Otrivin for children

Package leaflet: Information for the patient

Otrivin dla dzieci; 0.5 mg/ml, nasal spray, solution
Xylometazolini hydrochloridum
Please read this 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.

• 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 after 10 days, or if symptoms worsen, consult a doctor.

Table of contents:

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

1. What Otrivin dla dzieci is and what it is used for

The active substance in Otrivin dla dzieci is xylometazoline hydrochloride. Otrivin dla dzieci 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 special formulation (ingredients with moisturizing properties) helps prevent drying and irritation of the nasal mucosa.
The effect of Otrivin dla dzieci begins within 2 minutes and lasts up to twelve hours.
Otrivin dla dzieci is indicated for use in children aged 2 to 11 years.
Indications:
Excessive nasal mucosal congestion associated with 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 supportive treatment in otitis media.
Otrivin dla dzieci facilitates nasal endoscopy (examination of the nasal cavity).

2. 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 narrow-angle glaucoma (increased pressure in the eye),
• if the patient has very dry nasal mucosa (atrophic rhinitis or rhinitis sicca),
• in children under 2 years of age.

Warnings and precautions
Before using Otrivin for children, consult a doctor if:

• the patient has high blood pressure,
• the patient has heart disease (e.g. long QT syndrome),
• the patient has hyperthyroidism,
• the patient has diabetes,
• the patient has benign prostatic hyperplasia,
• the patient has a benign adrenal gland tumour producing large amounts of adrenaline and noradrenaline (pheochromocytoma),
• the patient is taking certain antidepressants known as monoamine oxidase inhibitors (MAOIs), or has taken them within the last 2 weeks,
• the patient is taking tricyclic or tetracyclic antidepressants (see below: Otrivin for children and other medicines),
• the patient is hypersensitive to substances with effects similar to xylometazoline. In sensitive patients, Otrivin for children may cause insomnia, dizziness, irregular heartbeat, high blood pressure, or tremor.

Do not use Otrivin for children for longer than 10 consecutive days. If symptoms persist, consult a doctor.
Using the medicine for longer than 10 days or in doses higher than recommended may worsen symptoms or cause their recurrence.
Do not apply Otrivin for children to the eyes or inside the mouth.
Do not exceed the recommended dose, especially in children and elderly people.

Children and adolescents
Do not use Otrivin for children in children under 2 years of age.
Use in children aged 2 to 11 years should be supervised by an adult.

Otrivin for children and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Do not use Otrivin for children if taking certain medicines used to treat depression. These include:

• monoamine oxidase inhibitors (MAOIs): Do NOT use Otrivin for children if taking MAOIs or have taken such medicines within the last 14 days,
• tricyclic or tetracyclic antidepressants.

If taking any of the above medicines, consult a doctor before using Otrivin for children.

Pregnancy and breastfeeding
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.
Do not use Otrivin for children during pregnancy.
During breastfeeding, Otrivin for children should be used only after consultation with a doctor.

Driving and operating machinery
Otrivin for children, when used at recommended doses, has no effect or has a negligible effect on the ability to drive and operate machinery.

Otrivin for children contains benzalkonium chloride
This medicine contains 0.007 mg of benzalkonium chloride per aerosol dose, equivalent to 0.1 mg of benzalkonium chloride per 1 ml of solution. Benzalkonium chloride may cause irritation or swelling inside the nose, especially if used for a prolonged period.

3. How to use Otrivin for Children

This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor.
If in doubt, consult a doctor or pharmacist.
Otrivin for Children is for nasal use only (including in cases of middle ear infection).
To avoid spreading infection, one package of the medicine should be used by only one patient.

Children aged 2 to 5 years (under adult supervision):
1 spray of Otrivin for Children into each nostril 1 to 2 times daily (every 8–10 hours).
Do not use more than 3 times daily.

Children aged 6 to 11 years (under adult supervision):
1 or 2 sprays of Otrivin for Children into each nostril 2 to 3 times daily.
Do not use more than 3 times daily.

Otrivin for Children must not be used in children under 2 years of age. Use in children aged 2 to 11 years should be under adult supervision. It is recommended to administer the last dose immediately before going to sleep.

Do not use for longer than 10 consecutive days.
Do not exceed the recommended dose, especially in children and elderly individuals.

Instructions for use
This medicine is intended for nasal use.
Take care not to spray into the eyes.

1. Do not cut the applicator tip. The spray is ready for use.

2. Remove the protective cap.
3. Before first use, press the pump 5 times. The pump is then ready for use throughout the recommended treatment period (do not use the medicine for longer than 10 consecutive days). If, after fully pressing the pump, no spray is released, or if the medicine has not been used for more than 7 days, re-prime the pump by pressing it twice.
4. Blow the nose.
5. Hold the bottle upright, supporting the bottom with the thumb and holding the tip between two fingers.

