Jurnista

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Hydromorphone hydrochloride 64mg

Available from:

Janssen-Cilag (New Zealand) Ltd

INN (International Name):

Hydromorphone hydrochloride 64 mg

Dosage:

64 mg

Pharmaceutical form:

Modified release tablet

Composition:

Active: Hydromorphone hydrochloride 64mg Excipient: Butylated hydroxytoluene Cellulose acetate Hypromellose Iron oxide black Macrogol 3350 Magnesium stearate Opacode black NS-78-17821 Opadry blue Y-30-10701 Opadry Clear YS-1-19025-A Polyethylene oxide Povidone Sodium chloride

Units in package:

Blister pack, PVC/Aclar-aluminium., 7 tablets

Class:

Class B3 Controlled Drug

Prescription type:

Class B3 Controlled Drug

Manufactured by:

Janssen Pharmaceuticals Inc

Therapeutic indications:

JURNISTA is indicated in the treatment of moderate to severe chronic pain.

Product summary:

Package - Contents - Shelf Life: Blister pack, PVC/Aclar-aluminium. - 7 tablets - 2 years from date of manufacture stored at or below 25°C - Blister pack, PVC/Aclar-aluminium. - 10 tablets - 2 years from date of manufacture stored at or below 25°C - Blister pack, PVC/Aclar-aluminium. - 14 tablets - 2 years from date of manufacture stored at or below 25°C - Blister pack, PVC/Aclar-aluminium. - 20 tablets - 2 years from date of manufacture stored at or below 25°C - Blister pack, PVC/Aclar-aluminium. - 28 tablets - 2 years from date of manufacture stored at or below 25°C - Blister pack, PVC/Aclar-aluminium. - 30 tablets - 2 years from date of manufacture stored at or below 25°C - Blister pack, PVC/Aclar-aluminium. - 35 tablets - 2 years from date of manufacture stored at or below 25°C - Blister pack, PVC/Aclar-aluminium. - 40 tablets - 2 years from date of manufacture stored at or below 25°C - Blister pack, PVC/Aclar-aluminium. - 50 tablets - 2 years from date of manufacture stored at or below 25°C - Blister pack, PVC/Aclar-aluminium. - 60 tablets - 2 years from date of manufacture stored at or below 25°C - Blister pack, PVC/Aclar-aluminium. - 100 tablets - 2 years from date of manufacture stored at or below 25°C

Authorization date:

2009-04-15

Patient Information leaflet

1
JURNISTA (170223) ACI
JURNISTA
®
PROLONGED-RELEASE TABLET
_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 IS JURNISTA 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)

have pain resulting from very recent surgery or
sudden pain which is long lasting

have had surgery which may have left you with
‘blind loop’ in your intestine

have seriously impaired liver function

have serious breathing difficulties

have severe acute asthma

get sudden severe

Summary of Product characteristics

CCDS 161123
1
JURNISTA(170706)ADS
JURNISTA
®
PROLONGED-RELEASE TABLETS
DATA SHEET
1.
PRODUCT NAME
JURNISTA 4 mg modified-release tablets
JURNISTA 8 mg modified-release tablets
JURNISTA 16 mg modified-release tablets
JURNISTA 32 mg modified-release tablets
JURNISTA 64 mg modified-release tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
JURNISTA is available as prolonged-release tablets containing 4, 8,
16, 32 and 64 mg hydromorphone
hydrochloride.
Excipient(s) with known effect:
One tablet of 4 mg tablet contains 0.01 mg lactose
One tablet of 8 mg tablet contains 4.37 mg lactose
One tablet of 16 mg tablet contains 6.81 mg lactose
One tablet of 32 mg tablet contains 10.02 mg lactose
One tablet of 64 mg tablet contains 8.03 mg lactose
For a full list of excipients, see
SECTION 6.1
LIST OF EXCIPIENTS
.
3.
PHARMACEUTICAL FORM
Modified-release tablets
JURNISTA 4 mg tablets are pale beige, round, biconvex with ‘HM 4’
printed in black ink on one side.
JURNISTA 8 mg tablets are red, round, biconvex with ‘HM 8’ printed
in black ink on one side.
JURNISTA 16 mg tablets are yellow, round, biconvex with ‘HM 16’
printed in black ink on one side.
JURNISTA 32 mg tablets are white, round, biconvex with ‘HM 32’
printed in black ink on one side.
JURNISTA 64 mg tablets are blue, round, biconvex with ‘HM 64’
printed in black ink on one side.
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.