NEO-ANGIN 1.2 mg/0.6 mg/5.7 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the User
   1. Read the package leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet
2. What is Neo-angin Sugar-Free and what is it used for
3. Important information before using Neo-angin Sugar-Free
   1. When not to use Neo-angin Sugar-Free:
   2. Warnings and precautions
   3. Neo-angin Sugar-Free and other medicines
   4. Pregnancy and breastfeeding
   5. Driving and operating machinery
   6. Neo-angin Sugar-Free contains E 124 (Ponceau 4R) and isomalt (E 953)
4. How to use Neo-angin Sugar-Free
   1. Using a higher dose of Neo-angin Sugar-Free than recommended
   2. Missing a dose of Neo-angin Sugar-Free
5. Possible side effects
   1. Reporting side effects
6. How to store Neo-angin Sugar-Free
7. Package contents and other information
   1. What Neo-angin Sugar-Free contains
   2. What Neo-angin Sugar-Free looks like and what the package contains
   3. Marketing authorization holder and manufacturer
   4. Date of last revision of the leaflet:

Package Leaflet: Information for the User

Neo-angin Sugar-Free, 1.2 mg + 0.6 mg + 5.72 mg, Sucking Tablets
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.

• This 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 the leaflet, the doctor or pharmacist should be informed. See section 4.
• If there is no improvement or the patient feels worse after 4-5 days, a doctor should be consulted.

Table of Contents of the Leaflet

• 1. What is Neo-angin Sugar-Free and what is it used for
• 2. Important information before using Neo-angin Sugar-Free
• 3. How to use Neo-angin Sugar-Free
• 4. Possible side effects
• 5. How to store Neo-angin Sugar-Free
• 6. Package contents and other information

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

Neo-angin Sugar-Free is a medicine in the form of sucking tablets, 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 active substances in Neo-angin Sugar-Free leads to the relief of sore throat and difficulty swallowing. Neo-angin Sugar-Free 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 there is no improvement or the patient feels worse after 4-5 days, a doctor should be consulted.

2. Important information before using Neo-angin Sugar-Free

When not to use Neo-angin Sugar-Free:

• if the patient is allergic to the active substances or any of the other ingredients of this medicine (listed in section 6).
• if the patient has fructose intolerance.
• in children under 6 years of age.

Warnings and precautions

Before starting to use Neo-angin Sugar-Free, the doctor or pharmacist should be consulted.

• If the patient has diabetes. One sucking tablet contains 2.58 g of isomalt.
• If the sore throat persists or symptoms such as cough and fever occur, a doctor should be consulted.

Neo-angin Sugar-Free and other medicines

The doctor or pharmacist should be informed about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. So far, no significant interactions with other orally administered medicines have been found.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before using this medicine. There is a lack of sufficient data on the use of the medicine in pregnant and breastfeeding women.

Driving and operating machinery

No studies have been conducted on the effect of the medicine on the ability to drive and operate machinery.

Neo-angin Sugar-Free contains E 124 (Ponceau 4R) and isomalt (E 953)

Neo-angin Sugar-Free contains 2.58 g of isomalt (E 953) per sucking tablet, which is a sweetening substance, 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 some sugars, the patient should consult a doctor before taking the medicine. Isomalt may have a mild laxative effect. Neo-angin Sugar-Free contains the dye Ponceau 4R (E 124), which may cause allergic reactions.

3. How to use Neo-angin Sugar-Free

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 doubt, the doctor or pharmacist should be consulted. The medicine is for oral use. The medicine is intended for use in adults and children over 6 years of age. One tablet should be sucked or dissolved in the mouth every 2-3 hours. No more than 6 tablets should be used in 24 hours. The tablets 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 4-5 days without a doctor's recommendation. If the patient feels that the effect of Neo-angin Sugar-Free is too strong or too weak, the doctor should be consulted.

Using a higher dose of Neo-angin Sugar-Free than recommended

After using a significantly higher dose than recommended, stomach and intestinal mucosa irritation may occur. In such a case, symptomatic treatment is recommended. If a higher dose of the medicine than recommended is taken, the doctor or pharmacist should be consulted immediately.

Missing a dose of Neo-angin Sugar-Free

A double dose should not be used to make up for a missed dose. In case of any further doubts about the use of the medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Very rarely (less than 1 in 10,000 patients using the medicine), irritation of the oral mucosa and gastrointestinal tract has been observed. Allergic reactions may also occur.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the doctor, pharmacist, or nurse should be informed. 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, more information can be gathered on the safety of the medicine.

5. How to store Neo-angin Sugar-Free

Store at a temperature below 30°C. The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month. Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of medicines that are no longer used. This will help protect the environment.

6. Package contents and other information

What Neo-angin Sugar-Free contains

• The active substances of the medicine are 2,4-dichlorobenzyl alcohol, amylmetacresol, and levomenthol. One sucking tablet 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, Ponceau 4R (E 124).

What Neo-angin Sugar-Free looks like and what the package contains

PVC/PVdC/Al blisters in a cardboard box. Package size: 12, 16, 24, or 48 sucking tablets.

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: