Neo-angin cherry
Poland
Table of Contents
Package leaflet: Information for the user
Neo-angin cherry, 1.2 mg + 0.6 mg + 5.9 mg, hard pastilles
Alcohol 2,4-dichlorobenzylicus + Amylmetacresolum + Levomentholum
Please read the entire 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 adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
- If there is no improvement after 3–4 days, or if your condition worsens, consult a doctor.
Leaflet contents:
- What Neo-angin cherry is and what it is used for
- Important information before using Neo-angin cherry
- How to use Neo-angin cherry
- Possible side effects
- How to store Neo-angin cherry
- Contents of the pack and other information
1. What Neo-angin cherry is and what it is used for
Neo-angin cherry is a medicine in the form of hard pastilles, 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 cherry helps relieve sore throat and difficulty in swallowing.
Neo-angin cherry is recommended for supportive treatment of inflammatory conditions of the mouth and throat associated with symptoms such as sore throat, redness, and swelling.
If there is no improvement after 3–4 days, or if your condition worsens, consult a doctor.
2. Important information before using Neo-angin cherry
When not to use Neo-angin cherry:
- if the patient is allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6).
Children
Do not use in children under 6 years of age.
Warnings and precautions
Before starting to use Neo-angin cherry, discuss it with your doctor or pharmacist.
- If the patient has chronic cough or hoarseness, consult a doctor before using Neo-angin cherry, as these may be symptoms of a serious disease.
Neo-angin cherry with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
No interactions with other medicines have been reported so far.
Taking Neo-angin cherry with food and drink
There are no data available regarding the effect of food and drink on the action of Neo-angin cherry.
Eating and drinking are not recommended immediately after using Neo-angin cherry to avoid removing the active substances from the surface of the oral and pharyngeal mucosa.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning to have a baby, she should consult a 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 during pregnancy and breastfeeding.
Driving and operating machinery
No studies have been conducted on the effect of the medicine on the ability to drive or operate machinery.
Neo-angin cherry contains Ponceau 4R (E 124), benzyl alcohol, butylated hydroxyanisole (E 320) and isomalt (E 953)
Neo-angin cherry contains the colouring agent Ponceau 4R (E 124), which may cause allergic reactions.
This medicine contains 0.30 mg of benzyl alcohol (a component of the cherry flavour) in each tablet (2.6 g). Benzyl alcohol may cause allergic reactions.
Pregnant or breastfeeding women, and patients with liver or kidney disease, should consult a doctor before using this medicine, as large amounts of benzyl alcohol may accumulate in their bodies and cause adverse effects (so-called metabolic acidosis).
The cherry flavour of the medicine also contains butylated hydroxyanisole (E 320), which may cause irritation of the mucous membranes.
Neo-angin cherry contains 2.58 g of isomalt (E 953) – a sweetening agent – per hard tablet, equivalent 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, he or she should consult a doctor before taking the medicine.
Isomalt may have a mild laxative effect.
3. How to use Neo-angin wiśnia
This medicine should always be used exactly as described in this patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Neo-angin wiśnia is intended for oral use.
Adults and children over 6 years of age:
slowly suck one tablet every 2-3 hours.
Do not swallow the tablets whole. Do not chew.
Do not use more than 6 tablets per day.
If symptoms of infection in the mouth and throat worsen or do not improve within 3-4 days, consult a doctor.
Neo-angin wiśnia should not be used in children under 6 years of age.
Use of more than the recommended dose of Neo-angin wiśnia
If a significantly higher dose than recommended is used, irritation of the oral mucosa and gastrointestinal tract may occur. If any adverse effects occur following an overdose, consult a doctor or pharmacist.
Missed dose of Neo-angin wiśnia
Do not take a double dose to make up for a missed dose.
If you have any further doubts regarding the use of this medicine, consult a doctor or pharmacist.
4. Possible adverse reactions
Like any medicine, this medicine can cause adverse reactions, although not everybody experiences them.
The following adverse reactions may occur after using Neo-angin wiśnia:
Very rare:
- irritation of the oral mucosa and gastrointestinal tract
Frequency not known:
- allergic reactions such as swelling of the lips and tongue
| The assessment of adverse reactions was based on their frequency of occurrence. | |
| 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 unknown: frequency cannot be determined from the available data
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in the package leaflet, inform your doctor, pharmacist, or nurse. 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, phone: +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 Neo-angin wiśnia
Keep this medicine 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 specified month.
Store below 30°C. Keep in the original packaging.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.
6. Contents of the package and other information
What Neo-angin wiśnia contains
- The active substances are: 2,4-dichlorobenzyl alcohol, amylobarbitone, and levomenthol. Each hard lozenge contains 1.2 mg of 2,4-dichlorobenzyl alcohol, 0.6 mg of amylobarbitone, and 5.9 mg of levomenthol.
- The other ingredients are: isomalt (E 953), tartaric acid, cherry flavour containing, among others, benzyl alcohol and butylated hydroxyanisole (E 320), peppermint oil, Ponceau 4R (E 124), indigo carmine (E 132).
What Neo-angin wiśnia looks like and contents of the pack
Neo-angin wiśnia hard lozenges are round, red and slightly transparent.
Neo-angin wiśnia hard lozenges are available in blister packs within a cardboard box.
Pack sizes: 12, 16, 24 or 48 hard lozenges.
Not all pack sizes may be marketed.
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:
Klosterfrau Berlin GmbH
Motzener Str. 41
D-12277 Berlin
Germany