Olmesartan Medoxomil 40 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Olmesartan medoxomil

Available from:

Accord Healthcare Ireland Ltd.

ATC code:

C09CA; C09CA08

INN (International Name):

Olmesartan medoxomil

Dosage:

40 milligram(s)

Pharmaceutical form:

Film-coated tablet

Therapeutic area:

Angiotensin II antagonists, plain; olmesartan medoxomil

Authorization status:

Marketed

Authorization date:

2016-01-29

Patient Information leaflet

NL/H/4553/001-003/IA/020, Ver 01, 10/2023
PACKAGE LEAFLET: INFORMATION FOR THE USER
OLMESARTAN MEDOXOMIL 10 MG FILM COATED TABLETS
OLMESARTAN MEDOXOMIL 20 MG FILM COATED TABLETS
OLMESARTAN MEDOXOMIL 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 sign of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist or
nurse. This includes any
possible side effects not listed in this leaflet (see section 4).
WHAT IS IN THIS LEAFLET:
1.
What Olmesartan Medoxomil
is and what it is used for
2.
What you need to know before you take Olmesartan Medoxomil
3.
How to take Olmesartan Medoxomil
4.
Possible side effects
5.
How to store Olmesartan Medoxomil
6.
Contents of the pack and other information
1.
WHAT OLMESARTAN MEDOXOMIL IS AND WHAT IT IS USED FOR
Olmesartan Medoxomil
belongs to a group of medicines called angiotensin-II receptor
antagonists. They lower blood pressure by relaxing the blood vessels.
Olmesartan Medoxomil
are 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 Medoxomil. 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, reduc

Summary of Product characteristics

Health Products Regulatory Authority
11 May 2022
CRN00CXVQ
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Olmesartan Medoxomil 40 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 40 mg Olmesartan Medoxomil.
Excipients- with known effect:
Each 40mg tablet contains 247.92 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
White to off-white, oval, biconvex, film coated tablets, debossed with
“IO4” on one side and plain on other side. Length, width
and thickness of the film-coated tablet is 15.1 mm ± 0.1 mm, 7.0 mm
± 0.1 mm and 5.1 mm ± 0.3 mm respectively.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of essential hypertension.
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 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 40mg 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