APO-TRAMADOL SR tramadol hydrochloride 200 mg oral tablet blister pack

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

tramadol hydrochloride, Quantity: 200 mg

Tilgjengelig fra:

Southern Cross Pharma Pty Ltd

INN (International Name):

Tramadol hydrochloride

Legemiddelform:

Tablet, modified release

Sammensetning:

Excipient Ingredients: colloidal anhydrous silica; magnesium stearate; hyprolose; calcium hydrogen phosphate dihydrate

Administreringsrute:

Oral

Enheter i pakken:

20 tablets

Resept typen:

(S4) Prescription Only Medicine

Indikasjoner:

Indicated for the management of severe pain where: ? other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain, and ? the pain is opioid-responsive, and ? requires daily, continuous, long-term treatment. Not indicated for use in chronic non-cancer pain other than in exceptional circumstances. Not indicated as an as-needed (PRN) analgesia.

Produkt oppsummering:

Visual Identification: off-white, capsule shaped tablet; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Autorisasjon status:

Licence status A

Autorisasjon dato:

2009-03-10

Informasjon til brukeren

APO-TRAMADOL
SR
1
APO-TRAMADOL SR MODIFIED RELEASE TABLETS
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
WARNING: Important safety information is provided in a boxed warning
in the full CMI. Read before using this medicine.
APO-TRAMADOL SR contains the active ingredient tramadol hydrochloride.
APO-TRAMADOL SR is used to relieve severe pain.
For more information, see Section 1. Why am I taking APO-TRAMADOL SR?
in the full CMI.
Do not take if you have ever had an allergic reaction to tramadol
hydrochloride, other opioids or any of the ingredients listed at the
end
of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
FOR MORE INFORMATION, SEE SECTION 2. WHAT SHOULD I KNOW BEFORE I TAKE
APO-TRAMADOL SR? IN THE FULL CMI.
Some medicines may interfere with APO-TRAMADOL SR and affect how it
works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.

Swallow the tablets whole with a glass of water.

Discuss with your doctor the correct dose for you. Do not take more
than four of the 100 mg tablets per day or two of the 150
mg or of the 200 mg tablets per day.
More instructions can be found in Section 4. How do I take
APO-TRAMADOL SR? in the full CMI.
THINGS YOU
SHOULD DO

Remind any doctor, dentist or pharmacist you visit that you are taking
APO-TRAMADOL SR.

Remind your doctor if you are allergic to tramadol, opioids or any of
the ingredients in this medicine or
if you
have had any problems with drug or alcohol dependence.

If you become pregnant or plan to breast-feed while taking this
medicine, tell your doctor immediately.

If you are about started any new medicine, tell your doctor or
pharmacist that you are taking this medicine.

If your pain is not as severe or if your pain is not helped or gets
worse, talk to your doctor.

If you are going to have surger

Preparatomtale

APO-Tramadol SR – AUSTRALIAN PRODUCT INFORMATION
AUSTRALIAN PRODUCT INFORMATION
APO-TRAMADOL SR, 100MG, 150MG AND 200MG MODIFIED RELEASE TABLETS
WARNINGS
_LIMITATIONS OF USE _
Because of the risks associated with the use of opioids, APO-Tramadol
SR 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 _
APO-Tramadol SR 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 APO-Tramadol SR. 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 APO-Tramadol SR.
APO-Tramadol SR – AUSTRALIAN PRODUCT INFORMATION
1.
NAME OF THE MEDICINE
Tramadol hydrochloride
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
APO-Tramadol SR tablets contain the active ingredient tramadol
hydrochloride
Each modified release