TRENTAL 400 pentoxifylline (oxpentifylline) 400 mg modified release tablet blister pack

Land: Australien

Språk: engelska

Källa: Department of Health (Therapeutic Goods Administration)

Aktiva substanser:

pentoxifylline, Quantity: 400 mg

Tillgänglig från:

Clinect Pty Ltd

Läkemedelsform:

Tablet, modified release

Sammansättning:

Excipient Ingredients: povidone; hyetellose; titanium dioxide; hypromellose; erythrosine; purified talc; macrogol 8000; magnesium stearate

Administreringssätt:

Oral

Enheter i paketet:

50 tablets, 30 tablets

Receptbelagda typ:

(S4) Prescription Only Medicine

Terapeutiska indikationer:

Treatment of patients with intermittent claudication on the basis of chronic occlusive arterial disease of the limbs. Trental 400 can thus improve function and symptoms but is not intended to replace more definitive therapy, such as vascular surgery, or removal of arterial obstructions when treating peripheral vascular disease.

Produktsammanfattning:

Visual Identification: OBLONG, BICONVEX, PINK FILM COATED TABLETS WITH THE ATA STAMP ON ONE SIDE.; Container Type: Blister Pack; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Bemyndigande status:

Registered

Tillstånd datum:

2001-12-14

Bipacksedel

TRENTAL
® 400
_Pentoxifylline (Oxpentifylline)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Trental 400.
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 TRENTAL 400 IS
USED FOR
Trental 400 is a type of medicine
used to improve the circulation of the
blood.
Trental 400 is used to treat the
symptoms of a condition called
chronic occlusive arterial disease.
Symptoms of this disease can include
lameness and pain, usually in the leg
muscles.
Trental 400 is a slow release tablet,
which means that the active
ingredient is released slowly over
several hours.
Your doctor, however, may prescribe
Trental 400 for another purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY IT HAS BEEN
PRESCRIBED FOR YOU.
This medicine is only available with
a doctor's prescription.
BEFORE YOU TAKE IT
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE TRENTAL 400 IF YOU
HAVE:
•
had a recent operation
•
bleeding problems
•
heart problems, such as having
suffered a heart attack
•
kidney or liver problems
•
stomach ulcers or a history of
stomach ulcers
•
had an allergic reaction to
caffeine or theophylline (a
medicine used to treat asthma)
DO NOT TAKE TRENTAL 400 IF YOU ARE
ALLERGIC TO IT OR ANY OF THE
INGREDIENTS LISTED AT THE END OF THIS
LEAFLET.
Some symptoms of an allergic
reaction include skin rash, itching,
shortness of breath or swelling of the
face, lips or tongue, which may cause
difficulty in swallowing or breathing.
DO NOT GIVE TRENTAL 400 TO A CHILD
OR ADOLESCENT.
There is no experience with its use in
children or adolescents under 18
years old.
DO NOT TAKE IT IF YOU ARE PREGNANT
OR INTEND

Produktens egenskaper

trental-ccdsv7-piv7-19jun20
Page 1 of 10
AUSTRALIAN PRODUCT INFORMATION – TRENTAL
® 400
(PENTOXIFYLLINE (OXPENTIFYLLINE))
1
NAME OF THE MEDICINE
Pentoxifylline (oxpentifylline)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Trental 400 tablets contain 400 mg of pentoxifylline (oxpentifylline).
Oxpentifylline and Pentoxifylline are interchangeable and refer to the
same molecule.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Modified release tablet.
Oblong, biconvex, pink film-coated tablets with the ‘ATA’ stamp on
one side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
The treatment of patients with intermittent claudication on the basis
of chronic occlusive
arterial disease of the limbs. Trental 400 can thus improve function
and symptoms but is not
intended to replace more definitive therapy, such as vascular surgery,
or removal of arterial
obstructions when treating peripheral vascular disease.
4.2
DOSE AND METHOD OF ADMINISTRATION
The usual dosage of Trental 400 in controlled-release tablet form is
one tablet (400 mg) three
times a day with or after meals, to be swallowed whole with some
liquid. While the effect of
Trental 400 may be seen within 2 to 4 weeks, it is recommended that
treatment be continued
for at least 8 weeks. Efficacy has been demonstrated in double-blind
clinical studies of 6
months' duration.
Digestive and central nervous system side effects are dose related. If
patients develop these
side effects it is recommended that the dosage be lowered to one
tablet twice a day
(800mg/day). If side effects persist at this lower dosage, the
administration of Trental 400
should be discontinued.
trental-ccdsv7-piv7-19jun20
Page 2 of 10
In patients with low or labile blood pressure or hepatic dysfunction,
an individual dosage
adjustment is required. This also applies to patients with renal
dysfunction (creatinine
clearance of less than 30 mL/min) where, according to individual
tolerance, a dosage
adjustment of 30 to 50% may be necessary.
4.3
CONTRAINDICAT