Benzidamine neo-angin

Leaflet attached to the packaging: patient information

Benzydamine neo-angin

1.5 mg/ml, spray for oral use, solution

Benzydamine hydrochloride

Read the 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, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If after 3 days there is no improvement or you feel worse, consult a doctor.

Table of contents of the leaflet

• 1. What is Benzydamine neo-angin and what is it used for
• 2. Important information before using Benzydamine neo-angin
• 3. How to use Benzydamine neo-angin
• 4. Possible side effects
• 5. How to store Benzydamine neo-angin
• 6. Contents of the packaging and other information

1. What is Benzydamine neo-angin and what is it used for

Benzydamine neo-angin contains the active substance benzydamine hydrochloride and belongs to a group of non-steroidal anti-inflammatory drugs (NSAIDs). It has analgesic and anti-inflammatory properties.
Benzydamine neo-angin is indicated for the symptomatic treatment of acute sore throat with accompanying typical symptoms of inflammation, such as pain, redness, or swelling in the mouth and throat, in adults and children over 6 years of age.

2. Important information before using Benzydamine neo-angin

When not to use Benzydamine neo-angin

• if you are allergic to benzydamine hydrochloride or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before using Benzydamine neo-angin, discuss it with your doctor or pharmacist.

• If you are allergic to salicylates (e.g., acetylsalicylic acid and salicylic acid) or other medicines with antipyretic, analgesic, and anti-inflammatory effects (so-called NSAIDs).
• If you have asthma or allergic diseases, as there is an increased risk of bronchospasm or allergic reactions.

In case of an allergic reaction, discontinue use and consult a doctor or emergency department.
Mouth and throat ulcers may be a symptom of more serious diseases.
If after 3 days the symptoms have not improved or you feel worse, if you have a fever or other symptoms, consult a doctor.
Prolonged use of the medicine may have a harmful effect on the oral bacterial flora and may cause irritation. In such cases, it will be necessary to temporarily discontinue use and consult a doctor.
The duration of treatment should not exceed 7 days.
Avoid contact of the medicine with the eyes.

Children

Benzydamine neo-angin is not recommended for children who cannot hold their breath during the use of the spray.

Benzydamine neo-angin and other medicines

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine.
Pregnancy
There are no data or only limited data on the use of benzydamine in pregnant women, therefore, Benzydamine neo-angin is not recommended during pregnancy.
Breastfeeding
It cannot be excluded that there is a risk to newborns/infants. Benzydamine neo-angin should not be used during breastfeeding.
Fertility
There are no data on the effects of benzydamine on human fertility.

Driving and using machines

Benzydamine neo-angin has no or negligible influence on the ability to drive and use machines.
Benzydamine neo-angin contains 13.22 mg of alcohol (ethanol)in each dose unit

• one spray corresponding to 0.17 ml. The amount of alcohol in one dose of this medicine is equivalent to less than 0.5 ml of beer or wine. The small amount of alcohol in this medicine will not cause noticeable effects.

Benzydamine neo-angin contains methyl parahydroxybenzoate:

The medicine may cause allergic reactions (possible late reactions) and exceptionally bronchospasm.

Benzydamine neo-angin contains macrogolglycerol hydroxystearate (derived from castor oil):

The medicine may cause gastrointestinal disorders and diarrhea.
Benzydamine neo-angin contains less than 1 mmol (23 mg) of sodiumin each dose unit, which means that the medicine is considered "sodium-free".

3. How to use Benzydamine neo-angin

This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist. In case of doubt, consult a doctor or pharmacist. Benzydamine neo-angin is intended for use in the mouth and throat. Do not use a larger dose than recommended. Continuous treatment should not last longer than 7 days.
Instructions for use:

• 1. Lift the spray nozzle.
• 2. Insert the nozzle into the mouth and direct the spray towards the affected area. Press the spray head with your index finger.

Before the first use of Benzydamine neo-angin, press the button several times until a uniform mist is obtained.
During spraying, hold your breath.
Children: do not use in children who cannot hold their breath during the use of the spray.
This medicine should not be used immediately before eating or drinking.

