Omesar Plus
6. Content of the pack and other information
1. WHAT OMESAR PLUS IS AND WHAT IT IS USED FOR
Omesar Plus contains two active substances, olmesartan medoxomil and
hydrochlorothiazide, that are
used to treat high blood pressure (hypertension):
•
Olmesartan medoxomil is one of a group of medicines called angiotensin
II-receptor antagonists.
It lowers blood pressure by relaxing the blood vessels.
•
Hydrochlorothiazide is one of a group of medicines called thiazide
diuretics (“water tablets”). It
lowers blood pressure by helping the body to get rid of extra fluid by
making your kidneys
produce more urine.
You will only be given Omesar Plus if Omesar (olmesartan medoxomil)
alone has not adequately
controlled your blood pressure. When given together, the two active
substances in Omesar Plus help to
lower blood pressure more than if either of them were given alone.
You may already be taking medicines to treat your high blood pressure,
but your doctor may want you
to take Omesar Plus to lower it more.
High blood pressure can be controlled with medicines such as Omesar
Plus tablets. Your doctor has
probably also recommended

Scheda tecnica

Page
1
of
21
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Omesar Plus 40 mg/12.5 mg film-coated tablets
Omesar Plus 40 mg/25 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Omesar Plus 40 mg/12.5 mg film-coated tablets:
Each film-coated tablet contains 40 mg olmesartan medoxomil and 12.5
mg hydrochlorothiazide.
Omesar Plus 40 mg/25 mg film-coated tablets:
Each film-coated tablet contains 40 mg olmesartan medoxomil and 25 mg
hydrochlorothiazide.
Excipient(s) with known effect
Omesar Plus 40 mg/12.5 mg film-coated tablets:
Each film-coated tablet contains 233.9 mg lactose monohydrate.
Omesar Plus 40 mg/25 mg film-coated tablets:
Each film-coated tablet contains 221.4 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablets.
Omesar Plus 40 mg/12.5 mg film-coated tablets:
Reddish-yellow, oval, film-coated tablets of 15 x 7 mm with C23
debossed on one side.
Omesar Plus 40 mg/25 mg film-coated tablets:
Pinkish, oval, film-coated tablets of 15 x 7 mm with C25 debossed on
one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of essential hypertension.
Omesar Plus 40 mg/12.5 mg and 40 mg/25 mg fixed dose combinations are
indicated in adult patients
whose blood pressure is not adequately controlled on olmesartan
medoxomil 40 mg alone.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults _
The recommended dose of Omesar Plus 40 mg/12.5 mg or 40 mg/25 mg is 1
tablet per day.
Omesar Plus 40 mg/12.5 mg may be administered in patients whose blood
pressure is not adequately
controlled by olmesartan medoxomil 40 mg alone.
Omesar Plus 40 mg/25 mg may be administered in patients whose blood
pressure is not adequately
controlled on Omesar Plus 40 mg/12.5 mg fixed dose combination.
Page
2
of
21
For convenience, patients receiving olmesartan medoxomil and
hydrochlorothiazide from separate tablets
may be switched to Omesar Plus 40 mg/12.5 mg and 40 mg/25 mg tablets
containing the same component
doses.
Omesar Plu