Olmesartan Rowex 10 mg film-coated tablets

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Olmesartan medoxomil

Tilgjengelig fra:

Rowex Ltd

ATC-kode:

C09CA; C09CA08

INN (International Name):

Olmesartan medoxomil

Dosering :

10 milligram(s)

Legemiddelform:

Film-coated tablet

Resept typen:

Product subject to prescription which may be renewed (B)

Terapeutisk område:

Angiotensin II antagonists, plain; olmesartan medoxomil

Autorisasjon status:

Marketed

Autorisasjon dato:

2016-04-15

Informasjon til brukeren

PACKAGE LEAFLET: INFORMATION FOR THE USER
OLMESARTAN ROWEX 10MG FILM-COATED TABLETS
OLMESARTAN ROWEX 20MG FILM-COATED TABLETS
OLMESARTAN ROWEX 40MG 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 Rowex is and what it is used for
2. What you need to know before you take Olmesartan Rowex
3. How to take Olmesartan Rowex
4. Possible side effects
5. How to store Olmesartan Rowex
6. Contents of the pack and other information
1. WHAT OLMESARTAN ROWEX IS AND WHAT IT IS USED FOR
Olmesartan Rowex belongs to a group of medicines called angiotensin II
receptor antagonists. They
lower blood pressure by relaxing the blood vessels.
Olmesartan Rowex is used for the treatment of high blood pressure
(also known as ‘hypertension’) in
adults and in 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 Rowex 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 doct

Preparatomtale

Health Products Regulatory Authority
13 February 2024
CRN00CTVD
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Olmesartan Rowex 10 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10 mg olmesartan medoxomil.
Excipient with known effect:
Contains 55.525 mg lactose monohydrate
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated Tablet
White, round, biconvex film-coated tablet with inscription ’10’ on
one side.
Dimension: 6.4 mm - 6.7 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.
Elderly (65 years or over)
No adjustment of dosage is generally required in elderly 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.
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 this patient group. The use of olmesartan
medoxomil in patients with severe renal