Short-term use for haemorrhage or risk of haemorrhage in increased fibrinolysis or fibrinogenolysis. Local fibrinolysis as occurs in the following conditions:
Prostatectomy and bladder surgery
Menorrhagia
Epistaxis
Conisation of the cervix
Traumatic hyphaema
Hereditary angioneurotic oedema
Management of dental extraction in haemophiliacs

Route of administration: Oral.

1.      Local fibrinolysis: The recommended standard dosage is 15 - 25 mg/kg bodyweight (i.e. 2 - 3 tablets) two to three times daily. For the indications listed below the following doses may be used:
1a.  Prostatectomy: Prophylaxis and treatment of haemorrhage in high risk patients should commence pre- or post-operatively with tranexamic acid injection; thereafter 2 tablets three to four times daily until macroscopic haematuria is no longer present.
1b.  Menorrhagia: Recommended dosage is 2 tablets 3 times daily as long as needed for up to 4 days. If very heavy menstrual bleeding, dosage may be increased. A total dose of 4 g daily (8 tablets) should not be exceeded. Treatment with Femic should not be initiated until menstrual bleeding has started.
1c.   Epistaxis: Where recurrent bleeding is anticipated oral therapy (2 tablets three times daily) should be administered for 7 days.
1d.  Conisation of the cervix: 3 tablets three times daily.
1e.   Traumatic hyphaema: 2 - 3 tablets three times daily. The dose is based on 25 mg/kg three times a day.

2.      Hereditary angioneurotic oedema: Some patients are aware of the onset of the illness; suitable treatment for these patients is intermittently 2 - 3 tablets two to three times daily for some days. Other patients are treated continuously at this dosage.

3.      Haemophilia: In the management of dental extractions 2 - 3 tablets every eight hours. The dose is based on 25 mg/kg.

Renal insufficiency: By extrapolation from clearance data relating to the intravenous dosage form, the following reduction in the oral dosage is recommended for patients with mild to moderate renal insufficiency.

Serum Creatinine (μmol/l)                  Dose tranexamic acid
120 – 249                                                  15 mg/kg body weight twice daily
250 – 500                                                 15 mg/kg body weight/day

Children's dosage: This should be calculated according to body weight at 25 mg/kg per dose. However, data on efficacy, posology and safety for these indications are limited.

Elderly patients: No reduction in dosage is necessary unless there is evidence of renal failure (see guidelines below).

Hypersensitivity to tranexamic acid or any of the other ingredients. Severe renal impairment because of risk of accumulation. Active thromboembolic disease. History of venous or arterial thrombosis. Fibrinolytic conditions following consumption coagulopathy. History of convulsions.

In case of haematuria of renal origin (especially in haemophilia), there is a risk of mechanical anuria due to formation of a ureteral clot.

In the long-term treatment of patients with hereditary angioneurotic oedema, regular eye examinations (e.g. visual acuity, slit lamp, intraocular pressure, visual fields) and liver function tests should be performed.

Patients with irregular menstrual bleeding should not use Femic until the cause of irregular bleeding has been established. If menstrual bleeding is not adequately reduced by Femic, 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.

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

The blood levels are increased in patients with renal insufficiency. Therefore, a dose reduction is recommended (see section 4.2).

The use of tranexamic acid in cases of increased fibrinolysis due to disseminated intravascular coagulation is not recommended.

Patients who experience visual disturbance should be withdrawn from treatment.

Clinical experience with Femic in menorrhagic children under 15 years of age is not available.

Femic will counteract the thrombolytic effect of fibrinolytic preparations.

Pregnancy
Although there is no evidence from animal studies of a teratogenic effect, the usual caution with use of drugs in pregnancy should be observed.

Tranexamic acid crosses the placenta.

Lactation
Tranexamic acid passes into breast milk to a concentration of approximately one hundredth of the concentration in the maternal blood. An antifibrinolytic effect in the infant is unlikely.

None known.

Adverse events are listed below by system organ class and frequency. Frequencies are defined as: very common (≥1/l0), common (≥1/100 and <1/10), uncommon (≥1/1000 and <1/100), rare (≥ 1/10,000 and <1/1000) and very rare (<1/10,000) including isolated reports, 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

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

Skin and subcutaneous tissue disorders
Rare: Allergic skin reactions

To reports any side effect(s):

• Saudi Arabia:

The National Pharmacovigilance Center (NPC):

• Fax: +966 11 205 7662
• SFDA Call Center: 19999
• Email: npc.drug@sfda.gov.sa
• Website: https://ade.sfda.gov.sa

 

• Other GCC States:

Please contact the relevant competent authority.

Symptoms may be nausea, vomiting, orthostatic symptoms and/or hypotension. Initiate vomiting, then stomach lavage, and charcoal therapy. Maintain a high fluid intake to promote renal excretion. There is a risk of thrombosis in predisposed individuals. Anticoagulant treatment should be considered.

Pharmacotherapeutic group: Antihemorrhagics, Antifibrinolytics. ATC code: B02AA02

Tranexamic acid is an antifibrinolytic compound which is a potent competitive inhibitor of the activation of plasminogen to plasmin. At much higher concentrations it is a non-competitive inhibitor of plasmin. The inhibitory effect of tranexamic acid in plasminogen activation by urokinase has been reported to be 6 - 100 times and by streptokinase 6 - 40 times greater than that of aminocaproic acid. The antifibrinolytic activity of tranexamic acid is approximately ten times greater than that of aminocaproic acid.

Absorption
Peak plasma tranexamic acid concentration is obtained immediately after intravenous administration (500 mg). Then concentration decreases until the 6th hour. Elimination half-life is about 3 hours.

Distribution
Tranexamic acid administered parenterally is distributed in a two compartment model. Tranexamic acid is delivered in the cell compartment and the cerebrospinal fluid with delay. The distribution volume is about 33% of the body mass.

Tranexamic acid crosses the placenta, and may reach one hundredth of the serum peak concentration in the milk of lactating women.

Elimination
Tranexamic acid is excreted in urine as unchanged compound. 90% of the administered dose is excreted by the kidney in the twelve first hours after administration (glomerular excretion without tubular reabsorption).

Following oral administration, 1.13% and 39% of the administered dose were recovered after 3 and 24 hours respectively.

Plasma concentrations are increased in patients with renal insufficiency.

There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the Summary of Product Characteristics.

Core
Microcrystalline cellulose;
Povidone K30;
Hydroxypropyl cellulose;
Colloidal anhydrous silica;
Purified talc;
Magnesium stearate

Coating
Ferric oxide red;
Ferric oxide yellow;
Lake sunset yellow;
Polyethylene glycol;
Polyvinyl alcohol;
Talc;
Titanium dioxide.

None known.

24 months.

Store below 30°C.

Blister packs of clear PVC film with printed aluminium blister foil containing 60 tablets.

No special requirements.