Kraj: Malta
Język: angielski
Źródło: Medicines Authority
TRANEXAMIC ACID
Remedica Limited Limassol Industrial Estate, Aharnon Street, 3056 Limassol, Cyprus
B02AA02
TRANEXAMIC ACID 500 mg
FILM-COATED TABLET
TRANEXAMIC ACID 500 mg
POM
ANTIHEMORRHAGICS
Authorised
2007-04-05
1 OF 5 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT 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 effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Tranexamic Acid is and what it is 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 IS AND WHAT IT IS USED FOR The product Tranexamic Acid 500 mg film-coated tablets contains the active substance tranexamic acid and 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 Przeczytaj cały dokument
Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Tranexamic Acid 500 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 500 mg of tranexamic acid. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Off-white, capsule shaped, scored, film-coated tablets. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4. CLINICAL PARTICULARS _ _ 4.1 THERAPEUTIC INDICATIONS Short-term use for haemorrhage or risk of haemorrhage in increased fibrinolysis or fibrinogenolysis. Local fibrinolysis as occurs in the following conditions: • prostatectomy and bladder surgery. • menorrhagia. • epistaxis. • conisation of the cervix. • traumatic hyphaema. • hereditary angioneurotic oedema. • 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: 1A. PROSTATECTOMY: Prophylaxis and treatment of haemorrhage in high risk patients should commence per- or post-operatively with tranexamic acid injection; 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 for up to 4 days. If very heavy menstrual bleeding, dosage may be increased. A total dose of 4 g Page 2 of 6 (8 tablets) daily should not be exceeded. Treatment with tranexamic acid should not be initiated until menstrual bleeding has started. 1C. EPISTAXIS: Where recurrent bleeding is anticipated oral therapy (2 tablets three times daily) should be administered for 7 days. 1D. CONISATION OF THE CERVIX: 3 tablets three times daily. 1E. TRAUMATIC HYPHAEMA: 2-3 tablets three times daily. The dose is based on 25 mg/kg three times a day. 2. HEREDITARY ANGIONEUROTIC OEDEMA: S Przeczytaj cały dokument