Olmetec

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Olmesartan medoxomil

Available from:

Merck Sharp & Dohme Australia Pty Ltd

Class:

Medicine Registered

Patient Information leaflet

OLMETEC
®

_Olmesartan medoxomil_
CONSUMER MEDICINE INFORMATION

WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about OLMETEC.
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 OLMETEC
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
OLMETEC TABLETS OR SUSPENSION.
You may need to read it again.
WHAT OLMETEC IS
USED FOR
OLMETEC 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 OLMETEC WORKS_
 OLMETEC 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. OLMETEC blocks the action
of angiotensin-II and therefore
relaxes your blood vessels. This
helps lower your blood pressure.
 Your doctor may have prescribed
OLMETEC for another reason. Ask
your doctor if you have any questions
about why OLMETEC has been
prescribed for you.
 OLMETEC is not addictive.
 This medicine is available only with
a doctor's prescription.
BEFORE YOU TAKE
OLMETEC
_WHEN YOU MUST NOT TAKE IT_
 DO NOT TAKE OLMETEC IF:
•
YOU HAVE AN ALLERGY TO
OLMETEC OR ANY OF THE
INGREDIENTS LISTED AT THE END OF

Summary of Product characteristics

Olmetec PI v8 A130621 CCDS
ref v6 101130 LRN S-000000-OLM-TB-PIPB.1 
Page 1 
APPROVED PRODUCT INFORMATION 
OLMETEC


(olmesartan medoxomil) 
NAME OF THE MEDICINE 
OLMETEC (olmesartan medoxomil), a prodrug, is hydrolyzed to
olmesartan during 
absorption from the gastrointestinal tract.  Olmesartan is a selective
AT
1
 subtype angiotensin 
II receptor antagonist.  
Olmesartan medoxomil (CAS no. 144689-63-4) is described chemically 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. 
Its empirical formula is C
29
H
30
N
6
O
6
 and its structural formula is: 
DESCRIPTION 
Olmesartan medoxomil is a white to light yellowish-white
powder or crystalline powder with a 
molecular weight of 558.59.  It is practically insoluble
in water and sparingly soluble in 
methanol. OLMETEC is available
for oral use as film-coated tablets containing 10 mg, 20 mg, 
or 40 mg
olmesartan medoxomil.  OLMETEC tablets also contain the following inactive 
ingredients: microcrystalline cellulose, low-substituted hydroxypropylcellulose, lactose, 
hydroxypropylcellulose, magnesium stearate, and
Opadry OY-S-38956 that contains titanium 
dioxide, talc, and hydroxypropylmethylcellulose. 
OLMETEC extemporaneous suspension contains additional inactive
ingredients: purified 
water, Ora-Sweet
® 
(syrup vehicle) and Ora-Plus
®
 (suspending vehicle).  Ora-Sweet
® 
contains 
citric acid, flavouring, glycerine, methylparaben, potassium sorbate, sodium phosphate, 
sorbitol, sucrose, and purified water.  Ora-Plus
® 
contains calcium sulphate, carrageenan, 
citric acid, dimethicone
antifoam emulsion, methylparaben, microcrystalline cellulose, sodium 
carboxymethylcellulose, potassium sorbate, sodium phosphate monobasic, trisodium 
phosphate, xanthan gum, and purified wat