Otrivin

Package Leaflet: Information for the User

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Otrivin, 1 mg/ml, Nasal Spray, Solution

Xylometazoline Hydrochloride

Before using the medicine, carefully read the contents of the leaflet, 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.

• The leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement after 10 days or if the patient feels worse, they should contact their doctor.

Table of Contents of the Leaflet:

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

1. What is Otrivin and what is it used for

The active substance of Otrivin is xylometazoline hydrochloride.
Otrivin is a locally acting medicine that, by constricting blood vessels, reduces congestion and swelling of the nasal mucosa and the amount of discharge.
For patients with a feeling of a blocked nose, it facilitates breathing through the nose. The special composition of the medicine (moisturizing substances) prevents drying and irritation of the nasal mucosa.
The effect of Otrivin starts within 2 minutes and lasts for up to twelve hours.
Otrivin 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 outflow of discharge from inflamed paranasal sinuses. By reducing congestion of the nasal-pharyngeal mucosa, it can be used as an adjunct in otitis media.
Otrivin facilitates nasal examination (examination of the nasal cavity).

2. Important information before using Otrivin

When not to use Otrivin

• 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),
• in children under 12 years of age.

Warnings and precautions

Before using Otrivin, the patient should consult a doctor in the case of:

• high blood pressure,
• heart disease (e.g. long QT syndrome),
• hyperthyroidism,
• diabetes,
• prostate enlargement,
• a benign adrenal tumor that produces large amounts of adrenaline and noradrenaline (pheochromocytoma),
• taking certain antidepressant medicines known as monoamine oxidase inhibitors (MAOIs) or taking them within the last 2 weeks,
• taking tricyclic and tetracyclic antidepressants,
• hypersensitivity to substances with a similar effect to xylometazoline. In sensitive patients, Otrivin may cause insomnia, dizziness, irregular heartbeat, increased blood pressure, or tremors.

Otrivin should not be used for more than 10 consecutive days. If symptoms persist, the patient should contact their doctor.
Using the medicine for a period longer than 10 days or in doses larger than recommended may cause worsening of symptoms or their recurrence.
Otrivin should not be used in the eyes or in the mouth.
A higher dose than recommended should not be used, especially in children and the elderly.

Children and adolescents

Otrivin should not be used in children under 12 years of age.

Otrivin and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Otrivin should not be used in the case of taking certain medicines used to treat depression. These are:

• monoamine oxidase inhibitors (MAOIs): Otrivin should not be used in the case of concurrent use of MAOIs or use of such medicines within the last 14 days,
• tricyclic and tetracyclic antidepressants. In the case of taking any of the above medicines, the patient should consult their doctor before using Otrivin.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
Otrivin should not be used during pregnancy.
During breastfeeding, Otrivin can be used only after consulting a doctor.

Driving and using machines

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

Otrivin contains benzalkonium chloride

This medicine contains 0.014 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 cause irritation
or swelling inside the nose, especially if used for a long time.

3. How to use Otrivin

This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.

Otrivin should be used only in the nose (also in otitis media).

To avoid spreading the infection, one package of the medicine should be used by only one patient.
Adults and adolescents over 12 years of age:
1 dose of Otrivin into each nostril up to 3 times a day.
It should not be used more than 3 times a day. It is recommended to take the last dose of the medicine directly before going to bed.
It should not be used for more than 10 consecutive days.
Otrivin should not be used in children under 12 years of age.

Method of use

The medicine is intended for use in the nose.
Caution should be exercised to avoid spraying the aerosol into the eyes.

• 1. The tip of the applicator should not be cut. 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 (not longer 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, the pump should be prepared again by pressing it 4 times.
• 4. Clean the nose.
• 5. Hold the bottle upright, with the thumb holding the bottom of the bottle and the tip held between two fingers.

• 6. Tilt the head forward and insert the tip into the nostril.
• 7. Press the pump and simultaneously inhale through the 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 eliminates the possibility of accidental overdose.

Using a higher dose of Otrivin than recommended

In the event of using a higher dose of the medicine than recommended, the patient should immediately consult their doctor or pharmacist.
In the event of an overdose, the following may occur: headaches and dizziness, sweating, decreased body temperature, slowed heart rate, increased blood pressure, respiratory disorders, coma, convulsions.
Symptomatic treatment should be applied.

Missing a dose of Otrivin

A double dose should not be used to make up for a missed dose.
If there are any further doubts about using this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Otrivin can cause side effects, although not everybody gets them.
The patient should STOPusing Otrivin and immediately consult their doctor if they 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 the patient experiences any side effects, including those not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Medicinal Product Monitoring 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
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Otrivin

The medicine should be stored out of 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.
After the first opening, the nasal spray can be used until the end of the expiry date.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Otrivin contains

• The active substance of Otrivin is xylometazoline hydrochloride. One ml of the solution contains 1 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 liquid, non-crystallizing 70% (E 420), hypromellose 4000, purified water.

What Otrivin looks like and contents of the pack

Otrivin is a package containing a HDPE bottle with a dosing pump and a protective cap, containing 10 ml of the solution, in a cardboard box.
To obtain more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Lithuania, the country of export:

Haleon Hungary Kft.
1124 Budapest, Csörsz utca 43
Hungary

Manufacturer:

Haleon Germany GmbH
Barthstraße 4
80339 Munich
Germany

Parallel importer:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Lithuanian, the country of export, marketing authorization number: LT/1/95/0102/001

Parallel import authorization number: 124/25

Date of leaflet approval: 02.04.2025

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