Risk What is known Preventability Increased symptoms of congestion when the effects of

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1 VI.2 Elements for a Public Summary VI.2.1 Overview of disease epidemiology Nasal congestion Nasal congestion and rhinorrhoea (runny nose) are symptoms that commonly occur together. The most common causes are viral infections and allergic reactions. Dry air may provoke congestion. Acute sinusitis (inflammation of the sinus) is slightly less common, and a nasal foreign body is unusual (and occurs predominantly in children). Patients who use topical decongestants (applied directly to the nasal cavity) for more than one day often experience significant rebound congestion (swelling of the nasal mucosa) when the effects of the drug wear off, causing them to continue using the decongestant in a vicious circle of persistent, worsening congestion. This situation (rhinitis medicamentosa) may persist and may be misinterpreted as a continuation of the original problem rather than a consequence of treatment. Nasal congestion can also lead to sinusitis, otitis media, and the onset or worsening of mild to severe sleep disturbances, including obstructive sleep apnoea (temporary pause in breathing). VI.2.2 Summary of treatment benefits 14 The rapid onset and duration of xylometazoline decongestive properties have been shown throughout all literature trials and the substance shows a good local tolerance. Long-term treatment (more than 7 days) is not beneficial due to the occurrence of increased symptoms of congestion when the effects of the medicine wear off. VI.2.3 Unknowns relating to treatment benefits Based on the currently available data an important gap in knowledge was identified in rela- tion to xylometazoline efficacy in children less than 2 years of age. VI.2.4 Summary of safety concerns Important identified risks Risk What is known Preventability Increased symptoms of congestion when the effects of As for all other locally administered vasoconstrictors, xythe medicine wear off (Rhinitis medicamentosa) lometazoline hydrochloride Swelling of the nasal mucosa (the inner lining of the nose and sinuses) may recur when long-term treatment with xylometazoline is stopped. In order to prevent this, the treatment period should be kept as short as possible. should not be used for more than seven consecutive days. Long or excessive use can cause "rebound" conges- tion. The recommended dose may not be exceeded, espe- cially in children. The symp- toms should be monitored.

2 Use after some surgical operations: removal of a tumour (adenoma) of the pituitary gland (transsphenoidal hypophysectomy) or transnasal/transoral operations where the membrane covering of brain and spinal cord (the dura mater) has been exposed Xylometazoline can increase blood pressure and heart rate may occur. This can lead to an unsatisfactory hormonal recovery after the mentioned surgical operations and to decrease in the pituitary gland function Xylometazoline should not be used after the above mentioned operations and should be used with caution in patients with conditions that may be associated with changes in blood pressure Risk Using a drug in quantities bigger than are recommended (Overdose) Use in patients with increased pressure in the eye (angle-closure glaucoma) Use in patients: with diseases relating to the heart and blood vessels (cardiovascular diseases), increased blood pressure, over-active thyroid gland, a metabolic disorder where sugar is not used properly in the body (diabetes), in connection with increase in the size of the prostate, high blood pressure due to a tumour near the kidney (phaeochromocytoma) Concomitant use of xylometazoline with drugs for depression treatment (tri- or tetracyclic antidepressants) What is known (Including reason why it is considered a potential risk) Using too much, especially in infants, can cause major problems with the central nervous system. Symptoms of overdose may include sleepiness, dry mouth, sweating, fast or irregular heartbeat and increased blood pressure. Xylometazoline can affect blood pressure and this can lead to uncontrolled intraocular pressure. As a consequence, the eyes disease and visual field loss may progress. Xylometazoline can affect blood pressure and increase of arterial pressure and heart rate may occur. Function of the thyroid gland and elevations of the sugar in the blood were noted. Worsening of limitation of the urinary flow and difficulty in passing water (urinary retention) has been described for substances similar with xylometazoline (oral sympathomimetics) Substances similar with xylometazoline (sympathomimetic nasal decongestants) are liable to cause an increased blood pressure crisis if used concomitantly with drugs for depression treatment. This is a theoretical drug interaction

3 Concomitant use of xylometazoline with drugs for depression treatment (Monoamine oxidase (MAO) inhibitors), or for two weeks following the use of the drugs taken for depression Substances similar with xylometazoline (sympathomimetic nasal decongestants) are liable to cause an increased blood pressure crisis if used concomitantly with drugs for depression treatment. This is a theoretical drug interaction Missing information Risk NA What is known NA VI.2.5 Summary of risk minimisation measures by safety concern All medicines have a Summary of Product Characteristics (SmPC) which provides physi- cians, pharmacists and other health care professionals with details on how to use the medicine, the risks and recommendations for minimising them. An abbreviated version of this in lay language is provided in the form of the package leaflet (PL). The measures in these documents are known as routine risk minimisation measures. This medicine has no additional risk minimisation measures. VI.2.6 Planned post authorisation development plan No post-authorisation safety or efficacy studies are ongoing or are planned to be conducted for xylometazoline. VI.2.7 Summary of changes to the Risk Management Plan over time Major changes to the Risk Management Plan over time Version Date Safety Concerns Comment Important identified risks Rebound effect Misuse Overdose Long term use (more than 7 days) Lack of efficacy in children aged 2-6 years Lack of efficacy in children aged 6-12 years Important identified risks Rebound effect Misuse Overdose Long term use (more than 7 days) Four products have been removed from the RMP because they were transferred. The product related risks were also removed. Inclusion of one product (DK/H/2402/ /DC)

4 The safety concern Rebound effect was renamed to Rhinitis medicamentosa Deletion of the following safety concerns: Misuse and Long term use (more than 7 days) Addition of the following safety concerns: Important identified risk Use after transsphenoidal hypophysectomy or transnasal/transoral operations where the dura mater has been exposed Changes made according to the the requests from the Day 70 AR from the RMS of the procedure DK/H/2402/ /DC Use in patients with angleclosure glaucoma Use in patients with cardiovascular diseases, hypertension, hyperthyroidism or diabetes, and in connection with prostat- ic hypertrophy and phaeochromocytoma Concomitant use of xylometazoline with tri- or tetracyclic antidepressants Concomitant use of xylometazoline with Monoamine oxidase (MAO) inhibitors, or for two weeks following the use of MAO inhibitors No change Administrative update; Annex 2 - SmPC & Package Leaflet are updated according to the latest version of the PI. Annex 3 - Licensing status in the EEA is updated.

5 5.0 xx No change Changes made according to the latest proposed PI which affected the proposed indication and the information regarding the safety concerns