Otrivin menthol

Package leaflet: Information for the user

Warning! Keep the leaflet – the information on the immediate packaging is in a foreign language!
Otrivin Menthol
1 mg/ml, nasal spray, solution
Xylometazolini hydrochloridum
Please read the entire leaflet carefully before using this 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, pharmacist, or nurse.

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

Table of contents of the leaflet:

1. What Otrivin Menthol is and what it is 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 pack and other information

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

The active substance in Otrivin Menthol is xylometazoline hydrochloride.
Otrivin Menthol is a locally acting medicine that reduces congestion and swelling of the nasal mucosa. It clears a blocked nose and facilitates breathing.
The product also contains auxiliary substances such as menthol and eucalyptol, which produce a cooling sensation on the mucous membranes.
The effect of Otrivin Menthol begins within 2 minutes and lasts up to twelve hours.
Otrivin Menthol is indicated for use in adults and adolescents over 12 years of age.
Otrivin Menthol 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 otitis media. Otrivin Menthol facilitates nasal endoscopy (examination of the nasal cavity).
Otrivin Menthol does not contain preservatives.

2. Information before using Otrivin Menthol

When not to use Otrivin Menthol

• 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. pituitary gland removal 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 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,
• 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),
• taking certain antidepressant medicines known as monoamine oxidase inhibitors (MAOIs), or has taken them within the last 2 weeks,
• taking tricyclic or tetracyclic antidepressant medicines,
• like other medicines that constrict the nasal mucosa, Otrivin Menthol 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 Menthol should not be used for longer than 10 consecutive days. If symptoms persist, consult a doctor. Prolonged use beyond 10 days or use in higher than recommended doses may lead to worsening or recurrence of symptoms.
• Otrivin Menthol should not be used in the eyes or mouth.
• Do not exceed the recommended dose, especially in children and elderly patients.

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 currently taking, have recently taken, or plan to take.
Otrivin Menthol should not be used if taking certain medicines used to treat depression. These include:

• monoamine oxidase inhibitors (MAOIs): DO NOT use Otrivin Menthol if taking MAOI inhibitors 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 Menthol.
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 Menthol during pregnancy.
During breastfeeding, Otrivin Menthol should only be used after consulting a doctor.
Driving and operating machinery
When used at recommended doses, Otrivin Menthol has no effect or negligible effect on the ability to drive or operate machinery.
Otrivin Menthol contains macrogolglycerol hydroxystearate
This medicine contains 2.75 mg/ml of macrogolglycerol hydroxystearate. This 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, pharmacist, or nurse. If in doubt, consult your doctor, 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 spray of Otrivin Menthol into each nostril up to 3 times daily. It is recommended to take the last dose just before going to bed.
Do not use more than 3 times daily in each nostril.
Otrivin Menthol should not be used for longer than 10 consecutive days.

Method of administration
This medicine is for nasal use only.
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, no aerosol is released, or if the product has not been used for more than 6 days, re-prime the pump by pressing it 4 times. Do not spray towards the eyes or mouth.
5. Hold the bottle vertically, supporting the bottom with your thumb, and place 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.

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.

Use of a higher than recommended dose of Otrivin Menthol
If more than the 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, seizures, high blood pressure (hypertension), followed possibly by low blood pressure.
Symptomatic treatment should be administered.

Missed dose of Otrivin Menthol
Do not use a double dose to make up for a missed dose.
If you have any further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
You should STOP using Otrivin Menthol 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 symptoms are very rare (occurring in fewer than 1 in 10,000 people using the medicine).

Common (may occur in fewer than 1 in 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 fewer than 1 in 100 people using the medicine):
nosebleeds.
Very rare (may occur in fewer than 1 in 10,000 people using the medicine):
allergic reaction (skin rash, itching), transient visual disturbances, arrhythmia or increased heart rate.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can also be reported directly to the Department of Monitoring Adverse Drug Reactions at 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
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Otrivin Menthol

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.
Do not store above 25°C.
Medicines should 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 pack and other information

What Otrivin Menthol contains

• The active substance in Otrivin Menthol is xylometazoline hydrochloride. 1 ml of solution contains 1 mg of xylometazoline hydrochloride.
• Other components of the medicine are: disodium dihydrogen phosphate dihydrate, disodium phosphate dodecahydrate, sodium chloride, disodium edetate, levomenthol, cineol, sorbitol, macrogolglycerol hydroxystearate, purified water.

What Otrivin Menthol looks like and contents of the pack
Otrivin Menthol is supplied in a HDPE bottle with a metering pump and a PP nozzle, containing
10 ml of colourless to slightly white solution with a smell of menthol and eucalyptus. The metering pump
allows accurate dosing of the medicine.
For further information, please contact the Marketing Authorisation Holder or the Parallel Importer.
Marketing Authorisation Holder in Lithuania, country of export:
Haleon Hungary Kft.
Csörsz utca 43
1124 Budapest
Hungary
Manufacturer:
Haleon Germany GmbH
Barthstraße 4
80339 Munich
Germany
Parallel Importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing Authorisation number in Lithuania, country of export: LT/1/95/0102/002
Parallel Import licence number: 212/20