APO-TRAMADOL/PARACETAMOL 37.5/325 tramadol hydrochloride/paracetamol 37.5 mg/325 mg film-coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

tramadol hydrochloride, Quantity: 37.5 mg; paracetamol, Quantity: 325 mg

Available from:

Arrotex Pharmaceuticals Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: microcrystalline cellulose; stearic acid; hyprolose; croscarmellose sodium; titanium dioxide; iron oxide yellow; macrogol 8000; hypromellose; povidone; pregelatinised maize starch

Administration route:

Oral

Units in package:

6, 8, 10 Tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Tramadol/paracetamol is 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: Yellow, capsule shaped, biconvex, film-coated tablet. Engraved APO on one side and 37.5 - 325 on the other.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2018-02-22

Patient Information leaflet

APO-TRAMADOL/PARACETAMOL 37.5/325 TABLETS
1
APO-
TRAMADOL/PARACETAMOL
37.5/325 TABLETS
_Tramadol hydrochloride and paracetamol _
CONSUMER MEDICINE INFORMATION
WARNINGS
LIMITATIONS OF USE
Tramadol/Paracetamol tablets 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
Tramadol/Paracetamol tablets 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
Tramadol/Paracetamol tablets 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 Tramadol/Paracetamol tablets 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 TRAMADOL/PARACETAMOL TABLETS
Using Tramadol/Paracetamol tablets 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
Tramadol/Paracetamol tablets.
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 _
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about this medicine. 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 using this medicine
against the benefits

Summary of Product characteristics

1
AUSTRALI AN PRODUCT INFORMATION – APO-
TRAMADOL/PARACETAMOL 37.5/325 (TRAMADOL
HYDROCHLORIDE, PARACETAMOL) TABLETS
WARNINGS
LIMITATIONS OF USE
Because of the risks associated with the use of opioids,
tramadol/paracetamol tablets
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
Tramadol/paracetamol tablets 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
tramadol/paracetamol tablets. 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 tramadol/paracetamol tablets.
1
NAME OF THE MEDICINE
Tramadol hydrochloride and paracetamol.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 37.5 mg tramadol hydrochloride and
325 mg paracetamol,
as the active ingredients.
LIST OF EX