Xylometazoline vibrocil
Poland
Table of Contents
Patient Information Leaflet
Xylometazolin Vibrocil; 1 mg/ml, nasal drops, solution
Xylometazolini hydrochloridum
Please read this leaflet carefully before using the medicine, as it contains important information for you.
Always use this medicine exactly as described in this patient leaflet or as directed by your doctor or pharmacist.
- Keep this leaflet for future reference.
- If you need advice or further information, please consult your pharmacist.
- If you experience any side effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
- If there is no improvement or if you feel worse after 10 days, consult your doctor.
Table of contents:
- What Xylometazolin Vibrocil is and what it is used for
- Important information before using Xylometazolin Vibrocil
- How to use Xylometazolin Vibrocil
- Possible side effects
- How to store Xylometazolin Vibrocil
- Contents of the pack and other information
1. What Xylometazolin Vibrocil is and what it is used for
The active substance in Xylometazolin Vibrocil is xylometazoline hydrochloride.
Xylometazolin Vibrocil is a locally acting medicine that reduces nasal mucosal congestion and swelling, as well as nasal discharge, by constricting blood vessels.
It helps patients with a stuffy nose to breathe more easily through the nose.
The special formulation of the medicine (containing moisturizing agents) prevents drying out and irritation of the nasal mucosa.
The effect of Xylometazolin Vibrocil begins 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:
Excessive nasal mucosal congestion occurring during colds, hay fever, allergic rhinitis, and sinusitis. The medicine facilitates drainage of secretions from inflamed paranasal sinuses. By reducing congestion of the nasopharyngeal mucosa, it may be used as supportive treatment in otitis media.
Xylometazolin Vibrocil facilitates nasal speculum examination (examination of the nasal cavity).
2. Important information before using Xylometazolin Vibrocil
When not to use Xylometazolin Vibrocil
- if the patient is allergic to xylometazoline hydrochloride or any of the other ingredients of this medicine (listed in section 6),
- if the patient has undergone surgery via the nose, e.g. removal of the pituitary gland or any procedure exposing the dura mater (brain surgery performed through the nose or mouth),
- if the patient has narrow-angle glaucoma (increased pressure in the eye),
- if the patient has very dry nasal mucosa (atrophic rhinitis or drying inflammation of the nasal mucosa).
Warnings and precautions
Before using Xylometazolin Vibrocil, consult a doctor if the patient:
- has high blood pressure,
- has heart disease (e.g. long QT syndrome),
- has hyperthyroidism,
- has diabetes,
- has benign prostatic hyperplasia,
- has a benign adrenal gland tumour producing high levels of adrenaline and noradrenaline (pheochromocytoma),
- is taking certain antidepressant medicines known as monoamine oxidase inhibitors (MAOIs), or has taken them within the last 2 weeks,
- is hypersensitive to substances with effects similar to xylometazoline. In sensitive patients, Xylometazolin Vibrocil may cause insomnia, dizziness, irregular heartbeat, high blood pressure, or tremor.
Do not use Xylometazolin Vibrocil for longer than 10 consecutive days. If symptoms persist, consult a doctor.
Using this medicine for longer than 10 days or in doses higher than recommended may worsen symptoms or cause their recurrence.
Do not apply Xylometazolin Vibrocil to the eyes or inside the mouth.
Do not exceed the recommended dose, especially in children and elderly people.
Children and adolescents
Do not use Xylometazolin Vibrocil in children under 12 years of age.
Other medicines and Xylometazolin Vibrocil
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines planned for use.
Do not use Xylometazolin Vibrocil if taking certain medicines used to treat depression, such as:
- monoamine oxidase inhibitors (MAOIs): DO NOT use Xylometazolin Vibrocil if taking MAOIs or have taken such medicines within the last 14 days,
- tricyclic and tetracyclic antidepressants.
If any of the above medicines are being taken, consult a doctor before using Xylometazolin Vibrocil.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Do not use Xylometazolin Vibrocil during pregnancy.
During breastfeeding, Xylometazolin Vibrocil should only be used after consulting a doctor.
Driving and operating machinery
Xylometazolin Vibrocil, when used at recommended doses, has no effect or negligible effect on the ability to drive and operate machinery.
Xylometazolin Vibrocil contains benzalkonium chloride
This medicine contains approximately 0.0025 mg of benzalkonium chloride per drop, equivalent to 0.1 mg of benzalkonium chloride per 1 ml of solution. Benzalkonium chloride may cause irritation or swelling inside the nose, especially if used for prolonged periods.
3. How to use Xylometazolin Vibrocil
This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor. If in doubt, consult your doctor or pharmacist.
Xylometazolin Vibrocil is for nasal use only (also in middle ear infection).
To avoid spreading 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 three times daily.
Do not use more than 3 doses per nostril per day. It is recommended that the last dose be taken immediately before going to bed.
Do not use for longer than 10 consecutive days.
Xylometazolin Vibrocil must not be used in children under 12 years of age.
Instructions for use
- Clear the nose.
- Unscrew the cap containing the dropper.
- Tilt the head backward.
- Instill drops into both nostrils and keep the head tilted for a while to allow the drops to spread throughout the nasal cavity.
- After use, replace the cap on the bottle.
Overdose of Xylometazolin Vibrocil
If more than the recommended dose has been used, consult a doctor or pharmacist immediately.
Symptoms of overdose include severe dizziness, excessive sweating, significantly lowered body temperature, headache, slow heart rate, breathing difficulties, coma, convulsions, high blood pressure (hypertension), followed possibly by low blood pressure.
Symptomatic treatment should be administered.
Missed dose of Xylometazolin Vibrocil
Do not use a double dose to make up for a missed dose.
If you have any further doubts about the use of this medicine, consult your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this product may cause adverse effects, although not everyone experiences them.
You should STOP using Xylometazolin Vibrocil and immediately consult a doctor
if any of the following adverse symptoms occur, as they may be signs of
an allergic reaction:
- difficulty breathing or swallowing,
- swelling of the face, lips, tongue or throat,
- itching with red rash or blisters.
These symptoms are very rare (occurring in fewer than 1 in 10,000 people using the medicine).
Common adverse effects (occur 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 adverse effects (occur in fewer than 1 in 100 patients):
nosebleeds.
Very rare adverse effects (occur in fewer than 1 in 10,000 patients):
allergic reaction (skin rash, itching), transient visual disturbances, arrhythmia or
accelerated heart rate.
Reporting of adverse effects
If any adverse effects occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309,
website: https://smz.ezdrowie.gov.pl.
Reporting adverse effects helps to provide more information on the safety of the medicine.
Adverse effects can also be reported to the marketing authorization holder.
5. How to store Xylometazolin Vibrocil
Keep the medicine out of sight and reach of children.
Store 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 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 Vibrocil contains
- The active substance in Xylometazolin Vibrocil is xylometazoline hydrochloride. One ml of solution contains 1 mg of xylometazoline hydrochloride.
- Other ingredients are: benzalkonium chloride, disodium edetate, disodium dihydrogen phosphate dihydrate, disodium phosphate dodecahydrate, sodium chloride, sorbitol 70%, hypromellose 4000, purified water.
What Xylometazolin Vibrocil looks like and contents of the pack
Xylometazolin Vibrocil pack is a bottle with a cap containing a dropper pipette,
containing 10 ml of solution, in a cardboard box.
Marketing Authorisation Holder:
Haleon Poland Sp. z o.o.
Rzymowskiego 53 Street
02-697 Warsaw
tel. 800 702 849
Importer:
Haleon Germany GmbH
Barthstrasse 4
80339 Munich
Germany
November 2024