Tranexamic acid

For patient with mild to moderate renal impairment, the dosage of tranexamic acid should be reduced according to the serum creatinine level:

Before use of TXA, risk factors of thromboembolic disease should be considered. In patients with a history of thromboembolic diseases or in those with increased incidence of thromboembolic events in their family history (patients with a high risk of thrombophilia), Tranexamic acid solution for injection should only be administered if there is a strong medical indication after consulting a physician experienced in hemostaseology and under strict medical supervision. Tranexamic acid should be administered with care in patients receiving oral contraceptives because of the increased risk of thrombosis.

Attention should be paid to possible visual disturbances including visual impairment, vision blurred, impaired colour vision and if necessary the treatment should be discontinued. With continuous long-term use of TXA solution for injection, regular ophthalmologic examinations (eye examinations including visual acuity, colour vision, fundus, visual field etc.) are indicated. With pathological ophthalmic changes, particularly with diseases of the retina, the physician must decide after consulting a specialist on the necessity for the long-term use of TXA solution for injection in each individual case.

Women of childbearing potential have to use effective contraception during treatment.

There is insufficient clinical data on the use of tranexamic acid in pregnant women. As a result, although studies in animals do not indicate teratogenic effects, as precaution for use, tranexamic acid is not recommended during the first trimester of pregnancy. Limited clinical of the use of tranexamic acid in different clinical haemorrhagic settings during the second and third trimesters did not identify deleterious effect for the foetus. Tranexamic acid should be used throughout pregnancy only if the expected benefit justifies the potential risk.

Tranexamic acid is excreted in human milk. Therefore, breastfeeding is not recommended.

Fertility

There are no clinical data on the effects of Tranexamic acid on fertility.

No studies have been performed on the ability to drive and use machines.

The ADRs reported from clinical studies and post-marketing experience are listed below according to system organ class.

Adverse reactions reported are presented below. Adverse reactions are listed according to MedDRA primary system organ class. Within each system organ class, adverse reactions are ranked by frequency. Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness. Frequencies were defined as follows: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100), not know (can not be estimated from the available data).

Skin and subcutaneous tissue disorders

Uncommon: Dermatitis allergic

Gastrointestinal disorders

Common: Diarrhoea, Vomiting, Nausea

Nervous system disorders

Not known: Convulsions particularly in case of misuse

Eye disorders

Not known: Visual disturbances including impaired colour vision

Vascular disorders

Not known: Malaise with hypotension, with or without loss of consciousness (generally following a too fast intravenous injection, exceptionally after oral administration), Arterial or venous thrombosis at any sites

Immune system disorders

Not known: Hypersensitivity reactions including anaphylaxis