ASPEN METHADONE SYRUP 25mg/5mL oral liquid

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

methadone hydrochloride, Quantity: 5 mg/mL

Available from:

Aspen Pharma Pty Ltd

Pharmaceutical form:

Oral Liquid, solution

Composition:

Excipient Ingredients: glycerol; sodium benzoate; purified water; sorbitol solution (70 per cent) (non-crystallising); ethanol; sunset yellow FCF; Flavour

Administration route:

Oral

Units in package:

1000mL, 200mL

Prescription type:

(S8) Controlled Drug

Therapeutic indications:

Methadone Syrup is indicated for the treatment of dependence on opioid drugs.,Methadone Syrup is indicated for the management of severe pain where: (i) other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain, and (ii) the pain is opioid-responsive, and (iii) requires daily, continuous, long-term treatment.,Methadone Syrup is not indicated for use in chronic non-cancer pain other than in exceptional circumstances.,Methadone Syrup is not indicated as an as-needed (PRN) analgesia.,Methadone Syrup is not recommended for use in ambulant patients.

Product summary:

Visual Identification: Bright amber coloured syrup, aromatic odour.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

1994-06-22

Patient Information leaflet

ASPEN METHADONE SYRUP- Consumer Medicine Information
Page 1 of 6
ASPEN METHADONE SYRUP
METHADONE HYDROCHLORIDE
_CONSUMER MEDICINE INFORMATION (CMI) _
WARNING
LIMITATIONS OF USE
ASPEN METHADONE SYRUP 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
ASPEN METHADONE SYRUP poses risks of abuse, misuse and addiction which
can lead to overdose and death. Your doctor will monitor your
regularly
during treatment.
LIFE THREATENING RESPIRATORY DEPRESSION
ASPEN METHADONE SYRUP 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 ASPEN METHADONE SYRUP 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 ASPEN METHADONE SYRUP
USING ASPEN METHADONE SYRUP WITH OTHER MEDICINES THAT CAN 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 minimise 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 ASPEN METHADONE SYRUP.
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions
about ASPEN METHADONE SYRUP. It does
not contain all of 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 this
medicine against the benefits they expect it will
have for you.
ASK YOUR DOCTOR OR PHARMACIST IF YOU HAVE
ANY CONCERNS ABOUT TAKING T

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
ASPEN METHADONE SYRUP (METHADONE HYDROCHLORIDE)
ORAL LIQUID
WARNINGS
_LIMITATIONS OF USE _
Because of the risks associated with the use of opioids, ASPEN
METHADONE SYRUP 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 _
ASPEN METHADONE SYRUP 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 ASPEN
METHADONE SYRUP. 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).
_CONCOMITANT USE OF BENZODIAZEPINES AND OTHER CENTRAL NERVOUS SYSTEM
(CNS) _
_DEPRESSANTS, INCLUDING ALCOHOL _
Concomitant use of opioids with benzodiazepines, gabapentinoids,
antihistamines, tricyclic
antidepressants, antipsychotics, cannabis or other central nervous
system (CNS) depressants,
including alcohol, may result in profound sedation, respiratory
depression, coma, and death.
Limit dosages and durations to the minimum required; and monitor
patients for signs and
symptoms of respiratory depression and sedation. Caution patients not
to drink alcohol while
taking ASPEN METHADONE SYRUP.
1
NAME OF THE MEDICINE
Methadone hydrochloride.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
ASPEN METHADONE SYRUP is an oral solution of 5 mg/mL methadone
hydrochloride.
List of excipients with known effect: sodium benzoate, ethanol and
sorbitol solution (70%)
(non-cryst