Xilometazolin Vp

Package Leaflet: Information for the Patient

Xylometazolin VP, 1 mg/g, Nasal Drops, Solution

Xylometazolini hydrochloridum

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in the package leaflet for the patient or as directed by a doctor or pharmacist.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement after 5 days or the patient feels worse, they should contact their doctor.

Table of Contents of the Leaflet

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

Xylometazolin VP contains the active substance xylometazoline hydrochloride, which acts on receptors, including those found in the blood vessels of the nasal mucosa. The medicine narrows the blood vessels of the nasal mucosa and throat, reducing its congestion, swelling, and discharge. It clears the nasal passages and the passages leading from the nasal cavity to the paranasal sinuses, reduces nasal discharge, and makes breathing through the nose easier.
The effect of the medicine starts within 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 in the course of acute rhinitis (e.g., in colds and flu),
• 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 nasal decongestants, or 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, the patient should discuss it with their doctor or pharmacist.
Particular caution should be exercised when using Xylometazolin VP:

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

For hygiene reasons (risk of infection transmission), the packaging of the medicine should be used by one patient only.

Xylometazolin VP and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Xylometazolin VP should not be used at the same time as medicines belonging to the group of:

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

Using Xylometazolin VP with food, drink, and alcohol

The medicine is administered nasally - food and drink do not affect its action.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before using this medicine.
The medicine should not be used during pregnancy, unless the doctor considers it absolutely necessary.

Driving and using machines

Xylometazolin VP does not affect the ability to drive or operate machinery if used as recommended and for a short period (up to 5 days). However, using too high a dose and taking the medicine for too long may impair these abilities (causing nausea, headache, palpitations, arrhythmia, insomnia).

3. How to use Xylometazolin VP

This medicine should always be used exactly as described in the package leaflet for the patient or as directed by a doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.
Usually, the recommended 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 a day.
Children between 2 and 12 years of age: a medicine with a lower concentration of xylometazoline hydrochloride (0.5 mg/g) should be used.
If the patient feels that the effect of the medicine is too strong or too weak, they should consult their doctor.

Using a higher than recommended dose of Xylometazolin VP

Very rarely, overdose or accidental oral ingestion of the medicine (mainly in children) has been observed. Symptoms of overdose include: lowered body temperature, slowed heart rate, sweating, slowed movement, drowsiness, and even coma (especially in children).
In case of overdose, the patient should consult their doctor. Symptomatic treatment is used.

Missing a dose of Xylometazolin VP

If a dose of the medicine is missed, it should be taken as soon as possible. However, if it is almost time for the next dose, the missed dose should be skipped. A double dose should not be taken to make up for a missed dose.

Stopping the use of Xylometazolin VP

Stopping the use of Xylometazolin VP may cause the symptoms for which it is used to worsen.
If the patient has any further doubts about the use of this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Xylometazolin VP can cause side effects, although not everybody gets them.
Uncommon side effects (less common than 1 in 100 people):

• nosebleeds.

The frequency of the following side effects is not known (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 (drug-induced rhinitis), sneezing (these symptoms may occur after prolonged use of xylometazoline),
• headache and dizziness,
• insomnia,
• palpitations, arrhythmia,
• nausea,
• blurred vision,
• increased blood pressure.

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Xylometazolin VP

Store in a temperature below 25°C.
Store in the original packaging to protect from light.
The medicine should be kept 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 month stated.
Shelf life after opening the bottle: 60 days
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Xylometazolin VP contains

• The active substance of the medicine is xylometazoline hydrochloride. 1 g of nasal drops contains 1 mg of xylometazoline hydrochloride.
• The 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. The carton contains a polyethylene (HDPE or LDPE) bottle with a polyethylene (LDPE) dropper and a polyethylene (HDPE) cap with a tamper-evident ring, containing 10 ml of solution, and a patient leaflet.

Marketing authorization holder

PharmaSwiss Česká republika s.r.o.
Jankovcova 1569/2c
170 00 Prague 7
Czech Republic

Manufacturer

ICN Polfa Rzeszów S.A.
ul. Przemysłowa 2
35-959 Rzeszów
Poland

Date of last revision of the leaflet: