XYLOMETAZOLIN 1 mg /Ml Drops

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Xylometazolin APTEO MED
3. 1 mg/ml, nasal drops, solution
   1. Read the leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet:
4. What is Xylometazolin Apteo Med and what is it used for
   1. Indications for use
5. Important information before using Xylometazolin Apteo Med
   1. When not to use Xylometazolin Apteo Med:
   2. Warnings and precautions
   3. Children and adolescents
   4. Xylometazolin Apteo Med and other medicines
   5. Pregnancy and breastfeeding
   6. Driving and using machines
6. How to use Xylometazolin Apteo Med
   1. Xylometazolin Apteo Med should be used only in the nose (also in otitis media).
   2. Xylometazolin Apteo Med should not be used for more than 7 consecutive days.
   3. Method of use
   4. Using a higher dose of Xylometazolin Apteo Med than recommended
   5. Missing a dose of Xylometazolin Apteo Med
7. Possible side effects
   1. Reporting side effects
8. How to store Xylometazolin Apteo Med
9. Package contents and other information
   1. What Xylometazolin Apteo Med contains
   2. What Xylometazolin Apteo Med looks like and what the package contains
   3. Marketing authorization holder and manufacturer:
   4. Marketing authorization holder:
   5. Manufacturer:
   6. Date of last revision of the leaflet: April 2021

Leaflet attached to the packaging: patient information

Xylometazolin APTEO MED

1 mg/ml, nasal drops, solution

Xylometazolini hydrochloridum

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 the patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should tell their doctor or pharmacist. See section 4.
• If there is no improvement after 7 days or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet:

• 1. What is Xylometazolin Apteo Med and what is it used for
• 2. Important information before using Xylometazolin Apteo Med
• 3. How to use Xylometazolin Apteo Med
• 4. Possible side effects
• 5. How to store Xylometazolin Apteo Med
• 6. Package contents and other information

1. What is Xylometazolin Apteo Med and what is it used for

The active substance of Xylometazolin Apteo Med is xylometazoline hydrochloride. Xylometazolin Apteo Med is a locally acting medicine that, by constricting blood vessels, reduces congestion and swelling of the nasal mucosa and the amount of discharge. It makes breathing easier for patients with a stuffy nose. The effect of Xylometazolin Apteo Med starts within 2 minutes of application and lasts up to 10 hours. Xylometazolin Apteo Med 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 congestion of the nasal mucosa, it can be used as an adjunct in the treatment of otitis media. Xylometazolin Apteo Med facilitates nasal endoscopy (examination of the nasal cavity).

2. Important information before using Xylometazolin Apteo Med

When not to use Xylometazolin Apteo Med:

• 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, e.g. 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's nasal mucosa is very dry (atrophic rhinitis or dry rhinitis).

Warnings and precautions

Before using Xylometazolin Apteo Med, consult a doctor in case of:

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

Xylometazolin Apteo Med should not be used for more than 7 consecutive days. If symptoms persist, consult a doctor. Using the medicine for a period longer than 7 days or in doses higher than recommended may cause worsening of symptoms or their recurrence, or atrophy of the nasal mucosa. Xylometazolin Apteo Med should not be used in the eyes or in the mouth. Do not exceed the recommended dose.

Children and adolescents

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

Xylometazolin Apteo Med and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take. Do not use Xylometazolin Apteo Med if you are taking certain medicines used to treat depression. These are:

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

If you have taken any of the above medicines before using Xylometazolin Apteo Med, consult your doctor.

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. Do not use Xylometazolin Apteo Med during pregnancy. During breastfeeding, Xylometazolin Apteo Med can be used only after consulting a doctor.

Driving and using machines

Xylometazolin Apteo Med used in recommended doses does not affect or has a negligible effect on the ability to drive and use machines. Xylometazolin Apteo Med contains benzalkonium chloride,which may cause irritation of the mucous membranes.

3. How to use Xylometazolin Apteo Med

This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor. If you have any doubts, consult your doctor or pharmacist.

Xylometazolin Apteo Med should be used only in the nose (also in otitis media).

To avoid spreading the infection, the packaging of the medicine should be used by only one patient. Adults and adolescents over 12 years of age: 2 to 4 drops of Xylometazolin Apteo Med solution into each nostril 3 times a day. Do not use more than 3 doses of the medicine into each nostril per day. It is recommended to take the last dose of the medicine directly before bedtime.

Xylometazolin Apteo Med should not be used for more than 7 consecutive days.

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

Method of use

• 1. Clean the nose.
• 2. Unscrew the cap containing the dropper.
• 3. Tilt your head back.
• 4. Put the drops into both nostrils and for some time keep your head tilted back, so that the drops spread throughout the nasal cavity.

• 5. After using the medicine, carefully clean the dropper tip with a clean paper tissue and then screw on the bottle.

Using a higher dose of Xylometazolin Apteo Med than recommended

In case of using a higher dose of the medicine than recommended, consult a doctor or pharmacist immediately. Symptoms of overdose are severe dizziness, excessive sweating, significantly lowered body temperature, headache, slow heartbeat, breathing difficulties, coma, convulsions, high blood pressure (hypertension), which may be followed by hypotension. Symptomatic treatment should be applied.

Missing a dose of Xylometazolin Apteo Med

Do not use a double dose to make up for a missed dose. If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Xylometazolin Apteo Med can cause side effects, although not everybody gets them. STOP using Xylometazolin Apteo Med and consult a doctor immediatelyif you 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,
• itching with red rash or blisters. These symptoms occur very rarely (less than 1 in 10,000 patients using the medicine).

Common side effects(occurring in 1 to 10 out of 100 patients):
dryness or irritation of the nasal mucosa, nausea, headache, burning sensation at the site of administration.
Uncommon side effects(occurring in 1 to 10 out of 1,000 patients):
nasal bleeding
Very rare side effects(occurring less than 1 in 10,000 patients):
allergic reaction (skin rash, itching), transient vision disturbances, irregular or accelerated heart rate.

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department for Monitoring of Adverse Reactions to Medicinal Products, Medical Devices, and Biocides of the Office for Registration of Medicinal Products, Medical Devices, and Biocides, Al. 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. By reporting side effects, you can help provide more information on the safety of the medicine.

5. How to store Xylometazolin Apteo Med

Keep the medicine out of the sight and reach of children. Store in a temperature below 25°C. 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 batch number (LOT) on the packaging indicates the batch number. Discard the bottle after 4 weeks from first opening, even if there is still some solution left. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Xylometazolin Apteo Med contains

• The active substance of Xylometazolin Apteo Med is xylometazoline hydrochloride. One ml of solution contains 1 mg of xylometazoline hydrochloride, which corresponds to 0.024 - 0.032 mg of xylometazoline hydrochloride per drop of solution (0.028 ± 15%).
• The other ingredients of the medicine are: sodium chloride, benzalkonium chloride, solution, disodium phosphate dihydrate, potassium dihydrogen phosphate, purified water.

What Xylometazolin Apteo Med looks like and what the package contains

Xylometazolin Apteo Med is a nasal drop in the form of a colorless, clear liquid. The packaging of the medicine is a LDPE bottle with a LDPE dropper, with an HDPE cap with a tamper-evident closure, containing 10 ml of solution, in a cardboard box.

Marketing authorization holder and manufacturer:

Marketing authorization holder:

Synoptis Pharma Sp. z o.o.
ul. Krakowiaków 65
02-255 Warsaw
phone: 22 321 62 40

Manufacturer:

Jadran-Galenski laboratorij d.d.
Svilno 20
51000 Rijeka
Croatia

Date of last revision of the leaflet: April 2021