Olmesartan/Hydrochlorothiazide Krka 40 mg/12.5 mg film-coated tablets

Negara: Irlandia

Bahasa: Inggris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Olmesartan medoxomil; Hydrochlorothiazide

Tersedia dari:

KRKA, d.d., Novo mesto

Kode ATC:

C09DA; C09DA08

INN (Nama Internasional):

Olmesartan medoxomil; Hydrochlorothiazide

Dosis:

40 mg/12.5 milligram(s)

Bentuk farmasi:

Film-coated tablet

Jenis Resep:

Product subject to prescription which may be renewed (B)

Area terapi:

Angiotensin II antagonists and diuretics; olmesartan medoxomil and diuretics

Status otorisasi:

Marketed

Tanggal Otorisasi:

2016-07-08

Selebaran informasi

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
OLMESARTAN/HYDROCHLOROTHIAZIDE KRKA 40 MG/12.5 MG FILM-COATED TABLETS
OLMESARTAN/HYDROCHLOROTHIAZIDE KRKA 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 Krka is and what it is used for
2.
What you need to know before you take Olmesartan/Hydrochlorothiazide
Krka
3.
How to take Olmesartan/Hydrochlorothiazide Krka
4.
Possible side effects
5.
How to store Olmesartan/Hydrochlorothiazide Krka
6.
Contents of the pack and other information
1.
WHAT OLMESARTAN/HYDROCHLOROTHIAZIDE KRKA IS AND WHAT IT IS USED FOR
Olmesartan/Hydrochlorothiazide Krka contains two active substances,
olmesartan medoxomil and
hydrochlorothiazide that are used to treat high blood pressure
(hypertension) in adult patients:
-
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 Krka if
olmesartan medoxomil alone has not
adequately controlled your blood pressure. When given together, the
two active substances in
Olmesartan/Hydrochlorothiazide Krka help to lower blood pressure more
than if either of them were
given alone.
Yo

Karakteristik produk

Health Products Regulatory Authority
20 June 2022
CRN00CTNJ
Page 1 of 19
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Olmesartan/Hydrochlorothiazide Krka 40 mg/12.5 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 40 mg olmesartanmedoxomil and 12.5 mg
hydrochlorothiazide.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
White to almost white, round film-coated tablets with bevel edge,
engraved with a mark C3 on one side of the tablet; diameter
12 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of essential hypertension.
Olmesartan/Hydrochlorothiazide Krka 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 Olmesartan/Hydrochlorothiazide Krka 40 mg/12.5
mg or 40 mg/25 mg is 1 tablet per day.
Olmesartan/Hydrochlorothiazide Krka 40 mg/12.5 mg may be administered
in patients whose blood pressure is not adequately
controlled by olmesartan medoxomil 40 mg alone.
Olmesartan/Hydrochlorothiazide Krka 40 mg/25 mg may be administered in
patients whose blood pressure is not adequately
controlled on Olmesartan/Hydrochlorothiazide Krka 40 mg/12.5 mg fixed
dose combination.
For convenience, patients receiving olmesartan medoxomil and
hydrochlorothiazide from separate tablets may be switched to
Olmesartan/Hydrochlorothiazide Krka 40 mg/12.5 mg and 40 mg/25 mg
tablets containing the same component doses.
Olmesartan/Hydrochlorothiazide Krka 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 closely monitored.
Health Products Regulatory Authority
20 June 2022
CRN00CTNJ
Page 2 of 19
RENAL IMPAIRMENT
Olmesartan/Hydrochlorothiazide Krka is contraindicate