Neo-angin sage
Poland
Table of Contents
Package leaflet: Information for the user
Neo-angin sage, 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 doctor or pharmacist.
- Keep this leaflet for future reference.
- If you need advice or further information, please consult your pharmacist.
- If you experience any adverse reactions, including any possible side effects 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 your doctor.
Leaflet contents:
- What Neo-angin sage is and what it is used for
- Important information before using Neo-angin sage
- How to use Neo-angin sage
- Possible side effects
- How to store Neo-angin sage
- Contents of the pack and other information
1. What Neo-angin sage is and what it is used for
Neo-angin sage 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 these active substances in Neo-angin sage helps relieve sore throat and swallowing difficulties.
Neo-angin sage is indicated as supportive treatment for 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 your doctor.
2. Important information before using Neo-angin szałwia
When not to use Neo-angin szałwia:
- 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 szałwia, discuss it with your doctor or pharmacist.
- If the patient has chronic cough or hoarseness, consult a doctor before using Neo-angin szałwia, as these may be symptoms of a serious disease.
Neo-angin szałwia with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to use.
No interactions with other medicines have been reported so far.
Taking Neo-angin szałwia with food and drink
There is no data available on the effect of food and drink on the action of Neo-angin szałwia.
Eating and drinking are not recommended immediately after using Neo-angin szałwia 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 may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
There are insufficient clinical data on the use of Neo-angin szałwia in pregnant women.
Therefore, the use of Neo-angin szałwia is not recommended in pregnant and breastfeeding women.
Driving and operating machinery
Studies on the influence of the medicine on the ability to drive vehicles and operate machinery have not been conducted.
Neo-angin szałwia contains Ponceau 4R (E 124) and isomalt (E 953)
Neo-angin szałwia contains the colouring agent Ponceau 4R (E 124), which may cause allergic reactions.
Neo-angin szałwia contains 2.58 g of isomalt (E 953) – a sweetening agent in one hard tablet, 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 certain sugars, the patient should consult a doctor before taking this medicine. Isomalt may have a mild laxative effect.
3. How to use Neo-angin szałwia
This medicine should always be used exactly as described in the patient leaflet or as
recommended by a doctor or pharmacist.
If in doubt, consult a doctor or pharmacist.
Neo-angin szałwia is intended for oral use.
Adults and children over 6 years of age:
slowly suck 1 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 after 3-4 days,
consult a doctor.
Neo-angin szałwia should not be used in children under 6 years of age.
Use of a higher than recommended dose of Neo-angin szałwia
If a significantly higher dose than recommended is used, irritation of the mucous membranes of the mouth and gastrointestinal tract may occur. If adverse effects occur following an overdose, consult a doctor or pharmacist.
Missed dose of Neo-angin szałwia
Do not use 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 effects
Like all medicines, this medicine can cause adverse effects, although they do not occur in everyone.
The following adverse effects may be observed after using Neo-angin szałwia:
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 available data
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in the leaflet,
you should 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, tel.: + 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.
By reporting adverse reactions, additional information regarding the safety of the medicinal product can be collected.
5. How to store Neo-angin szałwia
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 sewage systems or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.
6. Contents of the package and other information
What Neo-angin szałwia contains
- The active substances are: 2,4-dichlorobenzyl alcohol, amylobarbitone, and levomenthol. Each hard pastille contains 1.2 mg of 2,4-dichlorobenzyl alcohol, 0.6 mg of amylobarbitone, and 5.9 mg of levomenthol.
- 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 szałwia looks like and contents of the pack
Neo-angin szałwia hard pastilles are round, honey-coloured and slightly transparent.
Neo-angin szałwia hard pastilles are available in blister packs within a cardboard box.
Pack sizes: 12, 16, 24 or 48 hard pastilles.
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