Land: Storbritannien
Sprog: engelsk
Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)
Tranexamic acid
Sovereign Medical Ltd
B02AA02
Tranexamic acid
500mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02110000; GTIN: 05021730009885
REGULATORY AUTHORITY APPROVAL CONFIRMATION Confirmation that this artwork has been approved by the appropriate market authority (if applicable, e.g. MHRA, IMB, etc and that Waymade Plc have license approval to distribute this component for sale in the relevent market. Accept Artwork ................................................................ Reject Artwork ................................................................. Signature .......................................................................... Name ................................................................................ Date .................................................................................. PAGE 1 OF 2 Received Date: 23/05/2018 CDL JOB No. : 65458 Required By : 29/05/2018 PRODUCT NAME: Tranexamic Acid 500 mg Tablets PIP CODE: GB 674-5947-APIL COMPONENT: Leaflet SIZE: 148x400 mm MARKET: Great Britain PRODUCT SITE: TBC SCALE: 100% COLOURS: Black Pharma Code DATE: 23/05/2018 FONT SIZE: 11 pt VERSION NO: 4 AMENDED BY: VK PROJECT: Sovereign Medical GB 674-5947-APIL PACKAGE LEAFLET: INFORMATION FOR THE USER TRANEXAMIC ACID 500 MG TABLETS READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Tranexamic Acid 500 mg Tablets are and what they are used for 2. What you need to know before you take Tranexamic Acid 500 mg Tablets 3. How to take Tranexamic Acid 500 mg Tablets 4. Possible side effects 5. How to store Tranexamic Acid 500 mg Tablets 6. Contents of the pack and other information 1. WHAT TRANEXAMIC ACID 500 MG TABL Læs hele dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Tranexamic Acid 500 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains Tranexamic acid 500 mg For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Film-coated tablet Each film-coated tablet is white to off-white, oblong, biconvex with a break line and marked “TA” on one side of the break line. The breakline is not intended for breaking the tablet. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 1. Short-term use for haemorrhage or risk of haemorrhage in increased fibrinolysis or fibrinogenolysis. Local fibrinolysis as occurs in the following conditions: a) Prostatectomy and bladder surgery b) Menorrhagia c) Epistaxis d) Conisation of the cervix e) Traumatic hyphaema 2. Hereditary angioneurotic oedema 3. Management of dental extraction in haemophiliacs 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology 1. Local fibrinolysis The recommended standard dosage is 15-25 mg /kg bodyweight (i.e. 2- 3 tablets) two to three times daily. For the indications listed below the following doses may be used: a) Prostatectomy: Prophylaxis and treatment of haemorrhage in high risk patients should commence pre- or post-operatively with intravenous tranexamic acid injection; thereafter 2 tablets three to four times daily until macroscopic haematuria is no longer present. b) Menorrhagia: Recommended dosage is 2 tablets 3 times daily as long as needed for up to 4 days. If very heavy menstrual bleeding, dosage may be increased. A total dose of 4g daily (8 tablets) should not be exceeded. Treatment with Tranexamic acid should not be initiated until menstrual bleeding has started. c) Epistaxis: Where recurrent bleeding is anticipated oral therapy (2 tablets three times daily) should be administered for 7 days. d) Conisation of the cervix: 3 tablets three times daily. e) Traumatic hyphaema: 2-3 tablets three times daily. The dose is based on 25 mg /kg three times a day. 2. Hereditary angioneurotic oedema Some patie Læs hele dokumentet