Sevikar

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Amlodipine besylate; Olmesartan medoxomil

Available from:

Merck Sharp & Dohme Australia Pty Ltd

Class:

Medicine Registered

Patient Information leaflet

SEVIKAR
®

_Olmesartan medoxomil and amlodipine besylate_
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
besylate, 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

Summary of Product characteristics

SEVIKAR PI V3 A111221 CCDS ref v3 301110

Page 1 
PRODUCT INFORMATION 
SEVIKAR
®

(olmesartan medoxomil and amlodipine as besylate) 
SEVIKAR 20/5   
SEVIKAR 20/10   
SEVIKAR 40/5   
SEVIKAR 40/10  
NAME OF THE MEDICINE 
OLMESARTAN MEDOXOMIL is chemically described as 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1-
methylethyl)-2-propyl-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 
2,3-carbonate.  The empirical formula is C
29
H
30
N
6
O
6
 and its molecular weight is 558.59.  Its 
CAS number is 144689-63-4.  Its structural formula is: 

AMLODIPINE BESYLATE is a racemic mixture
and is chemically described as 3-ethyl-5-methyl-2-
(2-aminoethoxymethyl)-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5- pyridinedicarboxylate 
benzene sulphonate.  The empirical formula is C
20
H
25
CIN
2
O
5
•C
6
H
6
O
3
S and its molecular 
weight is 567.1.  The CAS number is 111470-99-6 and
its structural formula is: 

DESCRIPTION 
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 BESYLATE is a white crystalline powder,
slightly soluble in water and sparingly 
soluble in ethanol. 
EXCIPIENTS: Microcrystalline cellulose, colloidal
anhydrous silica, pregelatinised maize 
starch, croscarmellose sodium, magnesium stearate,
polyvinyl alcohol, macrogol 3350, 
titanium dioxide, purified talc, iron oxide yellow (SEVIKAR 20/10,
SEVIKAR 40/5, 
SEVIKAR 40/10), iron oxide red (SEVIKAR 20/10, SEVIKAR 40/10),
and iron oxide black 
(SEVIKAR 20/10). 
SEVIKAR PI V3 A111221 CCDS ref v3 301110

Page 2 
PHARMACOLOGY 
PHARMACODYNAMIC PROPERTIES 
SEVIKAR is a combination of two
antihypertensive drugs: olmesartan medoxomil, an 
angiotensin receptor blocker and amlodipine besylate,
a dihydropyridine calcium channel 
blocker.  The combi