Neo-angin sugar-free

Package leaflet: Information for the user

Neo-Angin bez cukru, 1.2 mg + 0.6 mg + 5.72 mg, lozenges
Alcohol 2,4-dichlorobenzylicus + Amylmetacresolum + Levomentholum
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
physician or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, please 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 your condition worsens, consult your doctor.

Table of contents

1. What Neo-Angin bez cukru is and what it is used for
2. Important information before taking Neo-Angin bez cukru
3. How to take Neo-Angin bez cukru
4. Possible side effects
5. How to store Neo-Angin bez cukru
6. Contents of the pack and other information

1. What Neo-Angin bez cukru is and what it is used for

Neo-Angin bez cukru 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 the active substances in Neo-Angin bez cukru helps relieve sore throat and swallowing difficulties.
Neo-Angin bez cukru 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 bez cukru is indicated for use in adults, adolescents, and children aged 6 years and older.
If there is no improvement after 3 to 4 days, or if symptoms worsen, consult a doctor.

2. Important information before using Neo-Angin without sugar

When not to use Neo-Angin without sugar:

• 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 without sugar, discuss it with your doctor or pharmacist.
If sore throat persists beyond 3 to 4 days or symptoms such as cough and fever occur,
consult a doctor.
Children
Do not give Neo-Angin without sugar to children under 6 years of age.
When treating children with Neo-Angin without sugar, children must be able to suck the tablet in a controlled manner.
Interaction of Neo-Angin without sugar with other medicines
Inform 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 effects on fertility
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning to have a child, 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 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 are insufficient data on the passage of active substances and/or their metabolites into human milk. Therefore, Neo-Angin without sugar should not be used during breastfeeding.
Fertility
No studies have been conducted to evaluate the effect on fertility.
Driving and operating machinery
Appropriate studies have not been conducted.
Neo-Angin without sugar contains cochineal red A (E 124) and isomalt (E 953)
Neo-Angin without sugar contains the colouring agent cochineal red A (E 124), which may cause allergic reactions.
The colouring agent in this medicine contains less than 1 mmol (23 mg) of sodium per lozenge, meaning the medicine is considered "sodium-free".
Neo-Angin without sugar contains 2.58 g of isomalt (E 953) – a sweetening agent – per lozenge, corresponding to 6 kcal (26 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. Isomalt may have a mild laxative effect.

3. How to use Neo-Angin without sugar

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following adverse reactions occur, discontinue use of
Neo-Angin bez cukru immediately and contact your doctor without delay:
Very rarely (less frequently than in 1 out of 10,000 patients), irritation of the oral mucosa and gastrointestinal tract has been observed, such as dyspepsia, nausea.
Frequency not known (frequency cannot be estimated from the available data): allergic reactions, such as swelling of the mouth, tongue and lips, rash.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store the medicine Neo-Angin bez cukru

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack. The expiry date refers to the last day of the stated month.
Store below 30°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the package and other information

What Neo-Angin sugar-free contains

• The active substances in this medicine are 2,4-dichlorobenzyl alcohol, amylmetacresol, and levomenthol. Each lozenge contains 1.2 mg of 2,4-dichlorobenzyl alcohol, 0.6 mg of amylmetacresol, and 5.72 mg of levomenthol.
• The other ingredients are: star anise oil, peppermint oil, isomalt (E 953), tartaric acid, cochineal red A (E 124), which contains, among others, sodium.

What Neo-Angin sugar-free looks like and contents of the pack
Round, slightly biconvex lozenges with a grooved red surface and characteristic odour.
Acceptable variations include: colour differences, presence of air bubbles in the boiled mass, and slightly irregular edges. A thin white layer may possibly appear on the surface.
Pack sizes: 12, 16, 24 or 48 lozenges in PVC/PVdC blisters with aluminium foil, packed in a cardboard box.

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