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JURNISTA
®
1
JURNISTA
®
_Hydromorphone hydrochloride _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about JURNISTA
prolonged-release tablets. 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 JURNISTA
against the benefits this medicine is
expected to have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING JURNISTA, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE. You may need to read it
again.
WHAT JURNISTA IS
TAKEN FOR
JURNISTA is taken to relieve
moderate to severe pain, which
requires strong painkillers.
JURNISTA is only for patients with
chronic, around the clock pain that is
moderate to severe and expected to
be long lasting. JURNISTA should
not usually be the first medicine
prescribed for your pain.
JURNISTA prolonged-release tablets
contain a medicine called
hydromorphone hydrochloride. This
strong pain reliever belongs to a
group of medicines known as opioid
analgesics. Hydromorphone
hydrochloride relieves pain by
blocking the nerves that recognise
pain messages from the body._ _
Your doctor may have prescribed
JURNISTA for another reason. Ask
your doctor if you have any questions
about why this medicine has been
prescribed for you.
BEFORE YOU TAKE
JURNISTA
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE JURNISTA IF YOU:
• have an allergy to
hydromorphone
hydrochloride or any of the
ingredients. See PRODUCT
DESCRIPTION at the end of
this leaflet for a list of
ingredients.
• have been diagnosed with
serious narrowing of the
stomach and/or intestine
(bowel)
• ha
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제품 특성 요약
JURNISTA
®
PROLONGED-RELEASE TABLETS
PRODUCT INFORMATION
NAME OF THE MEDICINE
Hydromorphone hydrochloride
DESCRIPTION
Hydromorphone hydrochloride has four asymmetric carbon atoms (C
5
, C
9
, C
13
and C
14
), with a
specific rotation (20°C, 589 nm) of –136.5° to –138.5°.
No cis-trans isomerism or threo-erythro
isomerism was detected. No other isomers are known.
Hydromorphone hydrochloride
has the following structural formula:
4,5
α-epoxy-3-hydroxy-17-methyl-morphinan-6-one hydrochloride
CAS: 71-68-1
C
17
H
19
NO
3
.HCl
MW: 321.8
Hydromorphone hydrochloride is freely soluble
in water, very slightly soluble in ethanol and
practically insoluble in methylene chloride.
JURNISTA tablets have been formulated using the OROS
®
osmotic pump (push-pull) bilayer
tablet with a semi-permeable cellulose acetate
coating that controls the rate at which water is
absorbed into the tablet after it has been swallowed.
A laser-drilled hole on the drug side of
the tablet allows the dissolved/suspended drug to be released
from the tablet at a controlled
rate as it passes through the gastrointestinal tract.
The JURNISTA tablet is non-deformable and
does not appreciably change in shape in the GI
tract; patients should be advised not to be alarmed
if they notice what appears to be the
JURNISTA tablet in their stools, as it is simply the
non-dissolvable shell.
JURNISTA is available as prolonged-release
tablets containing 4, 8, 16, 32 and 64 mg
hydromorphone hydrochloride.
JURNISTA tablets contain the inactive ingredients:
CCDS Dec12
2
jcpjurni10313
_Coated tablet core:_ polyethylene
oxide, povidone, magnesium stearate, butylated
hydroxytoluene (E321), polyethylene
oxide, sodium chloride, hypromellose, iron oxide black
(E172), lactose anhydrous, cellulose acetate, macrogo
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