OLMESARTAN MEDOXOMIL/HYDROCHLOROTHIAZIDE ACCORD

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

OLMESARTAN MEDOXOMIL ; HYDROCHLOROTHIAZIDE EP

Διαθέσιμο από:

Accord Healthcare Limited

Φαρμακολογική κατηγορία (ATC):

C09DA08

INN (Διεθνής Όνομα):

OLMESARTAN MEDOXOMIL ; HYDROCHLOROTHIAZIDE EP

Δοσολογία:

40/25 Milligram

Φαρμακοτεχνική μορφή:

Film Coated Tablet

Τρόπος διάθεσης:

Product subject to prescription which may be renewed (B)

Θεραπευτική περιοχή:

olmesartan medoxomil and diuretics

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2017-08-18

Φύλλο οδηγιών χρήσης

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
OLMESARTAN MEDOXOMIL/HYDROCHLOROTHIAZIDE 40 MG/12.5 MG FILM-COATED
TABLETS OLMESARTAN MEDOXOMIL/HYDROCHLOROTHIAZIDE 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 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, the two active substances in
Olmesarta

Αρχείο Π.Χ.Π.

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Olmesartan Medoxomil/Hydrochlorothiazide 40 mg/25 mg film-coated
tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 40 mg olmesartan medoxomil and 25 mg
hydrochlorothiazide.
Excipients- with known effect:
Each 40 mg olmesartan medoxomil and 25 mg hydrochlorothiazide
film-coated tablet contains 221 mg of lactose
monohydrate.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-coated tablet.
Pinkish, oval film-coated tablets; debossed with “OH3” on one side
and plain on other side.
Approximate dimensions: Length 15.3 mm, width 7.1 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of essential hypertension.
Olmesartan Medoxomil/Hydrochlorothiazide tablets 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 Olmesartan Medoxomil/Hydrochlorothiazide
tablets 40 mg/25 mg is 1 tablet per day.
Olmesartan Medoxomil/Hydrochlorothiazide tablets 40 mg/12.5 mg may be
administered in patients whose blood
pressure is not adequately controlled by olmesartan medoxomil 40 mg
alone.
Olmesartan Medoxomil/Hydrochlorothiazide tablets
40 mg /25 mg may be administered in patients whose blood
pressure is not adequately controlled on Olmesartan
Medoxomil/Hydrochlorothiazide tablets 40 mg/12.5 mg fixed dose
combination.
For convenience, patients receiving olmesartan medoxomil and
hydrochlorothiazide from separate tablets may be
switched to Olmesartan Medoxomil/Hydrochlorothiazide tablets 40
mg/12.5 mg and 40 mg/25 mg tablets containing
the same component doses.
Olmesartan Medoxomil/Hydrochlorothiazide tablets 40 mg/12.5 mg and 40
mg/25 mg can be taken with or without
food.
_Older people (age 65 years or over)_
In older people the same dosage of the combination is recommended as
for adults.
Blood pressure should be clo