Xylometazolin apteo med

Package leaflet: Information for the user

Xylometazolin APTEO MED
0.5 mg/ml, nasal drops, solution
Xylometazolini hydrochloridum
Please read the entire 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 physician 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 5 days of treatment, or if symptoms worsen, consult a doctor.

Contents of the leaflet:

1. What Xylometazolin Apteo Med is and what it is 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. Contents of the pack and other information

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

The active substance in Xylometazolin Apteo Med is xylometazoline hydrochloride.
Xylometazolin Apteo Med is a locally acting medicine that reduces nasal mucosal congestion and swelling, as well as nasal discharge, by constricting blood vessels.
It helps patients with a stuffy nose to breathe more easily through the nose.
The effect of Xylometazolin Apteo Med begins within 2 minutes after application and lasts up to 10 hours.
Xylometazolin Apteo Med is indicated for use in children aged 2 to 11 years.

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 an adjunctive treatment in otitis media.
Xylometazolin Apteo Med facilitates nasal speculum examination (examination of the nasal cavity).

2. 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 exposing the dura mater (brain surgery performed through the nose or mouth),
• if the patient has narrow-angle glaucoma (increased pressure in the eye),
• if the patient has very dry nasal mucosa (atrophic rhinitis or drying inflammation of the nasal mucosa).

Warnings and precautions
Before using Xylometazolin APTEO MED, consult a doctor in the following cases:

• high blood pressure,
• heart disease (e.g. long QT syndrome),
• hyperthyroidism,
• diabetes,
• benign prostatic hyperplasia,
• benign tumour of the adrenal gland producing large amounts of adrenaline and noradrenaline (pheochromocytoma),
• taking certain antidepressant medicines known as monoamine oxidase inhibitors (MAOIs), or having taken them within the previous 2 weeks,
• hypersensitivity to substances with effects similar to xylometazoline. In sensitive patients, Xylometazolin APTEO MED may cause insomnia, dizziness, irregular heartbeat, high blood pressure, or tremor.

Xylometazolin APTEO MED should not be used for longer than 5 consecutive days. If symptoms persist, consult a doctor.
Prolonged use beyond 5 days or use in doses higher than recommended may lead to worsening or recurrence of symptoms, or atrophy of the nasal mucosa.
Do not apply Xylometazolin APTEO MED to the eyes or inside the mouth.
Do not exceed the recommended dose.

Children and adolescents
Xylometazolin APTEO MED should not be used in children under 2 years of age.
Use in children aged 2 to 11 years should be supervised by an adult.

Xylometazolin APTEO MED and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Do not use Xylometazolin APTEO MED if taking certain medicines used to treat depression, including:

• monoamine oxidase inhibitors (MAOIs): DO NOT use Xylometazolin APTEO MED if 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 APTEO MED.

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.
Do not use Xylometazolin APTEO MED during pregnancy.
During breastfeeding, Xylometazolin APTEO MED should be used only after consulting a doctor.

Driving and operating machinery
Xylometazolin APTEO MED, when used at recommended doses, has no effect or has a negligible effect on the ability to drive vehicles or operate machinery.

Xylometazolin APTEO MED contains benzalkonium chloride, which may cause irritation of mucous membranes.

3. How to use Xylometazolin Apteo Med

This medicine should always be used exactly as described in the patient information leaflet or as advised by your doctor. If in doubt, consult your doctor or pharmacist.
Xylometazolin Apteo Med is for nasal use only (also in middle ear inflammation).
To avoid spreading infection, the medicine container should be used by only one patient.

Children aged 2 to 5 years (under adult supervision):
1 or 2 drops of Xylometazolin Apteo Med solution into each nostril 1 to 2 times daily (every 8 to 10 hours).
Do not use more than 2 doses per nostril per day.

Children aged 6 to 11 years (under adult supervision):
2 to 4 drops of Xylometazolin Apteo Med solution into each nostril 2 to 3 times daily, if necessary.
Do not use more than 3 doses per nostril per day.
It is recommended that the last dose be taken immediately before bedtime.
Xylometazolin Apteo Med should not be used for longer than 5 consecutive days.
Xylometazolin Apteo Med should not be used in children under 2 years of age. Use in children aged 2 to 11 years should be under adult supervision.

Instructions for use

1. Clear the nose.
2. Unscrew the cap containing the dropper.
3. Tilt the head backward.
4. Instill the drops into both nostrils and keep the head tilted for a while to allow the drops to spread throughout the nasal cavity.

5. After using the medicine, carefully wipe the dropper tip with a clean paper tissue and then replace the cap on the bottle.

Use of more than the recommended dose of Xylometazolin Apteo Med
If more than the recommended dose has been used, consult your doctor or pharmacist immediately.
Symptoms of overdose include severe dizziness, excessive sweating, significantly lowered body temperature, headache, slow heart rate, breathing difficulties, coma, convulsions, arterial hypertension (high blood pressure), followed possibly by hypotension.
Symptomatic treatment should be administered.

Missed dose of Xylometazolin Apteo Med
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.
You should DISCONTINUE use of Xylometazolin APTEO MED and immediately consult a
physician if any of the following adverse symptoms occur, which may be signs of an allergic reaction:

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

Common adverse reactions (occur 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 adverse reactions (occur in 1 to 10 out of 1,000 patients):
nosebleed
Very rare adverse reactions (occur in fewer than 1 in 10,000 patients):
allergic reaction (skin rash, itching), transient visual disturbances, arrhythmia or
accelerated heart rate.

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

5. How to store Xylometazolin APTEO MED

Keep out of the 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 "EXP".
The expiry date refers to the last day of the stated month.
The code "LOT" on the packaging indicates the batch number.
Discard the bottle 4 weeks after first opening, even if some solution remains.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This helps protect the environment.

6. Contents of the package and other information

What Xylometazolin APTEO MED contains

• The active substance in Xylometazolin APTEO MED is xylometazoline hydrochloride. One ml of solution contains 0.5 mg of xylometazoline hydrochloride, corresponding to 0.012–0.016 mg per drop (0.014 ± 15%).
• The other ingredients are: sodium chloride, benzalkonium chloride solution, disodium phosphate dihydrate, potassium dihydrogen phosphate, purified water.

What Xylometazolin APTEO MED looks like and contents of the pack
Xylometazolin APTEO MED is a nasal drop solution in the form of a colourless, transparent liquid.
The medicine is packaged in an LDPE bottle with an LDPE dropper and an HDPE screw cap with a tamper-evident seal, containing 10 ml of solution, with a cardboard carton.

Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder
Synoptis Pharma Sp. z o.o.
ul. Krakowiaków 65
02-255 Warsaw
tel. 22 321 62 40

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