OLMERTAN olmesartan medoxomil 40 mg tablet blister pack

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

olmesartan medoxomil, Quantity: 40 mg

Tilgjengelig fra:

Pharmacor Pty Ltd

INN (International Name):

Olmesartan medoxomil

Legemiddelform:

Tablet

Sammensetning:

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

Administreringsrute:

Oral

Enheter i pakken:

30

Resept typen:

(S4) Prescription Only Medicine

Indikasjoner:

Olmesartan medoxomil is indicated for the treatment of hypertension.

Produkt oppsummering:

Visual Identification: White to off white coloured, oval shape film coated tablets debossed with OLM on one side & 40 on other side; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Autorisasjon status:

Licence status A

Autorisasjon dato:

2016-02-25

Informasjon til brukeren

OLMERTAN
Ver 04
1
OLMERTAN TABLETS
_Olmesartan medoxomil_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about OLMERTAN.
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 OLMERTAN 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
OLMERTAN TABLETS.
You may need to read it again.
WHAT OLMERTAN IS USED
FOR
OLMERTAN 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 OLMERTAN WORKS_
OLMERTAN 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.
OLMERTAN blocks the action of
angiotensin-II and therefore relaxes
your blood vessels. This helps lower
your blood pressure.
Your doctor may have prescribed
OLMERTAN for another reason. Ask
your doctor if you have any questions
about why OLMERTAN has been
prescribed for you.
OLMERTAN is not addictive.
This medicine is available only with a
doctor's prescription.
BEFORE YOU TAKE
OLMERTAN
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE OLMERTAN IF:
•
YOU HAVE SERIOUS PROBLEMS WITH
YOUR KIDNEYS
•
YOU HAVE SERIOUS PROBLEMS WITH
YOU

Preparatomtale

Version: 04
1
AUSTRALIAN
PRODUCT
INFORMATION
–
OLMERTAN
(OLMESARTAN
MEDOXOMIL)
1.
NAME OF THE MEDICINE
Olmesartan Medoxomil
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
OLMERTAN is available in 2 strengths for oral administration
containing 20 mg and 40 mg
Olmesartan Medoxomil.
OLMERTAN 20 mg: Each film coated tablet contains olmesartan medoxomil
20 mg.
OLMERTAN 40 mg: Each film coated tablet contains olmesartan medoxomil
40 mg.
EXCIPIENTS WITH KNOWN EFFECT
Lactose monohydrate
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Film coated tablets
OLMERTAN 20 mg:
White to off white coloured, round shape film coated tablets debossed
with OLM on one side &
20 on other side.
OLMERTAN 40 mg: White to off white coloured, oval shape film coated
tablets debossed with
OLM on one side & 40 on other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Olmesartan medoxomil is indicated for the treatment of hypertension.
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSAGE
NOTE: A 10mg tablet is not available in this brand, therefore if
olmesartan 10mg tablets are
required, please use an alternative brand.
NOTE: ‘For children who cannot swallow tablets, the equivalent dose
may be given as an
extemporaneous suspension. This brand of product has not been approved
for use as an
extemporaneous
suspension.
An
alternative
brand
approved
for
use
to
compound
an
extemporaneous suspension is to be used if treatment is required in
the suspension form.’
Version: 04
2
ADULTS
Dosage must be individualised. The optimal recommended starting dose
of OLMERTAN 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 OLMERTAN
may be increased to a
maximum of 40 mg daily.
METHOD OF ADMINISTRATION
Tablets for oral administration.
OLMERTAN may be administered with or without food. In order to assist
compliance, it is
recommended that OLMERTAN tablets be taken at about the same time each
day. Twice- daily
dosing o