Tranexamic Acid 100 mg/ml Oral Solution – Summary of Product Characteristics (SmPC) for healthcare professionals

1 NAME OF THE MEDICINAL PRODUCT

Tranexamic Acid 100 mg/ml Oral Solution

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each 1 ml of solution contains 100 mg tranexamic acid.

Excipient(s) with known effect

Each 1 ml of solution contains 1.5 mg sodium methyl parahydroxybenzoate.

For the full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Oral solution

Clear, colourless to yellowish solution with strawberry odour.

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

1. 1. Short-term use for haemorrhage or risk of haemorrhage in increased fibrinolysis or fibrinogenolysis. Local fibrinolysis as occurs in the following conditions:

a. Prostatectomy and bladder surgery

b. Menorrhagia

c. Epistaxis

d. Conisation of the cervix

e. Traumatic hyphaema

1. 2. Hereditary angioedema.
2. 3. Management of dental extraction in haemophiliacs.

4.2 Posology and method of administration

Posology

1. 1. Local fibrinolysis: The recommended standard dosage is 15-25 mg/kg bodyweight (0.15 ml-0.25 ml/kg bodyweight) 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 10 ml of the oral solution three to four times daily until macroscopic haematuria is no longer present.

1b. Menorrhagia: Recommended dosage is 10 ml of the oral solution 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 (40 ml of the oral solution) should not be exceeded. Treatment with Tranexamic acid should not be initiated until menstrual bleeding has started.

1c. Epistaxis: Where recurrent bleeding is anticipated oral therapy (10 ml of the oral solution three times daily) should be administered for 7 days.

1d. Conisation of the cervix: 15 ml of the oral solution three times daily.

1e. Traumatic hyphaema: 10 ml-15 ml of the oral solution three times daily. The dose is based on 25 mg/kg (0.25 ml/kg) three times a day.

1. 2. Hereditary angioedema: Some patients are aware of the onset of the illness; suitable treatment for these patients is intermittently 10 ml-15 ml of the oral solution two to three times daily for some days. Other patients are treated continuously at this dosage.
2. 3. Haemophilia: In the management of dental extractions 10 ml-15 ml of the oral solution every eight hours. The dose is based on 25 mg/kg (0.25 ml/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 (0.15 ml/kg) body weight twice daily

250-500 15 mg/kg (0.15 ml/kg) body weight/day

Children’s dosage: This should be calculated according to body weight at 25 mg/kg (0.25 ml/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).

Method of administration

For oral use.

A 10 ml graduated oral syringe with intermediate graduations of 0.25 ml and a “Press-In” Bottle Adapter (PIBA) are provided with the product.

1. 1. Open the bottle and at first use insert the “Press-In” Bottle Adapter (PIBA).
2. 2. Insert the syringe into the PIBA and draw out the required volume from the inverted bottle.
3. 3. Remove the filled syringe from the bottle in the upright position.
4. 4. Discharge the syringe contents into the mouth. Repeat steps 2 to 4 as needed to achieve the required dose.
5. 5. Replace the cap on the bottle (PIBA remains in place).
6. 6. Rinse the syringe with water and allow to air dry.

If you are giving Tranexamic acid oral solution to a child:

• Make sure that the child is sitting up or standing.
• Put the syringe into the child’s mouth, placing the barrel-opening in the area between the gums and the inside of the cheek.
• Push the plunger slowly, giving the child time to swallow the medicine as it squirts out. Do not push the plunger too quickly as the medicine may come out too quickly and the child may choke.
• Give the child some water to drink in order to ensure that all the medicine is washed down.

Note

If necessary, Tranexamic acid oral solution can be administered via polyurethane (PUR) or polyvinyl chloride (PVC) intragastric feeding tubes (nasogastric (NG) or percutaneous endoscopic gastrostomy (PEG) tubes). Tubes should be rinsed with 5 ml of water immediately after administration.

For further information see section 6.6.

4.3 Contraindications

Hypersensitivity to the active substance or any of the excipients listed in section 6.1.

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.

4.4 Special warnings and precautions for use

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.

In the long-term treatment of patients with hereditary angioedema, 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 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.

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. 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 Tranexamic acid in menorrhagic children under 15 years of age is not available.

Cases of convulsions have been reported in association with tranexamic acid treatment. In cardiac surgery, most of the cases were reported following intravenous (i.v.) injection of tranexamic acid in high doses.

Tranexamic Acid 100 mg/ml Oral Solution contains sodium methyl parahydroxybenzoate and sodium.

Parahydroxybenzoates may cause allergic reactions (possibly delayed).

This medicinal product contains less than 1 mmol sodium (23 mg) per 15 ml of solution, that is to say essentially ‘sodium-free’.

4.5 Interaction with other medicinal products and other forms of interaction

Tranexamic acid will counteract the thrombolytic effect of fibrinolytic preparations.

4.6 Fertility, pregnancy and lactation

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.

Breast-feeding

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.

Fertility

No human data on the effect of tranexamic acid on fertility are available.

4.7 Effects on ability to drive and use machines

Tranexamic acid has no or negligible influence on the ability to drive and use machines. Visual disturbances may occur following administration of tranexamic acid.

4.8 Undesirable effects

Adverse events are listed below by system organ class and frequency.

Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 and < 1/10), uncommon (≥ 1/1 000 and < 1/100), rare (≥ 1/10 000 and < 1/1 000) and very rare (< 1/10 000) including isolated reports, not known (cannot be estimated from the available data).

≥

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 via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9 Overdose

Signs and symptoms may include nausea, diarrhoea, vomiting, orthostatic symptoms and/or hypotension, dizziness, headache and convulsions. 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.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

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.

5.2 Pharmacokinetic properties

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.

5.3 Preclinical safety data

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.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Sodium methyl parahydroxybenzoate (E219)

Sucralose (E955)

Sodium dihydrogen phosphate dihydrate (E339(i))

Strawberry flavour (including propylene glycol (E1520))

Phosphoric acid, concentrated (E338)

Purified water

6.2 Incompatibilities

None known.

6.3 Shelf life

15 months.

After first opening use within 4 months.

6.4 Special precautions for storage

Store below 25 °C.

Store in the original package in order to protect from light.

6.5 Nature and contents of container

Amber, type III glass bottle safely closed with a child resistant screw cap with tamper evident closure.

Each bottle contains 100 ml or 200 ml of this medicinal product.

Not all pack sizes may be marketed.

A 10 ml graduated oral syringe with intermediate graduations of 0.25 ml and a “press in” syringe/bottle adapter are also provided.

6.6 Special precautions for disposal

Instructions for administration of Tranexamic acid oral solution via nasogastric (NG) or percutaneous endoscopic gastrostomy (PEG) tubes.

Tranexamic acid oral solution is suitable for use with polyurethane (PUR) or polyvinyl chloride (PVC) NG and PEG tubes with diameters ranging from 6 to 14 Fr.

1. 1. Ensure the enteral feeding tube is free from any obstructions before administering this medicine.
2. 2. Administer the required dose of Tranexamic acid oral solution into the tube using a suitable measuring device.
3. 3. Immediately flush the tube with 5 ml of boiled cooled water.

No special requirements for disposal.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

7 MARKETING AUTHORISATION HOLDER

Colonis Pharma Limited

25 Bedford Square,

Bloomsbury, London,

WC1B 3HH,

United Kingdom

8 MARKETING AUTHORISATION NUMBER(S)

PL 41344/0084

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION

19/08/2026

10 DATE OF REVISION OF THE TEXT

19/08/2026