Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
tranexamic acid, Quantity: 500 mg
Southern Cross Pharma Pty Ltd
Tranexamic acid
Tablet, film coated
Excipient Ingredients: macrogol 8000; vanillin; magnesium stearate; microcrystalline cellulose; colloidal anhydrous silica; croscarmellose sodium; titanium dioxide; purified talc; povidone; basic butylated methacrylate copolymer
Oral
100 tablets
(S4) Prescription Only Medicine
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.
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
Licence status A
2017-01-30
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 Read the complete document
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 Read the complete document