Otrivin menthol

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 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 a
physician or pharmacist.

• Keep this leaflet, so it can be consulted again if necessary.
• If advice or additional information is needed, please contact a pharmacist or nurse.
• If the patient experiences any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform a doctor, pharmacist, or nurse. See section 4.
• If there is no improvement or if the patient feels worse after 10 days, consult a 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, 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 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 an adjunct in otitis media. Otrivin Menthol facilitates nasal speculum examination (examination of the nasal cavity).
Otrivin Menthol does not contain preservatives.

2. Important 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 recently undergone nasal surgery, 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 chronic atrophic rhinitis),
• in children under 12 years of age.

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

• the patient has high blood pressure,
• the patient has heart disease (e.g. long QT syndrome),
• hyperthyroidism,
• diabetes,
• benign prostatic hyperplasia,
• a benign tumour of the adrenal gland 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 previous 2 weeks,
• the patient is taking tricyclic and tetracyclic antidepressant medicines,
• like other medicines that constrict the nasal mucosa, Otrivin Menthol may in sensitive patients cause insomnia, dizziness, tremor, heart rhythm disorders, and increased blood pressure. 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, contact 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 mouth.
• Do not exceed the recommended dose, 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 you are currently taking, have recently taken, or plan to take.
Otrivin Menthol should 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 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 become pregnant, she should consult a doctor before using this medicine.
Otrivin Menthol must not be used during pregnancy.
During breastfeeding, Otrivin Menthol should be used only after consulting a doctor.
Driving and operating machinery
When used at the recommended doses, Otrivin Menthol does not affect or has negligible effect on the ability to drive or operate machinery.
Otrivin Menthol contains macrogol glycerol hydroxystearate (polyoxylated hydrogenated castor oil)
This medicine contains 2.75 mg/ml of macrogol glycerol hydroxystearate (polyoxylated hydrogenated castor oil). 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 that the last dose be taken immediately 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 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 tip of the applicator.

4. Before first use, press the pump 4 times to prime it. 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.
5. Hold the bottle upright, supporting the bottom with your thumb, and place the tip between two fingers.

6. Tilt your head forward and insert the tip into one 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 nozzle tip 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 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, arterial hypertension (high blood pressure), followed possibly by hypotension.
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 product may cause adverse reactions, although not everybody gets them.
You must 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 application.
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 reactions
If any adverse reactions occur, including any adverse reactions not listed in the leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 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.
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. 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.
• The other ingredients are: sodium dihydrogen phosphate dihydrate, disodium phosphate dodecahydrate, sodium chloride, disodium edetate, levomenthol, cineole (eucalyptol), sorbitol, macrogolglyceryl hydroxystearate (polyoxylated hydrogenated castor oil), 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 white solution with a menthol and eucalyptus odour. The metering pump allows accurate dosing of the medicine.
The pack contains 60 doses.
For further information, please contact the Marketing Authorisation Holder or the Parallel Importer.

Marketing Authorisation Holder in Lithuania, country of export:
Haleon Hungary Kft.
1124 Budapest, Csörsz utca 43
Hungary

Manufacturer:
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
Poland

Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Poland

Marketing Authorisation Number in Lithuania, country of export: LT/1/95/0102/002
Parallel Import Licence Number: 371/17