NEO-ANGIN 1.2 mg/0.6 mg/5.9 mg Lozenge

Contents of the leaflet

1. Leaflet attached to the packaging: information for the user
   1. You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet:
2. What is Neo-angin sage and what is it used for
3. Important information before using Neo-angin sage
   1. When not to use Neo-angin sage:
   2. Children
   3. Warnings and precautions
   4. Neo-angin sage and other medicines
   5. Using Neo-angin sage with food and drink
   6. Pregnancy and breastfeeding
   7. Driving and using machines
   8. Neo-angin sage contains Ponceau 4R (E 124) and isomalt (E 953)
4. How to use Neo-angin sage
   1. Using a higher dose of Neo-angin sage than recommended
   2. Missing a dose of Neo-angin sage
5. Possible side effects
   1. Reporting side effects
6. How to store Neo-angin sage
7. Contents of the packaging and other information
   1. What Neo-angin sage contains
   2. What Neo-angin sage looks like and what the packaging contains
   3. Marketing authorization holder and manufacturer
   4. Date of last revision of the leaflet:

Leaflet attached to the packaging: information for the user

Neo-angin sage, 1.2 mg + 0.6 mg + 5.9 mg, hard lozenges
Alcohol 2,4-dichlorobenzylicus + Amylmetacresolum + Levomentholum

You should carefully read the contents of the 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 as directed by a doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should tell 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 sage and what is it used for
• 2. Important information before using Neo-angin sage
• 3. How to use Neo-angin sage
• 4. Possible side effects
• 5. How to store Neo-angin sage
• 6. Contents of the packaging and other information

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

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

Neo-angin sage is recommended for the treatment of inflammatory conditions of the mouth and throat, accompanied by symptoms such as: sore throat, redness, 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 sage

When not to use Neo-angin sage:

Children

Do not use in children under 6 years of age.

Warnings and precautions

Before starting to use Neo-angin sage, you should discuss it with your doctor or pharmacist.

Neo-angin sage and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

No interactions with other medicines have been reported so far.

Using Neo-angin sage with food and drink

There is no data on the effect of food and drink on the action of Neo-angin sage.

It is not recommended to eat or drink immediately after using Neo-angin sage, to avoid removing the active substances from the surface of the mucous membrane 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 is insufficient clinical data on the use of Neo-angin sage in pregnant women.

Therefore, it is not recommended to use Neo-angin sage 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 sage contains Ponceau 4R (E 124) and isomalt (E 953)

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

Neo-angin sage contains 2.58 g of isomalt (E 953) - a sweetening substance in one 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 sage

This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor or pharmacist. If you have any doubts, you should consult your doctor or pharmacist.

Neo-angin sage is intended for oral use.

Adults and children over 6 years of age:

should slowly suck 1 lozenge every 2-3 hours.

Do not swallow lozenges whole. Do not chew.

Do not use more than 6 lozenges in 24 hours.

If the symptoms of mouth and throat infection worsen or do not improve after 3-4 days, you should contact your doctor.

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

Using a higher dose of Neo-angin sage than recommended

After using a significantly higher dose of the medicine than recommended, irritation of the mucous membrane of the mouth and digestive tract may occur. If side effects occur due to the use of a higher dose of the medicine than recommended, you should consult your doctor or pharmacist.

Missing a dose of Neo-angin sage

You should not use a double dose to make up for a missed dose.

If you have any further doubts about using the medicine, you should consult your doctor or pharmacist.

4. Possible side effects

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

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

Very rare:

• irritation of the mucous membrane 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 1000 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 you experience any side effects, including any side effects not listed in the leaflet, you should tell your 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.

By reporting side effects, you can help provide more information on the safety of the medicine.

5. How to store Neo-angin sage

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.

Store in a temperature below 30°C. Store in the original packaging.

Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Neo-angin sage 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, sage oil, peppermint oil, quinoline yellow (E 104), Ponceau 4R (E 124), patent blue V (E 131).

What Neo-angin sage looks like and what the packaging contains

Neo-angin sage hard lozenges are round, honey-colored, and slightly transparent.

Neo-angin sage 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: