Xilometazolin + Dexpanthenol Vzf

Leaflet attached to the packaging: patient information

Xylometazoline + Dexpanthenol WZF, (0.1 mg + 5.0 mg)/dose, nasal spray, solution
Xylometazoline hydrochloride+Dexpanthenol

Read the 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 advised by
your doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If after 7 days there is no improvement or you feel worse, contact your doctor.

Table of contents of the leaflet

• 1. What is Xylometazoline + Dexpanthenol WZF and what is it used for
• 2. Important information before using Xylometazoline + Dexpanthenol WZF
• 3. How to use Xylometazoline + Dexpanthenol WZF
• 4. Possible side effects
• 5. How to store Xylometazoline + Dexpanthenol WZF
• 6. Contents of the packaging and other information

1. What is Xylometazoline + Dexpanthenol WZF and what is it used for

Xylometazoline + Dexpanthenol WZF is a nasal spray containing the active substances xylometazoline hydrochloride (a sympathomimetic agent) and dexpanthenol (a vitamin B compound).
Xylometazoline + Dexpanthenol WZF, when applied to the nasal mucosa, reduces its swelling and congestion, reduces the amount of discharge, and facilitates its flow from the sinuses.
Xylometazoline + Dexpanthenol WZF accelerates wound healing and participates in the regeneration process of the nasal mucosa.
Xylometazoline + Dexpanthenol WZF clears the nose and supports the regeneration of the nasal mucosa.
Xylometazoline + Dexpanthenol WZF is used:

• for symptomatic treatment of nasal congestion during a cold (rhinitis);
• after nasal surgery to stimulate wound healing and improve nasal patency.

Xylometazoline + Dexpanthenol WZF is intended for adults and children over 6 years old.
If after 7 days there is no improvement or you feel worse, consult your doctor.

2. Important information before using Xylometazoline + Dexpanthenol WZF

When not to use Xylometazoline + Dexpanthenol WZF:

• in children under 6 years old;

Warnings and precautions

Before using Xylometazoline + Dexpanthenol WZF, discuss it with your doctor or pharmacist.
Be particularly careful when using Xylometazoline + Dexpanthenol WZF:

• If, during use in children, excitement or difficulty falling asleep occurs, discontinue use.
• If, during use, symptoms such as dizziness, insomnia, tremors, irregular heartbeat, increased blood pressure occur, discontinue use. This is especially true for patients who have previously experienced such symptoms after using similar medications.
• The patient should consult a doctor before using the medicine if they have:
• high blood pressure;
• severe heart disease (e.g., long QT syndrome);
• diabetes (elevated blood sugar levels);
• glaucoma (increased eye pressure);
• hyperthyroidism;
• chromaffin tumor of the adrenal gland (a tumor located above the kidneys);
• a metabolic disorder called porphyria;
• prostate enlargement.

Due to the risk of atrophy of the nasal mucosa, the use of the medicine in chronic rhinitis should only be done under medical supervision.

• Xylometazoline + Dexpanthenol WZF should not be used for more than 7 days, as prolonged use may cause irreversible changes in the nasal mucosa.

Xylometazoline + Dexpanthenol WZF and other medicines

Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken (including nasal sprays) and any medicines you plan to take.

• Do not use Xylometazoline + Dexpanthenol WZF while being treated with antidepressant medications called tricyclic antidepressants, as well as medications that increase blood pressure and monoamine oxidase inhibitors (MAOIs) such as tranylcypromine.
• Avoid concurrent use of Xylometazoline + Dexpanthenol WZF with medications such as ephedrine, pseudoephedrine (found in cold medications).

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.
Studies on the effect of the medicine on fetal development are insufficient, so Xylometazoline + Dexpanthenol WZF should not be used in pregnant women.
It is not known whether xylometazoline hydrochloride passes into breast milk, so Xylometazoline + Dexpanthenol WZF should not be used in breastfeeding women.

Driving and operating machinery

If the medicine is used as recommended, it is unlikely to affect your ability to drive or operate machinery.

Xylometazoline + Dexpanthenol WZF contains benzalkonium chloride

The medicine contains 0.2 mg of benzalkonium chloride per 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 Xylometazoline + Dexpanthenol WZF

This medicine should always be used exactly as described in this patient leaflet or as advised by
your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.

