Otrivin Katar i Zatoki

Package Leaflet: Information for the User

Otrivin Cold and Sinus, 1 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 for the patient or as directed by a doctor or pharmacist or nurse.

• Keep this package leaflet, in case you need to read it again.
• If you need advice or additional information, you should consult a pharmacist or nurse.
• If the patient experiences any side effects, including any possible side effects not listed in this package leaflet, they should inform their doctor or pharmacist or nurse. 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 Package Leaflet:

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

1. What is Otrivin Cold and Sinus and what is it used for

The active substance of Otrivin Cold and Sinus is xylometazoline hydrochloride.

Otrivin Cold and Sinus is a locally acting decongestant that reduces nasal congestion and swelling of the nasal mucosa. It unblocks the nose, making it easier to breathe.

The medicine also contains excipients such as menthol and eucalyptol, which give a cooling sensation on the mucous membranes.

The effect of Otrivin Cold and Sinus starts within 2 minutes and lasts for up to 12 hours.

Otrivin Cold and Sinus is indicated for use in adults and adolescents over 12 years of age.

Otrivin Cold and Sinus is used for excessive nasal congestion in the common cold, hay fever, allergic rhinitis, and sinusitis.

By reducing nasal congestion, the medicine can be used as an adjunct in the treatment of otitis media (middle ear infection). Otrivin Cold and Sinus facilitates nasal examination (examination of the nasal cavity).

Otrivin Cold and Sinus does not contain preservatives.

2. Important information before using Otrivin Cold and Sinus

When not to use Otrivin Cold and Sinus

• 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 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 the medicine, the patient should consult a doctor or pharmacist if they have:

• high blood pressure
• heart disease (e.g., long QT syndrome)
• hyperthyroidism
• diabetes
• prostatic hyperplasia
• a benign adrenal tumor that produces large amounts of adrenaline and noradrenaline (pheochromocytoma)
• are taking certain antidepressant medicines known as monoamine oxidase inhibitors (MAOIs) or have taken them in the last 2 weeks
• are taking tricyclic or tetracyclic antidepressants
• like other nasal decongestants, Otrivin Cold and Sinus may cause insomnia, dizziness, tremors, heart rhythm disturbances, and increased blood pressure in sensitive patients. If such symptoms occur, the patient should consult a doctor
• like other nasal decongestants, Otrivin Cold and Sinus should not be used for more than 10 consecutive days. If symptoms persist, the patient should consult a doctor. Using the medicine for a longer period than 10 days or in higher doses than recommended may lead to worsening of symptoms or their recurrence
• Otrivin Cold and Sinus should not be used in the eyes or mouth
• A higher dose than recommended should not be used, especially in children and the elderly

Children and adolescents

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

Otrivin Cold and Sinus and other medicines

The patient should inform 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 Cold and Sinus should not be used if the patient is taking certain medicines used to treat depression, such as:

• monoamine oxidase inhibitors (MAOIs): Otrivin Cold and Sinus should not be used if the patient is taking MAOIs or has taken them in the last 14 days
• tricyclic or tetracyclic antidepressants

If the patient has taken any of these medicines before using Otrivin Cold and Sinus, they should consult a doctor.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, or thinks they may be pregnant or plans to have a child, they should consult a doctor before using this medicine.

Otrivin Cold and Sinus should not be used during pregnancy.

During breastfeeding, Otrivin Cold and Sinus can be used only after consulting a doctor.

Driving and using machines

Otrivin Cold and Sinus, when used as recommended, does not affect or has a negligible effect on the ability to drive or use machines.

Otrivin Cold and Sinus contains macrogolglycerol hydroxystearate (hydrogenated polyoxyethylene castor oil)

This medicine contains 2.75 mg/ml of macrogolglycerol hydroxystearate (hydrogenated polyoxyethylene castor oil). The medicine may cause skin reactions.

3. How to use Otrivin Cold and Sinus

This medicine should always be used exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist or nurse.

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

Adults and adolescents over 12 years of age:

1 dose of Otrivin Cold and Sinus nasal spray into each nostril up to 3 times a day. It is recommended to take the last dose of the medicine directly before going to bed.

Do not use more than 3 times a day into each nostril.

Otrivin Cold and Sinus should not be used for more than 10 consecutive days.

Method of administration

The medicine is intended for nasal use.

Be careful not to spray the aerosol into the eyes.

• 1. Clean the nose.
• 2. Remove the protective cap.
• 3. Do not cut the tip of the applicator.

• 4. Before the first use, press the pump 4 times. The pump will be ready for further use throughout the recommended use period. If, after full pressing of the pump, the aerosol is not sprayed, or if the medicine has not been used for more than 6 days, the pump should be prepared again by pressing 4 times. Do not spray towards the eyes or mouth.
• 5. Hold the bottle upright, with your thumb supporting the bottom of the bottle, and place the tip between your two fingers.

• 6. Tilt your head forward and place the tip into the nostril.
• 7. Press the pump and inhale through your nose at the same time.

• 8. Repeat the steps when administering the medicine to the other nostril.
• 9. After use, clean and dry the applicator tip and put the protective cap back on.

For hygiene reasons, one package of the medicine should be used by only one patient.

Using a higher dose of Otrivin Cold and Sinus than recommended

If a higher dose of the medicine than recommended is used, the patient should immediately consult a doctor or pharmacist.

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

Symptomatic treatment should be applied.

Missing a dose of Otrivin Cold and Sinus

A double dose should not be used to make up for a missed dose.

If the patient has any further doubts about using this medicine, they should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Otrivin Cold and Sinus can cause side effects, although not everybody gets them.

The patient should STOP USINGOtrivin Cold and Sinus and IMMEDIATELY CONSULT A DOCTORif 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
• severe itching with red rash or blisters. These symptoms occur very rarely (less than 1 in 10,000 people using the medicine).

Common (may affect up to 1 in 10 people using the medicine):

dryness or irritation of the nasal mucosa, feeling of discomfort in the nose, nausea, headache, burning sensation at the site of application.

Uncommon (may affect up to 1 in 100 people using the medicine)

nosebleeds.

Rare (may affect up to 1 in 10,000 people using the medicine):

allergic reaction (skin rash, itching), transient vision disturbances, irregular or accelerated heart rate.

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in the package leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department for Monitoring of Adverse Reactions to Medicinal Products, Medical Devices, and Biocides, ul. 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.

Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Otrivin Cold and Sinus

The medicine should be stored out of sight and reach of children.

The medicine should not be used after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.

Store in a temperature below 25°C.

Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the package and other information

What Otrivin Cold and Sinus contains

• The active substance of Otrivin Cold and Sinus is xylometazoline hydrochloride. One ml of the solution contains 1 mg of xylometazoline hydrochloride.
• The other ingredients of the medicine are: sodium dihydrogen phosphate dihydrate, disodium phosphate dodecahydrate, sodium chloride, disodium edetate, levomenthol, cineole (eucalyptol), sorbitol, macrogolglycerol hydroxystearate (hydrogenated polyoxyethylene castor oil), purified water.

What Otrivin Cold and Sinus looks like and contents of the package

The package of Otrivin Cold and Sinus is a bottle with a dosing pump containing 10 ml of a colorless to pale yellow solution with a menthol and eucalyptol scent. The dosing pump allows for the precise dosing of the medicine. The package contains 60 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 package leaflet: November 2024