NEO-ANGIN 14.58 mg/2.92 mg/0.87 mg/ml Solution

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Neo-angin Spray
   1. Read the package leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet
3. What is Neo-angin Spray and what is it used for
4. Important information before using Neo-angin Spray
   1. When not to use Neo-angin Spray:
   2. Warnings and precautions
   3. Neo-angin Spray and other medicines
   4. Pregnancy and breastfeeding
   5. Driving and using machines
   6. Neo-angin Spray contains ethanol and propylene glycol
5. How to use Neo-angin Spray
   1. Using a higher dose of Neo-angin Spray than recommended
   2. Missing a dose of Neo-angin Spray
6. Possible side effects
   1. Reporting side effects
7. How to store Neo-angin Spray
8. Package contents and other information
   1. What Neo-angin Spray contains
   2. What Neo-angin Spray looks like and what the package contains
   3. Marketing authorization holder and manufacturer
   4. Date of last revision of the leaflet:

Package Leaflet: Information for the User

Neo-angin Spray

(14.58 mg + 2.92 mg + 0.87 mg)/ml, solution for use on the mucous membrane of the mouth and throat
2,4-Dichlorobenzyl alcohol + Amylmetacresol + Levomenthol

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in the package leaflet for the patient or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.
• If after 3-4 days there is no improvement or the patient feels worse, they should contact their doctor.

Table of Contents of the Leaflet

• 1. What is Neo-angin Spray and what is it used for
• 2. Important information before using Neo-angin Spray
• 3. How to use Neo-angin Spray
• 4. Possible side effects
• 5. How to store Neo-angin Spray
• 6. Package contents and other information

1. What is Neo-angin Spray and what is it used for

Neo-angin Spray is a medicine in the form of a solution for use on the mucous membrane of the mouth and throat.
It contains two substances (2,4-dichlorobenzyl alcohol and amylmetacresol) with antibacterial and antifungal effects, and levomenthol, which gives a cooling sensation on the mucous membranes and has a mild local anesthetic effect.
Neo-angin Spray is recommended for the supportive treatment of inflammatory conditions of the mouth and throat, accompanied by symptoms such as sore throat, redness, and swelling.
If after 3-4 days there is no improvement or the patient feels worse, they should consult their doctor.

2. Important information before using Neo-angin Spray

When not to use Neo-angin Spray:

• if the patient is allergic to the active substances or any of the other ingredients of this medicine (listed in section 6).
• if the patient has asthma or other respiratory diseases, in which spastic conditions occur, as the administration of the medicine may cause bronchospasm.
• in children under 6 years of age.

Warnings and precautions

Before starting to use Neo-angin Spray, the patient should discuss it with their doctor or pharmacist.

• If the sore throat persists or symptoms such as cough and fever occur, the patient should consult their doctor.

Neo-angin Spray and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking or have recently taken, as well as any medicines they plan to take.
No significant interactions with other orally administered medicines have been reported.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
There are no sufficient clinical data on the use of the medicine in pregnant women.
Due to the ethanol content of Neo-angin Spray, it should not be used in pregnant or breastfeeding women.

Driving and using machines

No studies have been conducted on the effect of the medicine on the ability to drive and use machines.

Neo-angin Spray contains ethanol and propylene glycol

This medicine contains 35 mg of ethanol in each dose - two sprays equivalent to 0.18 ml.
The amount of ethanol in one dose of this medicine is equivalent to less than 1 ml of beer or wine.
The small amount of ethanol in this medicine will not have noticeable effects.
This medicine contains approximately 137 mg of propylene glycol in each dose (2 sprays equivalent to 0.18 ml).

3. How to use Neo-angin Spray

This medicine should always be used exactly as described in the package leaflet for the patient or as directed by a doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.
The medicine is used on the mucous membrane of the mouth and throat.
The medicine is intended for use in adults and children over 6 years of age.
One dose of the medicine should be used up to 6 times a day.
To administer a dose of the medicine, the protective cap should be removed, the breath held, and the nozzle of the container pressed twice, introducing the solution into the mouth.
The medicine should not be used in children under 6 years of age.
The medicine should not be taken for longer than 3-4 days without a doctor's recommendation.
If the patient feels that the effect of Neo-angin Spray is too strong or too weak, they should consult their doctor.

Using a higher dose of Neo-angin Spray than recommended

After using a significantly higher dose of the medicine than recommended, irritation of the stomach and intestinal mucosa may occur. In such a case, symptomatic treatment is recommended.
If a higher dose of the medicine than recommended is taken, the patient should immediately consult their doctor or pharmacist.

Missing a dose of Neo-angin Spray

A double dose should not be used to make up for a missed dose.
In case of any further doubts related to the use of the medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very rarely (less than 1 in 10,000 patients using the medicine), irritation of the mucous membrane of the mouth and digestive tract has been observed.
Allergic reactions may also occur.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the patient should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will allow for the collection of more information on the safety of the medicine.

5. How to store Neo-angin Spray

Store at a temperature below 25°C.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and bottle. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Neo-angin Spray contains

• The active substances of the medicine are 2,4-dichlorobenzyl alcohol, amylmetacresol, and levomenthol. One ml of the solution contains 14.58 mg of 2,4-dichlorobenzyl alcohol, 2.92 mg of amylmetacresol, and 0.87 mg of levomenthol.
• The other ingredients are: star anise oil, peppermint oil, ethanol 96%, propylene glycol.

What Neo-angin Spray looks like and what the package contains

Brown glass bottle with a spray nozzle in a cardboard box.
Package size: 15 or 30 ml.

Marketing authorization holder and manufacturer

Marketing authorization holder:
M.C.M. Klosterfrau Healthcare Sp. z o.o.
ul. Hrubieszowska 2
01-209 Warsaw
Manufacturer:
Divapharma GmbH
Motzener Str. 41
D-12277 Berlin
Germany

Date of last revision of the leaflet: