TEMGESIC buprenorphine 200 microgram (as hydrochloride) sublingual tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

buprenorphine hydrochloride, Quantity: 0.216 mg

Available from:

Echo Therapeutics Pty Ltd

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: lactose monohydrate; mannitol; maize starch; povidone; magnesium stearate; citric acid; sodium citrate dihydrate

Administration route:

Sublingual

Units in package:

20, 50

Prescription type:

(S8) Controlled Drug

Therapeutic indications:

TEMGESIC sublingual tablets are indicated for the short-term (not more than one week) management of severe pain for which other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain. TEMGESIC is not recommended for use in children. TEMGESIC does not have an approved role in opioid dependence rehabilitation programmes.

Product summary:

Visual Identification: White, circular, biconvex tablet, debossed on one side with "L".; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 9 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

1992-07-22

Patient Information leaflet

TEMGESIC SUBLINGUAL
TABLETS
_Buprenorphine (as hydrochloride)_
CONSUMER MEDICINE INFORMATION
WARNINGS
Limitations of use
TEMGESIC should only be used when your doctor decides that other
treatment options are not able to effectively manage
your pain or you cannot tolerate them.
Hazardous and harmful use
TEMGESIC poses risks of abuse, misuse and addiction which can lead to
overdose and death. Your doctor will monitor you
regularly during treatment.
Life threatening respiratory depression
TEMGESIC can cause life-threatening or fatal breathing problems (slow,
shallow, unusual or no breathing) even when used
as recommended. These problems can occur at any time during use, but
the risk is higher when first starting TEMGESIC and
after a dose increase, if you are older, or have an existing problem
with your lungs. Your doctor will monitor you and change
the dose as appropriate.
Use of other medicines while using TEMGESIC
Using TEMGESIC with other medicines that make you feel drowsy such as
sleeping tablets (e.g. benzodiazepines), other
pain relievers, antihistamines, antidepressants, antipsychotics,
gabapentinoids (e.g. gabapentin and pregabalin), cannabis and
alcohol may result in severe drowsiness, decreased awareness,
breathing problems, coma and death. Your doctor will mini-
mise the dose and duration of use; and monitor you for signs and
symptoms of breathing difficulties and sedation. You must
not drink alcohol while using TEMGESIC.
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about TEMGESIC. 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 TEMGESIC
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING TEMGESIC, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT TEMGESIC IS
USED FOR
TEMGESIC is a "pain killer". It is
used for the short term relief o

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
TEMGESIC
® (BUPRENORPHINE)
1
NAME OF THE MEDICINE
TEMGESIC INJECTION and TEMGESIC SUBLINGUAL TABLETS contain
buprenorphine (as
hydrochloride).
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1mL of TEMGESIC Injection contains 300 micrograms of
buprenorphine (as hydrochloride).
Each TEMGESIC Sublingual Tablet contains 200 micrograms of
buprenorphine (as hydrochloride)
Excipients with known effect:
TEMGESIC Injection contains glucose.
TEMGESIC Sublingual Tablets contain lactose monohydrate and mannitol.
Chemically,
buprenorphine
is
21-Cyclopropyl-7

-

(S)–1-hydroxy-1,2,2-trimethylpropyl

-6,14-
endo–ethano-6,7,8,14-tetrahydrooripavine hydrochloride.
Buprenorphine hydrochloride has the
molecular formula C
29
H
41
NO
4
HCl and the molecular weight is 504.09.
Buprenorphine hydrochloride is a white powder, weakly acidic with
limited solubility in water
(19.5 mg/mL at 37

C, pH 4.1).
For the full list of excipients, see section 6.1.
WARNINGS
_LIMITATIONS OF USE _
Because of the risks associated with the use of opioids, TEMGESIC
should only be used in patients
for whom other treatment options, including non-opioid analgesics, are
ineffective, not tolerated or
otherwise inadequate to provide appropriate management of pain_ (see
section 4.4 Special Warnings _
_and Precautions for Use)._
_HAZARDOUS AND HARMFUL USE _
TEMGESIC poses risks of hazardous and harmful use which can lead to
overdose and death. Assess
the patient’s risk of hazardous and harmful use before prescribing
and monitor the patient
regularly during treatment (_see section 4.4. Special Warnings and
Precautions for Use)_.
_LIFE THREATENING RESPIRATORY DEPRESSION _
Serious, life-threatening or fatal respiratory depression may occur
with the use of TEMGESIC. Be
aware of situations which increase the risk of respiratory depression,
modify dosing in patients at
risk and monitor patients closely, especially on initiation or
following a dose increase _(see section _
_4.4 Special Warnings and Precautions for Use)_