Tranexamic Acid Tablets

Pays: Nouvelle-Zélande

Langue: anglais

Source: Medsafe (Medicines Safety Authority)

Ingrédients actifs:

Tranexamic acid 500mg

Disponible depuis:

Boucher & Muir (NZ) Ltd t/a Mercury Pharma (NZ)

DCI (Dénomination commune internationale):

Tranexamic acid 500 mg

Dosage:

500 mg

forme pharmaceutique:

Film coated tablet

Composition:

Active: Tranexamic acid 500mg Excipient: Basic butylated methacrylate copolymer Colloidal silicon dioxide Croscarmellose sodium Isopropyl alcohol Macrogol 8000 Magnesium stearate   Microcrystalline cellulose Povidone Purified talc   Purified water Titanium dioxide Vanillin

Unités en paquet:

Blister pack, PVC film/aluminium, 60 tablets

classe:

Prescription

Type d'ordonnance:

Prescription

Fabriqué par:

Asahi Kasei Finechem Co Ltd

indications thérapeutiques:

Haemorrhage or risk of haemorrhage in increased fibrinolysis or fibrinogenolysis. Local fibrinolysis may occur in the following conditions: -prostatectomy and bladder surgery -menorrhagia -epistaxis -conisation of the cervix - management of dental extraction in patients with coagulopathies - ulcerative colitis - haematuria (Tranexamic acid therapy is not indicated in haematuria caused by diseases of the renal parenchyma) -gastrointestinal haemorrhage General fibrinolysis as in prostatic and pancreatic cancer; after thoracic and other major surgery: - in obstetrical complications such as abruptio placentae and post-partum haemorrhage - in leukaemia and liver diseases and in connection with thrombolytic therapy with streptokinase Hereditary angioneurotic oedema. For the reduction of peri– and post-operative blood loss and the need for blood transfusion in adult patients undergoing cardiac surgery or total knee arthroplasty or total hip arthroplasty. For the reduction of peri- and post-operative blood loss and the need for blood transfusion in paediatric patients undergoing cardiac surgery.

Descriptif du produit:

Package - Contents - Shelf Life: Blister pack, PVC film/aluminium - 60 tablets - 36 months from date of manufacture stored at or below 25°C

Date de l'autorisation:

2009-11-09

Notice patient

1
TRANEXAMIC ACID TABLETS
Consumer Medicine Information
TRANEXAMIC ACID TABLETS
_TRANEXAMIC ACID _
Film-coated tablets, 500 mg
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully before you start taking Tranexamic
Acid Tablets.
This leaflet answers some common questions about Tranexamic Acid
Tablets. It does not
contain all the available information. The most up-to-date Consumer
Medicine Information
can be downloaded from www.medsafe.govt.nz.
Reading this leaflet 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
Tranexamic Acid Tablets against the benefits this medicine is expected
to 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 want to read it again.
WHAT TRANEXAMIC ACID TABLETS ARE USED FOR
Tranexamic Acid Tablets contain tranexamic acid. Tranexamic acid
belongs to a group of
medicines called antifibrinolytic agents that work by slowing the
processes that cause
bleeding.
Tranexamic Acid Tablets are used to treat and prevent excessive
bleeding in patients:
•
with blood clotting disorders
•
who are having surgery or dental extraction
•
with conditions such as heavy periods, nose bleeds, ulcerative
colitis, bleeding into
the urine or intestines, inflammation of the colon and bowel,
Tranexamic Acid Tablets may also be used to treat hereditary
angioneurotic oedema
(periodic swelling of the throat).
2
TRANEXAMIC ACID TABLETS
Your doctor may have prescribed this medicine for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY IT HAS BEEN
PRESCRIBED FOR
YOU.
Tranexamic Acid Tablets are only available with a doctor's
prescription.
Tranexamic Acid Tablets are not addictive.
BEFORE YOU TAKE TRANEXAMIC ACID TABLETS
_ _
Tranexamic Acid Tablets are not suitable for everyone.
_WHEN YOU MUST NOT TAKE IT _
_ _
DO NOT TAKE TRANEXAMIC ACID TABLETS IF YOU:
▪
are being treated for a stroke
▪
have a hist

Résumé des caractéristiques du produit

1
TRANEXAMIC ACID TABLETS
TRANEXAMIC ACID FILM-COATED TABLETS 500 MG
NEW ZEALAND DATA SHEET
1
TRANEXAMIC ACID TABLETS
TRANEXAMIC ACID TABLETS 500 mg film-coated tablets.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 500 mg tranexamic acid.
For the full list of excipients, see Section 6.1.
3
PHARMACEUTICAL FORM
Tranexamic Acid Tablets are white to off-white, film-coated, oblong
tablets of 6 mm,
marked on one side with ‘TA500’ with a break-line on the reverse.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Haemorrhage or risk of haemorrhage in increased fibrinolysis or
fibrinogenolysis. Local
fibrinolysis may occur in the following conditions:

menorrhagia

epistaxis

conisation of the cervix

management of dental extraction in patients with coagulopathies

ulcerative colitis

haematuria (tranexamic acid therapy is not indicated in haematuria
caused by diseases
of the renal parenchyma – see also Section 4.4)

gastrointestinal haemorrhage.
Hereditary angioneurotic oedema.
2
TRANEXAMIC ACID TABLETS
TRANEXAMIC ACID FILM-COATED TABLETS 500 MG
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSE
Adults
The recommended standard dose is 2-3 tablets of 0.5 g, taken two to
three times daily.
For the indications listed below the following doses are recommended.
_MENORRHAGIA _
1-1.5 g orally three to four times daily for 3-4 days. Tranexamic acid
therapy is initiated
when bleeding has become profuse.
_EPISTAXIS _
1.5 g orally three times daily for 4-10 days.
_HAEMATURIA _
1-1.5 g orally two to three times daily until macroscopic haematuria
is no longer present.
_CONISATION OF THE CERVIX _
1.5 g orally three times a day for 12-14 days post-operatively.
_DENTAL SURGERY IN PATIENTS WITH COAGULOPATHIES (ORAL POST-SURGERY
ADMINISTRATION ONLY) _
After surgery (when intravenous injection of tranexamic acid is
administered immediately
before surgery), 25 mg per kg body weight given orally three to four
times daily for 6-8
days. It may be necessary to administer coagulation factor
con