OTRIVIN 0.5 mg/ml Aerosol

Contents of the leaflet

1. Package Leaflet: Information for the Patient
   1. Read the package leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet:
2. What is Otrivin for Children and what is it used for
   1. Indications for use:
3. Important information before using Otrivin for Children
   1. When not to use Otrivin for Children
   2. Warnings and precautions
   3. Children and adolescents
   4. Otrivin for Children and other medicines
   5. Pregnancy and breastfeeding
   6. Driving and using machines
   7. Otrivin for Children contains benzalkonium chloride
4. How to use Otrivin for Children
   1. Otrivin for Children should be used only in the nose (also in middle ear inflammation).
   2. Method of use
   3. Using a higher dose of Otrivin for Children than recommended
   4. Missing a dose of Otrivin for Children
5. Possible side effects
   1. Reporting side effects
6. How to store Otrivin for Children
7. Contents of the pack and other information
   1. What Otrivin for Children contains
   2. What Otrivin for Children looks like and contents of the pack
   3. Marketing authorization holder:
   4. Importer:
   5. Date of last revision of the leaflet: November 2024

Package Leaflet: Information for the Patient

Otrivin for Children; 0.5 mg/ml, nasal spray, solution
Xylometazoline hydrochloride

Read the package 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 package leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or further information, ask your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If after 10 days there is no improvement or you feel worse, you should contact your doctor.

Table of Contents of the Leaflet:

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

1. What is Otrivin for Children and what is it used for

The active substance of Otrivin for Children is xylometazoline hydrochloride. Otrivin for Children is a locally acting medicine that reduces congestion and swelling of the nasal mucosa and the amount of discharge by constricting blood vessels.

For patients with a stuffy nose, it makes breathing through the nose easier. The special composition of the medicine (moisturizing substances) prevents drying and irritation of the nasal mucosa. The effect of Otrivin for Children starts within 2 minutes and lasts up to twelve hours.

Otrivin for Children is indicated for use in children from 2 to 11 years old.

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 outflow of discharge from inflamed paranasal sinuses. By reducing the congestion of the nasal mucosa, it can be used as an adjunct in the treatment of middle ear inflammation. Otrivin for Children facilitates nasal examination (examination of the nasal cavity).

2. Important information before using Otrivin for Children

When not to use Otrivin for Children

• 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 glaucoma with a narrow angle of filtration (increased pressure in the eye).
• if the patient's nasal mucosa is very dry (atrophic rhinitis or dry rhinitis).
• in children under 2 years of age.

Warnings and precautions

Before using Otrivin for Children, you should discuss it with your doctor if:

• you have high blood pressure,
• you have heart disease (e.g. long QT syndrome),
• you have hyperthyroidism,
• you have diabetes,
• you have an enlarged prostate,
• you have a benign tumor of the adrenal gland that produces large amounts of adrenaline and noradrenaline (pheochromocytoma),
• you are taking certain antidepressant medicines known as monoamine oxidase inhibitors (MAOIs) or have taken them in the last 2 weeks,
• you are taking tricyclic or tetracyclic antidepressants (see below Otrivin for Children and other medicines),
• you are hypersensitive to substances with a similar action to xylometazoline. In sensitive patients, Otrivin for Children may cause insomnia, dizziness, irregular heartbeat, increased blood pressure, or tremors.

Otrivin for Children should not be used for more than 10 consecutive days. If symptoms persist, you should contact your doctor.

Using the medicine for a longer period than 10 days or in doses higher than recommended may cause worsening of symptoms or their recurrence.

Otrivin for Children should not be used in the eyes or in the mouth.

Do not use a higher dose than recommended, especially in children and the elderly.

Children and adolescents

Otrivin for Children should not be used in children under 2 years of age.

Use in children from 2 to 11 years old should be under adult supervision.

Otrivin for Children and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.

Do not use Otrivin for Children if you are taking certain medicines used to treat depression. These include:

• monoamine oxidase inhibitors (MAOIs): DO NOT use Otrivin for Children if you are taking MAOIs or have taken them in the last 14 days,
• tricyclic and tetracyclic antidepressants.

If you are taking any of these medicines, consult your doctor before using Otrivin for Children.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before using this medicine.

Do not use Otrivin for Children during pregnancy.

During breastfeeding, Otrivin for Children can be used only after consulting a doctor.

