TRAMADOL SANDOZ SR tramadol hydrochloride 100mg modified release tablet blister pack

Riik: Austraalia

keel: inglise

Allikas: Department of Health (Therapeutic Goods Administration)

Toimeaine:

tramadol hydrochloride, Quantity: 100 mg

Saadav alates:

Sandoz Pty Ltd

Ravimvorm:

Tablet, modified release

Koostis:

Excipient Ingredients: hypromellose; lactose monohydrate; calcium hydrogen phosphate dihydrate; magnesium stearate; sodium starch glycollate; hydrogenated castor oil; povidone; microcrystalline cellulose; maize starch; colloidal anhydrous silica; Colour

Manustamisviis:

Oral

Ühikuid pakis:

20 tablets

Retsepti tüüp:

(S4) Prescription Only Medicine

Näidustused:

Tramadol Sandoz SR is 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. Tramadol Sandoz SR is not indicated for use in chronic non-cancer pain other than in exceptional circumstances. Tramadol Sandoz SR is not indicated as an as-needed (PRN) analgesia.

Toote kokkuvõte:

Visual Identification: Flat round bi-layer tablet with facet, initial layer white, slow release layer green with one-sided identification mark "T R/ 100 R"; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 5 Years; Container Temperature: Store below 25 degrees Celsius

Volitamisolek:

Licence status A

Loa andmise kuupäev:

2005-03-24

Infovoldik

TRAMADOL SANDOZ SR
®
1
TRAMADOL SANDOZ SR
®
_tramadol hydrochloride sustained-release tablets _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some common
questions about Tramadol Sandoz
SR.
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 they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT TRAMADOL
SANDOZ SR IS USED
FOR
The name of your medicine is
Tramadol Sandoz SR. This medicine
is used to relieve severe pain which
requires daily, long term treatment.
It contains the active ingredient
tramadol hydrochloride. Tramadol
hydrochloride belongs to a group of
medicines called opioid analgesics
(pain relievers).
Tramadol Sandoz SR tablets are
designed to release active medicine
gradually over several hours.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
Tramadol Sandoz SR is available
only on a doctor’s prescription.
TRAMADOL SANDOZ SR TABLETS IS FOR
USE IN ADULTS AND CHILDREN OVER 12
YEARS OF AGE.
It should not be used in
children under the age of 12 years or
following the removal of tonsils
and/or adenoids in people under 18.
BEFORE YOU TAKE
TRAMADOL SANDOZ
SR
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE THIS MEDICINE IF YOU
HAVE AN ALLERGY TO:
•
tramadol hydrochloride, the
active ingredient or to any of the
other ingredients listed at the end
of this leaflet under Product
Description.
•
any other similar medicines
known as opioid analgesics e.g.
morphine, codeine.
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
WARNING
LIMITATIONS OF USE
Tramadol Sandoz SR should only be used when your d

Toote omadused

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Page 1 of 19
AUSTRALIAN PRODUCT INFORMATION
TRAMADOL SANDOZ
®
SR (TRAMADOL HYDROCHLORIDE) SUSTAINED
RELEASE TABLETS
1.
NAME OF THE MEDICINE
Tramadol hydrochloride
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Tramadol Sandoz
®
SR 100 mg sustained release tablet contains 100 mg Tramadol
hydrochloride.
Each Tramadol Sandoz
®
SR 150 mg sustained release tablet contains 150 mg Tramadol
hydrochloride.
Each Tramadol Sandoz
®
SR 200 mg sustained release tablet contains 200 mg Tramadol
hydrochloride.
Excipients with known effects: Sugars as lactose
WARNINGS
LIMITATIONS OF USE
Because of the risks associated with the use of opioids, Tramadol
Sandoz SR should only be
used
in
patients
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 Sandoz 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 Tramadol
Sandoz 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 dur