HAEMONORD

Route of administration:

Haemonord 50mg/ml Mouthwash should be held in the mouth for 2 minutes and then spat out. Patients should be instructed not to swallow the mouthwash. The mouthwash should be gently swilled over the affected area and vigorous swilling should be avoided (please see Section

No systemic reactions have been reported in relation to the use of tranexamic acid mouthwash preparations. There is a potential for hypersensitivity reactions as found with systemically administered products. Tabulated list of adverse reactions 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.

System organ class Common ≥ 1/100 to < 1/10 Uncommon ≥ 1/1,000 to < 1/100 Frequency not known (cannot be estimated from the available data) Immune system disorders - Hypersensitivity reactions including anaphylaxis 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 4 of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

). Do not eat or drink for one hour after using Haemonord 50mg/ml Mouthwash.

Adults:

One ampoule (10 mL) of the 50 mg/ml solution equivalent to 500 mg tranexamic acid, used four times daily for 2 minutes and expectorated. The recommended duration of dosing is two days to a maximum of five days. The mouthwash should not be swallowed.

Paediatric Population:

For children aged 6-17 years the recommended dose is 5-10mL of the 50 mg/ml solution used four times a day for 2 minutes and expectorated. The recommended 2 duration of dosing is two days to a maximum of five days. The mouthwash should not be swallowed.

It is advised that children should be supervised to minimise the possibility of swallowing. 1.

Elderly:

No alteration of daily dosage or frequency of dosing, or route of administration are required.

Patients with Renal impairment:

No alteration of daily dosage or frequency of dosing, or route of administration are required. There are no clinical data on tranexamic acid mouthwash use in patients with severe renal impairment requiring dialysis. 3) Patients with Hepatic impairment: No alteration of daily dosage or frequency of dosing, or route of administration are required.

There are no clinical data on tranexamic acid mouthwash use in patients with hepatic failure. 1. Active thromboembolic disease. In patients in whom estimated creatinine clearance is less than 20mL/min, use of Haemonord 50mg/ml Mouthwash should be avoided due to the risk of accumulation.

4 Special warnings and precautions for use In order to avoid significant systemic absorption of tranexamic acid it is important to ensure that Haemonord 50mg/ml Mouthwash is held in the mouth for no longer than two minutes and then spat out, and that patients are instructed not to swallow the mouthwash.

Vigorous swilling of the mouthwash should be avoided to prevent displacing blood clots.

1. Active thromboembolic disease. In patients in whom estimated creatinine clearance is less than 20mL/min, use of Haemonord 50mg/ml Mouthwash should be avoided due to the risk of accumulation.