Otrivin menthol

Poland
Brand name Otrivin menthol
Form solution, nasal spray
Active substance / Dosage
xylometazoline hydrochloride · 1 mg/ml
Prescription type Over-the-counter
ATC code
R01AA07
Registration number 100407610
Manufacturer Haleon Hungary Kft.
Otrivin menthol solution, nasal spray

Table of Contents

Package leaflet: Information for the user

Warning! Keep this leaflet! Information on the immediate packaging 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.
Always use this medicine exactly as described in this patient leaflet or as directed by your
doctor, pharmacist, or nurse.

  • Keep this leaflet, so that you can read it again if necessary.
  • If you need advice or further information, please consult your pharmacist or nurse.
  • 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 after 10 days of treatment, or if you feel worse, 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 unblocks a stuffy nose, making breathing easier.
The medicine also contains excipients such as menthol and cineole (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 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 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. 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 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 this medicine, consult a doctor, pharmacist, or nurse if:

  • the patient has high blood pressure,
  • the patient has heart disease (e.g. long QT syndrome),
  • the patient has hyperthyroidism,
  • the patient has diabetes,
  • the patient has benign prostatic hyperplasia,
  • the patient has a benign tumour of the adrenal gland producing large amounts of adrenaline and noradrenaline (pheochromocytoma),
  • the patient is taking certain antidepressants 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 Menthol may in sensitive patients cause insomnia, dizziness, tremor, heart rhythm disturbances, and increased blood pressure. If such symptoms occur, consult a doctor,
  • like other nasal decongestants, Otrivin Menthol should not be used for longer than 10 consecutive days. If symptoms persist, contact a doctor. Using the medicine for longer than 10 days or in doses higher than recommended may worsen symptoms or cause their recurrence.
  • Otrivin Menthol must not be used in the eyes or in the mouth.
  • Do not use a higher dose than recommended, especially in children and elderly people.

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

  • monoamine oxidase inhibitors (MAOIs): Otrivin Menthol must not be used if the patient is taking MAOIs or has taken such medicines within the last 14 days,
  • tricyclic and tetracyclic antidepressants.

If the patient is 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.
Otrivin Menthol must not be used during pregnancy.
During breastfeeding, Otrivin Menthol may be used only after consultation with a doctor.
Driving and operating machinery
Otrivin Menthol, when used at the recommended doses, has no effect or has a 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 information leaflet or as advised 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 three times daily. It is recommended to take the last dose immediately before going to bed.
Do not use more than three times daily in each nostril.
Otrivin Menthol should not be used for longer than 10 consecutive days.

Instructions for use
This medicine is intended 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.
Blue icon showing scissors and a medicine bottle with a large cross symbol prohibiting their use
  1. 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 spray is released, or if the medicine 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.
  2. Hold the bottle upright, supporting the bottom with your thumb, and position the tip between two fingers.
White hand holding a small medicine bottle emitting a sprayed mist, surrounded by two white arrows pointing toward each other
  1. Tilt your head forward and insert the tip into one nostril.
  2. Press the pump while inhaling gently through the nose.
Profile view of a person holding an inhaler at the nose, with arrows indicating the direction of inhaling the medication into the respiratory tract
  1. Repeat the procedure for the second nostril.
  2. After use, clean and dry the spray nozzle and replace the protective cap.

For hygienic reasons, one package of this medicine should be used by only one patient.

Overdose of Otrivin Menthol
If more than the recommended dose of Otrivin Menthol 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 heart rate, 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 Menthol
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 reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You should STOP using Otrivin Menthol and seek immediate medical advice if any of the following adverse reactions 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 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 accelerated heart rate.

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 4921301, fax: +48 22 4921309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions helps to provide more information on the safe use 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 in use. This will help protect the environment.

6. Contents of the package and other information

What Otrivin Menthol contains

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

What Otrivin Menthol looks like and contents of the pack
The Otrivin Menthol package consists of an HDPE bottle with a metered pump dispenser and a PP cap, containing
10 ml of a white solution with a menthol and eucalyptus odour. The metering pump allows precise dosing
of the medicine.
For more detailed 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:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing Authorisation Number in Lithuania, country of export: LT/1/95/0102/002
Parallel Import Authorisation Number: 191/18