Ország: Egyesült Királyság
Nyelv: angol
Forrás: MHRA (Medicines & Healthcare Products Regulatory Agency)
Tranexamic acid
Rivopharm (UK) Ltd
B02AA02
Tranexamic acid
500mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02110000; GTIN: 5060388650186
Tranexamic Acid 500 mg Film Coated Tablets Ver 12/2017 PACKAGE LEAFLET: INFORMATION FOR THE USER TRANEXAMIC ACID 500 MG FILM-COATED TABLETS Tranexamic acid 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 effect not listed in this leaflet. See section 4 WHAT IS IN THIS LEAFLET: 1. What Tranexamic Acid is and what it used for 2. What you need to know before you take Tranexamic Acid 3. How to take Tranexamic Acid 4. Possible side effects 5. How to store Tranexamic Acid 6. Contents of the pack and other information. 1. WHAT TRANEXAMIC ACID TABLETS IS AND WHAT THEY ARE USED FOR Tranexamic Acid belongs to a group of medicines called anti-fibrinolytic drugs. These are used to stop or reduce unwanted bleeding. When you bleed your body forms clots to stop the bleeding. In some people these break down causing too much bleeding. Tranexamic Acid stops these clots dissolving and so reduces unwanted bleeding. Tranexamic Acid is used to prevent or reduce bleeding for a short period of time in many different conditions. You may have been prescribed it for one of the following: Following prostate surgery (post-prostatectomy) Following bladder surgery Heavy periods (menorrhagia) Nose bleeds (epistaxis) Cervical surgery (conisation of the cervix) Bleeding inside the eye (traumatic hyphaema) Tooth removal (dental extraction) in haemophiliacs (people who bleed more easily than normal). You will know if this refers to you A hereditary disease called angioneurotic oedema (HANO). A doctor will have told you if you have this. 2. WHAT YOU NEED TO KNOW BEFORE YOU Olvassa el a teljes dokumentumot
OBJECT 1 TRANEXAMIC ACID 500 MG FILM COATED TABLETS Summary of Product Characteristics Updated 26-Jan-2017 | Rivopharm UK Ltd 1. Name of the medicinal product Tranexamic Acid 500 mg film coated tablets. 2. Qualitative and quantitative composition Each film coated tablet contains: Tranexamic acid 500 mg. For a full list of excipients, see 6.1. 3. Pharmaceutical form Tablets. Tranexamic Acid 500 mg film coated tablets are white to off white, capsule shaped, biconvex film-coated tablets. They are marked with TXA 500 with a break line. 4. Clinical particulars 4.1 Therapeutic indications Tranexamic Acid 500 mg film coated tablets are indicated for short term use for haemorrhage or risk of haemorrhage in those with increased fibrinolysis or fibrinogenolysis. Local fibrinolysis as occurs in the following conditions: 1. a) Prostatectomy and bladder surgery b) Menorrhagia c) Epistaxis d) Conisation of the cervix e) Traumatic hyphaema 2. Management of dental extraction in haemophiliacs. 3. Hereditary angioneurotic oedema. 4.2 Posology and method of administration Route of administration: Oral. _Adults:_ Local Fibrinolysis: The recommended standard dose is 15-25mg/kg bodyweight (i.e. 2-3 tablets) two to three times daily. For the indications listed below the following doses may be used: 1a. Prostatectomy: Prophylaxis and treatment of haemorrhage in high risk patients should commence per- or post-operatively with an injectable form; thereafter 2 tablets three to four times daily until macroscopic haematuria is no longer present. 1b. 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. 1c. Epistaxis: When repeated bleeding is anticipated oral therapy (2 tablets three times daily) should be administered for 7 days. 1d. Cervix Conisation: 3 tablets three times daily 1e. Traumat Olvassa el a teljes dokumentumot