6. Tilt the head forward and insert the tip into one nostril.
7. Press the pump while inhaling gently through the nose to ensure optimal distribution of the spray.

8. Repeat the steps when administering the medicine into the other nostril.
9. Replace the protective cap after use.

The nasal spray allows precise dosing and ensures proper distribution of the solution over the entire nasal mucosal surface.
This prevents the risk of accidental overdose.

Overdose of Otrivin for Children
In case of an overdose, seek immediate medical advice from a doctor or pharmacist.
Symptoms of overdose include severe dizziness, excessive sweating, significantly lowered body temperature, headache, slow heart rate, breathing difficulties, coma, seizures, high blood pressure (hypertension), which may be followed by low blood pressure.
Symptomatic treatment should be administered.

Missed dose of Otrivin for Children
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 medicinal product may cause adverse reactions, although not everybody will experience them.
You should DISCONTINUE using Otrivin dla dzieci and immediately contact a doctor if any of the following adverse reactions occur, as they 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 frequently than in 1 out of 10,000 people using the medicine).

Common adverse reactions (occur less frequently than in 1 out of 10 patients):
dryness or irritation of the nasal mucosa, nausea, headache, burning sensation at the site of application.
Uncommon adverse reactions (occur less frequently than in 1 out of 100 patients):
nosebleeds.
Very rare adverse reactions (occur less frequently than in 1 out of 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 those not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 4921301, fax: +48 22 4921309,
website: https://smz.ezdrowie.gov.pl.
Adverse reactions can also be reported to the Marketing Authorisation Holder. Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Otrivin dla dzieci

Keep this medicine out of sight and reach of children.
Store 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the package and other information

What Otrivin for Children contains

• The active substance in Otrivin for Children is xylometazoline hydrochloride. One ml of solution contains 0.5 mg of xylometazoline hydrochloride.
• The other ingredients 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
The Otrivin for Children package consists of a bottle with a metered-dose pump containing 10 ml of solution,
in a cardboard box. The package contains 120 doses.
Marketing Authorisation 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

Package leaflet: information for the patient

Otrivin for Children; 0.5 mg/ml, nasal spray, solution
Xylometazolini hydrochloridum
Please read all of this leaflet carefully before using this medicine because it contains
important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed
by your doctor or pharmacist.

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

Contents of the leaflet:

1. What Otrivin for Children is and what it is 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 package and other information

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

The active substance in Otrivin for Children is xylometazoline hydrochloride. Otrivin for Children is
a locally acting medicine which, by constricting blood vessels, reduces congestion and swelling of the nasal
mucosa and decreases nasal discharge.
It helps patients with a blocked nose to breathe more easily through the nose. The special formulation
(containing moisturising agents) helps prevent drying and irritation of the nasal mucosa.
The effect of Otrivin for Children begins within 2 minutes and lasts up to twelve hours.
Otrivin for Children is indicated for use in children aged 2 to 11 years.
Indications:
Excessive nasal mucosal congestion associated with colds, hay fever, allergic rhinitis, sinusitis. The medicine facilitates drainage of secretions from inflamed paranasal sinuses. By reducing congestion of the nasal-pharyngeal mucosa, it may be used as supportive treatment in otitis media.
Otrivin for Children facilitates nasal endoscopy (examination of the nasal cavity).

2. Important information before using Otrivin for Children

When not to use Otrivin for Children

• if you are allergic to xylometazoline hydrochloride or any of the other ingredients of this medicine (listed in section 6).
• if you have undergone surgery via the nose, e.g. pituitary gland removal or any procedure involving exposure of the dura mater (brain surgery via the nose or mouth).
• if you have narrow-angle glaucoma (increased eye pressure).
• if your nasal mucosa is very dry (atrophic rhinitis or drying rhinitis).
• in children under 2 years of age.

Warnings and precautions
Before using Otrivin for Children, consult your doctor if you have:

• high blood pressure,
• heart disease (e.g. long QT syndrome),
• hyperthyroidism,
• diabetes,
• benign prostatic hyperplasia,
• a benign adrenal gland tumour producing large amounts of adrenaline and noradrenaline (pheochromocytoma),
• are taking certain antidepressants known as monoamine oxidase inhibitors (MAOIs), or have taken them within the last 2 weeks,
• are taking tricyclic or tetracyclic antidepressants (see below: Otrivin for Children and other medicines),
• hypersensitivity to substances with effects similar to xylometazoline. In sensitive patients, Otrivin for Children may cause insomnia, dizziness, irregular heartbeat, increased blood pressure, or tremor.

