Source: European Medicines Agency (EU) Revision Year: 2019
Hypersensitivity to the active substance or to any of its excipients listed in section 6.1.
Acute venous or arterial thrombosis (see section 4.4 Special).
Fibrinolytic conditions following consumption coagulopathy except in those with predominant activation of the fibrinolytic system with acute severe bleeding (see section 4.4).
Severe renal impairment (risk of accumulation).
History of convulsions.
Intrathecal and intraventricular injection, intracerebral application (risk of cerebral oedema and convulsions).
The indications and method of administration indicated above should be followed strictly:
Cases of convulsions have been reported in association with tranexamic acid treatment. In coronary artery bypass graft (CABG) surgery, most of these cases were reported following intravenous (i.v.) injection of tranexamic acid in high doses. With the use of the recommended lower doses of TXA, the incidence of post-operative seizures was the same as that in untreated patients.
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.
In case of haematuria from the upper urinary tract, there is a risk for urethral obstruction.
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 (see section 4.3). Tranexamic acid should be administered with care in patients receiving oral contraceptives because of the increased risk of thrombosis (See section 4.5).
Patients with disseminated intravascular coagulation (DIC) should in most cases not be treated with tranexamic acid (see section 4.3). If tranexamic acid is given it must be restricted to those in whom there is predominant activation of the fibrinolytic system with acute severe bleeding. Characteristically, the haematological profile approximates to the following: reduced euglobulin clot lysis time; prolonged prothrombin time; reduced plasma levels of fibrinogen, factors V and VIII, plasminogen fibrinolysin and alpha-2 macroglobulin; normal plasma levels of P and P complex; i.e. factors II (prothrombin), VIII and X; increased plasma levels of fibrinogen degradation products; a normal platelet count. The foregoing presumes that the underlying disease state does not of itself modify the various elements in this profile. In such acute cases a single dose of 1g tranexamic acid is frequently sufficient to control bleeding.. Administration of Tranexamic acid in DIC should be considered only when appropriate haematological laboratory facilities and expertise are available.
No interaction studies have been performed. Simultaneous treatment with anticoagulants must take place under the strict supervision of a physician experienced in this field. Medicinal products that act on haemostasis should be given with caution to patients treated with tranexamic acid. There is a theoretical risk of increased thrombus-formation potential, such as with oestrogens. Alternatively, the antifibrinolytic action of the drug may be antagonised with thrombolytic drugs.
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.
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 in table 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).
Uncommon: Dermatitis allergic
Common: Diarrhoea, Vomiting, Nausea
Not known: Convulsions particularly in case of misuse (refer to sections 4.3 and 4.4)
Not known: Visual disturbances including impaired colour vision
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
Not known: Hypersensitivity reactions including anaphylaxis
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