Dosage:

Benzydamine neo-angin is usually used 2 to 6 times a day (not more often than every 1.5 to 3 hours):
For adults and children over 12 years of age, spray 4 to 8 doses per administration. For children between 6 and 12 years of age, spray 4 doses per administration.
Unless otherwise prescribed by a doctor, for elderly patients, use the recommended adult dose.

Using a larger dose of Benzydamine neo-angin than recommended

In case of using too large a dose or accidental ingestion of a large amount of Benzydamine neo-angin, consult a doctor or pharmacist immediately.
In case of overdose, vomiting can be induced as a first aid measure.

Missing a dose of Benzydamine neo-angin

Do not use a double dose to make up for a missed dose.
If you have any further doubts about the use of this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Uncommon (may affect up to 1 in 100 people):

Photosensitivity (skin becomes more sensitive to sunlight than usual, causing an itchy, red, scaly rash, sometimes with blisters)

Rare (may affect up to 1 in 1,000 people):

Itching and dryness in the mouth.
Numbness of the mouth and throat (within the scope of the medicine's effect and passes quickly).
Nausea.
Vomiting.

Very rare (may affect up to 1 in 10,000 people):

Difficulty breathing or swallowing (laryngospasm or bronchospasm)
Painful swelling of the submucosal tissue (angioedema)

Frequency not known

• Allergic reactions (hypersensitivity)
• If you experience any of the following side effects, seek medical attention immediately.Severe allergic reaction (anaphylactic shock), which may include difficulty breathing, chest pain or a feeling of tightness in the chest, and (or) dizziness/fainting, severe itching of the skin or hives, swelling of the face, lips, tongue, and (or) throat, and which may be life-threatening.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Pharmacovigilance of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje 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 this medicine.

5. How to store Benzydamine neo-angin

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and bottle after EXP.
The expiry date (EXP) means the last day of the month stated.
After first opening the medicinal product, do not use for more than 6 months.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Benzydamine neo-angin contains:

The active substance is benzydamine hydrochloride.
1 ml of oral spray solution contains 1.5 mg of benzydamine hydrochloride.
A single dose of the spray (0.17 ml) contains 0.255 mg of benzydamine hydrochloride.
The other ingredients are:
Glycerol 85%
Etanol 96%
Macrogolglycerol hydroxystearate
Methyl parahydroxybenzoate (E 218)
Sodium saccharin (E 954)
Sodium bicarbonate (E 500) to adjust pH
Cherry flavor
Purified water

What Benzydamine neo-angin looks like and contents of the pack

Benzydamine neo-angin is packaged in HDPE bottles with a metering pump made of polyethylene containing 15 ml, 30 ml, or 60 ml of solution with a cherry flavor and aroma. The whole thing is in a cardboard box.
Pack sizes: 88 doses (15 ml), 176 doses (30 ml), 352 doses (60 ml).
Not all pack sizes may be marketed.

Marketing authorization holder

M.C.M. Klosterfrau Healthcare Sp. z o.o.
Hrubieszowska 2
01-209 Warsaw

Manufacturer

Laboratorios Bohm SA.
Calle de Molinaseca, 23
28947 Fuenlabrada (Madrid)
Spain
Laboratorium Sanitatis S.L.
Parque Tecnológico de Álava
c/ Leonardo Da Vinci 11
01510 Miñano (Álava)
Spain
MCM Klosterfrau Vertriebsgesellschaft mbH
Gereonsmühlengasse 1-11
D-50670 Cologne
Germany

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Austria: Med-angin 1.5 mg/ml Spray zur Anwendung in der Mundhöhle, Lösung
Germany: neo-angin Benzydamin Spray gegen akute Halsschmerzen
Czech Republic: Orocalm, 1.5 mg/ml oral spray, solution
Slovakia: Orocalm, 1.5 mg/ml orálna roztoková aerodisperzia Poland: Benzydamine neo-angin
Belgium: Orocalm, 1.5 mg/ml solution pour pulvérisation buccale / spray voor oromucosaal gebruik
Date of last revision of the leaflet:November 2023