OLMETEC 20MG FILM-COATED TABLET

Negara: Malaysia

Bahasa: Inggris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

OLMESARTAN MEDOXOMIL

Tersedia dari:

PFIZER (MALAYSIA) SDN. BHD.

INN (Nama Internasional):

OLMESARTAN MEDOXOMIL

Unit dalam paket:

30 Tablets; 30 Tablets; 30 Tablets; 30 Tablets; 30 Tablets

Diproduksi oleh:

DAIICHI SANKYO EUROPE GMBH

Selebaran informasi

Pfizer Confidential
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
OLMETEC
®
Olmesartan medoxomil (10 mg, 20 mg, 40 mg)
1
PLD TITLE
:
Olmetec
PLD DATE
:
14 June 2019
COUNTRY
:
Malaysia
REFERENCE DOCUMENT
:
Malaysia LPD Dated: 18 July 2017
REASON FOR CHANGE
:
To update PRH address
: To update serial number
Pfizer Confidential
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
OLMETEC
®
Olmesartan medoxomil (10 mg, 20 mg, 40 mg)
2
WHAT IS IN THIS LEAFLET
1.
What Olmetec is used for
2.
How Olmetec works
3.
Before you use Olmetec
4.
How to use Olmetec
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Olmetec
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT OLMETEC IS USED FOR
Olmetec is used to treat high blood
pressure.
HOW OLMETEC WORKS
Olmetec belongs to a group of
medicines called angiotensin-II
receptor antagonists. It lowers blood
pressure by relaxing the blood vessels.
BEFORE YOU USE OLMETEC
-
_When you must not use it _
Do not take Olmetec if you:
•
are allergic to olmesartan
medoxomil or to any of the other
ingredients of Olmetec.
•
are in the second and third
trimesters of pregnancy.
•
suffer from problems with
drainage of the bile from the
gallbladder (biliary obstruction).
•
have diabetes or impaired kidney
function and you are treated with
a blood pressure lowering
medicine containing aliskiren.
_Pregnancy and lactation _
Do not take Olmetec if you are
pregnant, trying to get pregnant or
think you may be pregnant.
Do not take Olmetec if you are breast-
feeding. Ask your doctor or
pharmacist for advice before taking
any medicine.
-
_Before you start use it _
Before you take Olmetec, tell your
doctor.if you:
•
have diarrhoea, vomiting, or you
are on a treatment with high doses
of diuretics or on a low salt diet
•
are taking medicinal products that
affect the renin-angiotensin-
aldosterone system
•
have kidney problems or have had
a recent kidney transplant
•
have liver disease
•
have low potassium levels in
blood
•
a

Karakteristik produk

Page 1 of 16
APPROVED PRODUCT INFORMATION
OLMETEC

(Olmesartan medoxomil)
1.
NAME OF THE MEDICINAL PRODUCT
Olmetec 10 mg film-coated tablet
Olmetec 20 mg film-coated tablet
Olmetec 40 mg film-coated tablet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10 mg olmesartan medoxomil
Each film-coated tablet contains 20 mg olmesartan medoxomil
Each film-coated tablet contains 40 mg olmesartan medoxomil
Excipient with known effect:
Olmetec 10 mg film-coated tablets: each film-coated tablet contains
61.6 mg lactose
monohydrate
Olmetec 20 mg film-coated tablets: each film-coated tablet contains
123.2 mg lactose
monohydrate
Olmetec 40 mg film-coated tablets: each film-coated tablet contains
246.4 mg lactose
monohydrate
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Film-coated tablet.
_10 mg tablet:_ White, circular film coated tablet with characteristic
odour approximately
6.5 mm in diameter, with C13 embossed on one side.
_20 mg tablet:_ White, circular film coated tablet with characteristic
odour approximately
8.5 mm in diameter, with C14 embossed on one side.
_40 mg tablet:_ White, oval film coated tablet with characteristic
odour approximately
15 x 7 mm in size, with C15 embossed on one side.
Page 2 of 16
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Olmetec
®
is indicated for the treatment of essential hypertension.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
_ADULTS_
Dosage must be individualized. The usual recommended starting dose of
olmesartan
medoxomil is 20 mg once daily when used as monotherapy in patients who
are not volume-
contracted. 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
an