OLMESARTAN/ AMLODIPINE

Χώρα: Αυστραλία

Γλώσσα: Αγγλικά

Πηγή: Department of Health (Therapeutic Goods Administration)

Δραστική ουσία:

olmesartan medoxomil, Quantity: 40 mg; amlodipine besilate, Quantity: 13.888 mg (Equivalent: amlodipine, Qty 10 mg)

Διαθέσιμο από:

ORGANON PHARMA PTY LTD

INN (Διεθνής Όνομα):

amlodipine besilate,Olmesartan medoxomil

Φαρμακοτεχνική μορφή:

Tablet, film coated

Σύνθεση:

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

Οδός χορήγησης:

Oral

Μονάδες σε πακέτο:

30 Tablets, 10 tablets

Τρόπος διάθεσης:

(S4) Prescription Only Medicine

Θεραπευτικές ενδείξεις:

OLMESARTAN/ AMLODIPINE-MYL is indicated for the treatment of hypertension. Treatment should not be initiated with this fixed-dose combination.

Περίληψη προϊόντος:

Visual Identification: Round, brownish red, film-coated tablet, debossed "C77" on one side.; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Καθεστώς αδειοδότησης:

Licence status A

Ημερομηνία της άδειας:

2016-06-08

Φύλλο οδηγιών χρήσης

OLMESARTAN/
AMLODIPINE - MYL
_Olmesartan medoxomil and amlodipine besilate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about OLMESARTAN/
AMLODIPINE - MYL.
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
OLMESARTAN/ AMLODIPINE -
MYL 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 TABLETS.
You may need to read it again.
WHAT OLMESARTAN/
AMLODIPINE - MYL IS
USED FOR
OLMESARTAN/ AMLODIPINE -
MYL 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 OLMESARTAN/_
_AMLODIPINE - MYL WORKS_
OLMESARTAN/ AMLODIPINE -
MYL 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.
OLMESARTAN/ AMLODIPINE -
MYL blocks the action of
angiotensin-II and therefore relaxes
your blood vessels. This helps lower
your blood pressure.
OLMESARTAN/ AMLODIPINE -
MYL 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 a

Αρχείο Π.Χ.Π.

OLMESARTAN/ AMLODIPINE - MYL
Page 1 of 26
AUSTRALIAN PRODUCT INFORMATION
OLMESARTAN/ AMLODIPINE - MYL
(OLMESARTAN MEDOXOMIL AND AMLODIPINE AS BESILATE)
TABLETS
1
NAME OF THE MEDICINE
Olmesartan medoxomil and amlodipine as besilate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
OLMESARTAN/ AMLODIPINE - MYL 20/5 contains 20 mg of olmesartan
medoxomil and
amlodipine 5 mg as besilate.
OLMESARTAN/ AMLODIPINE - MYL 40/5 contains 40 mg of olmesartan
medoxomil and
amlodipine 5 mg as besilate.
OLMESARTAN/ AMLODIPINE - MYL 40/10 contains 40 mg of olmesartan
medoxomil and
amlodipine 10 mg as besilate.
OLMESARTAN MEDOXOMIL is a white to light yellowish-white powder or
crystalline powder. It is
practically insoluble in water and sparingly soluble in methanol.
AMLODIPINE BESILATE is a white crystalline powder, slightly soluble in
water and sparingly
soluble in ethanol.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
OLMESARTAN/ AMLODIPINE - MYL 20/5 is a round tablet, approximately 6
mm in diameter,
white in colour with C73 debossed on one side.
OLMESARTAN/ AMLODIPINE - MYL 40/5 is a round tablet, approximately 8
mm in diameter,
cream in colour with C75 debossed on one side.
OLMESARTAN/ AMLODIPINE - MYL 40/10 is a round tablet, approximately 8
mm in
diameter, brownish red in colour with C77 debossed on one side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
OLMESARTAN/ AMLODIPINE - MYL is indicated for the treatment of
hypertension. Treatment
should not be initiated with this fixed-dose combination (see SECTION
4.2 DOSE AND METHOD
OF ADMINISTRATION).
4.2
DOSE AND METHOD OF ADMINISTRATION
OLMESARTAN/ AMLODIPINE - MYL is registered in three strengths:
OLMESARTAN/
AMLODIPINE - MYL 20/5 (olmesartan medoxomil 20 mg and amlodipine as
besilate 5 mg);
OLMESARTAN/ AMLODIPINE - MYL 40/5 (olmesartan medoxomil 40 mg and
amlodipine as
besilate 5 mg); OLMESARTAN/ AMLODIPINE - MYL 40/10 (olmesartan
medoxomil 40 mg
and amlodipine as besilate 10 mg). (See SECTION 6.5 NATURE AND
CONTENTS OF CONTAINER