TRAMAL ORAL DROPS tramadol hydrochloride 100mg/mL oral liquid bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

tramadol hydrochloride, Quantity: 100 mg/mL

Available from:

Seqirus Pty Ltd

Pharmaceutical form:

Oral Liquid, solution

Composition:

Excipient Ingredients: sucrose; propylene glycol; sodium cyclamate; saccharin sodium; purified water; glycerol; ethoxylated hydrogenated castor oil; mint oil dementholised; potassium sorbate; Flavour

Administration route:

Oral

Units in package:

10mL with dropper

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Tramal oral drops are indicated for the short-term 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.

Product summary:

Visual Identification: Clear, slightly viscous liquid. Free from visible impurities. Colourless to weakly yellow (not exceeding Colour Reference Solution B9 of Ph.Eur.); Container Type: Bottle; Container Material: Glass Type III Coloured; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

2005-04-04

Patient Information leaflet

Tramal
®
oral drops
1
TRAMAL
 ORAL DROPS
Tramadol hydrochloride: 100 mg is contained in each mL of the solution
CONSUMER MEDICINE INFORMATION
WARNING
LIMITATIONS OF USE
TRAMAL
®
oral drops 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
TRAMAL
®
oral drops 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
TRAMAL
®
oral drops 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 TRAMAL
®
oral drops 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 TRAMAL
® ORAL DROPS
USING TRAMAL
® ORAL DROPS 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 TRAMAL
®
oral drops.
WHAT IS IN THIS
LEAFLET?
This leaflet answers some
common questions about
Tramal
®
oral drops. 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
this medicine against the
benefits it is expected to have
for you.
IF YOU HAVE ANY CONCERNS
ABOUT TAKING THIS MEDICINE,
ASK YOUR DOCTOR OR
PHARMACIST.
K

Summary of Product characteristics

Page 1 of 31
AUSTRALIAN PRODUCT INFORMATION – TRAMAL [TRAMADOL
HYDROCHLORIDE]
WARNINGS
LIMITATIONS OF USE
Because of the risks associated with the use of opioids, Tramal
®
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
_ _
Tramal
®
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 Tramal
®
.
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 Tramal
®
.
Page 2 of 31
1
NAME OF THE MEDICINE
Tramadol hydrochloride.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Tramal

(tramadol hydrochloride) immediate release capsules 50 mg
Tramal

(tramadol hydrochloride) solution for injection 50 mg/mL, 100 mg/2 mL
Tramal

SR (tramadol hydrochloride) sustained release tablets 50 mg,