BENZYDAMINE 3 mg /Ml Aerosol

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Benzydamine neo-angin forte
3. 3 mg/ml, oral spray, solution
   1. Read the package leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of Contents of the Package Leaflet
4. What is Benzydamine neo-angin forte and what is it used for
5. Important information before using Benzydamine neo-angin forte
   1. When not to use Benzydamine neo-angin forte
   2. Warnings and precautions
   3. Benzydamine neo-angin forte and other medicines
   4. Pregnancy, breastfeeding, and fertility
   5. Driving and using machines
   6. Benzydamine neo-angin forte contains methyl parahydroxybenzoate:
   7. Benzydamine neo-angin forte contains macrogolglycerol hydroxystearate (derived from castor oil):
6. How to use Benzydamine neo-angin forte
   1. Dosage:
   2. Using a higher dose of Benzydamine neo-angin forte than recommended
   3. Missing a dose of Benzydamine neo-angin forte
7. Possible side effects
   1. Uncommon (may affect up to 1 in 100 people):
   2. Rare (may affect up to 1 in 1,000 people):
   3. Very rare (may affect up to 1 in 10,000 people):
   4. Frequency not known
   5. Reporting side effects
8. How to store Benzydamine neo-angin forte
9. Contents of the package and other information
   1. What Benzydamine neo-angin forte contains:
   2. What Benzydamine neo-angin forte looks like and contents of the package
   3. Marketing authorization holder
   4. Manufacturer
   5. This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Package Leaflet: Information for the Patient

Benzydamine neo-angin forte

3 mg/ml, oral spray, solution

Benzydamine hydrochloride

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 this package leaflet for the patient or as directed by a doctor or pharmacist.
• Keep this package 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 package 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 Package Leaflet

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

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

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

2. Important information before using Benzydamine neo-angin forte

When not to use Benzydamine neo-angin forte

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

Warnings and precautions

Before starting to use Benzydamine neo-angin forte, discuss it with your doctor or pharmacist.

• If you are allergic to salicylates (e.g., acetylsalicylic acid and salicylic acid) or other medicines with anti-fever, 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 of the medicine 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. Long-term use of the medicine may have a harmful effect on the oral bacterial flora and may cause irritation. In such a case, 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.

Benzydamine neo-angin forte and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as about 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 forte is not recommended during pregnancy. Breastfeeding It cannot be excluded that there is a risk to newborns/infants. Benzydamine neo-angin forte should not be used during breastfeeding. Fertility There are no data on the effect of benzydamine on human fertility.

Driving and using machines

Benzydamine neo-angin forte has no or negligible influence on the ability to drive and use machines. Benzydamine neo-angin forte 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 forte contains methyl parahydroxybenzoate:

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

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

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

3. How to use Benzydamine neo-angin forte

This medicine should always be used exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist. In case of doubt, consult a doctor or pharmacist. Benzydamine neo-angin forte is intended for use in the mouth and throat. Do not use a higher 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 aerosol towards the treated area. Press the aerosol head with your index finger.

Before the first use of Benzydamine neo-angin forte, press the button several times until a uniform mist is obtained. While spraying the medicine, hold your breath. This medicine should not be used immediately before eating or drinking.

Dosage:

Benzydamine neo-angin forte is usually used from 2 to 6 times a day (not more often than every 1.5-3 hours): from 2 to 4 doses per administration. Unless the doctor has prescribed otherwise, the recommended dose for adults should be used in elderly patients.

Using a higher dose of Benzydamine neo-angin forte than recommended

In case of using too high a dose or accidental ingestion of a large amount of Benzydamine neo-angin forte, 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 forte

Do not use a double dose to make up for a missed dose. If you have any further doubts about using 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 effect of this medicine and quickly passes). 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 help immediately.Severe allergic reaction (anaphylactic shock), the symptoms of which may include difficulty breathing, chest pain, or a feeling of compression in the chest, and/or dizziness/fainting, severe itching of the skin, or hives on the skin, 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 the package 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: 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 this medicine.

5. How to store Benzydamine neo-angin forte

Keep the 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 refers to 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 package and other information

What Benzydamine neo-angin forte contains:

The active substance of the medicine is benzydamine hydrochloride. 1 ml of oral spray, solution contains 3 mg of benzydamine hydrochloride. One dose of the aerosol (0.17 ml) contains 0.51 mg of benzydamine hydrochloride. The other ingredients are: Glycerol 85% Ethanol 96% Macrogolglycerol hydroxystearate Methyl parahydroxybenzoate (E 218) Sodium saccharin (E 954) Sodium hydrogencarbonate (E 500) to adjust pH Cherry flavor Purified water

What Benzydamine neo-angin forte looks like and contents of the package

Benzydamine neo-angin forte is packaged in HDPE bottles with a dosing pump made of polyethylene containing 15 ml or 30 ml of cherry-flavored and scented solution. The whole thing is in a cardboard box. Package sizes: 88 doses (15 ml), 176 doses (30 ml) Not all package 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 Köln Germany

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

Austria: Med-angin 3 mg/ml Spray zur Anwendung in der Mundhöhle, Lösung Germany: neo-angin Benzydamin Spray forte gegen akute Halsschmerzen Czech Republic: Orocalm Forte, 3 mg/ml orální sprej, roztok Slovakia: Orocalm Forte, 3 mg/ml Orálna roztoková aerodisperzia Poland: Benzydamine neo-angin forte Belgium: Orocalm Forte, 3 mg/ml solution pour pulvérisation buccale / spray voor oromucosaal gebruik Date of last revision of the package leaflet:November 2023