OLMEKAR 40/10 olmesartan medoxomil 40 mg / amlodipine (as besilate) 10 mg tablet blister pack

Nchi: Australia

Lugha: Kiingereza

Chanzo: Department of Health (Therapeutic Goods Administration)

Nunua Sasa

Shusha Taarifa za kipeperushi (PIL)
05-10-2021
Shusha Tabia za bidhaa (SPC)
05-10-2021

Viambatanisho vya kazi:

olmesartan medoxomil, Quantity: 40 mg; amlodipine besilate, Quantity: 13.87 mg (Equivalent: amlodipine, Qty 10 mg)

Inapatikana kutoka:

Arrotex Pharmaceuticals Pty Ltd

Dawa fomu:

Tablet, film coated

Tungo:

Excipient Ingredients: croscarmellose sodium; colloidal anhydrous silica; silicified microcrystalline cellulose; pregelatinised maize starch; magnesium stearate; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; polyvinyl alcohol; macrogol 3350

Njia ya uendeshaji:

Oral

Vitengo katika mfuko:

30 Tablets, 10 tablets

Dawa ya aina:

(S4) Prescription Only Medicine

Matibabu dalili:

It is indicated for the treatment of hypertension. Treatment should not be initiated with this fixed-dose combination (see Dosage and Administration).

Bidhaa muhtasari:

Visual Identification: Red (brownish red), round, biconvex, film-coated tablets debossed with L78 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

Idhini hali ya:

Registered

Idhini ya tarehe:

2018-06-13

Taarifa za kipeperushi

                                OLMEKAR
Olmesartan medoxomil and amlodipine besilate
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some
common questions about
OLMEKAR. 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 using
OLMEKAR against the benefits
it is expected to have for you.
IF YOU HAVE ANY CONCERNS
ABOUT USING THIS MEDICINE,
ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE. You may need to
read it again.
WHAT OLMEKAR IS
USED FOR
OLMEKAR 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 OLMEKAR WORKS _
OLMEKAR contains
Olmesartan medoxomil,
which 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. OLMEKAR
blocks the action of
angiotensin-II and therefore
relaxes your blood vessels.
This helps lower your blood
pressure.
OLMEKAR also contains
amlodipine besilate, a calcium
channel blocker. This reduces
the movement of calcium into
the cells of the heart and
blood vessels. This also helps
to lower blood pressure as it
relaxes the blood vessels and
increases the supply of blood
and oxygen to the heart.
Your doctor may have
prescribed OLMEKAR for
another reason. Ask your
doctor if you have any
questions about w
                                
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Tabia za bidhaa

                                AUSTRALIAN PRODUCT INFORMATION – OLMEKAR tablets
(Olmesartan medoxomil/ amlodipine besilate)
NAME OF THE MEDICINE
Olmesartan medoxomil and amlodipine besilate
QUALITATIVE AND QUANTITATIVE COMPOSITION
OLMEKAR 20/5 tablets contain 20 mg olmesartan medoxomil and 5 mg
amlodipine (as
besilate).
OLMEKAR 20/10 tablets contain 20 mg olmesartan medoxomil and 10 mg
amlodipine (as
besilate).
OLMEKAR 40/5 tablets contain 40 mg olmesartan medoxomil and 5 mg
amlodipine (as
besilate).
OLMEKAR 40/10 tablets contain 40 mg olmesartan medoxomil and 10 mg
amlodipine (as
besilate).
The tablets contain no excipients with a known effect. For the full
list of excipients, see
Section 6.1 List of excipients.
PHARMACEUTICAL FORM
OLMEKAR 20/5 - white, round, biconvex, film-coated tablets debossed
with “L75” on one
side and plain on other side.
OLMEKAR 20/10 - greyish-orange, round, biconvex, film-coated tablets
debossed with
“L76” on one side and plain on other side.
OLMEKAR 40/5 - light yellow, round, biconvex, film-coated tablets
debossed with “L77” on
one side and plain on other side.
OLMEKAR 40/10 - red (brownish red), round, biconvex, film-coated
tablets debossed with
“L78” on one side and plain on other side.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
OLMEKAR is indicated for the treatment of hypertension. Treatment
should not be initiated
with this fixed-dose combination (see 4.2 Dose and Method of
Administration).
4.2
DOSE AND METHOD OF ADMINISTRATION
OLMEKAR is registered in four strengths:
OLMEKAR 20/5 (olmesartan medoxomil 20 mg and amlodipine as besilate 5
mg);
OLMEKAR 20/10 (olmesartan medoxomil 20 mg and amlodipine as besilate
10 mg);
OLMEKAR 40/5 (olmesartan medoxomil 40 mg and amlodipine as besilate 5
mg);
OLMEKAR 40/10 (olmesartan medoxomil 40 mg and amlodipine as besilate
10 mg).
USUAL ADULT DOSE
The recommended dosage of OLMEKAR is one tablet daily, with or without
food. Treatment
should not be initiated with this combination.
REPLACEMENT THERAPY
For convenience, patients receiving olmesartan medox
                                
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