SEVIKAR HCT 40/5/25 olmesartan medoxomil 40 mg amlodipine (as besilate) 5 mg and hydrochlorothiazide 25 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

olmesartan medoxomil, Quantity: 40 mg; hydrochlorothiazide, Quantity: 25 mg; amlodipine besilate, Quantity: 6.944 mg (Equivalent: amlodipine, Qty mg)

Available from:

ORGANON PHARMA PTY LTD

INN (International Name):

amlodipine besilate,Hydrochlorothiazide,Olmesartan medoxomil

Pharmaceutical form:

Tablet

Composition:

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

Administration route:

Oral

Units in package:

30, 10

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

SEVIKAR HCT is indicated for the treatment of hypertension, either as replacement for olmesartan medoxomil, amlodipine and hydrochlorothiazide being already taken as separate tablets or as add-on therapy where a patient's blood pressure is not controlled on a dual combination (see DOSAGE AND ADMINISTRATION). This fixed dose combination is not indicated for initial therapy

Product summary:

Visual Identification: It is an oval film-coated tablet, approximately 15 x 7 mm, light yellow in colour with C54 debossed on one side; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 36 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:

2013-09-20

Patient Information leaflet

SEVIKAR
® HCT
_Olmesartan medoxomil, amlodipine (as besilate) and
hydrochlorothiazide_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about SEVIKAR HCT. 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
HCT against the benefits they expect
it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT SEVIKAR HCT IS
USED FOR
SEVIKAR HCT 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 HCT WORKS_
SEVIKAR HCT 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
HCT blocks the action of
angiotensin-II and therefore relaxes
your blood vessels. This helps lower
your blood pressure.
SEVIKAR HCT 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.
SEVIKAR HCT also contains
hydrochloroth

Summary of Product characteristics

SEVIKAR HCT
Page 1 of 36
AUSTRALIAN PRODUCT INFORMATION
SEVIKAR
® HCT
(OLMESARTAN MEDOXOMIL/AMLODIPINE (AS BESILATE) AND
HYDROCHLOROTHIAZIDE)
TABLETS
1
NAME OF THE MEDICINE
Olmesartan medoxomil, amlodipine (as besilate) and
hydrochlorothiazide.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
OLMESARTAN MEDOXOMIL is a white or almost white crystalline powder. It
is practically insoluble
in water and slightly soluble in ethanol (96 per cent), practically
insoluble in heptane. The pH
of a solution (2% w/v) of olmesartan medoxomil in water is 5.6. The
dissociation constant
(pKa) is 4.3. The partition coefficient Log P is 1.0 at pH 7.0.
AMLODIPINE BESILATE is a white or almost white powder, slightly
soluble in water and freely
soluble in methanol, sparingly soluble in anhydrous ethanol, slightly
soluble in 2-propanol. The
pH of solution (1.0% w/v) of amlodipine besilate is in the pH range of
5.0-7.0. The dissociation
constant (pKa) is 8.6.
HYDROCHLOROTHIAZIDE is a white, or almost white, crystalline powder.
Hydrochlorothiazide is
very slightly soluble in water, soluble in acetone, sparingly soluble
in alcohol. It dissolves in
dilute solutions of alkali hydroxides.
SEVIKAR HCT 20/5/12.5 MG contains 20 mg olmesartan medoxomil, 5 mg
amlodipine as
besilate and 12.5 mg hydrochlorothiazide.
SEVIKAR HCT 40/5/12.5 MG contains 40 mg of olmesartan medoxomil, 5 mg
amlodipine as
besilate and 12.5 mg hydrochlorothiazide.
SEVIKAR HCT 40/5/25 MG contains 40 mg of olmesartan medoxomil, 5 mg
amlodipine as
besilate and 25 mg hydrochlorothiazide.
SEVIKAR HCT 40/10/12.5 MG contains 40 mg of olmesartan medoxomil, 10
mg amlodipine
as besilate and 12.5 mg hydrochlorothiazide.
SEVIKAR HCT 40/10/25 MG contains 40 mg of olmesartan medoxomil, 10 mg
amlodipine as
besilate and 25 mg hydrochlorothiazide.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
SEVIKAR HCT 20/5/12.5 MG is a round film-coated tablet, approximately
8 mm in diameter,
orange white in colour with C51 debossed on one side.
SEVIKAR HCT 40/5/1