Neo-angin

Package Leaflet: Information for the User

Neo-angin, 1.2 mg + 0.6 mg + 5.9 mg, lozenges
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 this package leaflet for the patient or as directed by a doctor or pharmacist.

• This package leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in this package leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse after 3 to 4 days, they should contact their doctor.

Table of Contents of the Package Leaflet

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

1. What is Neo-angin and what is it 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 causes a cooling sensation on the mucous membranes. The simultaneous use of the active substances in Neo-angin results in the relief of sore throat and difficulty swallowing.
Neo-angin is recommended for the supportive treatment of inflammatory conditions of the mouth and throat, accompanied by 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 or the patient feels worse after 3 to 4 days, they should consult their doctor.

2. Important information before using Neo-angin

When not to use Neo-angin:

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

Warnings and precautions

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

• If the sore throat persists after 3 to 4 days or symptoms such as cough and fever occur, the patient should consult their doctor.

Children

Neo-angin should not be given to children under 6 years of age. When treating children with Neo-angin, they must be able to suck the lozenge in a controlled manner.

Neo-angin and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently 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, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before using this medicine.
Pregnancy
There are no data or only limited data 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 the lack of data, this medicine should not be used during pregnancy.
Breastfeeding
There are no sufficient 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 evaluate the effect on fertility.

Driving and using machines

No appropriate studies have been conducted.

Neo-angin contains E 124 (Ponceau 4R), glucose, and sucrose, including sulfur dioxide and sulfites

Neo-angin contains Ponceau 4R (E 124), which may cause allergic reactions.
The Ponceau 4R coloring in this medicine contains less than 1 mmol (23 mg) of sodium per lozenge, which means the medicine is considered 'sodium-free'.
Neo-angin contains glucose syrup, including 1.14 g of glucose (anhydrous) and 1.42 g of sucrose per lozenge, which corresponds 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 some sugars, they should consult their doctor before taking the medicine.
The medicine may contain sulfur dioxide (which may be present in the glucose syrup) or sulfites (which may be present in sucrose), which can rarely cause severe hypersensitivity reactions and bronchospasm.

3. How to use Neo-angin

This medicine should always be used exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.
The medicine is for oral use.
The medicine is intended for use in adults, adolescents, and children over 6 years of age.
The patient should slowly suck or dissolve 1 lozenge in the mouth every 2-3 hours.
The maximum daily dose is 6 lozenges.
The lozenges should not be swallowed whole. Do not chew.
The medicine should not be used in children under 6 years of age.
The medicine should not be taken for more than 3 to 4 days without the advice of a doctor.
If the patient feels that the effect of Neo-angin is too strong or too weak, they should consult their doctor.

Using more than the recommended dose of Neo-angin

In the unlikely event of an overdose, the adverse reactions described in section 4 may be intensified. In such a case, the patient should consult their doctor or pharmacist.

Missing a dose of Neo-angin

The patient should not take a double dose to make up for a missed dose.
If the patient has any further doubts about the use of this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Neo-angin can cause side effects, although not everybody gets them.

If any of the following side effects occur, the patient should stop using Neo-angin and contact their doctor immediately:

Very rare (less than 1 in 10,000 patients): irritation of the mucous membranes of the mouth and gastrointestinal tract, such as dyspepsia, nausea.
Frequency not known (cannot be estimated from the available data): allergic reactions, such as swelling of the lips, tongue, and face, rash.

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in the package leaflet, they 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.
By reporting side effects, it is possible to gather more information on the safety of the medicine.

5. How to store Neo-angin

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

6. Contents of the pack and other information

What Neo-angin contains

• The active substances of Neo-angin are: 2,4-dichlorobenzyl alcohol, amylmetacresol, and levomenthol. One lozenge contains 1.2 mg of 2,4-dichlorobenzyl alcohol, 0.6 mg of amylmetacresol, and 5.9 mg of levomenthol.
• The other ingredients are: star anise oil, peppermint oil, sucrose (may contain sulfites), glucose syrup (contains glucose and may contain sulfur dioxide (E 220)), tartaric acid, Ponceau 4R (E 124) containing sodium.

What Neo-angin looks like and contents of the pack

Round, slightly biconvex lozenges with a red scored surface and characteristic odor.
Permitted are: color variation, presence of air bubbles in the cooked mass, and slightly irregular edges. A thin layer of white coating is possible.
Blisters of PVC/PVdC and aluminum foil in a cardboard box.
Pack sizes: 12, 24, 36, or 48 lozenges.

Marketing authorization holder and manufacturer

Marketing authorization 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

Date of last revision of the package leaflet: