Olmesartan/Hydrochlorothiazide 20mg/12.5mg film-coated tablets

Nazione: Malta

Lingua: inglese

Fonte: Medicines Authority

Principio attivo:

HYDROCHLOROTHIAZIDE, OLMESARTAN MEDOXOMIL

Commercializzato da:

Aurobindo Pharma (Malta) Limited Vault 14, Level 2, Valletta Waterfront, Floriana FRN 1913, Malta

Codice ATC:

C09DA08

INN (Nome Internazionale):

HYDROCHLOROTHIAZIDE 12.5 mg OLMESARTAN MEDOXOMIL 20 mg

Forma farmaceutica:

FILM-COATED TABLET

Composizione:

HYDROCHLOROTHIAZIDE 12.5 mg OLMESARTAN MEDOXOMIL 20 mg

Tipo di ricetta:

POM

Area terapeutica:

AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM

Stato dell'autorizzazione:

Authorised

Data dell'autorizzazione:

2014-10-16

Foglio illustrativo

1.3.1 SPC, LABELLING AND PACKAGE LEAFLET
Page 1 of 9
PACKAGE LEAFLET: INFORMATION FOR THE USER
OLMESARTAN/HYDROCHLOROTHIAZIDE 20 MG/12.5 MG FILM-COATED TABLETS
OLMESARTAN/HYDROCHLOROTHIAZIDE 20 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 IS IN THIS LEAFLET
1
What Olmesartan/Hydrochlorothiazide Aurobindo is and what it is used
for
2
What you need to know before you take Olmesartan/Hydrochlorothiazide
Aurobindo
3
How to take Olmesartan/Hydrochlorothiazide Aurobindo
4
Possible side effects
5
How to store Olmesartan/Hydrochlorothiazide Aurobindo
6
Contents of the pack and other information
1.
WHAT OLMESARTAN/HYDROCHLOROTHIAZIDE IS AND WHAT IT IS USED FOR
Olmesartan/Hydrochlorothiazide Aurobindo 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 Olmesartan/Hydrochlorothiazide Aurobindo
if olmesartan medoxomil alone
has not adequately controlled your blood pressure. When given
together, the two active substances
in Olmesartan/Hydrochlorothiazide Aurobindo
help to lower bloo

Scheda tecnica

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Olmesartan/Hydrochlorothiazide 20 mg/12.5 mg film-coated tablets
Olmesartan/Hydrochlorothiazide 20 mg/25 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Olmesartan/Hydrochlorothiazide 20 mg/12.5 mg: _
Each film-coated tablet contains 20 mg olmesartan medoxomil and 12.5
mg
hydrochlorothiazide.
Excipients with known effect: Each film-coated tablet contains 118.000
mg of lactose mоnоhуdгаte.
_Olmesartan/Hydrochlorothiazide 20 mg/25 mg: _
Each film-coated tablet contains 20 mg olmesartan medoxomil and 25 mg
hydrochlorothiazide.
Excipients with known effect: Each film-coated tablet contains 105.500
mg of lactose mоnоhуdгаte.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
_Olmesartan/Hydrochlorothiazide 20 mg/12.5 mg: _
Reddish-yellow, round shaped (diameter 8.5 mm), biconvex film-coated
tablets debossed with' K' on
one side and ‘23' on the other side.
_Olmesartan/Hydrochlorothiazide 20 mg/25 mg: _
Pink, round shaped (diameter 8.5 mm), biconvex film-coated tablets
debossed with' K' on one side
and ‘24' on the other side.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of essential hypertension.
Olmesartan/Hydrochlorothiazide fixed dose combination is indicated in
adult patients whose blood
pressure is not adequately controlled on olmesartan medoxomil alone.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
ADULTS
Olmesartan/Hydrochlorothiazide is not for use as initial therapy, but
in patients whose blood
pressure is not adequately controlled by 20 mg olmesartan medoxomil
alone.
Olmesartan/Hydrochlorothiazide is administered once daily, with or
without food.
Page 2 of 23
When clinically appropriate, direct change from monotherapy with 20 mg
olmesartan medoxomil
to the fixed combination may be considered, taking into account that
the antihypertensive effect
of olmesartan medoxomil is maximal by about 8 weeks after initiating
therapy (see section 5.1).
Dose tit