Otrivin Menthol

Leaflet accompanying the packaging: information for the user

Otrivin Menthol, 1 mg/ml, nasal spray, solution

Xylometazoline hydrochloride

Read the 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 your doctor or pharmacist or nurse.

• Keep this leaflet, you may need to read it again.
• If you need advice or further information, ask your pharmacist or nurse.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist or nurse. 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 Menthol and what is it used for
• 2. Important information before using Otrivin Menthol
• 3. How to use Otrivin Menthol
• 4. Possible side effects
• 5. How to store Otrivin Menthol
• 6. Contents of the packaging and other information

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

The active substance of Otrivin Menthol is xylometazoline hydrochloride.
Otrivin Menthol 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 Menthol starts within 2 minutes and lasts for up to 12 hours.
Otrivin Menthol is indicated for use in adults and adolescents over 12 years of age.
Otrivin Menthol is used for excessive nasal congestion in the common cold, hay fever, allergic rhinitis, and sinusitis.
By reducing nasal congestion, the medicine can also be used as an adjunct in the treatment of middle ear infections. Otrivin Menthol facilitates nasal endoscopy (examination of the nasal cavity).
Otrivin Menthol does not contain preservatives.

2. Important information before using Otrivin Menthol

When not to use Otrivin Menthol

• in children under 12 years of age.

Warnings and precautions

Before using the medicine, consult your doctor or pharmacist if you have:

• 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),
• if you are taking certain antidepressants known as monoamine oxidase inhibitors (MAOIs) or have taken them in the last 2 weeks,
• if you are taking tricyclic or tetracyclic antidepressants,
• like other nasal decongestants, Otrivin Menthol may cause insomnia, dizziness, tremors, heart rhythm disturbances, and increased blood pressure in sensitive patients. If such symptoms occur, consult your doctor,
• like other nasal decongestants, Otrivin Menthol should not be used for more than 10 consecutive days. If symptoms persist, consult your doctor. Using the medicine for more than 10 days or in doses higher than recommended may lead to worsening of symptoms or their recurrence.
• Otrivin Menthol should not be used in the eyes or mouth.
• Do not use a higher dose than recommended, especially in children and the elderly.

Children and adolescents

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

Otrivin Menthol and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
Otrivin Menthol should not be used if you are taking certain medicines used to treat depression. These include:

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

If you have taken any of these medicines before using Otrivin Menthol, consult your doctor.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor for advice before using this medicine.
Otrivin Menthol should not be used during pregnancy.
During breastfeeding, Otrivin Menthol can be used only after consulting a doctor.

Driving and using machines

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

Otrivin Menthol 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 Menthol

This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor or pharmacist or nurse. If you are unsure, ask your doctor or pharmacist or nurse.
Otrivin Menthol should not be used in children under 12 years of age.
Adults and adolescents over 12 years of age:
1 dose of Otrivin Menthol spray into each nostril up to 3 times a day. It is recommended to take the last dose of the medicine before going to bed.
Do not use more than 3 times a day into each nostril.
Otrivin Menthol 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. Before the first use, press the pump 5 times to prepare it for use. The pump will be ready for further use throughout the recommended use period. If, after pressing the pump, the aerosol is not sprayed, or if the medicine has not been used for more than 7 days, prepare the pump again by pressing it twice. Do not spray towards the eyes or mouth.

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

• 4. Press the pump and inhale through the nose at the same time.

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

For hygiene reasons, one package of the medicine should only be used by one patient.
The pump on the side of the dispenser allows for precise dosing and ensures proper distribution of the solution on the surface of the nasal mucosa by spraying a fine mist.
This eliminates the possibility of accidental overdose.
Each dose of Otrivin Menthol spray delivers 0.14 ml of spray, which corresponds to 0.14 mg of xylometazoline hydrochloride.

Using a higher dose of Otrivin Menthol than recommended

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

Missing a dose of Otrivin Menthol

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, this medicine can cause side effects, although not everybody gets them.
You should STOP usingOtrivin Menthol and SEEK MEDICAL HELP IMMEDIATELYif 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
• 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, discomfort in the nose, nausea, headache, burning sensation at the site of administration.

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 you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Medicinal Product Monitoring, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, 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.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Otrivin Menthol

Store the medicine out of the 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 month.
Store in a temperature below 25°C.
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 packaging and other information

What Otrivin Menthol contains

• The active substance of Otrivin Menthol is xylometazoline hydrochloride. One ml of solution contains 1 mg of xylometazoline hydrochloride.
• The other ingredients 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 Menthol looks like and contents of the pack

Otrivin Menthol is a clear to pale yellow solution with a menthol and eucalyptol scent, in a 10 ml bottle with a metering pump, which allows for precise dosing. The pack 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 leaflet: November 2024