Nazione: Irlanda
Lingua: inglese
Fonte: HPRA (Health Products Regulatory Authority)
TRANEXAMIC ACID
Meda Health Sales Ireland Limited
B02AA02
TRANEXAMIC ACID
500 Milligram
Film Coated Tablet
Product subject to prescription which may be renewed (B)
tranexamic acid
Marketed
1983-04-01
PACKAGE LEAFLET: INFORMATION FOR THE USER CYKLOKAPRON 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. The name of your medicine is Cyklokapron 500 mg film-coated tablets, which will be called Cyklokapron tablets throughout this leaflet. WHAT IS IN THIS LEAFLET: 1. What Cyklokapron tablets are and what they are used for 2. What you need to know before you take Cyklokapron tablets 3. How you take Cyklokapron tablets 4. Possible side effects 5. How to store Cyklokapron tablets 6. Contents of the pack and other information 1. WHAT CYKLOKAPRON TABLETS ARE AND WHAT THEY ARE USED FOR Cyklokapron tablets contain the active ingredient tranexamic acid, which belongs to a group of medicines called antifibrinolytic drugs. Cyklokapron tablets are used for the short-term treatment or prevention of haemorrhage (severe bleeding) for the following conditions: - Prostatectomy (removal of part or all of the prostate gland) - Bladder surgery - Menorrhagia (a heavy and prolonged period in women) - Epistaxis (nosebleed) - Conisation of the cervix (removal of part of the cervix to help diagnosis) - Traumatic hyphaema (bleeding behind the eye caused by injury) Cyklokapron tablets are also used: - Treatment of hereditary angioneurotic oedema (an inherited condition causing swelling of the face and hands) - To prevent severe bleeding after tooth extraction in haemophiliacs (people with a bleeding disorder) - To treat severe bleeding of the upper digestive tract. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CYKLOK Leggi il documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cyklokapron 500 mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 500 mg Tranexamic Acid. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film coated tablet White, capsule-shaped, film coated tablet with the letters CY with arcs above and below on one side and scored on the other side. 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 - Management of upper gastrointestinal haemorrhage 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Route of Administration: Oral Local fibrinolysis: The recommended standard dosage is 15-25mg/kg body weight (2-3tablets) 2-3 times daily.For the indications listed below the following doses may be used: PROSTATECTOMY: Prophylaxis and treatment of haemorrhage in high risk patients should commence per-or-post operatively with Cyklokapron Injection; thereafter 2 tablets (l.0g) 3-4 times daily until macroscopic haematuria is no longer present. MENORRHAGIA: 2-3tablets (l.0-1.5g) 3-4 times daily for 3-4 days.Cyklokapron therapy should be initiated only after heavy bleeding has started. EPISTAXIS: Where recurrent bleeding is anticipated oral therapy (2 (l.0g) tablets 3 times daily) should be administered for 7 days. CONISATION OF THE CERVIX:3(1.5g) tablets 3 times daily. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ Leggi il documento completo