Xilometazolin Vzf 0,1%

Package Leaflet: Information for the Patient

XYLOMETAZOLIN WZF 0.1%, 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 this package leaflet for the patient or as directed by a doctor or pharmacist.

• This package 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 side effects not listed in this package leaflet, the doctor or pharmacist should be informed. See section 4.
• If there is no improvement or the patient feels worse after 3 to 5 days, a doctor should be consulted.

Table of Contents of the Package Leaflet

• 1. What is Xylometazolin WZF 0.1% and what is it used for
• 2. Important information before using Xylometazolin WZF 0.1%
• 3. How to use Xylometazolin WZF 0.1%
• 4. Possible side effects
• 5. How to store Xylometazolin WZF 0.1%
• 6. Contents of the package and other information

1. What is Xylometazolin WZF 0.1% and what is it used for

Xylometazolin WZF 0.1% is a nasal drop solution containing xylometazoline hydrochloride as the active substance, belonging to a group of medicines called sympathomimetics.
Xylometazolin WZF 0.1% applied to the nasal mucosa reduces its swelling and congestion, reduces the amount of discharge, and facilitates its flow from the sinuses. This reduces the feeling of a blocked nose and sinuses.
Xylometazolin WZF 0.1% is used:

• for acute rhinitis caused by viruses or bacteria,
• for acute or chronic exacerbating sinusitis,
• for allergic rhinitis,
• for acute otitis media (to unblock the Eustachian tube in the ear).

2. Important information before using Xylometazolin WZF 0.1%

When not to use Xylometazolin WZF 0.1%:

• If the patient is allergic (symptoms such as rash, face and throat swelling, shortness of breath) to xylometazoline hydrochloride or any of the other ingredients of this medicine (listed in section 6).
• If the patient has had their pituitary gland removed or has undergone other neurosurgical procedures.
• If the patient has defects or changes in the nasal mucosa.

Warnings and precautions

Before starting to use Xylometazolin WZF 0.1%, the doctor or pharmacist should be consulted.

• If symptoms such as insomnia, dizziness, tremors, irregular heartbeat, high blood pressure occur during use, the medicine should be discontinued. This is especially true for patients who have previously experienced such symptoms after using similar medicines.
• The patient should consult a doctor before using the medicine if they have:
• heart disease (e.g., long QT syndrome),
• high blood pressure,
• angina pectoris (chest pain during exertion) or other cardiovascular disease,
• diabetes (high blood sugar),
• glaucoma with closed angle (high eye pressure),
• prostate enlargement,
• hyperthyroidism.
• Xylometazolin WZF 0.1% should not be used for more than 5 days, as prolonged use may cause irreversible changes in the nasal mucosa.

Xylometazolin WZF 0.1% and other medicines

The doctor or pharmacist should be informed about all medicines currently or recently taken by the patient, as well as any planned to be taken.

• Xylometazolin WZF 0.1% should not be used during treatment with tricyclic antidepressants and MAO inhibitors.

Xylometazolin WZF 0.1% should be avoided with medicines such as ephedrine, pseudoephedrine (found in cold medicines).

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before using this medicine.
Xylometazolin WZF 0.1% should not be used during pregnancy.
Breastfeeding patients should consult a doctor before using the medicine.

Driving and using machines

If Xylometazolin WZF 0.1% is used as directed in this package leaflet, it usually does not affect driving or using machines.
If Xylometazolin WZF 0.1% is used for a long time or in high doses, the patient may experience side effects described in section 4 (e.g., rapid and irregular heartbeat, high blood pressure, headache, drowsiness). In such cases, the patient should not drive or use machines until these symptoms resolve.

Xylometazolin WZF 0.1% contains benzalkonium chloride

The medicine contains 0.1 mg of benzalkonium chloride per 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 WZF 0.1%

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

• The medicine should be used only for the nose (also in case of otitis media).
• For hygiene reasons, the medicine packaging should be used by only one patient.
• The medicine should not be used for more than 3 to 5 days. If there is no improvement or the patient feels worse after 3 to 5 days, a doctor should be consulted.
• Doses higher than those specified below should not be used.

Adults and adolescents over 12 years old:
2 to 3 drops into each nostril every 8 to 10 hours. Do not administer more than 3 doses into each nostril per day.

Using a higher dose of Xylometazolin WZF 0.1% than recommended

If the patient has used a higher dose than recommended (overdosed) or accidentally ingested the medicine, especially if a child has done so, a doctor should be consulted immediately.
A doctor should be consulted immediately if the following symptoms occur, as they may indicate an overdose or accidental ingestion by a child:

• rapid and irregular heartbeat,
• high blood pressure (symptoms: e.g., persistent, severe headache - especially in the back of the head; weakness, malaise),
• drowsiness,
• irregular breathing or difficulty breathing,
• altered consciousness,
• excessive sedation in children.

Missing a dose of Xylometazolin WZF 0.1%

A double dose should not be used to make up for a missed dose.

4. Possible side effects

Like all medicines, Xylometazolin WZF 0.1% can cause side effects, although not everybody gets them.
If the patient experiences allergic reactions, such as face, lip, tongue, or throat swelling, causing difficulty breathing or swallowing, shortness of breath, the medicine should be discontinued and a doctor consulted immediately. Such reactions are very rare.
Uncommon (occurring in less than 1 in 100 people):

• nasal bleeding.

Rare (occurring in less than 1 in 10,000 people):

• nausea,
• headache,
• weakness,
• fatigue,
• drowsiness,
• vision disturbances,
• palpitations,
• rapid heartbeat,
• increased blood pressure (especially in patients with cardiovascular disease).

The following may occur: irritation and dryness in the nose, burning sensation in the nose and throat, sneezing.
Using the medicine for a longer period than recommended and/or in higher doses than recommended may cause irreversible changes in the nasal mucosa.

Reporting side effects

If any side effects occur, including any side effects not listed in this package leaflet, the doctor or pharmacist should be informed. Side effects can be reported directly to the Department of Drug Safety Monitoring of 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
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 WZF 0.1%

Store in a temperature below 25°C.
Store the bottle tightly closed in the outer packaging to protect from light.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and bottle after: EXP.
The expiry date refers to the last day of the month stated.
After opening the bottle, the medicine should not be used for more than 12 weeks.
Medicines should not be disposed of via wastewater or household waste. A pharmacist should be asked how to dispose of unused medicines. This will help protect the environment.

6. Contents of the package and other information

What Xylometazolin WZF 0.1% contains

• The active substance of the medicine is xylometazoline hydrochloride. Each ml of solution contains 1 mg of xylometazoline hydrochloride. Each drop contains 0.05 mg of xylometazoline hydrochloride.
• The other ingredients are: disodium phosphate dodecahydrate; sodium dihydrogen phosphate monohydrate; sodium chloride; sorbitol; disodium edetate; benzalkonium chloride solution; purified water.

What Xylometazolin WZF 0.1% looks like and contents of the package

Xylometazolin WZF 0.1% is a nasal drop solution in the form of a colorless or almost colorless, clear liquid.
The package contains a polyethylene bottle with a dropper and a protective cap, containing 10 ml of solution, in a cardboard box.

Marketing authorization holder

Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
phone: +48 22 364 61 01

Manufacturer

Zakłady Farmaceutyczne POLPHARMA S.A.
Medana Branch in Sieradz
ul. Władysława Łokietka 10, 98-200 Sieradz
Date of last revision of the package leaflet:December 2024