TRANEXAMIC ACID MEVON FILM-COATED TABLETS 500 MG [SIN17452P]
Active ingredients: TRANEXAMIC ACID MEVON FILM-COATED TABLETS 500 MG
Product Info
TRANEXAMIC ACID MEVON FILM-COATED TABLETS 500 MG
[SIN17452P]
Product information
Active Ingredient and Strength | TRANEXAMIC ACID - 500 MG |
Dosage Form | TABLET, FILM COATED |
Manufacturer and Country | LABIANA PHARMACEUTICALS, S.L.U. - SPAIN |
Registration Number | SIN17452P |
Licence Holder | NOVEM HEALTHCARE PTE LTD |
Forensic Classification | PRESCRIPTION ONLY MEDICINES |
Anatomical Therapeutic Chemical (ATC) code | B02AA02 |
Prescription-only Medicines with Exemptions for Supply without Prescription | NA |
Indication
4.1 Therapeutic indications
Haemorrhage or risk of haemorrhage in increased fibrinolysis or fibrinogenolysis.
Local fibrinolysis may occur in the following conditions: Menorrhagia, prostatectomy and bladder surgery, haematuria, gastrointestinal haemorrhage, epistaxis, ulcerative colitis, conisation of the cervix, and dental extraction in patients with coagulopathies.
Hereditary angioneurotic oedema.
Dosing
4.2. Posology and method of administration
The recommended standard dose is 2 to 3 tablets of 0.5 g 2 to 3 times daily.
For the indications listed below, the following doses are recommended:
Prostatectomy: Intravenous injection should be given for the first 3 days after surgery; thereafter 1g to 1.5 g orally (2 to 3 tablets) 2 to 3 times daily until macroscopic haematuria is no longer present.
Haematuria: 1 g to 1.5 g orally (2 to 3 tablets) 2 to 3 times daily until macroscopic haematuria is no longer present.
Epistaxis: 1.5 g orally (3 tablets) 3 times a day should be administered for 4 to 10 days.
Menorrhagia: 1 g to 1.5 g orally (2 to 3 tablets) 3 to 4 times daily for 3 to 4 days. Tranexamic acid therapy is initiated when bleeding has become profuse.
Conisation of the cervix: 1.5 g orally (3 tablets) 3 times a day for 12 to 14 days postoperatively.
Dental extraction in patients with coagulopathies: After surgery, 25 mg/kg body weight is given orally 3 to 4 times daily for 6–8 days.
Hereditary angioneurotic oedema: 1 g to 1.5 g orally (2 to 3 tablets) 2 to 3 times daily as intermittent or continuous treatment, depending on whether the patient has prodromal symptoms or not.
For patients with moderate to severe impaired renal function, the following dosages are recommended:

Method of administration: oral administration.
Contraindications
4.3 Contraindications
Active thromboembolic disease, such as deep vein thrombosis, pulmonary embolism and cerebral thrombosis.
Subarachnoid haemorrhage. The limited clinical experience shows that a reduced risk for re-bleeding is offset by an increase in the rate of cerebral ischaemia.
Hypersensitivity to tranexamic acid or any of the ingredients listed in Section 6.1 List of excipients – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.
