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

Pays: Irlande

Langue: anglais

Source: HPRA (Health Products Regulatory Authority)

Ingrédients actifs:

Hydrochlorothiazide ep; Olmesartan medoxomil

Disponible depuis:

Accord Healthcare Limited

Code ATC:

C09DA; C09DA08

DCI (Dénomination commune internationale):

Hydrochlorothiazide ep; Olmesartan medoxomil

Dosage:

20/12.5

forme pharmaceutique:

Film-coated tablet

Type d'ordonnance:

Product subject to prescription which may be renewed (B)

Domaine thérapeutique:

Angiotensin II antagonists and diuretics; olmesartan medoxomil and diuretics

Statut de autorisation:

Authorised

Date de l'autorisation:

2017-08-18

Notice patient

FRONT SIDE
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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Olmesartan Medoxomil/
Hydrochlorothiazide
20 mg/12.5 mg film-coated
tablets
Olmesartan Medoxomil/
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 Medoxomil/Hydrochlorothiazide tablets
are and what they are used for
2. What you need to know before you take Olmesartan
Medoxomil/Hydrochlorothiazide tablets
3. How to take Olmesartan Medoxomil/Hydrochlorothiazide
tablets
4. Possible side effects
5. How to store Olmesartan Medoxomil/Hydrochlorothiazide
tablets
6. Contents of the pack and other information 1.
WHAT OLMESARTAN MEDOXOMIL/
HYDROCHLOROTHIAZIDE TABLETS ARE AND
WHAT THEY ARE USED FOR
Olmesartan Medoxomil/Hydrochlorothiazide tablets 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
Medoxomil/Hydrochlorothiazide tablets if olmesartan
medoxomil alone has not adequately controlled your blood
pressure. When given together,

Résumé des caractéristiques du produit

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Olmesartan Medoxomil/Hydrochlorothiazide 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 20 mg olmesartan medoxomil and 12.5 mg hydrochlorothiazide
film-coated tablet contains 111 mg of lactose
monohydrate.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-coated tablet.
Reddish-Yellow, round, film-coated tablets; debossed with “OH1” on
one side and plain on other side.
Dimension: Diameter approximately 8.6 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of essential hypertension.
Olmesartan Medoxomil/Hydrochlorothiazide tablets 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 Medoxomil/Hydrochlorothiazide tablets 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 tablets 20 mg/12.5 mg 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.
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