Olmesartan Krka 40 mg film-coated tablets

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

유효 성분:

Olmesartan medoxomil

제공처:

KRKA, d.d., Novo mesto

ATC 코드:

C09CA; C09CA08

INN (국제 이름):

Olmesartan medoxomil

복용량:

40 milligram(s)

약제 형태:

Film-coated tablet

처방전 유형:

Product subject to prescription which may be renewed (B)

치료 영역:

Angiotensin II antagonists, plain; olmesartan medoxomil

승인 상태:

Marketed

승인 날짜:

2016-06-10

환자 정보 전단

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
OLMESARTAN KRKA 10 MG FILM-COATED TABLETS
OLMESARTAN KRKA 20 MG FILM-COATED TABLETS
OLMESARTAN KRKA 40 MG FILM-COATED TABLETS
olmesartan medoxomil
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 Krka is and what it is used for
2.
What you need to know before you take Olmesartan Krka
3.
How to take Olmesartan Krka
4.
Possible side effects
5.
How to store Olmesartan Krka
6.
Contents of the pack and other information
1.
WHAT OLMESARTAN KRKA IS AND WHAT IT IS USED FOR
Olmesartan Krka belongs to a group of medicines called angiotensin-II
receptor antagonists. They
lower blood pressure by relaxing the blood vessels.
Olmesartan Krka is used for the treatment of high blood pressure (also
known as ‘hypertension’) in
adults and children and adolescents aged 6 to less than 18 years. High
blood pressure can damage
blood vessels in organs such as the heart, kidneys, brain and eyes. In
some cases this may lead to a
heart attack, heart or kidney failure, stroke or blindness. Usually
high blood pressure has no
symptoms. It is important to have your blood pressure checked to
prevent damage occurring.
High blood pressure can be controlled with medicines such as
Olmesartan Krka tablets. Your doctor
has probably also recommended that you make some changes in your
lifestyle to help lower your
blood pressure (for example losing weight, giving up smoking, reducing
the amount of alcohol you
drink and reducing the amount of salt in your diet). Your doctor may
a

제품 특성 요약

Health Products Regulatory Authority
05 October 2022
CRN00CTN8
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Olmesartan Krka 40 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 40 mg olmesartan medoxomil.
Excipient(s) with known effect:
Each tablet contains 230.00 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White, oval, biconvex film-coated tablets, engraved with a mark S3 on
one side of the tablet; tablet dimensions: 13x8 mm,
thickness 4.3 mm – 5.5 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of essential hypertension in adults.
Treatment of hypertension in children and adolescents from 6 to less
than 18 years of age.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults_
The recommended starting dose of olmesartan medoxomil is 10 mg once
daily. In patients whose blood pressure is not
adequately controlled at this dose, the dose of olmesartan medoxomil
may be increased to 20 mg once daily as the optimal
dose. If additional blood pressure reduction is required, olmesartan
medoxomil dose may be increased to a maximum of 40 mg
daily or hydrochlorothiazide therapy may be added.
The antihypertensive effect of olmesartan medoxomil is substantially
present within 2 weeks of initiating therapy and is
maximal by about 8 weeks after initiating therapy. This should be
borne in mind when considering changing the dose regimen
for any patient.
_Older people (65 years or older)_
No adjustment of dosage is generally required in older people (see
below for dose recommendations in patients with renal
impairment). If up-titration to the maximum dose of 40 mg daily is
required, blood pressure should be closely monitored.
_Patients with renal impairment_
The maximum dose in patients with mild to moderate renal impairment
(creatinine clearance of 20 – 60 ml/min) is 20 mg
olmesartan medoxomil once daily, owing to limited experience of higher
dosages in