DUROTRAM XR tramadol hydrochloride 100mg prolonged release tablet blister pack

Država: Australija

Jezik: engleski

Izvor: Department of Health (Therapeutic Goods Administration)

Aktivni sastojci:

tramadol hydrochloride, Quantity: 100 mg

Dostupno od:

iNova Pharmaceuticals (Australia) Pty Ltd

INN (International ime):

Tramadol hydrochloride

Farmaceutski oblik:

Tablet, modified release

Sastav:

Excipient Ingredients: hydrogenated vegetable oil; sodium lauryl sulfate; colloidal anhydrous silica; hydroxypropyl distarch phosphate; povidone; magnesium stearate; polyvinyl acetate; xanthan gum

Administracija rute:

Oral

Jedinice u paketu:

30 tablet pack, 2 tablet pack, 10 tablet pack, 5 tablet pack, 20 tablet pack

Tip recepta:

(S4) Prescription Only Medicine

Terapijske indikacije:

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.

Proizvod sažetak:

Visual Identification: white to off-white, plain bevelled edge, round biconvex tablets; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Status autorizacije:

Registered

Datum autorizacije:

2008-02-28

Uputa o lijeku

DUROTRAM
® XR
(DURO-TRAM)
_Tramadol hydrochloride (tram-ma-dol hy-dro-klor-ide)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Durotram XR. 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 provide.
IF YOU HAVE ANY CONCERNS ABOUT THIS
MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT DUROTRAM XR IS
USED FOR
Durotram XR is used to relieve
moderate to severe pain. It belongs to
the group of medicines called
analgesics (pain relievers).
Durotram XR has been specially
designed to release the pain reliever
gradually over a 24-hour period, so
that you need to only take one dose
per day.
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.
When used as prescribed by your
doctor, addiction to Durotram XR is
very unlikely.
If you are taking Durotram XR for a
prolonged period of time, your body
may become used to the medicine
and mild withdrawal symptoms may
occur if you suddenly stop taking the
medicine.
It is important, therefore, to take
Durotram XR only as directed by
your doctor.
Durotram XR is available only with a
doctor's prescription.
Durotram XR is not recommended
for the elderly (over 75 years) or
children under the age of 18 years.
BEFORE YOU TAKE
DUROTRAM XR
_WHEN YOU MUST NOT TAKE IT_
Do not take Durotram XR:
•
IF YOU HAVE EVER HAD AN ALLERGIC
REACTION TO TRAMADOL (THE ACTIVE
INGREDIENT) OR ANY OF THE
INGREDIENTS LISTED AT THE END OF
THIS LEAFLET;
If you have an allergic reaction
you may get a skin rash, have
difficulty in breathing, get
symptoms of hayfever or feel
faint;
•
IF YOU HAVE AN ALLERGY TO ANY
OTHER MEDICINES KNOWN AS
OPIOID ANALGESICS (E.G. MORPHINE
OR CODEINE);
•
if yo

Svojstava lijeka

1
AUSTRALIAN PRODUCT INFORMATION –
DUROTRAM
® (TRAMADOL HYDROCHLORIDE) XR TABLETS
1
NAME OF THE MEDICINE
Tramadol hydrochloride.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
The active ingredient of DUROTRAM
®
XR is tramadol hydrochloride. DUROTRAM
®
XR tablets are
available in strengths of 100 mg, 200 mg and 300 mg tramadol
hydrochloride.
DUROTRAM
®
XR tablets contain the following excipients: Contramid
®
(Hydroxypropyl distarch
phosphate (E 1442)), polyvinyl acetate, povidone, sodium lauryl
sulfate, xanthan gum, hydrogenated
vegetable oil, magnesium stearate and colloidal anhydrous silica.
3
PHARMACEUTICAL FORM
DUROTRAM
®
XR is available as 100 mg, 200 mg and 300 mg tablets. They are white
to off-white, plain,
bevelled edge round biconvex tablets.
DUROTRAM
®
XR tablets are composed of a dual-matrix delivery system with an outer
compression
coat which releases tramadol hydrochloride immediately and a core
containing Contramid
®
, which
controls the release of tramadol hydrochloride.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Relief of moderate to severe pain.
4.2
D
OSE AND METHOD OF ADMINISTRATION
GENERAL ADVICE
DUROTRAM
®
XR tablets must be swallowed whole with liquid and not broken, chewed,
dissolved or
crushed.
DUROTRAM
®
XR can be taken with or without food. DUROTRAM
®
XR dosage should be individualised
according to patient need using the lowest effective dose. The maximum
recommended dose of 400
mg once daily should not be exceeded.
Before using DUROTRAM
®
XR for longer than three months, re-assessment of the patient should
be
undertaken in order to determine whether ongoing treatment is
required. If long-term tramadol
treatment is required, careful and regular monitoring should be
undertaken to establish whether, and
to what extent, ongoing treatment with the medicine is necessary.
Alternative tablet strengths of DUROTRAM® XR are available. Use
appropriate tablet strengths to
achieve the required dose.
ADULTS
The starting dose is one 100 mg prolonged-release tablet once daily.
The usu