Xylorin protect

Patient leaflet: information for the user

Xylorin Protect, 0,5 mg/ml, nasal spray, solution
Oxymetazolini hydrochloridum
Please read all of this leaflet carefully before using the medicine, because it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet, or as directed by
the doctor or pharmacist.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, please consult your 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 or if you feel worse, consult your doctor.

Contents of the leaflet

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

1. What Xylorin Protect is and what it is used for

Xylorin Protect is used for short-term treatment of nasal congestion caused by
the common cold and sinusitis in adults and children aged 10 years and older.
Xylorin Protect acts quickly to reduce congestion of the nasal mucosa, thereby reducing nasal and sinus blockage and making breathing easier. The effect occurs within a few minutes and lasts up to 12 hours.
Xylorin Protect also contains dexpanthenol, which moisturizes the dry nasal mucosa.

2. Important information before using Xylorin Protect

When not to use Xylorin Protect

• if the patient is allergic to oxymetazoline hydrochloride or any of the other ingredients of this medicine (listed in section 6)
• if the patient has chronic inflammation of the nasal mucosa with very dry nasal passages (atrophic rhinitis or dry rhinitis).

Warnings and precautions
Before using Xylorin Protect, consult a doctor or pharmacist if:

• the patient has cardiovascular diseases (e.g. angina pectoris)
• the patient has high blood pressure
• the patient has diabetes
• the patient has a benign tumour of the adrenal gland (pheochromocytoma) producing large amounts of adrenaline and noradrenaline
• the patient has difficulty urinating and/or has an enlarged prostate gland
• the patient has increased intraocular pressure (narrow-angle glaucoma)
• the patient has hyperthyroidism
• the patient is taking antidepressant medicines (tricyclic and tetracyclic antidepressants (e.g. amitriptyline, imipramine) or monoamine oxidase inhibitors) or has received such treatment within the last two weeks.

Children
Do not use in children under 10 years of age.
Xylorin Protect and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently using, has recently used, or plans to use.
It is especially important to mention:

• Tricyclic and tetracyclic antidepressants (used in depression, e.g. amitriptyline, imipramine). If the patient is taking or has taken these medicines within the last two weeks, blood pressure may increase significantly (hypertensive crisis).
• Monoamine oxidase inhibitors (used in the treatment of depression). If the patient is taking or has taken these medicines within the last two weeks, blood pressure may increase significantly (hypertensive crisis).
• Beta-blockers (used to treat high blood pressure). Oxymetazoline contained in Xylorin Protect may alter the effect of certain beta-blockers.
• Medicines with adrenaline-like effects (e.g. ephedrine, pseudoephedrine), as they may intensify the effect of Xylorin Protect.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Pregnancy
As data on the use of this medicine during pregnancy are limited, Xylorin Protect should be used during pregnancy only on the advice of a doctor, as a precaution.
Breastfeeding
As no studies have been conducted, it is unknown whether Xylorin Protect passes into breast milk.
Fertility
The effect of Xylorin Protect on fertility is unknown.
Driving and operating machinery
Xylorin Protect has no effect or negligible effect on the ability to drive vehicles and operate machinery.

3. How to use Xylorin Protect

This medicine should always be used exactly as described in this patient information leaflet, or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Recommended dose:
Adults and children aged 10 years and older: 2 sprays into each nostril 2 to 3 times daily.
Xylorin Protect must not be used for longer than 10 consecutive days, and the recommended dose must not be exceeded.
Prolonged use of Xylorin Protect may cause congestion of the nasal mucosa and nasal obstruction.

User instructions
Before first use of the spray, the pump must be primed. Hold the bottle upright and spray the medicine 5 times into the air until a fine, even mist is produced. If the pump has not been used for an extended period, prime it again by spraying 3 times into the air.

1. Blow your nose. Remove the protective cap.
2. Hold the bottle as shown in the illustration.
3. Insert the nozzle into one nostril and spray the number of doses prescribed (according to the dosing instructions above). Repeat for the other nostril.
4. Replace the protective cap.

Since complete emptying of the bottle may be difficult, it is filled with slightly more solution than 7.5 ml. This ensures the declared number of doses can be delivered.

Accidental overdose of Xylorin Protect
If more than the recommended dose has been used, seek advice from a doctor or pharmacist immediately.

Missed dose of Xylorin Protect
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 will experience them.
Uncommon (may occur in less than 1 in 100 people): sneezing, dryness of the mouth and throat.
Rare (may occur in less than 1 in 1000 people): restlessness, irritability, local nasal irritation, sleep disturbances in children.
Prolonged use of Xylorin Protect may lead to nasal mucosal hyperaemia and nasal congestion.

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 enables further information on the safety of the medicine to be collected.

5. How to store Xylorin Protect

Keep this medicine out of sight and reach of children.
Store below 25 °C.
Do not use this medicine after the expiry date stated on the carton and bottle after:
"Expiry date (EXP)" or "EXP". The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. These measures help protect
the environment.

6. Contents of the package and other information

What Xylorin Protect contains

• The active substance is oxymetazoline hydrochloride. 1 ml of Xylorin Protect 0.5 mg/ml nasal spray contains 0.5 mg of oxymetazoline hydrochloride.
• Other ingredients are: dexpanthenol, disodium edetate, sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate, sodium chloride, and purified water.

Xylorin Protect nasal spray does not contain preservatives. Therefore, for technical reasons, the bottle is not completely filled.

What Xylorin Protect looks like and contents of the pack

Xylorin Protect 0.5 mg/ml nasal spray, solution, is a clear, colourless or slightly coloured solution in a plastic bottle (HDPE) with a capacity of 7.5 ml, with a nasal applicator PP and a metered dose spray pump (HDPE/PP/PE/stainless steel) and a protective PP cap, packed in a cardboard box.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Perrigo Poland Sp. z o.o.
ul. Domaniewska 48
02-672 Warsaw
tel.: +48 (22) 852 55 51

Manufacturer
Curida AS
Solbærvegen 5
No-2409 Elverum
Norway
Farmaclair
440 Avenue du Général de Gaulle
14200 Hérouville-Saint-Clair
France

This medicinal product is authorised in the European Economic Area countries under the following names:
Sweden Nezebi
Poland Xylorin Protect