Neo-angin vishnia

Package Leaflet: Information for the User

Neo-angin Cherry, 1.2 mg + 0.6 mg + 5.9 mg, Hard 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 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 Cherry and what is it used for
• 2. Important information before using Neo-angin Cherry
• 3. How to use Neo-angin Cherry
• 4. Possible side effects
• 5. How to store Neo-angin Cherry
• 6. Package contents and other information

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

Neo-angin Cherry is a medicine in the form of hard lozenges, containing two active substances (2,4-dichlorobenzyl alcohol and amylmetacresol) with antiseptic action and levomenthol, which causes a cooling sensation on the mucous membranes. The simultaneous use of active substances in Neo-angin Cherry results in the relief of sore throat and difficulty swallowing.

Neo-angin Cherry 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 Cherry

When not to use Neo-angin Cherry:

Children

Do not use in children under 6 years of age.

Warnings and precautions

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

Neo-angin Cherry 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 interactions with other medicines have been reported to date.

Using Neo-angin Cherry with food and drink

There are no data on the effect of food and drink on the action of Neo-angin Cherry.

The patient should not eat or drink immediately after using Neo-angin Cherry to avoid removing the active substances from the surface of the mucous membranes of the mouth and throat.

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 insufficient clinical data on the use of Neo-angin Cherry in pregnant women.

Therefore, the use of Neo-angin Cherry is not recommended in pregnant and 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 Cherry contains Ponceau 4R (E 124), benzyl alcohol, butylhydroxyanisole (E 320), and isomalt (E 953)

Neo-angin Cherry contains the dye Ponceau 4R (E 124), which may cause allergic reactions.

This medicine contains 0.30 mg of benzyl alcohol (a component of the cherry flavor) in each lozenge (2.6 g). Benzyl alcohol may cause allergic reactions.

Pregnant or breastfeeding women, patients with liver or kidney disease should consult their doctor before using the medicine, as a large amount of benzyl alcohol may accumulate in their body and cause side effects (so-called metabolic acidosis).

The cherry flavor of the medicine also contains butylhydroxyanisole (E 320), which may cause irritation of the mucous membranes.

Neo-angin Cherry contains 2.58 g of isomalt (E 953) - a sweetening substance - per hard lozenge, which corresponds 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 some sugars, they should consult their doctor before taking the medicine.

Isomalt may have a mild laxative effect.

3. How to use Neo-angin Cherry

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 doubts, the patient should consult their doctor or pharmacist.

Neo-angin Cherry is intended for oral use.

Adults and children over 6 years of age:

should slowly suck 1 lozenge every 2-3 hours.

Lozenges should not be swallowed whole. Do not chew.

No more than 6 lozenges should be used in 24 hours.

If the symptoms of mouth and throat infection worsen or do not improve after 3-4 days, the patient should consult their doctor.

Neo-angin Cherry should not be used in children under 6 years of age.

Using a higher dose of Neo-angin Cherry than recommended

After using a significantly higher dose of the medicine than recommended, irritation of the mucous membranes of the mouth and digestive tract may occur.

In case of side effects caused by using a higher dose of the medicine than recommended, the patient should consult their doctor or pharmacist.

Missing a dose of Neo-angin Cherry

A double dose should not be used to make up for a missed dose.

In case of any further doubts about using the medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

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

The following side effects may be observed after using Neo-angin Cherry:

Very rare:

• irritation of the mucous membranes of the mouth and digestive tract

Frequency not known:

• allergic reactions, such as swelling of the lips and tongue

The assessment of side effects is based on their frequency.

Very common: in more than 1 in 10 people

Common: in less than 1 in 10 people

Uncommon: in less than 1 in 100 people

Rare: in less than 1 in 1,000 people

Very rare: in less than 1 in 10,000 people

Frequency not known: frequency cannot be estimated from the available data

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should inform their doctor or 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 help to gather more information on the safety of the medicine.

5. How to store Neo-angin Cherry

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 blister.

The expiry date refers to the last day of the month stated.

Store in a temperature below 30°C.

Store in the original package.

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 Cherry contains

• The active substances of the medicine are: 2,4-dichlorobenzyl alcohol, amylmetacresol, and levomenthol. One hard 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: isomalt (E 953), tartaric acid, cherry flavor containing benzyl alcohol and butylhydroxyanisole (E 320), peppermint oil, Ponceau 4R (E 124), indigo carmine (E 132).

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

Neo-angin Cherry hard lozenges are round, red, and slightly transparent.

Neo-angin Cherry hard lozenges are available in blisters in a cardboard box.

Package size: 12, 16, 24, or 48 hard lozenges.

Not all package sizes may be marketed.

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 leaflet: