Otrivin for cold and sinuses

Package leaflet: Information for the user

Otrivin Cold & Sinus, 1 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, pharmacist, or nurse.

• 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 reactions, including any possible adverse reactions not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.
• If there is no improvement or if you feel worse after 10 days, you should consult your doctor.

Contents of the leaflet:

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

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

The active substance in Otrivin Cold & Sinus is xylometazoline hydrochloride.
Otrivin Cold & Sinus is a locally acting medicine that reduces congestion and swelling of the nasal mucosa. It unblocks the congested nose, making breathing easier.
The medicine also contains auxiliary substances such as menthol and eucalyptol, which produce a cooling sensation on the mucous membranes.
The effect of Otrivin Cold & Sinus begins within 2 minutes and lasts up to twelve hours.
Otrivin Cold & Sinus is indicated for use in adults and adolescents over 12 years of age.
Otrivin Cold & Sinus is used in excessive congestion of the nasal mucosa occurring during colds, hay fever, allergic rhinitis, and sinusitis.
By reducing congestion of the nasopharyngeal mucosa, the medicine may be used as supportive treatment in otitis media. Otrivin Cold & Sinus facilitates nasal endoscopy (examination of the nasal cavity).
Otrivin Cold & Sinus does not contain preservatives.

2. Important information before using Otrivin Katar i Zatoki

When not to use Otrivin Katar i Zatoki

• 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 has very dry nasal mucosa (atrophic rhinitis or drying inflammation of the nasal mucosa)
• in children under 12 years of age.

Warnings and precautions
Before using the medicine, consult a doctor, pharmacist, or nurse if:

• the patient has high blood pressure,
• the patient has heart disease (e.g. long QT syndrome),
• hyperthyroidism,
• diabetes,
• benign prostatic hyperplasia,
• a benign adrenal gland tumor producing large amounts of adrenaline and noradrenaline (pheochromocytoma),
• the patient is taking certain antidepressant medicines known as monoamine oxidase inhibitors (MAOIs) or has taken them within the last 2 weeks,
• the patient is taking tricyclic or tetracyclic antidepressants,
• like other medicines that constrict the nasal mucosa, Otrivin Katar i Zatoki may cause insomnia, dizziness, tremor, heart rhythm disturbances, and increased blood pressure in sensitive patients. If such symptoms occur, consult a doctor,
• as with other nasal decongestants, Otrivin Katar i Zatoki should not be used for longer than 10 consecutive days. If symptoms persist, contact a doctor. Use beyond 10 days or in doses higher than recommended may worsen or cause recurrence of symptoms.
• Otrivin Katar i Zatoki must not be applied to the eyes or inside the mouth.
• Do not exceed the recommended dose, especially in children and elderly patients.

Children and adolescents
Otrivin Katar i Zatoki must not be used in children under 12 years of age.
Otrivin Katar i Zatoki and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
Otrivin Katar i Zatoki must not be used if the patient is taking certain medicines used to treat depression. These include:

• monoamine oxidase inhibitors (MAOIs): DO NOT use Otrivin Katar i Zatoki if taking MAOIs or have taken such medicines within the last 14 days,
• tricyclic and tetracyclic antidepressants.

If taking any of the above-mentioned medicines, consult a doctor before using Otrivin Katar i Zatoki.
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 before using this medicine.
Do not use Otrivin Katar i Zatoki during pregnancy.
During breastfeeding, Otrivin Katar i Zatoki should only be used after consulting a doctor.
Driving and operating machinery
Otrivin Katar i Zatoki, when used at recommended doses, has no effect or has negligible effect on the ability to drive and operate machinery.
Otrivin Katar i Zatoki contains macrogolglycerol hydroxystearate (polyoxylated hydrogenated castor oil).
This medicine contains 2.75 mg/ml macrogolglycerol hydroxystearate (polyoxylated hydrogenated castor oil). This medicine may cause skin reactions.

3. How to use Otrivin Katar i Zatoki

This medicine should always be used exactly as described in this patient leaflet or as directed by a
doctor, pharmacist, or nurse. If in doubt, consult a doctor,
pharmacist, or nurse.
Otrivin Katar i Zatoki should not be used in children under 12 years of age.
Adults and adolescents aged over 12 years:
1 spray of Otrivin Katar i Zatoki into each nostril up to 3 times daily. It is recommended to take the
last dose immediately before going to bed.
Do not use more than 3 times daily in each nostril.
Otrivin Katar i Zatoki should not be used for longer than 10 consecutive days.
Instructions for use
This medicine is intended for nasal use.
Take care not to spray the aerosol into the eyes.

1. Clear the nose.
2. Remove the protective cap.
3. Do not cut the applicator tip.

4. Before first use, press the pump 4 times. The pump will then be ready for use throughout the recommended treatment period. If, after fully pressing the pump, the aerosol is not released, or if the medicine has not been used for more than 6 days, re-prepare the pump by pressing it 4 times. Do not spray towards the eyes or mouth.
5. Hold the bottle upright, supporting the bottom with the thumb, and place the tip between two fingers.

6. Tilt the head forward and insert the tip into the nostril.
7. Press the pump while inhaling through the nose.

8. Repeat the procedure when administering the medicine into the other nostril.
9. After use, clean and dry the dispenser tip and replace the protective cap.

For hygienic reasons, one package of the medicine should be used by only one
patient.
Overdose of Otrivin Katar i Zatoki
If more than the recommended dose has been used, seek immediate medical advice from a doctor
or pharmacist.
Symptoms of overdose include severe dizziness, excessive sweating, significantly lowered body temperature, headache, slow heartbeat, 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 Katar i Zatoki
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 effects

Like all medicines, this product may cause adverse effects, although not everyone experiences them.
You should STOP using Otrivin Katar i Zatoki and seek immediate medical advice
if any of the following adverse effects occur, as they 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 effects occur very rarely (less frequently than in 1 out of 10,000 people using the medicine).

Common (may occur in less than 1 out of 10 people using the medicine):
dryness or irritation of the nasal mucosa, nasal discomfort, nausea, headache, burning sensation at the site of administration.
Uncommon (may occur in less than 1 out of 100 people using the medicine):
nosebleeds.
Very rare (may occur in less than 1 out of 10,000 people using the medicine):
allergic reaction (skin rash, itching), transient visual disturbances, arrhythmia or rapid heartbeat.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Otrivin Katar i Zatoki

Keep this medicine out of sight and reach of children.
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.
Store below 25°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Otrivin Cold and Sinuses Contains

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

What Otrivin Cold and Sinuses Looks Like and Contents of the Pack
The Otrivin Cold and Sinuses pack consists of a bottle with a metering pump containing 10 ml of colourless to whitish solution with a smell of menthol and eucalyptol. The metering pump allows precise dosing of the medicine. The pack contains 60 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
November 2024

Package Leaflet: Information for the User

Otrivin Cold and Sinuses, 1 mg/ml, nasal spray, solution
Xylometazolini hydrochloridum
Please read all of 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 advised by a doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, consult your pharmacist or nurse.
• If you experience any adverse effects, including any possible side effects not listed in this leaflet, inform your doctor, pharmacist or nurse. See section 4.
• If there is no improvement after 10 days or if your condition worsens, consult your doctor.

Leaflet Contents:

1. What Otrivin Cold and Sinuses Is and What It Is Used For
2. Important Information Before Using Otrivin Cold and Sinuses
3. How to Use Otrivin Cold and Sinuses
4. Possible Side Effects
5. How to Store Otrivin Cold and Sinuses
6. Contents of the Pack and Other Information

1. What Otrivin Cold and Sinuses Is and What It Is Used For

The active substance in Otrivin Cold and Sinuses is xylometazoline hydrochloride.
Otrivin Cold and Sinuses is a locally acting medicine that reduces congestion and swelling of the nasal mucosa. It unblocks a stuffy nose, making breathing easier.
The medicine also contains auxiliary substances such as menthol and eucalyptol, which produce a cooling sensation on the mucous membranes.
The effect of Otrivin Cold and Sinuses begins within 2 minutes and lasts up to twelve hours.
Otrivin Cold and Sinuses is indicated for use in adults and adolescents over 12 years of age.
Otrivin Cold and Sinuses is used for excessive congestion of the nasal mucosa occurring during colds, hay fever, allergic rhinitis, and sinusitis.
By reducing congestion of the nasopharyngeal mucosa, the medicine may be used as supportive treatment in middle ear infections. Otrivin Cold and Sinuses facilitates nasal endoscopy (examination of the nasal cavity).
Otrivin Cold and Sinuses does not contain preservatives.

2. Important Information Before Using Otrivin Cold and Sinuses

When Not to Use Otrivin Cold and Sinuses

• 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 performed via the nose, e.g. pituitary gland removal or surgery involving exposure of the dura mater (brain surgery performed via the nose or mouth)
• if you have narrow-angle glaucoma (increased eye pressure)
• if your nasal mucosa is very dry (atrophic rhinitis or rhinitis sicca)
• in children under 12 years of age

Warnings and Precautions
Consult your doctor or pharmacist before using the medicine if:

• you have high blood pressure,
• you have heart disease (e.g. long QT syndrome),
• you have hyperthyroidism,
• you have diabetes,
• you have benign prostatic hyperplasia,
• you have a benign tumour of the adrenal gland producing large amounts of adrenaline and noradrenaline (pheochromocytoma),
• you are taking certain antidepressants known as monoamine oxidase inhibitors (MAOIs), or have taken them within the last 2 weeks,
• you are taking tricyclic or tetracyclic antidepressants,
• like other medicines that constrict the nasal mucosa, Otrivin Cold and Sinuses may cause insomnia, dizziness, tremor, heart rhythm disturbances, and increased blood pressure in sensitive patients. If such symptoms occur, consult your doctor,
• like other nasal decongestants, Otrivin Cold and Sinuses should not be used for longer than 10 consecutive days. If symptoms persist, consult your doctor. Using the medicine for longer than 10 days or in higher than recommended doses may worsen or cause recurrence of symptoms.
• Do not use Otrivin Cold and Sinuses in the eyes or in the mouth.
• Do not exceed the recommended dose, especially in children and elderly people.

