OLMETEC olmesartan medoxomil 20 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

olmesartan medoxomil, Quantity: 20 mg

Available from:

ORGANON PHARMA PTY LTD

INN (International Name):

Olmesartan medoxomil

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: microcrystalline cellulose; hyprolose; lactose monohydrate; magnesium stearate; titanium dioxide; hypromellose; purified talc

Administration route:

Oral

Units in package:

10, 30

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Olmetec is indicated for the treatment of hypertension.

Product summary:

Visual Identification: White, circular film-coated tablet with characteristic odour approximately 8.5 mm in diameter, with 'C14' embossed on one side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 4 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2005-09-06

Patient Information leaflet

OLMETEC
®
_Olmesartan medoxomil_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about OLMETEC.
It does not contain all the available
information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking OLMETEC
against the benefits he/she expects it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
OLMETEC TABLETS OR SUSPENSION.
You may need to read it again.
WHAT OLMETEC IS
USED FOR
OLMETEC is used to treat high
blood pressure which is sometimes
called hypertension.
Everyone has blood pressure. This
pressure helps push blood all around
your body. Your blood pressure
changes at different times of the day,
depending on how busy or worried
you are. You have hypertension (high
blood pressure) when your blood
pressure stays higher than is needed,
even when you are calm and relaxed.
There are usually no symptoms of
hypertension. The only way of
knowing that you have hypertension
is to have your blood pressure
checked on a regular basis. If high
blood pressure is not treated it can
lead to serious health problems,
including stroke, heart disease and
kidney failure.
_HOW OLMETEC WORKS_
OLMETEC belongs to a group of
medicines known as angiotensin-II
receptor antagonists. Angiotensin-II
is a substance produced in the body
which causes blood vessels to
tighten. OLMETEC blocks the action
of angiotensin-II and therefore
relaxes your blood vessels. This
helps lower your blood pressure.
Your doctor may have prescribed
OLMETEC for another reason. Ask
your doctor if you have any questions
about why OLMETEC has been
prescribed for you.
OLMETEC is not addictive.
This medicine is available only with
a doctor's prescription.
BEFORE YOU TAKE
OLMETEC
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE OLMETEC IF:
•
YOU HAVE SERIOUS PROBLEMS WITH
YOUR KIDNEYS
•
YOU HAVE SERIOUS PROBLEMS WITH
YOUR LIVER
•
YOU HAVE DI

Summary of Product characteristics

OLMETEC
Page 1 of 23
AUSTRALIAN PRODUCT INFORMATION
OLMETEC

(OLMESARTAN MEDOXOMIL)
TABLETS
1
NAME OF THE MEDICINE
Olmesartan medoxomil
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
Olmesartan medoxomil is a white to light yellowish-white powder or
crystalline powder. It is
practically insoluble in water and sparingly soluble in methanol.
OLMETEC is available for oral
use as film-coated tablets containing 10 mg, 20 mg, or 40 mg
olmesartan medoxomil.
List of excipients with known effect:
-
lactose (as monohydrate)
For full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
10 MG TABLET: White, circular film-coated tablet with C13 embossed on
one side.
20 MG TABLET: White, circular film-coated tablet with C14 embossed on
one side.
40 MG TABLET: White, oval film-coated tablet with C15 embossed on one
side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
OLMETEC is indicated for the treatment of hypertension.
4.2
DOSE AND METHOD OF ADMINISTRATION
ADULTS
Dosage must be individualised. The optimal recommended starting dose
of OLMETEC is 20
mg once daily when used as monotherapy in patients who are not
volume-contracted. If
additional blood pressure reduction is required, the dose of OLMETEC
may be increased to a
maximum of 40 mg daily.
OLMETEC may be administered with or without food. In order to assist
compliance, it is
recommended that OLMETEC tablets be taken at about the same time each
day. Twice-daily
dosing offers no advantage over the same total dose given once daily.
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.
OLMETEC
Page 2 of 23
Hydrochlorothiazide therapy should be considered in those pati