Package leaflet: Information for the user

Xylometazolin Fortis, 1 mg/mL, nasal spray, solution
Xylometazolini hydrochloridum
Please read all of this leaflet carefully before using this medicine, because it contains
important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed by
your doctor or pharmacist.

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

Contents of the leaflet

What Xylometazolin Fortis is and what it is used for
Important information before using Xylometazolin Fortis
How to use Xylometazolin Fortis
Possible side effects
How to store Xylometazolin Fortis
Contents of the pack and other information

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

The active substance in Xylometazolin Fortis is xylometazoline hydrochloride.
Xylometazolin Fortis is a locally acting medicine that reduces nasal mucosal congestion and swelling, as well as secretion volume, by constricting blood vessels.
It helps patients with a blocked nose to breathe more easily through the nose.
The effect of Xylometazolin Fortis begins within 2 minutes and lasts up to 12 hours.
Xylometazolin Fortis 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 acute otitis media.
Xylometazolin Fortis facilitates nasal endoscopy (examination of the nasal cavity).
If there is no improvement after 7 days of treatment, or if you feel worse, consult your doctor.

2. Important information before using Xylometazolin Fortis

When not to use Xylometazolin Fortis

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 performed through the nose, removal of the pituitary gland, or surgery involving exposure of the dura mater (brain surgery performed through the nose or mouth);
if the patient has narrow-angle glaucoma (increased eye pressure);
if the patient has very dry nasal mucosa (atrophic rhinitis or drying inflammation of the nasal mucosa);
in children under 12 years of age.

Warnings and precautions
Before starting to use Xylometazolin Fortis, consult your doctor or pharmacist if:

you have high blood pressure,
you have heart or circulatory disease (e.g. long QT syndrome),
you have hyperthyroidism,
you have diabetes,
you have enlarged prostate,
you have a benign adrenal gland tumour producing large amounts of adrenaline and noradrenaline (pheochromocytoma),
you are taking certain antidepressants known as monoamine oxidase inhibitors (MAOIs) or have taken them within the last 2 weeks,
you are hypersensitive to substances with effects similar to xylometazoline. In sensitive patients, Xylometazolin Fortis may cause insomnia, dizziness, irregular heartbeat, increased blood pressure, or tremors.

Do not use Xylometazolin Fortis for longer than 7 consecutive days. If symptoms persist, consult a doctor.
Using the medicine for longer than 7 days or in higher doses than recommended may worsen symptoms or cause their recurrence.
Do not apply Xylometazolin Fortis to the eyes or inside the mouth.
Do not exceed the recommended dose, especially in children and elderly patients.

Children
Do not use Xylometazolin Fortis in children under 12 years of age.

Xylometazolin Fortis and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
The effect of Xylometazolin Fortis may be intensified when used together with antidepressant medicines, such as:

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

If you are taking any of the above medicines, consult your doctor before using Xylometazolin Fortis.

Pregnancy and breastfeeding
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.

Pregnancy
Do not use Xylometazolin Fortis during pregnancy.

Breastfeeding
Xylometazolin Fortis may be used during breastfeeding only after consultation with a doctor.

Driving and using machines
Xylometazolin Fortis, when used at the recommended doses, has no effect or has negligible effect on the ability to drive or operate machinery.

Xylometazolin Fortis contains benzalkonium chloride
This medicine contains 0.1 mg of benzalkonium chloride per millilitre of nasal spray. Benzalkonium chloride may cause irritation or swelling inside the nose, especially if used for prolonged periods.

3. How to use Xylometazolin Fortis
Always use this medicine exactly as described in this patient leaflet or as advised by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Xylometazolin Fortis is for nasal use only (including in cases of middle ear infection).
To avoid spreading infection, each package should be used by only one patient.

Recommended dose:
Adults and adolescents over 12 years of age:
1 spray into each nostril, 3 times daily. There should be an interval of 8–10 hours between doses. Do not administer more than 3 doses into each nostril per day.
Do not use Xylometazolin Fortis in children under 12 years of age.

Instructions for use
This medicine is intended for nasal use.
Take care not to spray the medicine into the eyes or mouth.

Do not cut the tip of the applicator.
Remove the protective cap.
Before first use, press the pump 5 times. The pump will then be ready for use throughout the recommended treatment period (do not use for longer than 7 consecutive days). If, after fully pressing the pump, no spray is released, or if the medicine has not been used for more than 14 days, prime the pump again by pressing once.
Clear the nose.
Hold the bottle upright, supporting the bottom with your thumb, and hold the nozzle between two fingers.
Tilt your head forward and insert the nozzle into one nostril.
Press the pump while inhaling through the nose to ensure optimal distribution of the spray.
Repeat the procedure for the second nostril.
Replace the protective cap after use.

The nasal spray ensures precise dosing and proper distribution of the solution over the entire surface of the nasal mucosa.
This prevents accidental overdose.

Accidental overdose of Xylometazolin Fortis
If you accidentally use more than the recommended dose, contact your doctor or pharmacist immediately.
Symptoms of overdose may include: headache, dizziness, sweating, lowered body temperature, slowed heart rate, increased blood pressure, breathing difficulties, coma, or seizures.
Symptomatic treatment should be administered.

Missed dose of Xylometazolin Fortis
Do not use a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
You should DISCONTINUE using Xylometazolin Fortis and seek immediate medical help if any of the following adverse reactions occur, as they may be symptoms of an allergic reaction:

difficulty breathing or swallowing;
swelling of the face, lips, tongue or throat;
severe itching with red rash or blisters (urticaria). These symptoms are very rare (occurring in fewer than 1 in 10,000 people using the medicine).

Common (may occur in fewer than 1 in 10 patients):

headache;
dryness of the nasal mucosa;
nasal discomfort;
nausea;
burning sensation at the site of administration.

Uncommon (may occur in fewer than 1 in 100 patients):

nosebleeds.

Very rare (may occur in fewer than 1 in 10,000 patients):

allergic reaction (skin rash, itching);
tremor;
dizziness;
insomnia;
transient visual disturbances;
irregular and rapid heartbeat.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department for Monitoring Adverse Drug Reactions of 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
Reporting adverse reactions helps to provide more information on the safety of the medicine.
Adverse reactions can also be reported to the responsible entity.

5. How to store Xylometazolin Fortis

Keep the medicine out of the sight and reach of children.
Store below 25°C.
Do not store in the refrigerator or freeze.
Do not use this medicine after the expiry date stated on the carton after: Expiry (EXP) and on the bottle after: EXP. The expiry date refers to the last day of the stated month.
Usable period after first opening the bottle: 1 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 Fortis contains

The active substance is xylometazoline hydrochloride. 1 mL of solution contains 1 mg of xylometazoline hydrochloride.
The other ingredients (excipients) are: benzalkonium chloride, solution; disodium edetate; sodium dihydrogen phosphate dihydrate; disodium phosphate dodecahydrate; sodium chloride; purified water.

What Xylometazolin Fortis looks like and contents of the pack
Xylometazolin Fortis is a clear, colourless or almost colourless solution.
Xylometazolin Fortis is packed in an amber glass bottle (with a capacity of 10 mL) with a spray pump and nozzle, placed in a cardboard box.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Fortis Pharmaceuticals Sp. z o.o.
ul. Mickiewicza 29
40-085 Katowice
email: [email protected]
Manufacturer
Basic Pharma Manufacturing B.V.
Burgemeester Lemmensstraat 352
6163 JT Geleen
The Netherlands