Do not use Otrivin for Children for longer than 10 consecutive days. If symptoms persist, contact your doctor.
Using the medicine for longer than 10 days or in higher than recommended doses may worsen symptoms or cause their recurrence.
Do not apply Otrivin for Children to the eyes or inside the mouth.
Do not exceed the recommended dose, especially in children and elderly people.
Children and adolescents
Otrivin for Children must not be used in children under 2 years of age.
Use in children aged 2 to 11 years should be supervised by an adult.
Otrivin for Children 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 Otrivin for Children if you are taking certain antidepressants 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 within the last 14 days,
• tricyclic and tetracyclic antidepressants.

If you are taking any of the above medicines, consult your doctor before using Otrivin for Children.
Pregnancy and breastfeeding
If you are pregnant or 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 Otrivin for Children during pregnancy.
During breastfeeding, Otrivin for Children should only be used after consultation with a doctor.
Driving and using machines
Otrivin for Children, when used at recommended doses, has no effect or has a negligible effect on the ability to drive and operate machinery.
Otrivin for Children contains benzalkonium chloride
This medicine contains 0.007 mg of benzalkonium chloride per spray dose, equivalent to 0.1 mg of benzalkonium chloride per 1 ml of solution. Benzalkonium chloride may cause
irritation or swelling inside the nose, especially if used for prolonged periods.

3. How to use Otrivin for Children

Always use this medicine exactly as described in this patient leaflet or as directed by your doctor.
If in doubt, consult your doctor or pharmacist.
Otrivin for Children is for nasal use only (including in otitis media).
To avoid spreading infection, one package should be used by only one patient.
Children aged 2 to 5 years (under adult supervision):
1 spray of Otrivin for Children into each nostril 1 to 2 times daily (every 8–10 hours).
Do not use more than 3 times daily.
Children aged 6 to 11 years (under adult supervision):
1 or 2 sprays of Otrivin for Children into each nostril 2 to 3 times daily.
Do not use more than 3 times daily.
Otrivin for Children must not be used in children under 2 years of age. Use in children aged 2 to 11 years should be supervised by an adult. It is recommended to take the last dose just before going to sleep.
Do not use for longer than 10 consecutive days.
Do not exceed the recommended dose, especially in children and elderly people.
Instructions for use
The medicine is intended for nasal use.
Be careful not to spray the solution into the eyes.
Before first use, prime the pump by pressing the dispenser on the side of the pump 7 times. The pump will then be ready for use throughout the recommended treatment period (do not use the medicine for longer than 10 consecutive days). If no spray is released when pressing the dispenser, or if the medicine has not been used for more than 7 days, re-prime the pump by pressing the dispenser twice.
Remove the protective cap.

1. Clear the nose.

2. Hold the bottle upright. Place your thumb on the dispenser on the side of the pump.

3. Remain upright to prevent dripping. Gently insert the short nozzle into one nostril.

4. Press the dispenser and gently inhale through the nose. Repeat steps 2 to 4 when administering the medicine into the other nostril.

5. After each use, clean and dry the nozzle.

6. Replace the protective cap until you hear a distinct click.

If an incomplete dose is administered, do not repeat the application.
The dispenser activated from the side of the pump ensures accurate dosing and proper distribution of the solution over the nasal mucosa by producing a fine mist. This prevents accidental overdosing.
Accidental overdose of Otrivin for Children
If more than the recommended dose is used, contact your doctor or pharmacist immediately.
Symptoms of overdose include severe dizziness, excessive sweating, significantly lowered body temperature, headache, slow heartbeat, breathing difficulties, coma, seizures, high blood pressure (hypertension), followed by low blood pressure.
Symptomatic treatment should be administered.
Missed 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, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
You should STOP using Otrivin for Children and contact your doctor immediately if any of the following side effects occur, as they 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 effects are very rare (occurring in fewer than 1 in 10,000 people using the medicine).

Common side effects (occur in fewer than 1 in 10 patients):
dryness or irritation of the nasal mucosa, nausea, headache, burning sensation at the site of application.
Uncommon side effects (occur in fewer than 1 in 100 patients):
nosebleeds.
Very rare side effects (occur in fewer than 1 in 10,000 patients):
allergic reaction (skin rash, itching), transient visual disturbances, arrhythmia or rapid heartbeat.
Reporting of side effects
If you experience any adverse effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, tel: +48 22 4921301, fax: +48 22 4921309,
website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorisation holder. Reporting adverse effects helps provide more information on the safety of the medicine.

5. How to store Otrivin for Children

Keep the medicine out of sight and reach of children.
Store 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 stated month.
Do not dispose of medicines via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer in use. These measures help protect the environment.

6. Contents of the package and other information

What Otrivin for Children contains

• The active substance in Otrivin for Children is xylometazoline hydrochloride. One ml of solution contains 0.5 mg of xylometazoline hydrochloride.
• The other ingredients 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
The Otrivin for Children package consists of a bottle with a metered-dose pump containing 10 ml of solution,
in a cardboard box. The metered-dose pump ensures accurate dosing of the medicine. The package contains 120 doses.
Marketing Authorisation 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