Otrivin

Patient Information Leaflet

Warning! Keep the leaflet, information on the immediate packaging in a foreign language
Otrivin
1 mg/ml, nasal spray, solution
Xylometazolini hydrochloridum
Please read this 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 doctor or pharmacist.

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

Table of contents:

1. What Otrivin is and what it is used for
2. Important information before using Otrivin
3. How to use Otrivin
4. Possible side effects
5. How to store Otrivin
6. Contents of the pack and other information

1. What Otrivin is and what it is used for

The active substance in Otrivin is xylometazoline hydrochloride.
Otrivin is a locally acting medicine which, by constricting blood vessels, reduces congestion and swelling of the nasal mucosa and decreases nasal discharge.
It helps patients with a stuffy nose to breathe more easily through the nose. The special formulation (containing moisturizing agents) helps prevent drying and irritation of the nasal mucosa.
The effect of Otrivin begins within 2 minutes and lasts up to twelve hours.
Otrivin is indicated for use in adults and adolescents over the age of 12.
Indications:
Excessive congestion of the nasal mucosa occurring during colds, hay fever, allergic rhinitis, and sinusitis. The medicine facilitates drainage of secretions from inflamed paranasal sinuses. By reducing congestion of the nasopharyngeal mucosa, it may be used as an adjunct in middle ear infections.
Otrivin facilitates nasal endoscopy (examination of the nasal cavity).

2. Important information before using Otrivin

When not to use Otrivin

• 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 chronic atrophic rhinitis),
• in children under 12 years of age.

Warnings and precautions
Before using Otrivin, consult a doctor 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 antidepressants known as monoamine oxidase inhibitors (MAOIs), or has taken them within the last 2 weeks,
• taking tricyclic or tetracyclic antidepressants,
• hypersensitivity to substances with action similar to xylometazoline. In sensitive patients, Otrivin may cause insomnia, dizziness, irregular heartbeat, increased blood pressure or tremor.

Otrivin 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 should not be applied to the eyes or into the mouth.
Do not exceed the recommended dose, especially in children and elderly people.
Children and adolescents
Otrivin should not be used in children under 12 years of age.
Otrivin and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking,
have recently taken, or plan to take.
Do not use Otrivin if taking certain medicines used to treat depression. These are:

• monoamine oxidase inhibitors (MAOIs): DO NOT use Otrivin if you are taking MAOIs 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.
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 or pharmacist before using this medicine.
Do not use Otrivin during pregnancy.
During breastfeeding, Otrivin should be used only after consulting a doctor.
Driving and operating machinery
Otrivin, when used at recommended doses, has no effect or has a negligible effect on the ability
to drive or operate machinery.
Otrivin contains benzalkonium chloride
This medicine contains 0.014 mg of benzalkonium chloride per spray dose, equivalent to 0.1 mg
of benzalkonium chloride per 1 ml of solution. Benzalkonium chloride may cause
irritation or swelling inside the nose, especially if used for prolonged periods.

3. How to use Otrivin

This medicine should always be used exactly as described in this patient information leaflet or as directed by a doctor. If in doubt, consult a doctor or pharmacist.
Otrivin should be used only in the nose (including in cases of middle ear infection).
To avoid spreading infection, one package of the medicine should be used by only one patient.

Adults and adolescents over 12 years of age:
1 spray of Otrivin into each nostril, up to 3 times daily.
Do not use more than 3 times a day. It is recommended to take the last dose immediately before going to bed.
Do not use for longer than 10 consecutive days.

Otrivin should not be used in children under 12 years of age.

Instructions for use
The medicine is intended for nasal use.
Take care not to spray the aerosol into the eyes.

1. Do not cut the tip of the applicator. The spray is ready for use.

2. Remove the protective cap.
3. Before first use, press the pump 5 times. The pump is then ready for use throughout the recommended treatment period (do not use for longer than 10 consecutive days). If the spray does not dispense after fully pressing the pump, or if the medicine has not been used for more than 7 days, re-prime the pump by pressing it 4 times.
4. Clear the nose.
5. Hold the bottle upright, supporting the bottom with the thumb, and hold the tip between two fingers.

6. Tilt the head forward and insert the tip into a nostril.
7. Press the pump while inhaling through the nose to ensure optimal distribution of the spray.

8. Repeat the procedure when administering the medicine into the other nostril.
9. After use, replace the protective cap.

The nasal spray allows precise dosing and ensures proper distribution of the solution over the entire nasal mucosal surface.
This eliminates the risk of accidental overdose.

Use of more than the recommended dose of Otrivin
If more than the recommended dose is used, seek immediate advice from a doctor or pharmacist.
In case of overdose, the following symptoms may occur: headache, dizziness, sweating, lowered body temperature, slowed heart function, elevated blood pressure, breathing difficulties, coma, and seizures.
Symptomatic treatment should be administered.

Missed dose of Otrivin
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 everybody will experience them.
You should STOP using Otrivin and immediately contact a doctor 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,
• itching with red rash or blisters.
  These symptoms occur very rarely (less than 1 in 10,000 people receiving the medicine).

Common adverse reactions (occur in less than 1 in 10 patients):
dryness or irritation of the nasal mucosa, nausea, headache, burning sensation at the site of administration.
Uncommon adverse reactions (occur in less than 1 in 100 patients):
nosebleeds.
Very rare adverse reactions (occur in less than 1 in 10,000 patients):
allergic reaction (skin rash, itching), transient visual disturbances, arrhythmia or
accelerated heart rate.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. 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
Tel: + 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 medicine

Keep the medicine out of sight and reach of children.
Do not store above 30°C.
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.
After first opening, the nasal spray can be used until the end of the expiry period.
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 packaging and other information

What Otrivin contains

• The active substance in Otrivin is xylometazoline hydrochloride. One ml of solution contains 1 mg of xylometazoline hydrochloride.
• The other ingredients are: benzalkonium chloride, disodium edetate, sodium dihydrogen phosphate dihydrate, disodium phosphate dodecahydrate, sodium chloride, sorbitol liquid, non-crystallizing 70% (E 420), hypromellose 4000, purified water.

What Otrivin looks like and contents of the pack
Bottle made of HDPE with a pump dispenser activated in the upright position and a protective cap, in a cardboard box.
For more detailed information, please contact the responsible entity or 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/1/95/0102/001
Parallel import licence number: 364/25