OLMESARTAN MEDOXOMIL/HYDROCHLOROTHIAZIDE TEVA 20/12.5 Milligram Film Coated Tablet

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

OLMESARTAN MEDOXOMIL, HYDROCHLOROTHIAZIDE

Commercializzato da:

Teva Pharma B.V.

Codice ATC:

C09DA08

INN (Nome Internazionale):

OLMESARTAN MEDOXOMIL, HYDROCHLOROTHIAZIDE

Dosaggio:

20/12.5 Milligram

Forma farmaceutica:

Film Coated Tablet

Tipo di ricetta:

Product subject to prescription which may be renewed (B)

Area terapeutica:

Angiotensin II antagonists and diuretics

Stato dell'autorizzazione:

Authorised

Data dell'autorizzazione:

2012-11-05

Foglio illustrativo

Olmesartan/HCT, PT/H/0731_0743/003-004/IA/0014/G, 11.01.2017
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
OLMESARTAN/HYDROCHLOROTHIAZIDE TEVA 40 MG/12.5 MG FILM-COATED TABLETS
OLMESARTAN/HYDROCHLOROTHIAZIDE TEVA 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 IS IN THIS LEAFLET
1. What Olmesartan/Hydrochlorothiazide is and what it is used for
2. What you need to know before you take
Olmesartan/Hydrochlorothiazide
3. How to take Olmesartan/Hydrochlorothiazide
4. Possible side effects
5. How to store Olmesartan/Hydrochlorothiazide
6. Contents of the pack and other information
1.
WHAT OLMESARTAN/HYDROCHLOROTHIAZIDE IS AND WHAT IT IS USED FOR
Olmesartan/Hydrochlorothiazide 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 if olmesartan
medoxomil alone has not
adequately controlled your blood pressure. When given together, the
two active substances in this
medicine help to lower blood pressure more than if either of them were
given alone.
You m

Scheda tecnica

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Olmesartan Medoxomil/Hydrochlorothiazide Teva 20 mg/12.5 mg
Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 20 mg olmesartan medoxomil and 12.5
mg hydrochlorothiazide.
Excipients with known effect:
Each film-coated tablet contains 144.0 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Reddish-yellow, round, biconvex film-coated tablet.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of essential hypertension.
Olmesartan Medoxomil/Hydrochlorothiazide Teva fixed dose combination
is indicated in patients whose blood
pressure is not adequately controlled on olmesartan medoxomil alone.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults_
Olmesartan Medoxomil/Hydrochlorothiazide Teva is not for use as
initial therapy, but in patients whose blood pressure
is not adequately controlled by 20 mg olmesartan medoxomil alone.
Olmesartan Medoxomil/Hydrochlorothiazide Teva
is administered once daily, with or without food.
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 titration of the individual components is
recommended:
20 mg olmesartan medoxomil/12.5 mg hydrochlorothiazide may be
administered in patients whose blood pressure is
not adequately controlled by the optimal monotherapy olmesartan
medoxomil 20 mg alone.
20 mg olmesartan medoxomil/25 mg hydrochlorothiazide may be
administered in patients whose blood pressure is not
adequately controlled by 20 mg olmesartan medoxomil/12.5 mg
hydrochlorothiazide.
_Older people (age 65 years or over)_
In older people the same dosage of the combination is recommended as
for adults.
_Renal impairment_
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