• Use the medicine only for the nose.
• For hygiene reasons, the packaging of the medicine should only be used by one patient.
• Do not use the medicine for more than 7 days. If after 7 days there is no improvement or you feel worse, consult your doctor.
• Always consult a doctor regarding the duration of use in children.
• A few days' break should be taken before reusing the medicine.
• Do not use higher doses than those listed below.

Adults and children over 6 years old
One dose of nasal spray into each nostril once or twice a day (every 8-10 hours). Do not administer more than 3 doses into each nostril per day (a total of 6 doses per day).
Method of use

• 1. Remove the protective cap.
• 2. Before the first administration, press the pump several times until a mist of medicine appears. For subsequent administrations, it is not necessary to press the pump several times.
• 3. Insert the pump nozzle into the nostril.
• 4. Holding the bottle upright, press the pump, which will spray a dose of medicine into the nose.
• 5. Repeat the steps when administering the medicine to the other nostril.
• 6. After use, put the protective cap back on.

Using a higher dose of Xylometazoline + Dexpanthenol WZF than recommended

If you have used a higher dose than recommended (overdosed) or accidentally taken the medicine orally, especially if a child has done so, seek medical attention immediately.
In case of overdose, the following may occur:

• restlessness, excitement, hallucinations, and convulsions;
• decreased body temperature, fatigue, drowsiness, and coma;
• pupil constriction, pupil dilation, sweating, fever, pallor, cyanosis, nausea, accelerated heart rate (tachycardia), slow heart rate (bradycardia), arrhythmia, cardiac arrest, hypertension, hypotension similar to shock, pulmonary edema, respiratory disorders, and apnea.

respiratory arrest.

Missing a dose of Xylometazoline + Dexpanthenol WZF

Do not use a double dose to make up for a missed dose, and do not use more than 3 doses into each nostril per day.
If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Xylometazoline + Dexpanthenol WZF can cause side effects, although not everybody gets them.
Uncommon (affecting 1 to 10 people in 1,000):

• allergic reactions (e.g., angioedema, rash, itching). Rare (affecting 1 to 10 people in 10,000):
• palpitations;
• accelerated heart rate;
• increased blood pressure (hypertension).

Very rare (affecting less than 1 person in 10,000):

• excitement, insomnia, fatigue (e.g., drowsiness, sedation), headache, hallucinations (especially in children);
• arrhythmias;
• increased swelling of the nasal mucosa due to decreased effectiveness of the medicine, nosebleeds;
• convulsions (especially in children).

Unknown (frequency cannot be estimated from available data):

• burning sensation and dryness of the nasal mucosa, sneezing.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. 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:
Aleje 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 gather more information on the safety of this medicine.

5. How to store Xylometazoline + Dexpanthenol WZF

There are no special precautions for storing the medicine.
Keep the medicine 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.
The shelf life of Xylometazoline + Dexpanthenol WZF after opening the bottle is 12 weeks.
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. Contents of the packaging and other information

What Xylometazoline + Dexpanthenol WZF contains

• The active substances of the medicine are xylometazoline hydrochloride and dexpanthenol. Each dose of nasal spray contains 0.1 mg of xylometazoline hydrochloride and 5.0 mg of dexpanthenol.
• The other ingredients are disodium phosphate dodecahydrate; potassium dihydrogen phosphate; benzalkonium chloride solution; purified water.

What Xylometazoline + Dexpanthenol WZF looks like and contents of the pack

Xylometazoline + Dexpanthenol WZF is a nasal spray in the form of a colorless or almost colorless, clear solution.
Xylometazoline + Dexpanthenol WZF is available in a 15 ml bottle containing 10 ml of solution, closed with a dosing pump with a volume of 0.1 ml, with an aluminum cap and applicator with a nozzle, in a cardboard box.

Marketing authorization holder

Polpharma S.A.
Pelplińska 19, 83-200 Starogard Gdański
phone: +48 22 364 61 01

Manufacturer

Polpharma S.A.
Medana Division in Sieradz
Władysława Łokietka 10, 98-200 Sieradz

Date of last revision of the leaflet: