EVANA HEAVY PERIOD RELIEF

Posology Treatment with tranexamic acid is initiated only once heavy bleeding has started. The recommended dosage is 2 tablets 3 times daily as long as needed but for a maximum of 4 days. If there is very heavy menstrual bleeding, the dosage may be increased.

A total dose of 4g daily (8 tablets) should not be exceeded. Tranexamic acid can be used as long as periods remain regular and heavy.

Elderly:

Not recommended for use in the elderly.

Children:

Not for use in children and adolescents under 18 years of age.

Method of Administration Route of administration:

Oral

Gastrointestinal discomfort is the most common undesirable effect that may occur but disappears when the dosage is reduced.

Immune system disorders Very rare (<1/10 000):

Hypersensitivity reactions including anaphylaxis.

Frequency of undesirable effects at a dose of 4g/day (MedDRA LLT):

Gastrointestinal disorders Common (≥1/100 to <1/10): Nausea, vomiting, diarrhoea. Skin and subcutaneous tissue disorders Uncommon (≥1/1,000 to <1/100) Allergic skin reactions.

Frequency not known:

Fixed drug eruption.

Renal and urinary disorders Frequency not known:

Acute renal cortical necrosis. 4). 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.

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Patients should consult their doctor if menstrual bleeding is not reduced after three menstrual cycles. Patients with irregular menstrual bleeding should not use tranexamic acid until the cause of irregular bleeding has been established.

If menstrual bleeding is not adequately reduced by tranexamic acid, an alternative treatment should be considered. Tranexamic acid should be administered with care in patients receiving oral contraceptives because of the increased risk of thrombosis.

The following patients should consult their doctor prior to taking the product: • Women over the age of 45 years • Patients who are obese or diabetic • Those with polycystic ovary syndrome or a history of endometrial cancer in a first-degree relative • Women receiving unopposed oestrogen or tamoxifen.

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

The blood levels are increased in patients with renal insufficiency. 2). The use of tranexamic acid in cases of increased fibrinolysis due to disseminated intravascular coagulations is not recommended. Patients who experience visual disturbance should stop taking the product.

Clinical experience with tranexamic acid in menorrhagic children under 15 years of age is not available. In case of haematuria of renal origin (especially in haemophilia), there is a risk for urinary obstruction at the lower levels of the tract.

If left untreated, urinary obstruction may lead to serious consequences such as renal insufficiency, urinary tract infection, hydronephrosis, and anuria. Therefore, close monitoring is recommended for those patients with haematuria or risk of haematuria from the upper urinary tract.

1 • Mild to moderate renal insufficiency • Severe renal impairment (risk of accumulation) • Active thromboembolic disease • A previous thromboembolic event and a family history of thrombophilia • Haematuria • Irregular menstrual bleeding • Patients taking warfarin or other anticoagulants • Patients taking oral contraceptives because of the increased risk of thrombosis • Fibrinolytic conditions following disseminated intravascular coagulation • History of convulsions.