TRANEXAMIC ACID LUPIN tranexamic acid 500 mg tablet blister pack

Nchi: Australia

Lugha: Kiingereza

Chanzo: Department of Health (Therapeutic Goods Administration)

Viambatanisho vya kazi:

tranexamic acid, Quantity: 500 mg

Inapatikana kutoka:

Southern Cross Pharma Pty Ltd

INN (Jina la Kimataifa):

Tranexamic acid

Dawa fomu:

Tablet, film coated

Tungo:

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

Njia ya uendeshaji:

Oral

Vitengo katika mfuko:

100 tablets

Dawa ya aina:

(S4) Prescription Only Medicine

Matibabu dalili:

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.

Bidhaa muhtasari:

Visual Identification: White to slightly yellowish, film coated, capsule shaped, biconvex, 18 mm x 8 mm, with a break-line and embossed "TXA 500"; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Idhini hali ya:

Licence status A

Idhini ya tarehe:

2017-01-30

Taarifa za kipeperushi

1
Tranexamic acid Lupin
_contains the active ingredient tranexamic acid _
CONSUMER MEDICINE INFORMATION
What is in this leaflet
This leaflet answers some common
questions about TRANEXAMIC ACID
LUPIN.
It does not contain all of the
available information. It does not
take the place of talking to your
doctor or pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking TRANEXAMIC
ACID LUPIN against the benefits
they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
Keep this leaflet with your
medicine. You may need to read it
again.
What TRANEXAMIC ACID
LUPIN is used for
TRANEXAMIC ACID LUPIN is 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).
TRANEXAMIC ACID LUPIN contains
tranexamic acid. Tranexamic acid
is an antifibrinolytic that works by
slowing the processes that cause
bleeding.
•
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 TAKE TRANEXAMIC ACID
LUPIN IF THE EXPIRY DATE (EXP.)
PRINTED ON THE PACK HAS PASSED.
DO NOT TAKE TRANEXAMIC ACID
LUPIN IF THE PACKAGING IS TORN
OR SHOWS SIGNS OF TAMPERING.
DO NOT USE TRANEXAMIC ACID
LUPIN TO TREAT ANY OTHER
COMPLAINT UNLESS YOUR DOCTOR TELLS
YOU TO.
_BEFORE YOU START TO TAKE IT _
TELL YOUR DOCTOR IF YOU HAVE ANY
OF THE FOLLOWING:
•
you, or someone in your family,
has ever suffered from blood
clots
•
severe bruising
•
kidney disease with or without
blood in the urine
•
irregular periods and the reason
is not known.
TELL YOUR DOCTOR IF YOU HAVE OR
HAVE EVER SUFFERED FROM
CONVULSION, FITS OR SEIZURES

Tabia za bidhaa

Tranexamic acid Tablets v1.0 1
AUSTRALIAN PRODUCT INFORMATION – TRANEXAMIC ACID LUPIN
(TRANEXAMIC ACID) TABLETS
1
NAME OF THE MEDICINE
Tranexamic acid.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
TRANEXAMIC ACID LUPIN tablets contain 500 mg tranexamic acid.
For the full list of excipients, see Section 6.1 LIST OF EXCIPENTS.
3
PHARMACEUTICAL FORM
TRANEXAMIC ACID LUPIN tablets are white to slightly yellowish, film
coated, capsule shaped, biconvex,
18 mm x 8 mm, with a break-line and embossed “TXA 500”.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC 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
D
OSE 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.
_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.
_ _
_ _
Tranexamic acid Tablets v1.0 2
_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 VI