Xilometazolin Fortis

Leaflet attached to the packaging: patient information

Xylometazolin Fortis, 1 mg/mL, nasal spray, solution

Xylometazoline hydrochloride

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 directed by a doctor or pharmacist.

• This 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 those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement after 7 days or if the patient feels worse, they should consult a doctor.

Table of contents of the leaflet

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

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

The active substance of Xylometazolin Fortis is xylometazoline hydrochloride.
Xylometazolin Fortis is a locally acting medicine that reduces congestion and swelling of the nasal mucosa and the amount of discharge by constricting blood vessels.
It helps patients with a stuffy nose to breathe more easily through the nose.
The effect of Xylometazolin Fortis starts 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 for use

Excessive congestion of the nasal mucosa occurring in the course of a cold, hay fever, allergic rhinitis, sinusitis. The medicine facilitates the drainage of discharge from inflamed paranasal sinuses. By reducing the congestion of the nasal and pharyngeal mucosa, it can be used as an adjunct in the treatment of otitis media.
Xylometazolin Fortis facilitates the examination of the nose (nasal examination).
If there is no improvement after 7 days or if the patient feels worse, they should consult a 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 glaucoma with a narrow angle of filtration (increased eye pressure);
• if the patient's nasal mucosa is very dry (atrophic rhinitis or dry rhinitis);
• in children under 12 years of age.

Warnings and precautions

Before starting to use Xylometazolin Fortis, the patient should discuss it with their doctor or pharmacist in the following cases:

• high blood pressure,
• heart and circulatory disease (e.g., long QT syndrome),
• hyperthyroidism,
• diabetes,
• enlarged prostate,
• benign tumor of the adrenal gland that produces large amounts of adrenaline and noradrenaline (pheochromocytoma),
• taking certain antidepressant medicines known as monoamine oxidase inhibitors (MAOIs) or taking them within the last 2 weeks,
• hypersensitivity to substances with a similar effect to xylometazoline. In sensitive patients, Xylometazolin Fortis may cause insomnia, dizziness, irregular heartbeat, increased blood pressure, or tremors.

Xylometazolin Fortis should not be used for more than 7 consecutive days. If symptoms persist, the patient should consult a doctor.
Using the medicine for a longer period than 7 days or in higher doses than recommended may cause worsening of symptoms or their recurrence.
Xylometazolin Fortis should not be used in the eyes or in the mouth.
A higher dose than recommended should not be used, especially in children and the elderly.

Children

Xylometazolin Fortis should not be used in children under 12 years of age.

Xylometazolin Fortis and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
The effect of Xylometazolin Fortis may be enhanced when used with certain antidepressant medicines. These include:

• monoamine oxidase inhibitors (MAOIs): Xylometazolin Fortis should not be used if the patient is taking MAOIs or has taken them within the last 14 days,
• tricyclic and tetracyclic antidepressants.

If the patient is taking any of these medicines, they should consult their doctor before using Xylometazolin Fortis.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before using this medicine.
Pregnancy
Xylometazolin Fortis should not be used during pregnancy.
Breastfeeding
Xylometazolin Fortis can be used during breastfeeding only after consulting a doctor.

Driving and using machines

Xylometazolin Fortis used in recommended doses does not affect or has a negligible effect on the ability to drive and use machines.

Xylometazolin Fortis contains benzalkonium chloride

The medicine contains 0.1 mg of benzalkonium chloride in each milliliter of nasal spray. Benzalkonium chloride may cause irritation or swelling inside the nose, especially if used for a long time.

3. How to use Xylometazolin Fortis

This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.
Xylometazolin Fortis should be used only in the nose (also in the case of otitis media).
To avoid spreading the infection, one package of the medicine should be used by only one patient.
Recommended dose:
Adults and adolescents over 12 years of age:
1 dose of nasal spray into each nostril, 3 times a day. There should be an 8-10 hour interval between doses. No more than 3 doses should be administered into each nostril per day.
Xylometazolin Fortis should not be used in children under 12 years of age.
Method of administration
The medicine is intended for use in the nose.
Caution should be exercised to avoid spraying the nasal spray into the eyes and mouth.

• 1. Do not cut the tip of the applicator.
• 2. Remove the protective cap.
• 3. Before first use, press the pump 5 times. The pump will be ready for further use throughout the recommended treatment period (do not use for more than 7 consecutive days). If, after fully pressing the pump, the nasal spray is not sprayed, or if the medicine has not been used for more than 14 days, the pump should be re-prepared by pressing it once.
• 4. Clean the nose.
• 5. Hold the bottle upright, with the thumb on the bottom of the bottle and the tip between two fingers.
• 6. Tilt the head forward and insert the tip into the nostril.
• 7. Press the pump and inhale through the nose at the same time to ensure optimal distribution of the nasal spray.
• 8. Repeat the steps when administering the medicine to the other nostril.
• 9. After use, put the protective cap back on.

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

Using a higher dose of Xylometazolin Fortis than recommended

In case of accidental use of a higher dose of the medicine, the patient should immediately consult a doctor or pharmacist.
In case of overdose, the following symptoms may occur: headache, dizziness, sweating, decreased body temperature, slowed heart rate, increased blood pressure, respiratory disorders, coma, convulsions.
Symptomatic treatment should be applied.

Missing a dose of Xylometazolin Fortis

A double dose should not be used to make up for a missed dose.
If the patient has any further doubts about using this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Xylometazolin Fortis can cause side effects, although not everybody gets them.
The patient should STOP using Xylometazolin Fortis and seek medical help immediately if they experience any of the following side effects, which 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 (hives). These symptoms occur very rarely (less than 1 in 10,000 patients using the medicine).

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

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

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

• nasal bleeding.

Rare (may occur in less than 1 in 10,000 patients):

• allergic reaction (skin rash, itching);
• tremors;
• dizziness;
• insomnia;
• transient vision disturbances;
• irregular and rapid heartbeat.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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
By reporting side effects, more information can be collected on the safety of the medicine.
Side effects can also be reported to the marketing authorization holder.

5. How to store Xylometazolin Fortis

The medicine should be stored out of sight and reach of children.
Store in a temperature 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 Date (EXP) and on the bottle after: EXP. The expiry date refers to the last day of the month.
Shelf life after first opening the bottle: 1 month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Xylometazolin Fortis contains

• The active substance of Xylometazolin Fortis 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, colorless or almost colorless solution.
Xylometazolin Fortis is packed in a 10 mL glass bottle with a spray pump and a protective cap, placed in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder

Fortis Pharmaceuticals Sp. z o.o.
ul. Mickiewicza 29
40-085 Katowice
e-mail: kontakt@fortispharmaceuticals.pl

Manufacturer

Basic Pharma Manufacturing B.V.
Burgemeester Lemmensstraat 352
6163 JT Geleen
Netherlands

Date of last revision of the leaflet: