Xylometazoline vp

Patient Information Leaflet

Xylometazolin VP, 0,5 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, so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any possible adverse reactions 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 membrane. The medicine 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 leading from the nasal cavity to the paranasal sinuses, reduces nasal discharge and facilitates nasal breathing.
The effect of the medicine begins 5–10 minutes after administration and lasts for several hours (up to 10 hours).
Xylometazolin VP is used:

• in nasal congestion caused by swelling of the nasal mucosa, such as in acute rhinitis (e.g. in colds and influenza),
• in sinusitis,
• in allergic rhinitis (hay fever).

2. Important information before using Xylometazolin VP

When not to use Xylometazolin VP:

• if the patient is allergic to xylometazoline, other vasoconstrictor nasal mucosa medicines, 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 2 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 transmitting infection), the medicine container 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 intends 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 might be pregnant, or is planning to become pregnant, she should consult a doctor before using this medicine.
This medicine should not be used during pregnancy unless clearly necessary, as determined by a physician.
Xylometazolin VP (0.5 mg/g) is intended for use in children aged 2 to 12 years.
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 using 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 this patient leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The usual dose of Xylometazolin VP (0.5 mg/g) is:
Children aged 2 to 12 years: Apply locally, 1 to 2 drops of the medicine into each nostril once or twice daily.
Children over 12 years of age and adults: Should use the preparation with a higher concentration of xylometazoline hydrochloride (1 mg/g).
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: decreased body temperature, slowed heart rate, sweating, lethargy, drowsiness, and even coma (especially in children).
In case of overdose, seek medical advice immediately. Treatment is symptomatic.

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 result in worsening of symptoms for which the medicine was being used.

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Adverse reactions occurring not very frequently (less frequently than in 1 out of 100 people):

• nosebleed.

Frequency of the adverse reactions 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 mucosa inflammation), sneezing (these symptoms may occur after prolonged use of xylometazoline),
• pain and dizziness,
• insomnia,
• palpitations, cardiac arrhythmia,
• nausea,
• blurred vision,
• increased blood pressure.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions 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, Tel.: + 48 22 49 21 301, Fax: + 48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl.
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions 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 out of the 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.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Xylometazolin VP contains

• The active substance is xylometazoline hydrochloride. 1 g of nasal drops contains 0.5 mg of xylometazoline hydrochloride.
• Other ingredients of the medicine 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. In the cardboard box there is a polyethylene bottle
with a dropper and a cap with a polyethylene tamper-evident ring, containing 10 ml of solution.

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