Package leaflet: Information for the user

Neo-angin Spray
(14.58 mg + 2.92 mg + 0.87 mg)/ml, solution for application to the oral and pharyngeal mucosa
Alcohol 2,4-dichlorobenzylicus + Amylmetacresolum + Levomentholum
Please read carefully the entire leaflet before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in the patient leaflet or according to
the instructions given by the doctor or pharmacist.

Keep this leaflet, so that you can read it again if necessary.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 3–4 days, or if you feel worse, consult your doctor.

Table of contents

What Neo-angin Spray is and what it is used for
Important information before using Neo-angin Spray
How to use Neo-angin Spray
Possible side effects
How to store Neo-angin Spray
Contents of the pack and other information

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

Neo-angin Spray is a medicine in the form of a solution for application to the oral and pharyngeal mucosa.
It contains two substances (2,4-dichlorobenzyl alcohol and amylmetacresol) with antibacterial and antifungal activity, and levomenthol, which produces a cooling sensation on mucous membranes and has mild local anaesthetic properties.
Neo-angin Spray is indicated as an adjunctive treatment for inflammatory conditions of the mouth and throat associated with symptoms such as sore throat, redness, and swelling.
If there is no improvement after 3–4 days, or if you feel worse, consult your 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 to any of the other ingredients of this medicine (listed in section 6).
if the patient has bronchial asthma or other respiratory disorders involving spastic conditions, as administration of the medicine may cause bronchospasm.
in children under 6 years of age.

Warnings and precautions
Before starting to use Neo-Angin Spray, consult a doctor or pharmacist.

If sore throat persists or symptoms such as cough and fever occur, medical advice should be sought.

Neo-Angin Spray and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines planned for use.
To date, no significant interactions with other orally administered medicines have been reported.

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 or pharmacist before using this medicine.
There is insufficient clinical data on the use of this medicine in pregnant women.
Due to its ethanol content, Neo-Angin Spray should not be used during pregnancy or breastfeeding.

Driving and operating machinery
Studies on the influence of this medicine on the ability to drive or operate machinery have not been conducted.

Neo-Angin Spray contains ethanol and propylene glycol
This medicine contains 35 mg of alcohol (ethanol) per dose unit – two sprays corresponding to 0.18 ml.
The amount of alcohol in one dose of this medicine is equivalent to less than 1 ml of beer or wine.
The small amount of alcohol in this medicine is unlikely to produce noticeable effects.
This medicine contains approximately 137 mg of propylene glycol per dose (two sprays corresponding to 0.18 ml).

3. How to use Neo-Angin Spray

This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
The medicine is intended for application to the oral and pharyngeal mucosa.
The medicine is intended for use in adults and children over 6 years of age.
One dose should be administered up to 6 times daily.
To administer a dose, remove the protective cap, hold your breath, and press the pump head twice to release the solution into the mouth.
Do not use in children under 6 years of age.
Do not use the medicine for longer than 3–4 days without medical advice.
If you feel that the effect of Neo-Angin Spray is too strong or too weak, consult your doctor.
Use of more than the recommended dose of Neo-Angin Spray
If significantly more medicine than recommended is used, irritation of the gastric and intestinal mucosa may occur. In such cases, symptomatic treatment is advised.
If you have used more than the recommended dose, seek immediate advice from a doctor or pharmacist.
Missed dose of Neo-Angin Spray
Do not use a double dose to make up for a missed dose.
If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody gets them.
Very rarely (less frequently than in 1 out of 10,000 patients using the medicine), irritation of the
mucous membranes of the oral cavity and gastrointestinal tract has been observed.
Allergic reactions may also occur.
Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in the leaflet, inform a 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, tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Neo-Angin Spray

Store below 25°C.
Keep the medicine out of the 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Neo-Angin Spray contains

The active substances are 2,4-dichlorobenzyl alcohol, amylocresol, and levomenthol. One ml of solution contains 14.58 mg of 2,4-dichlorobenzyl alcohol, 2.92 mg of amylocresol, 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 contents of the pack
An amber glass bottle with a spray pump, packed in a cardboard box.
Pack sizes: 15 or 30 ml.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
M.C.M. Klosterfrau Healthcare Sp. z o.o.
ul. Hrubieszowska 2
01-209 Warsaw
Poland

Manufacturer:
Divapharma GmbH
Motzener Str. 41
D-12277 Berlin
Germany