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

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

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

Available from:

ORGANON PHARMA PTY LTD

INN (International Name):

amlodipine besilate,Olmesartan medoxomil

Pharmaceutical form:

Tablet, film coated

Composition:

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

Administration route:

Oral

Units in package:

10 tablets, 30 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

SEVIKAR is indicated for the treatment of hypertension. Treatment should not be initiated with this fixed-dose combination.

Product summary:

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

Authorization status:

Licence status A

Authorization date:

2010-05-14

Patient Information leaflet

SEVIKAR
®
_Olmesartan medoxomil and amlodipine besilate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about SEVIKAR.
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 SEVIKAR
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 SEVIKAR IS
USED FOR
SEVIKAR 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 SEVIKAR WORKS_
SEVIKAR 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. SEVIKAR
blocks the action of angiotensin-II
and therefore relaxes your blood
vessels. This helps lower your blood
pressure.
SEVIKAR 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
SEVIKAR for another reason. Ask
your doctor if you have any questi

Summary of Product characteristics

SEVIKAR
Page 1 of 26
AUSTRALIAN PRODUCT INFORMATION
SEVIKAR
®
(OLMESARTAN MEDOXOMIL AND AMLODIPINE AS BESILATE)
TABLETS
1
NAME OF THE MEDICINE
Olmesartan medoxomil and amlodipine as besilate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
SEVIKAR 20/5 contains 20 mg of olmesartan medoxomil and amlodipine 5
mg as besilate.
SEVIKAR 20/10 contains 20 mg of olmesartan medoxomil and amlodipine 10
mg as besilate.
SEVIKAR 40/5 contains 40 mg of olmesartan medoxomil and amlodipine 5
mg as besilate.
SEVIKAR 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
SEVIKAR 20/5 is a round tablet, approximately 6 mm in diameter, white
in colour with C73
debossed on one side.
SEVIKAR 20/10 is a round tablet, approximately 8 mm in diameter,
greyish-orange in colour
with C74 debossed on one side. (Not currently available in Australia).
SEVIKAR 40/5 is a round tablet, approximately 8 mm in diameter, cream
in colour with C75
debossed on one side.
SEVIKAR 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
SEVIKAR 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
SEVIKAR is registered in four strengths: SEVIKAR 20/5 (olmesartan
medoxomil 20 mg and
amlodipine as besilate 5 mg); SEVIKAR 20/10 (olmesartan medoxomil 20
mg and amlodipine
as besilate 10 mg); SEVIKAR 40/5 (olmesartan medoxomil 40 mg and
amlodipine as besilate
5 mg); SEVIKAR 40/10 (olmesartan medoxomil 40 mg and amlodipine as
besilate 10 m