Omesar 40 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Olmesartan medoxomil

Available from:

PCO Manufacturing Ltd.

ATC code:

C09CA; C09CA08

INN (International Name):

Olmesartan medoxomil

Dosage:

40 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Angiotensin II antagonists, plain; olmesartan medoxomil

Authorization status:

Authorised

Authorization date:

2011-04-08

Patient Information leaflet

_ _
PACKAGE LEAFLET: INFORMATION FOR THE USER
OMESAR
®
10 MG, 20 MG, 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 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. Ssee
section 4.
WHAT IS IN THIS LEAFLET
1.
What Omesar is and what it is used for
2.
What you need to know before you take Omesar
3.
How to take Omesar
4.
Possible side effects
5.
How to store Omesar
6.
Contents of the pack and other information
1.
WHAT OMESAR IS AND WHAT IT IS USED FOR
Omesar belongs to a group of medicines called angiotensin-II receptor
antagonists. They lower blood pressure by relaxing the blood vessels.
Omesar 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 Omesar
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 also have urged you to take regular exercise, such as
walking or swimming. It is important to follow this advice from your
doctor.
2.
WHAT

Summary of Product characteristics

Health Products Regulatory Authority
05 May 2021
CRN00CC3S
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Omesar 40 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Olmesartan medoxomil
Each tablet contains 40 mg of olmesartan medoxomil
Excipient with known effect:
Lactose monohydrate
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-coated tablets.
_Product imported from Italy, France, Portugal and Greece:_
White oval film-coated tablets with C15 embossed on one side.
4 CLINICAL PARTICULARS
As per PA0865/011/003
5 PHARMACOLOGICAL PROPERTIES
As per PA0865/011/003
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Cellulose, microcrystalline
Lactose monohydrate
Hydroxypropylcellulose
Low substituted hydroxypropylcellulose
Magnesium stearate
Titanium dioxide (E171)
Talc
Hypromellose
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date of this product shall be the date shown on
the blister pack and the outer package of the product on
the market in the country of origin.
Health Products Regulatory Authority
05 May 2021
CRN00CC3S
Page 2 of 2
6.4 SPECIAL PRECAUTIONS FOR STORAGE
This medicinal product does not require any special storage
conditions.
6.5 NATURE AND CONTENTS OF CONTAINER
Blister packs of 28 or 30 film-coated tablets.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR
WASTE MATERIALS DERIVED FROM SUCH MEDICINAL
PRODUCT AND OTHER HANDLING OF THE PRODUCT
No special requirements_._
7 PARALLEL PRODUCT AUTHORISATION HOLDER
PCO Manufacturing Ltd.
Unit 10, Ashbourne Business Park
Rath
Ashbourne
Co. Meath
Ireland
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 8th April 2011
10 DATE OF REVISION OF THE TEXT
May 2021