XYLOMETAZOLINE + DEXPANTHENOL WZF

Package leaflet: Information for the user

Xylometazolin + Dexpanthenol WZF, (0.1 mg + 5.0 mg)/dose, nasal spray, solution
Xylometazolini hydrochloridum + Dexpanthenolum
Please read the entire leaflet carefully before use, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by a
physician or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, consult a pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 7 days, or if you feel worse, consult your doctor.

Table of contents

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

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

Xylometazolin + Dexpanthenol WZF is a nasal spray medicine containing as active substances xylometazoline hydrochloride (belonging to a group of medicines called sympathomimetics) and dexpanthenol (belonging to the vitamin B group).
When applied to the nasal mucosa, Xylometazolin + Dexpanthenol WZF reduces swelling and congestion, decreases mucus secretion, and facilitates sinus drainage.
Xylometazolin + Dexpanthenol WZF accelerates wound healing and supports the regeneration process of the nasal mucosa.
Xylometazolin + Dexpanthenol WZF clears nasal passages and supports regeneration of the nasal mucosa.
Xylometazolin + Dexpanthenol WZF is used:

• for symptomatic treatment of nasal congestion during colds (rhinitis);
• after nasal surgery to stimulate healing of the mucosa and improve nasal patency.

Xylometazolin + Dexpanthenol WZF is intended for adults and children above 6 years of age.
If there is no improvement after 7 days, or if you feel worse, consult your doctor.

2. Important information before using the medicine Xylometazolin + Dexpanthenol WZF

When not to use the medicine Xylometazolin + Dexpanthenol WZF:

• if the patient is allergic (symptoms such as rash, facial and throat swelling, difficulty breathing) to xylometazoline hydrochloride, dexpanthenol, or any of the other ingredients of this medicine (listed in section 6);
• in children under 6 years of age;
• if the patient has recently undergone neurosurgery (brain surgery) or surgery performed through the nose (e.g. removal of the pituitary gland);
• if the patient has nasal mucosal defects or lesions.

Warnings and precautions
Before starting to use Xylometazolin + Dexpanthenol WZF, discuss this with your doctor or pharmacist.
Exercise special caution when using Xylometazolin + Dexpanthenol WZF:

• If excitement or difficulty sleeping occurs in children during treatment, discontinue the medicine.
• If symptoms such as dizziness, insomnia, tremor, irregular heartbeat, or increased blood pressure occur during treatment, discontinue the medicine. This especially applies to patients who previously experienced such symptoms after using other similarly acting medicines.
• 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;
• pheochromocytoma (a tumor located in the glands above the kidneys);
• a metabolic disorder called porphyria;
• benign prostatic hyperplasia.

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

• Do not use Xylometazolin + Dexpanthenol WZF for longer than 7 days, as prolonged use may lead to persistent changes in the nasal mucosa that are difficult to treat.

Xylometazolin + Dexpanthenol WZF and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken (including nasal medicines), as well as any medicines you plan to take.

• Do not use Xylometazolin + Dexpanthenol WZF during treatment with antidepressant medicines known as tricyclic antidepressants, medicines that increase blood pressure, or monoamine oxidase inhibitors (MAOIs) such as tranylcypromine.
• Avoid simultaneous use of Xylometazolin + Dexpanthenol WZF with medicines such as ephedrine or pseudoephedrine (components of medicines used for colds).

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Studies on the effects of the medicine on fetal development are insufficient; therefore, Xylometazolin + Dexpanthenol WZF should not be used in pregnant women.
It is not known whether xylometazoline hydrochloride passes into breast milk; therefore, Xylometazolin + Dexpanthenol WZF should not be used in breastfeeding women.

Driving and operating machinery
When used as directed, no effect on the ability to drive or operate machinery is expected.

Xylometazolin + Dexpanthenol WZF contains benzalkonium chloride
The medicine contains 0.2 mg of benzalkonium chloride per ml of solution. Benzalkonium chloride may cause irritation or swelling inside the nose, especially if used for prolonged periods.

3. How to use Xylometazolin + Dexpanthenol WZF

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

• This medicine is for nasal use only.
• For hygiene reasons, the medicine container should be used by only one person.
• Do not use this medicine for longer than 7 days. If there is no improvement or symptoms worsen after 7 days, consult a doctor.
• Always seek medical advice regarding the duration of treatment in children.
• A break of several days should be observed before reusing the medicine.
• Do not exceed the doses stated below.

Adults and children over 6 years of age
One spray into each nostril once or twice daily (every 8–10 hours). Do not administer more than 3 sprays into each nostril per day (maximum total of 6 sprays per day).

Instructions for use

1. Remove the protective cap.
2. Before first use, prime the pump by pressing it several times until a fine mist appears. For subsequent uses, repeated priming is not necessary.
3. Insert the nozzle into the nostril.
4. Holding the bottle upright, press the pump to release a dose of the medicine into the nose.
5. Repeat the procedure to administer the medicine into the other nostril.
6. Replace the protective cap after use.

Overdose of Xylometazolin + Dexpanthenol WZF
If an overdose has been used (more than recommended) or if the medicine has been accidentally swallowed, especially by a child, contact a doctor immediately.
Symptoms of overdose may include:

• restlessness, agitation, hallucinations, and seizures;
• lowered body temperature, fatigue, drowsiness, and coma;
• pupil constriction, pupil dilation, sweating, fever, pallor, cyanosis, nausea, rapid heartbeat (tachycardia), slow heart rate (bradycardia), arrhythmia, cardiac arrest, hypertension, shock-like hypotension, pulmonary edema, respiratory disturbances, and apnea.

Missed dose of Xylometazolin + Dexpanthenol WZF
Do not use a double dose to make up for a missed dose, and do not exceed more than 3 sprays into each nostril per day.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicinal products, this medicine can cause adverse reactions, although not everyone experiences them.

Uncommon (occurs in 1 to 10 people out of 1,000):

• hypersensitivity reactions (e.g. angioedema, rash, itching).

Rare (occurs in 1 to 10 people out of 10,000):

• palpitations;
• increased heart rate;
• elevated arterial pressure (hypertension).

Very rare (occurs in fewer than 1 person out of 10,000):

• excitation, insomnia, fatigue (e.g. drowsiness, sedation), headache, hallucinations (especially in children);
• cardiac arrhythmias;
• increased mucosal swelling due to diminished drug effect, nosebleeds;
• convulsions (especially in children).

Not known (frequency cannot be estimated from available data):

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

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions 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
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store the medicine Xylometazolin + Dexpanthenol WZF

There are no special storage requirements for this medicine.
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 stated month.
The shelf life of Xylometazolin + Dexpanthenol WZF after first opening the bottle is 12 weeks.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the package and other information

What Xylometazolin + Dexpanthenol WZF contains

• The active substances are: xylometazoline hydrochloride and dexpanthenol. Each dose of nasal spray contains 0.1 mg of xylometazoline hydrochloride and 5.0 mg of dexpanthenol.
• Other components: disodium phosphate dodecahydrate; potassium dihydrogen phosphate; benzalkonium chloride, solution; purified water.

What Xylometazolin + Dexpanthenol WZF looks like and contents of the pack
Xylometazolin + Dexpanthenol WZF is a nasal spray in the form of a colourless or almost colourless, clear solution.
Xylometazolin + Dexpanthenol WZF is available in a 15 ml bottle containing 10 ml of solution, closed with a pump dispenser delivering a 0.1 ml dose, equipped with an aluminium cap and a nasal applicator with a nozzle, packed in a cardboard box.

Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01

Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
Medana Branch in Sieradz
ul. Władysława Łokietka 10, 98-200 Sieradz