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 100508441
Manufacturer Haleon Hungary Kft.
Otrivin menthol solution, nasal spray

Table of Contents

Package leaflet: Information for the user

Warning! Keep the 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 use, 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 a
physician, pharmacist, or nurse.

  • Keep this leaflet for future reference.
  • If advice or additional information is needed, consult a pharmacist.
  • If the patient experiences any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform a physician, pharmacist, or nurse. See section 4.
  • If there is no improvement or if the patient feels worse after 10 days, consult a physician.

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 nasal mucosal congestion and swelling. It unblocks the nose and facilitates breathing.
The medicine 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 in excessive nasal mucosal congestion 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 acute otitis media. Otrivin Menthol facilitates nasal examination (rhinoscopy).
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 nasal surgery, 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),
  • hyperthyroidism,
  • diabetes,
  • benign prostatic hyperplasia,
  • a benign adrenal gland tumour 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 nasal mucosa-constricting medicines, Otrivin Menthol may cause insomnia, dizziness, tremor, heart rhythm disturbances, and increased blood pressure in sensitive patients. 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, consult a doctor. Using the medicine for longer than 10 days or in doses higher than recommended may worsen or cause recurrence of symptoms.
  • Otrivin Menthol must not be used in the eyes or in the mouth.
  • Do not exceed the recommended dose, especially in children and elderly patients.

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 you are currently taking, have recently taken, or plan to take.
Otrivin Menthol must not be used if the patient is taking certain medicines used to treat depression, such as:

  • monoamine oxidase inhibitors (MAOIs): Otrivin Menthol must not be used if the patient is taking MAOIs or has taken them within the previous 14 days,
  • tricyclic and 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 have a child, she should consult a doctor before using this medicine.
Do not use Otrivin Menthol during pregnancy.
During breastfeeding, Otrivin Menthol may be used only after consultation with a doctor.
Driving and operating machinery
When used at recommended doses, Otrivin Menthol has no or negligible effect on the ability to drive and operate machinery.
Otrivin Menthol contains macrogol glycerol hydroxystearate
This medicine contains 2.75 mg/ml of macrogol glycerol 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 directed by a doctor, pharmacist, or nurse. If in doubt, consult a 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 dose 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.

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.
Blue icon showing scissors cutting a medicine bottle, overlaid with a large cross symbol prohibiting the use of scissors
  1. Before first use, press the pump 4 times to prime. 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 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 the thumb, and place the fingers around the nozzle.
White hand holding a spray medication bottle, surrounded by two white arrows indicating up and down motion
  1. Tilt the head forward and insert the nozzle into one nostril.
  2. Press the pump while inhaling gently through the nose.
Profile of a face with a hand holding an inhaler at the nose, white arrows showing the direction of inhaling medication into the nostril against a blue background
  1. Repeat the procedure for the other nostril.
  2. After use, clean and dry the spray nozzle and replace the protective cap.

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

Overdose of Otrivin Menthol
In case of overdose, 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, convulsions, high blood pressure (hypertension), 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 doubts 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, 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 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 reactions
If any adverse reactions occur, including any 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 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions 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.
Store below 25°C.
Medicines must 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 pack 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 ingredients are: disodium dihydrogen phosphate dihydrate, disodium phosphate dodecahydrate, sodium chloride, disodium edetate, levomenthol, cineole, sorbitol, macrogol glycerol hydroxystearate, purified water.

What Otrivin Menthol looks like and contents of the pack
Otrivin Menthol is supplied in a bottle with a metering pump containing 10 ml of a white solution with a menthol and eucalyptol odour. The metering pump allows accurate dosing of the medicine.
For more detailed information, please contact the Marketing Authorisation Holder or the Parallel Importer.
Marketing Authorisation Holder in Latvia, country of export:
Haleon Hungary Kft.
Csörsz utca 43
1124 Budapest
Hungary
Manufacturer:
GSK Consumer Healthcare GmbH & Co. KG
Barthstraße 4, 80339 Munich, Germany
Haleon Germany GmbH
Barthstraße 4
80339 Munich
Germany
Parallel Importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing Authorisation number in Latvia, country of export: 98-0313
Parallel Import Authorisation number: 397/24