CYKLOKAPRON tranexamic acid 500mg tablet bottle

Land: Australien

Språk: engelska

Källa: Department of Health (Therapeutic Goods Administration)

Aktiva substanser:

tranexamic acid, Quantity: 500 mg

Tillgänglig från:

Pfizer Australia Pty Ltd

Läkemedelsform:

Tablet, film coated

Sammansättning:

Excipient Ingredients: microcrystalline cellulose; purified talc; magnesium stearate; colloidal anhydrous silica; povidone; hyprolose; titanium dioxide; macrogol 8000; vanillin; basic butylated methacrylate copolymer

Administreringssätt:

Oral

Enheter i paketet:

100 tablets, 20 tablets (sample pack)

Klass:

Medicine Registered

Receptbelagda typ:

(S4) Prescription Only Medicine

Terapeutiska indikationer:

Hereditary angioneurotic oedema. Short term use in the treatment of hyphaema and in patients with established coagulopathies who are undergoing minor surgery. Menorrhagia.

Produktsammanfattning:

Visual Identification: A white, capsular, film-coated tablet. Each tablet is engraved with a score and with arcs above and below the letters CY; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Bemyndigande status:

Registered

Tillstånd datum:

1991-09-05

Bipacksedel

CYKLOKAPRON
_Tranexamic acid Tablets and Solution for Injection_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common questions people ask about
CYKLOKAPRON. It does not
contain all the information that is
known about CYKLOKAPRON.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor will have
weighed the risks of you using
CYKLOKAPRON against the
benefits they expect it will have for
you.
Please read this leaflet carefully and
follow the instructions given to you
by your doctor and the advice
contained in this leaflet.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT CYKLOKAPRON
IS USED FOR
CYKLOKAPRON Tablets are used
to prevent excessive bleeding in
patients with:
•
traumatic hyphaema (bleeding
into the front part of the eye)
•
blood clotting disorders, who are
having minor surgery
•
heavy periods
•
hereditary angioneurotic oedema
(periodic swelling of the throat)
CYKLOKAPRON Solution for
Injection is used to reduce bleeding
and the need for transfusion of blood
in patients undergoing heart surgery,
total knee replacement and total hip
replacement surgery.
HOW CYKLOKAPRON
WORKS
CYKLOKAPRON contains
tranexamic acid. Tranexamic acid is
an antifibrinolytic that works by
slowing the processes that cause
bleeding.
BEFORE TREATMENT WITH
CYKLOKAPRON
_WHEN CYKLOKAPRON MUST_
_NOT BE USED_
CYKLOKAPRON must not be used
if you:
•
have an allergy to tranexamic
acid or any of the ingredients
listed at the end of this leaflet.
•
are being treated for stroke
•
are being treated for blood clots
in your legs, lungs or anywhere
else in your body.
•
have a problem with colour vision
that developed after you were
born.
DO NOT USE CYKLOKAPRON AFTER
THE EXPIRY DATE (EXP) PRINTED ON
THE PACK.
Medicine taken after the expiry date
has passed may not work as well.
DO NOT USE CYKLOKAPRON IF
THE PACKAGING IS TORN

Produktens egenskaper

Version: pfpcyklt10822
Supersedes: pfpcyklt10622
Page 1 of 11
AUSTRALIAN
PRODUCT
INFORMATION
–
CYKLOKAPRON
®
(TRANEXAMIC
ACID)
TABLETS
1.
NAME OF THE MEDICINE
Tranexamic acid.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Cyklokapron tablet contains 500 mg of tranexamic acid.
3.
PHARMACEUTICAL FORM
Cyklokapron is available as film coated tablets. Cyklokapron is a
white, capsule shaped tablet
with a score on one side and "CY" within upper and lower arcs on the
other.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ORAL ADMINISTRATION
Hereditary angioneurotic oedema.
Short term use in the treatment of hyphaema and in patients with
established coagulopathies
who are undergoing minor surgery.
Menorrhagia.
4.2 DOSE AND METHOD OF ADMINISTRATION
ORAL ADMINISTRATION
TRAUMATIC HYPHAEMA
1.0 to 1.5 g every 8 hours for six to seven days.
MENORRHAGIA
Two tablets (1 g) four times a day, increasing to three tablets (1.5
g) four times a day if needed,
for four days. Treatment should be initiated at the onset of visible
bleeding, and continued for
the first 4 days of the menstrual cycle. Patients should be assessed
after three months of
treatment.
No efficacy data are available from randomised, controlled clinical
trials for treatment beyond
three menstrual cycles.
Version: pfpcyklt10822
Supersedes: pfpcyklt10622
Page 2 of 11
HEREDITARY ANGIONEUROTIC OEDEMA
Patients who can sense the onset of attacks are best treated
intermittently with 2 - 3 tablets, 2 -
3 times a day until symptoms subside. Others should be treated
continuously with the same
dose.
PROSTATECTOMY
1 g orally six hours pre-operatively followed by 1 g orally 3 to 4
times a day until macroscopic
haematuria is no longer present. Treatment beyond two weeks is not
recommended.
PATIENTS WITH ESTABLISHED COAGULOPATHIES UNDERGOING MINOR SURGERY
CONISATION OF THE CERVIX
1.0 to 1.5g (2 to 3 tablets) every 8 to 12 hours for 12 days
post-operatively.
DENTAL OPERATIONS/EXTRACTION
25 mg/kg is given orally two hours before operation. Factor VIII and
Factor IX should be