OLSETAN olmesartan medoxomil 40 mg tablet blister pack

Riik: Austraalia

keel: inglise

Allikas: Department of Health (Therapeutic Goods Administration)

Toimeaine:

olmesartan medoxomil, Quantity: 40 mg

Saadav alates:

Accord Healthcare Pty Ltd

Ravimvorm:

Tablet, film coated

Koostis:

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

Manustamisviis:

Oral

Ühikuid pakis:

30 tablets

Retsepti tüüp:

(S4) Prescription Only Medicine

Näidustused:

OLSETAN is indicated for the treatment of hypertension.

Toote kokkuvõte:

Visual Identification: White to off-white, oval, biconvex, film coated tablets, debossed with IO4 on one side and plain on other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Volitamisolek:

Registered

Loa andmise kuupäev:

2022-05-19

Infovoldik

OLSETAN CMI v2
1
OLSETAN
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about taking this medicine, speak to your doctor or pharmacist.
1.
WHY AM I TAKING OLSETAN?
OLSETAN contains the active ingredient Olmesartan medoxomil. OLSETAN
is used to treat high blood pressure.
For more information, see Section 1. Why am I taking OLSETAN?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I TAKE OLSETAN?
Do not take if you have ever had an allergic reaction to OLSETAN or
any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I take
OLSETAN?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with OLSETAN and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines?
in the full CMI.
4.
HOW DO I TAKE OLSETAN?
•
For adult patients & children aged 6 – 18 years and weighing 35 Kg
or more; the usual dose is 20 mg once daily.
•
DO NOT GIVE OLSETAN TO CHILDREN UNDER 1 YEAR OF AGE.
More instructions can be found in Section 4. How do I take OLSETAN?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE TAKING OLSETAN?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are taking
OLSETAN.
•
TELL YOUR DOCTOR IMMEDIATELY, if you feel light-headed or dizzy after
taking your first dose of OLSETAN,
or when your dose is increased,
•
Make sure you drink enough water during exercise and hot weather when
you are taking OLSETAN.
THINGS YOU
SHOULD NOT DO
•
Do not stop taking this medicine suddenly.
•
Do not lower the dosage, without checking with your doctor.
DRIVING OR USING
MACHINES
•
OLSETAN may cause dizziness, light-headedness or tiredness in some
people.
•
Be careful before you drive or use any machines or tools until you
know how OLSETAN affects you.

Toote omadused

OLSETAN v1 05.22 inn 0121
Page 1 of 21
AUSTRALIAN PRODUCT
INFORMATION
OLSETAN
(OLMESARTAN
MEDOXOMIL)
TABLETS
1 NAME OF THE MEDICINE
Olmesartan medoxomil
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains either 10 mg, 20 mg or 40 mg of
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 to off-white, round, biconvex, film coated
tablets, debossed with
“IO2” on one side and plain on other side.
20 MG TABLET: White to off-white, round, biconvex, film coated
tablets, debossed with
“IO3” on one side and plain on other side.
40 MG TABLET: White to off-white, oval, biconvex, film coated tablets,
debossed with
“IO4” on one side and plain on other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
OLSETAN 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 OLSETAN is 20mg once
daily when used as monotherapy in patients who are not
volume-contracted. If additional blood
pressure reduction is required, the dose of OLSETAN may be increased
to a maximum of 40 mg daily.
OLSETAN may be administered with or without food. In order to assist
compliance, it is recommended
that OLSETAN 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.
Hydrochlorothiazide therapy should
be considered in those patients requiring additional blood pressure
control beyond 40 mg daily.
OLSETAN may be administered with other antihypertensive agents.
OLSETAN v1 05.22 inn 0121
Page 2 of 21
SPECIAL POPULATIONS
_ELDERLY_
No dosage