Children and Adolescents
Otrivin Cold and Sinuses should not be used in children under 12 years of age.
Otrivin Cold and Sinuses and Other Medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Otrivin Cold and Sinuses should not be used if you are taking certain medicines used to treat depression. These are:

• monoamine oxidase inhibitors (MAOIs): DO NOT use Otrivin Cold and Sinuses if you are 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 Otrivin Cold and Sinuses.
Pregnancy and Breastfeeding
If you are pregnant or breastfeeding, suspect you may be pregnant, or are planning to have a baby, consult your doctor before using this medicine.
Do not use Otrivin Cold and Sinuses during pregnancy.
During breastfeeding, Otrivin Cold and Sinuses may be used only after consultation with a doctor.
Driving and Operating Machinery
Otrivin Cold and Sinuses, when used at recommended doses, does not affect or has negligible effect on the ability to drive or operate machinery.
Otrivin Cold and Sinuses contains macrogol glycerol hydroxystearate (polyoxylated hydrogenated castor oil).
This medicine contains 2.75 mg/ml of macrogol glycerol hydroxystearate (polyoxylated hydrogenated castor oil). The medicine may cause skin reactions.

3. How to Use Otrivin Cold and Sinuses

This medicine should always be used exactly as described in this patient leaflet or as advised by your doctor, pharmacist or nurse. If in doubt, consult your doctor, pharmacist or nurse.
Otrivin Cold and Sinuses should not be used in children under 12 years of age.
Adults and adolescents over 12 years of age:
1 spray of Otrivin Cold and Sinuses into each nostril up to 3 times daily. It is recommended to take the last dose just before going to bed.
Do not exceed 3 times daily in each nostril.
Otrivin Cold and Sinuses should not be used for longer than 10 consecutive days.
Instructions for Use
The medicine is intended for nasal use.
Be careful not to spray the aerosol into the eyes. Remove the protective cap.

1. Blow your nose.

2. Place your thumb on the dosing device located on the side of the pump. Before first use, prime the pump by pressing the dosing device on the side of the pump 5 times. The pump will then be ready for use throughout the recommended treatment period. If after pressing the dosing device on the side of the pump the aerosol is not sprayed, or if the medicine has not been used for more than 7 days, re-prime the pump by pressing the dosing device twice. Do not spray towards eyes or mouth.

3. Remain upright to prevent dripping. Insert the short nozzle into the nostril.

4. Press the dosing device while inhaling through the nose.

5. Repeat the procedure when administering the medicine into the other nostril.
6. After each use, clean and dry the nozzle and replace the protective cap until you hear a distinct click.

For hygienic reasons, one pack of the medicine should be used by only one patient.
The dosing device located on the side of the pump ensures precise dosing and proper distribution of the solution over the surface of the nasal mucosa by spraying a fine mist. This prevents accidental overdose.
Each spray dose of Otrivin Cold and Sinuses delivers 0.14 ml of spray, corresponding to 0.14 mg of xylometazoline hydrochloride.
Use of a Higher than Recommended Dose of Otrivin Cold and Sinuses
If a higher than recommended dose is 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, high blood pressure (hypertension), followed by low blood pressure.
Symptomatic treatment should be administered.
Missed Dose of Otrivin Cold and Sinuses
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 may cause side effects, although not everybody gets them.
You should STOP using Otrivin Cold and Sinuses 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
• severe itching with red rash or blisters
  These symptoms occur very rarely (less than 1 in 10,000 people using the medicine).

Common (may occur in less than 1 in 10 people using the medicine):
dryness or irritation of the nasal mucosa, discomfort in the nose, nausea, headache, burning at the application site.
Uncommon (may occur in less than 1 in 100 people using the medicine):
nosebleeds.
Very rare (may occur in less than 1 in 10,000 people using the medicine):
allergic reaction (skin rash, itching), transient visual disturbances, arrhythmia or rapid heartbeat.
Reporting of Side Effects
If you experience any side effects, including any not listed in this leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department for Monitoring Adverse Drug Reactions 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 authorisation holder.
Reporting side effects helps to provide more information on the safety of the medicine.

5. How to Store Otrivin Cold and Sinuses

Keep the medicine out of sight and reach of children.
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.
Store below 25°C.
Do not dispose of medicines via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the Pack and Other Information

What Otrivin Cold and Sinuses Contains

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

What Otrivin Cold and Sinuses Looks Like and Contents of the Pack
The Otrivin Cold and Sinuses pack consists of a bottle with a metering pump containing 10 ml of colourless to whitish solution with a smell of menthol and eucalyptol. The metering pump allows precise dosing of the medicine. The pack contains 60 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