Xylometazoline vp

Patient Information Leaflet

Xylometazolin VP, 1 mg/g, nasal drops, solution
Xylometazolini hydrochloridum
Please read this leaflet carefully before using the medicine, as it contains important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet for future reference.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 5 days of treatment, or if you feel worse, consult your doctor.

Table of Contents

1. What Xylometazolin VP is and what it is used for
2. Important information before using Xylometazolin VP
3. How to use Xylometazolin VP
4. Possible side effects
5. How to store Xylometazolin VP
6. Contents of the pack and other information

1. What Xylometazolin VP is and what it is used for

Xylometazolin VP contains as the active substance xylometazoline hydrochloride, which acts on receptors located, among others, in blood vessels of the mucous membranes. The drug constricts blood vessels in the mucous membranes of the nose and throat, thereby reducing congestion, swelling, and exudation. It clears the nasal passages and the channels connecting the nasal cavity to the paranasal sinuses, reduces nasal discharge, and facilitates nasal breathing.
The effect of the medicine begins within 5–10 minutes after administration and lasts for several hours (up to 10 hours).
Xylometazolin VP is used:

• for nasal congestion due to swelling of the nasal mucosa in acute inflammation of the nasal mucosa (e.g. in colds and influenza),
• in sinusitis,
• in allergic rhinitis (hay fever).

2. Important information before using the medicine Xylometazolin VP

When not to use Xylometazolin VP:

• if the patient is allergic to xylometazoline, other vasoconstrictor medicines for nasal mucosa, or to any of the other ingredients of this medicine (listed in section 6),
• if the patient has chronic atrophic rhinitis,
• if the patient has narrow-angle glaucoma,
• in children under 12 years of age.

Warnings and precautions
Before starting to use Xylometazolin VP, consult a doctor or pharmacist.
Exercise particular caution when using Xylometazolin VP:

• if the patient has diabetes or hyperthyroidism,
• if the patient has heart disease, e.g. ischaemic heart disease, long QT syndrome, or hypertension,
• if symptoms persist for several days, as the medicine should not be used for longer than 5 days.

For hygienic reasons (risk of infection transmission), the medicine package should be used by only one patient.
Xylometazolin VP and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Do not use Xylometazolin VP simultaneously with medicines belonging to the following groups:

• monoamine oxidase inhibitors (e.g. selegiline, phenelzine),
• tricyclic antidepressants (e.g. imipramine, amitriptyline) due to the risk of increased blood pressure.

Use of Xylometazolin VP with food, drink and alcohol
The medicine is administered intranasally – food and drink do not affect its action.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor before using this medicine.
The medicine must not be used during pregnancy unless the doctor considers it absolutely necessary.
Driving and operating machinery
Xylometazolin VP does not affect the ability to drive or operate machinery when used at recommended doses and for a short period (up to 5 days). However, using excessively high doses or taking the medicine for too long may impair these abilities (causing nausea, headache, palpitations, cardiac arrhythmias, insomnia).

3. How to use Xylometazolin VP

This medicine should always be used exactly as described in the patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
The usual dose of Xylometazolin VP (1 mg/g) is:
Children over 12 years of age and adults: locally, 2 to 3 drops of the medicine into each nostril, 3 times daily.
Children from 2 to 12 years of age: a preparation with a lower concentration of xylometazoline hydrochloride (0.5 mg/g) should be used.
If you feel the effect of the medicine is too strong or too weak, consult your doctor.

Use of a higher than recommended dose of Xylometazolin VP
Overdose or accidental oral ingestion of the medicine (mainly in children) has been very rarely observed. Symptoms of overdose may include: lowered body temperature, slowed heart function, sweating, lethargy, drowsiness, and even coma (especially in children).
In case of overdose, consult a doctor immediately. Symptomatic treatment should be administered.

Missed dose of Xylometazolin VP
If you forget to use the next dose at the scheduled time, use it as soon as possible. However, if it is almost time for the next dose, skip the missed dose. Do not use a double dose to make up for a forgotten dose.

Stopping Xylometazolin VP
Discontinuation of Xylometazolin VP may lead to worsening of symptoms for which the medicine is being used.

If you have any further doubts concerning the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody will experience them.

Adverse effects occurring not very frequently (less than 1 in 100 people):

• Nosebleeds.

Frequency of the adverse effects listed below is unknown (cannot be estimated from the available data):

• Local burning sensation (may occur after prolonged use of xylometazoline), irritation,
• Dryness of the nasal mucosa, secondary swelling of the nasal mucosa (rebound nasal congestion), sneezing (these symptoms may occur after prolonged use of xylometazoline),
• Headache and dizziness,
• Insomnia,
• Palpitations, cardiac rhythm disturbances,
• Nausea,
• Blurred vision,
• Increased blood pressure.

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, Phone: +48 22 4921301, Fax: +48 22 4921309, Website: https://smz.ezdrowie.gov.pl.
Adverse effects can also be reported to the Marketing Authorization Holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Xylometazolin VP

Store below 25°C.
Keep in the original packaging to protect from light.
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Period of use after first opening the bottle: 60 days
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the package and other information

What Xylometazolin VP contains

• The active substance is xylometazoline hydrochloride. 1 g of nasal drops contains 1 mg of xylometazoline hydrochloride.
• The other ingredients are: disodium phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate, sodium chloride, benzalkonium bromide (10% solution), purified water.

What Xylometazolin VP looks like and contents of the pack
Xylometazolin VP is a solution. The carton box contains a polyethylene bottle (HDPE or LDPE) with a polyethylene dropper (LDPE) and a polyethylene cap (HDPE).
Marketing Authorisation Holder
PharmaSwiss Česká republika s.r.o.
Jankovcova 1569/2c
170 00 Prague 7
Czech Republic
Manufacturer
ICN Polfa Rzeszów S.A.
Przemysłowa 2
35-959 Rzeszów
Poland