AZEPTIL Capsule, hard Ref.[28139] Active ingredients: Tranexamic acid

In patients with renal insufficiency a reduction in dosage is recommended (see section 4.2) because of the risk of accumulation.

Tranexamic acid should be used with caution in massive haematuria from the upper urinary tract (especially in haemophilia) since in a few cases ureteric obstruction has been reported (i.e. formation of a ureteral clot).

Tranexamic acid should be used with caution when intravascular coagulation is in progress.

Patients with a high risk of thrombosis (a previous thromboembolic event and a family history of thromboembolic disease) should use tranexamic acid only if there is a strong medical indication and under strict medical supervision.

Patients with irregular menstrual bleeding should not use tranexamic acid until the cause of the irregularity has been established. Clinical experience with tranexamic acid in menorrhagic children under 15 years is not available.

Before use of tranexamic acid, risk factors of thromboembolic disease should be investigated.

Tranexamic acid should be administered with care in patients receiving oral contraceptives because of the increased risk of thrombosis.

Convulsions

In patients with a history of convulsion, tranexamic acid should not be administered. Cases of convulsions have been reported in association with tranexamic acid treatment. In cardiac surgery, most of these cases were reported following intravenous (i.v) injection of tranexamic acid in high doses.

This medicine contains carmoisine (E122). May cause allergic reactions.

This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium-free’.

Tranexamic acid will counteract the thrombolytic effect of fibrinolytic preparations.

Pregnancy

There is no evidence from animal studies of a teratogenic effect. Clinical use in pregnant women is limited and as tranexamic acid passes the placenta it should not be used during pregnancy unless considered essential by the physician.

Breast-feeding

Tranexamic acid passes into breast milk to a concentration of approximately one hundredth of the concentration in the maternal blood.

None known.

Adverse events are listed below by system organ class and frequency. Frequencies are defined as: very common (≥1/l0), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1000), very rare (<1/10,000), not known (cannot be estimated from the available data).

Immune system disorders

Very rare: Hypersensitivity reactions including anaphylaxis

Eye disorders

Rare: Colour vision disturbances, retinal/artery occlusion

Vascular disorders

Rare: Thromboembolic events

Very rare: Arterial or venous thrombosis at any sites

Cardio-vascular disorders

Very rare: Malaise with hypotension, with or without loss of consciousness (generally following too fast intravenous injection, exceptionally after oral administration).

Gastro-intestinal disorders

Very rare: Digestive effects such as nausea, vomiting and diarrhoea, may occur but disappear when the dosage is reduced.

Nervous system disorders

Very rare: Convulsions, particularly in case of misuse (see section 4.3 Contraindications and 4.4 Precautions and warnings).

Skin and subcutaneous tissue disorders

Rare: Allergic skin reactions

Postmarketing Surveillance

Rare cases of adverse events have been reported with use of tranexamic acid; thromboembolic events, impaired colour vision and other visual disturbances and dizziness.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions to Pharmaceutical Services, Ministry of Health, CY-1475 Nicosia, Tel: +357 22608607, Fax: +357 22608669, Website: www.moh.gov.cy/phs.

None known.