Driving and using machines

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

Otrivin for Children contains benzalkonium chloride

This medicine contains 0.007 mg of benzalkonium chloride in each dose of the spray, which corresponds to 0.1 mg of benzalkonium chloride in 1 ml of the solution. Benzalkonium chloride may causeirritation or swelling inside the nose, especially if used for a long time.

3. How to use Otrivin for Children

This medicine should always be used exactly as described in this package leaflet or as directed by your doctor. If you are unsure, ask your doctor or pharmacist.

Otrivin for Children should be used only in the nose (also in middle ear inflammation).

To avoid spreading the infection, one package of the medicine should be used by only one patient.

Children from 2 to 5 years old (under adult supervision):

1 dose of Otrivin for Children spray into each nostril 1 to 2 times a day (every 8-10 hours).

Do not use more than 3 times a day.

Children from 6 to 11 years old (under adult supervision):

1 or 2 doses of Otrivin for Children spray into each nostril 2 to 3 times a day.

Do not use more than 3 times a day.

Otrivin for Children should not be used in children under 2 years of age. Use in children from 2 to 11 years old should be under adult supervision. It is recommended to take the last dose of the medicine directly before bedtime.

Do not use for more than 10 consecutive days.

Do not use a higher dose than recommended, especially in children and the elderly.

Method of use

The medicine is intended for use in the nose.

Be careful not to spray the aerosol into the eyes.

• 1. Do not cut the tip of the applicator. The aerosol is ready for use.

• 2. Remove the protective cap.
• 3. Before the first use, press the pump 5 times. The pump will be ready for further use throughout the recommended use period (do not use the medicine for more than 10 consecutive days). If, after fully pressing the pump, the aerosol is not sprayed, or if the medicine has not been used for more than 7 days, you should prepare the pump again by pressing it 2 times.
• 4. Clean the nose.

• 5. Hold the bottle upright, with your thumb on the bottom of the bottle, and the tip between your fingers.

• 6. Tilt your head forward and place the tip in the nostril.
• 7. Press the pump and at the same time gently inhale through your nose to ensure optimal distribution of the aerosol.

• 8. Repeat the actions 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 excludes the possibility of accidental overdose.

Using a higher dose of Otrivin for Children than recommended

If you use a higher dose of the medicine than recommended, you should immediately contact your doctor or pharmacist.

Symptoms of overdose are severe dizziness, excessive sweating, significantly lowered body temperature, headache, slow heartbeat, breathing difficulties, coma, convulsions, hypertension (high blood pressure), which may be followed by hypotension.

Treatment should be symptomatic.

Missing a dose of Otrivin for Children

Do not use a double dose to make up for a missed dose.

If you have any further doubts about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Otrivin for Children can cause side effects, although not everybody gets them.

YOU SHOULD STOP USING Otrivin for Children and contact your doctor immediately if 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 often than in 1 in 10,000 patients using the medicine).

Common side effects(occurring in less than 1 in 10 patients):
dryness or irritation of the nasal mucosa, nausea, headache, burning sensation at the site of administration.
Uncommon side effects(occurring in less than 1 in 100 patients):
nosebleeds.
Rare side effects(occurring in 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 those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department for 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.

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 this medicine.

5. How to store Otrivin for Children

Keep the medicine out of the sight and reach of children.

Store in a temperature below 30°C.

Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Otrivin for Children contains

• The active substance of Otrivin for Children is xylometazoline hydrochloride. One ml of the solution contains 0.5 mg of xylometazoline hydrochloride.
• The other ingredients of the medicine are: benzalkonium chloride, disodium edetate, sodium dihydrogen phosphate dihydrate, disodium phosphate dodecahydrate, sodium chloride, sorbitol 70%, hypromellose 4000, purified water.

What Otrivin for Children looks like and contents of the pack

Otrivin for Children is a bottle with a dosing pump containing 10 ml of the solution, in a cardboard box. The dosing pump allows for the correct dose of the medicine to be administered. The pack contains 120 doses.

Marketing authorization holder:

Haleon Poland Sp. z o.o.

ul. Rzymowskiego 53

02-697 Warsaw

tel. 800 702 849

Importer:

Haleon Germany GmbH

Barthstrasse 4

80339 Munich

Germany

Date of last revision of the leaflet: November 2024