Package leaflet: Information for the user

Neo-angin, 1.2 mg + 0.6 mg + 5.9 mg, lozenges
Alcohol 2,4-dichlorobenzylicus + Amylmetacresolum + Levomentholum
Please read all of this leaflet carefully before using this medicine because it contains
important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed by
your doctor or pharmacist.

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

Contents of the leaflet

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

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

Neo-angin is a medicine in the form of lozenges containing two active substances (2,4-dichlorobenzyl alcohol and amylmetacresol) with antiseptic properties, and levomenthol, which produces a cooling sensation on mucous membranes. The combined action of these active ingredients in Neo-angin helps relieve sore throat and swallowing difficulties.
Neo-angin is recommended as an adjunctive treatment for inflammatory conditions of the mouth and throat associated with symptoms such as sore throat, redness, and swelling.
Neo-angin is indicated for use in adults, adolescents, and children over 6 years of age.
If there is no improvement after 3 to 4 days, or if symptoms worsen, consult your doctor.

2. Information before using Neo-Angin

When not to use Neo-Angin:

if the patient is allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting to use Neo-Angin, discuss it with your doctor or pharmacist.

If sore throat persists beyond 3 to 4 days, or if symptoms such as cough and fever occur, consult a doctor.

Children
Do not give Neo-Angin to children under 6 years of age. When treating children with Neo-Angin, they must be able to suck the tablet in a controlled manner.

Neo-Angin with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
To date, no significant interactions with other orally administered medicines have been reported.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.

Pregnancy
There are no data or only limited data available on the use of the active substances in pregnant women.
Animal studies have not shown any direct or indirect harmful effects on reproduction. Due to insufficient data, this medicine should not be used during pregnancy.

Breastfeeding
There is insufficient data on the passage of the active substances and (or) their metabolites into human milk. Therefore, Neo-Angin should not be used during breastfeeding.

Fertility
No studies have been conducted to assess the effect on fertility.

Driving and operating machinery
Appropriate studies have not been conducted.

Neo-Angin contains cochineal red A (E 124), glucose and sucrose, including sulfur dioxide and sulfites
Neo-Angin contains cochineal red A (E 124), which may cause allergic reactions.
The colouring agent cochineal red A in this medicine contains less than 1 mmol (23 mg) of sodium per lozenge, meaning the medicine is considered "sodium-free".
Neo-Angin contains glucose syrup, including 1.14 g of glucose (dry mass) and 1.42 g of sucrose per lozenge, corresponding to approximately 10 kcal (42 kJ). This should be taken into account in patients with diabetes. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
The medicine may contain sulfur dioxide (which may be present in glucose syrup) or sulfites (which may be present in sucrose), which rarely may cause severe hypersensitivity reactions and bronchospasm.

3. How to use Neo-Angin

This medicine should always be used exactly as described in this patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The medicine is for oral use.
This medicine is intended for use in adults, adolescents, and children above 6 years of age.
Slowly suck or dissolve 1 tablet in the mouth every 2-3 hours.
The maximum daily dose is 6 lozenges.
Do not swallow the tablets whole. Do not chew.
Do not use in children under 6 years of age.
Do not take this medicine for longer than 3 to 4 days without medical advice.
If you feel that the effect of Neo-Angin is too strong or too weak, consult your doctor.
Use of more than the recommended dose of Neo-Angin
In the very unlikely event of an overdose, adverse reactions described in section 4 may become more pronounced. In such a case, consult your doctor or pharmacist.
Missed dose of Neo-Angin
Do not take a double dose to make up for a missed dose.
If you have any further doubts concerning the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If any of the following adverse effects occur, stop using
the Neo-Angin medicine and contact your doctor immediately:
Very rare (less than 1 in 10,000 patients): irritation of the oral mucosa and gastrointestinal tract such as dyspepsia, nausea.
Frequency unknown (frequency cannot be estimated from the available data): allergic reactions such as swelling of the lips, tongue and mouth, rash.
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects 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, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Neo-Angin

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 blister. The expiry date refers to the last day of the stated month.
Store below 25°C.
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 pack and other information

What Neo-Angin contains

The active substances are: 2,4-dichlorobenzyl alcohol, amylobarbitone (amylometakrezol), and levomenthol. Each pastille contains 1.2 mg of 2,4-dichlorobenzyl alcohol, 0.6 mg of amylometakrezol, and 5.9 mg of levomenthol.
Other ingredients include: star anise oil, peppermint oil, sucrose (may contain sulphites), glucose syrup (contains glucose and may contain sulphur dioxide (E 220)), tartaric acid, carmine red A (E 124), which contains, among others, sodium.

What Neo-Angin looks like and contents of the pack
Round, slightly biconvex pastilles with a grooved red surface and characteristic aroma.
Variations in colour, presence of air bubbles in the boiled mass, and slightly irregular edges are acceptable. A thin layer of white film is possible.
Blister packs made of PVC/PVdC and aluminium foil, packed in a cardboard box.
Pack sizes: 12, 24, 36 or 48 pastilles for sucking.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
M.C.M. Klosterfrau Healthcare Sp. z o.o.
ul. Hrubieszowska 2
01-209 Warsaw
tel.: +48 22 231 8287
e-mail: [email protected]

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