Otrivin Menthol

Package Leaflet: Information for the User

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Otrivin Menthol, 1 mg/ml, Nasal Spray, Solution

Xylometazoline Hydrochloride

Before using the medicine, carefully read the contents of the leaflet, as it contains important information for the patient.

This medicine should always be used exactly as described in this patient information leaflet or as directed by a doctor, pharmacist, or nurse.

• The leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after 10 days or if the patient feels worse, they should contact their 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 pack 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 nasal spray. 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 colds, 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 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 undergone surgery through the nose, e.g., removal of the pituitary gland or an operation involving exposure of the dura mater (brain surgery through the nose or mouth),
• if the patient has narrow-angle glaucoma (increased pressure in the eye),
• if the patient has a very dry nasal mucosa (atrophic rhinitis or dry rhinitis),
• in children under 12 years of age.

Warnings and precautions

Before using the medicine, the patient should consult a doctor, pharmacist, or nurse in the following cases:

• high blood pressure,
• heart disease (e.g., long QT syndrome),
• hyperthyroidism,
• diabetes,
• prostatic hyperplasia,
• pheochromocytoma (a tumor of the adrenal gland that produces large amounts of adrenaline and noradrenaline),
• use of certain antidepressants known as monoamine oxidase inhibitors (MAOIs) or use of such medicines in the last 2 weeks,
• use of tricyclic and 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, the patient should consult a doctor,
• like other nasal decongestants, Otrivin Menthol should not be used for more than 10 consecutive days. If symptoms persist, the patient should consult a doctor. Using the medicine for a longer period than 10 days or in higher doses than recommended may worsen symptoms or cause them to recur.
• Otrivin Menthol should not be used in the eyes or mouth.
• A higher dose than recommended should not be used, 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

The patient should inform their doctor, pharmacist, or nurse about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Otrivin Menthol should not be used in combination with certain medicines used to treat depression. These include:

• monoamine oxidase inhibitors (MAOIs): Otrivin Menthol should not be used in combination with MAOIs or within 14 days of stopping such treatment,
• tricyclic and tetracyclic antidepressants.

If the patient is taking any of these medicines before using Otrivin Menthol, they should consult their doctor.

Pregnancy and breastfeeding

If the patient is pregnant, breastfeeding, or thinks they may be pregnant, they should consult their doctor 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, when used as directed, is unlikely to affect the ability to drive or use machines.

Otrivin Menthol contains macrogol glycerol hydroxystearate

This medicine contains 2.75 mg/ml of macrogol glycerol hydroxystearate. The medicine 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, the patient should consult their 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 a day. The last dose should be taken before going to bed.
The medicine should not be used 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 for nasal use only.
Caution should be taken not to spray the aerosol into the eyes.

• 1. Clean the nose.
• 2. Remove the protective cap.
• 3. Do not cut the tip of the applicator.

• 4. Before the first use, press the pump 4 times. The pump will then be ready for further use throughout the recommended use period. If, after full compression of the pump, the aerosol is not sprayed, or if the medicine has not been used for more than 6 days, the pump should be prepared again by pressing it 4 times. Do not spray towards the eyes or mouth.
• 5. Hold the bottle upright, supporting the base with the thumb, and place the tip between two fingers.

• 6. Tilt the head forward and insert the tip into the nostril.
• 7. Press the pump and inhale through the nose at the same time.

• 8. Repeat the steps when administering the medicine to the other nostril.
• 9. After use, clean and dry the applicator tip and replace the protective cap.

For hygiene reasons, one pack of the medicine should only be used by one patient.

Overdose of Otrivin Menthol

In case of overdose, the patient should immediately consult a doctor or pharmacist.
Symptoms of overdose are severe dizziness, excessive sweating, significantly lowered body temperature, headache, slow heart rate, breathing difficulties, coma, convulsions, high blood pressure (hypertension), which may be followed by low blood pressure.
Symptomatic treatment should be applied.

Missed dose of Otrivin Menthol

A double dose should not be used to make up for a missed dose.
If the patient has any further doubts about using this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Otrivin Menthol can cause side effects, although not everybody gets them.
The patient should STOP usingOtrivin Menthol and immediately consult a doctorif they 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 are very rare (less than 1 in 10,000 patients 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 application.

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 visual disturbances, irregular or rapid heart rate.

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych (Office for Registration of Medicinal Products, Medical Devices, and Biocides), Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Otrivin Menthol

The medicine should be kept out of the sight and reach of children.

The medicine should not be used 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. The patient should ask their 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 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, sorbitol, macrogol glycerol hydroxystearate, purified water.

What Otrivin Menthol looks like and contents of the pack

Otrivin Menthol is a white solution with a menthol and eucalyptol scent, available in a 10 ml bottle with a dosing pump. The dosing pump allows for the administration of an exact dose of the medicine.
For more detailed information, the patient should consult the marketing authorization holder or parallel importer.

Marketing authorization holder in Latvia, the 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 by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing authorization number in Latvia, the country of export: 98-0313

Parallel import authorization number: 397/24

Date of approval of the leaflet: 18.11.2024

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