TRAMAL tramadol hydrochloride 50mg capsule blister pack

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

tramadol hydrochloride, Quantity: 50 mg

Tilgjengelig fra:

Seqirus Pty Ltd

Legemiddelform:

Capsule, hard

Sammensetning:

Excipient Ingredients: colloidal anhydrous silica; magnesium stearate; microcrystalline cellulose; sodium starch glycollate; Gelatin; titanium dioxide; iron oxide yellow; sodium lauryl sulfate

Administreringsrute:

Oral

Enheter i pakken:

20 x 50mg, 6x50 mg, 10 x 50mg, 50 x 50mg, 30 x 50mg

Resept typen:

(S4) Prescription Only Medicine

Indikasjoner:

Tramal capsules 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.

Produkt oppsummering:

Visual Identification: oblong, yellow/yellow, size 4 hard gelatin capsule; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Autorisasjon status:

Registered

Autorisasjon dato:

1998-05-18

Informasjon til brukeren

TRAMAL
®
Capsules & Injection CMI
TRAMAL
®
_ _
TRAMADOL HYDROCHLORIDE
CAPSULES AND INJECTIONS
CONSUMER MEDICINE INFORMATION
WARNING
LIMITATIONS OF USE
TRAMAL
®
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
®
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
®
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
®
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
®
USING TRAMAL
® 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
®
.
WHAT IS IN THIS LEAFLET?
This leaflet answers some
common questions about
TRAMAL
®
. 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
TRAMAL
®
against the benefits
this medicine is expected to
have for you.
IF YOU HAVE ANY CONCERNS
ABOUT TAKING THIS MEDICINE,
ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT TRAMAL
® IS
USED FOR
TRAMAL
®
is used to rel

Preparatomtale

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,