PHARMACOR OLMESARTAN 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:

Pharmacor Pty Ltd

INN (International Name):

Olmesartan medoxomil

Pharmaceutical form:

Tablet

Composition:

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

Administration route:

Oral

Units in package:

30

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Olmesartan medoxomil is indicated for the treatment of hypertension.

Product summary:

Visual Identification: White to off white coloured, round shape film coated tablets debossed with OLM on one side & 20 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

Authorization status:

Licence status A

Authorization date:

2016-02-25

Patient Information leaflet

PHARMACOR OLMESARTAN
Ver 03
1
PHARMACOR OLMESARTAN TABLETS
_Olmesartan medoxomil_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THE LEAFLET
This leaflet answers some common
questions about PHARMACOR
OLMESARTAN.
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 PHARMACOR
OLMESARTAN 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
PHARMACOR OLMESARTAN
TABLETS.
You may need to read it again.
WHAT PHARMACOR
OLMESARTAN IS USED FOR
PHARMACOR OLMESARTAN 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 PHARMACOR _
_OLMESARTAN WORKS_
PHARMACOR OLMESARTAN
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. PHARMACOR
OLMESARTAN blocks the action of
angiotensin-II and therefore relaxes
your blood vessels. This helps lower
your blood pressure.
Your doctor may have prescribed
PHARMACOR OLMESARTAN for
another reason. Ask your doctor if you
have any questions about why
PHARMACOR OLMESARTAN has
been prescribed for you.
PHARMACOR OLMESARTAN is
not addictive.
This medicine is available only with a
doctor's prescription.
BEFORE

Summary of Product characteristics

Version: 03
1
AUSTRALIAN
PRODUCT
INFORMATION
–
PHARMACOR
OLMESARTAN
(OLMESARTAN MEDOXOMIL)
1.
NAME OF THE MEDICINE
Olmesartan Medoxomil
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
PHARMACOR OLMESARTAN is available in 2 strengths for oral
administration containing 20
mg and 40 mg Olmesartan Medoxomil.
PHARMACOR OLMESARTAN 20 mg: Each film coated tablet contains
olmesartan medoxomil 20
mg.
PHARMACOR OLMESARTAN 40 mg: Each film coated tablet contains
olmesartan medoxomil 40
mg.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Film coated tablets
PHARMACOR OLMESARTAN 20 mg:
White to off white coloured, round shape film coated tablets debossed
with OLM on one side &
20 on other side.
PHARMACOR OLMESARTAN 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: 03
2
ADULTS
Dosage must be individualised. The optimal recommended starting dose
of PHARMACOR
OLMESARTAN 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 PHARMACOR
OLMESARTAN may be increased to a maximum of 40 mg daily.
METHOD OF ADMINISTRATION
Tablets for oral administration.
PHARMACOR OLMESARTAN may be administered with or without food. In
order to assist
compliance, it is recommended that PHARMACOR OLMESARTAN