Xilometazolin Vibrocil

Package Leaflet: Information for the Patient

Xylometazolin Vibrocil; 1 mg/ml, 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 advised by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• 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 after 10 days there is no improvement or the patient feels worse, they should contact their doctor.

Table of Contents of the Leaflet:

• 1. What is Xylometazolin Vibrocil and what is it used for
• 2. Important information before using Xylometazolin Vibrocil
• 3. How to use Xylometazolin Vibrocil
• 4. Possible side effects
• 5. How to store Xylometazolin Vibrocil
• 6. Package contents and other information

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

The active substance of Xylometazolin Vibrocil is xylometazoline hydrochloride.
Xylometazolin Vibrocil is a locally acting medicine that, by constricting blood vessels, reduces congestion and swelling of the nasal mucosa and the amount of discharge.
For patients with a feeling of a blocked nose, it facilitates breathing through the nose.
The special composition of the medicine (moisturizing substances) prevents drying and irritation of the nasal mucosa.
The effect of Xylometazolin Vibrocil starts within 2 minutes and lasts up to twelve hours.
Xylometazolin Vibrocil is indicated for use in adults and adolescents over 12 years of age.
Indications for use:
Excessive congestion of the nasal mucosa occurring in the course of a cold, hay fever, allergic rhinitis, sinusitis. The medicine facilitates the flow of discharge from inflamed paranasal sinuses. Due to the reduction of congestion of the nasal-pharyngeal mucosa, it can be used as an adjunct in otitis media.
Xylometazolin Vibrocil facilitates nasal endoscopy (examination of the nasal cavity).

2. Important information before using Xylometazolin Vibrocil

When not to use Xylometazolin Vibrocil

Warnings and precautions

Before using Xylometazolin Vibrocil, consult a doctor in case of:

• high blood pressure,
• heart disease (e.g. long QT syndrome),
• hyperthyroidism,
• diabetes,
• prostate enlargement,
• a benign tumor of the adrenal gland that produces large amounts of adrenaline and noradrenaline (pheochromocytoma),
• taking certain antidepressant medicines known as monoamine oxidase inhibitors (MAOIs) or taking them within the last 2 weeks,
• hypersensitivity to substances with a similar effect to xylometazoline. In sensitive patients, Xylometazolin Vibrocil may cause insomnia, dizziness, irregular heartbeat, increased blood pressure, or tremors.

Xylometazolin Vibrocil should not be used for more than 10 consecutive days. If symptoms persist, consult a doctor.
Using the medicine for a period longer than 10 days or in doses larger than recommended may cause worsening of symptoms or their recurrence.
Xylometazolin Vibrocil should not be used in the eyes or in the mouth.
Do not use a higher dose than recommended, especially in children and the elderly.

Children and adolescents

Xylometazolin Vibrocil should not be used in children under 12 years of age.

Other medicines and Xylometazolin Vibrocil

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines you plan to take.
Do not use Xylometazolin Vibrocil if you are taking certain medicines used to treat depression. These are:

• monoamine oxidase inhibitors (MAOIs): DO NOT use Xylometazolin Vibrocil if you are taking MAOIs or have taken them within the last 14 days,
• tricyclic and tetracyclic antidepressants.

If you have taken any of the above medicines before using Xylometazolin Vibrocil, consult your doctor.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine.
Do not use Xylometazolin Vibrocil during pregnancy.
During breastfeeding, Xylometazolin Vibrocil can be used only after consulting a doctor.

Driving and using machines

Xylometazolin Vibrocil, when used as recommended, does not affect or has a negligible effect on the ability to drive and use machines.

Xylometazolin Vibrocil contains benzalkonium chloride

This medicine contains approximately 0.0025 mg of benzalkonium chloride in each drop, which corresponds to 0.1 mg of benzalkonium chloride in 1 ml of solution. Benzalkonium chloride may cause
irritation or swelling inside the nose, especially if used for a long time.

3. How to use Xylometazolin Vibrocil

This medicine should always be used exactly as described in the package leaflet for the patient or as advised by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.

Xylometazolin Vibrocil should be used only in the nose (also in otitis media).

To avoid spreading the infection, one package of the medicine should be used by only one patient.
Adults and adolescents over 12 years of age:
2 to 4 drops of Xylometazolin Vibrocil solution into each nostril 3 times a day.
Do not use more than 3 doses of the medicine into each nostril per day. It is recommended to take the last dose of the medicine directly before going to bed.
Do not use for more than 10 consecutive days.
Xylometazolin Vibrocil should not be used in children under 12 years of age.

Method of use

• 1. Clean the nose.
• 2. Unscrew the cap containing the dropper.
• 3. Tilt the head back.
• 4. Instill drops into both nostrils and for some time keep the head tilted back, so the drops spread throughout the nasal cavity.

• 5. After use, screw the bottle cap back on.

Using a higher dose of Xylometazolin Vibrocil than recommended

In case of using a higher dose of the medicine than recommended, consult a doctor or pharmacist immediately.
Symptoms of overdose are severe dizziness, excessive sweating, significantly lowered body temperature, headache, slow heartbeat, breathing difficulties, coma, convulsions, hypertension (high blood pressure), which may be followed by hypotension.
Apply symptomatic treatment.

Missing a dose of Xylometazolin Vibrocil

Do not use a double dose to make up for a missed dose.
If you have any further doubts about using this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Xylometazolin Vibrocil can cause side effects, although not everybody gets them.
STOP using Xylometazolin Vibrocil and consult a doctor immediately if you experience any of the following side effects, which may be symptoms of an allergic reaction:

• difficulty breathing or swallowing,
• swelling of the face, lips, tongue, or throat,
• itching with red rash or blisters. These symptoms occur very rarely (less often than in 1 in 10,000 patients using the medicine).

Common side effects(occurring in 1 to 10 out of 100 patients):
dryness or irritation of the nasal mucosa, nausea, headache, burning sensation at the site of administration.
Uncommon side effects(occurring less often than in 1 out of 100 patients):
nasal bleeding.
Very rare side effects(occurring less often than in 1 out of 10,000 patients):
allergic reaction (skin rash, itching), transient vision disturbances, irregular or accelerated heart rate.

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, tell your 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:
Aleje Jerozolimskie 181C, 02-222 Warsaw, tel: +48 22 49 21 301, fax: +48 22 49 21 309,
website: https://smz.ezdrowie.gov.pl.
Reporting side effects will help to gather more information on the safety of the medicine.
Side effects can also be reported to the marketing authorization holder.

5. How to store Xylometazolin Vibrocil

Keep the medicine out of the sight and reach of children.
Store in a temperature below 30°C.
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.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Xylometazolin Vibrocil contains

• The active substance of Xylometazolin Vibrocil is xylometazoline hydrochloride. One ml of solution contains 1 mg of xylometazoline hydrochloride.
• The other ingredients of the medicine are: benzalkonium chloride, disodium edetate, sodium dihydrogen phosphate dihydrate, disodium phosphate dodecahydrate, sodium chloride, sorbitol 70%, hypromellose 4000, purified water.

What Xylometazolin Vibrocil looks like and what the package contains

The package of Xylometazolin Vibrocil is a bottle with a screw cap containing a dropper with a pipette, containing 10 ml of solution, in a cardboard box.

Marketing authorization holder:

Haleon Poland Sp. z o.o.
ul. Rzymowskiego 53
02-697 Warsaw
tel. 800 702 849

Importer:

Haleon Germany GmbH
Barthstrasse 4
80339 Munich
Germany

Date of last revision of the leaflet:

November 2024