Benzydamine neo-angin forte

Patient Information Leaflet

Benzydamine neo-angin forte
3 mg/ml, oral spray, solution
Benzydamini hydrochloridum
Please read this leaflet carefully before using the medicine, as it contains important information for you.

• This medicine should always be used exactly as described in this leaflet or as directed by your doctor or pharmacist.
• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If there is no improvement after 3 days, or if you feel worse, you should contact your doctor.

Table of contents

1. What Benzydamine neo-angin forte is and what it is 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 pack and other information

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

Benzydamine neo-angin forte contains an active substance called benzydamine hydrochloride and belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs). It acts as a local analgesic and anti-inflammatory (anti-edematous) agent.
Benzydamine neo-angin forte is indicated for symptomatic local treatment of acute sore throat associated with typical inflammatory signs such as pain, redness, or swelling in the mouth and throat in adults.

2. Important information before using Benzydamine neo-angin forte

When not to use Benzydamine neo-angin forte

• If the patient is 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 the patient is allergic to salicylates (e.g. acetylsalicylic acid and salicylic acid) or other medicines with antipyretic, analgesic, and anti-inflammatory effects (so-called NSAIDs).
• If the patient currently has or has ever had bronchial asthma or allergic diseases, because there is an increased risk of bronchospasm or allergic reactions.

If an allergic reaction occurs, discontinue use of the medicine and contact a doctor or emergency department.
Ulceration of the mouth or throat may be a symptom of more serious diseases.
If symptoms do not improve after 3 days, or if the patient feels worse, has fever or other symptoms, contact a doctor.
Prolonged use of the medicine may have a harmful effect on the bacterial flora of the mouth and may cause irritation. In such cases, temporary discontinuation of the medicine and consultation with a doctor are necessary.
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 the patient is currently taking or has recently used, as well as any medicines the patient plans to take.
Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Pregnancy
Benzydamine neo-angin forte should not be used during pregnancy unless absolutely necessary and recommended by a doctor. If use is necessary, the lowest possible dose for the shortest possible duration should be used.
Breastfeeding
A risk to newborns/infants cannot be excluded. Benzydamine neo-angin forte should not be used during breastfeeding.
Fertility
There are no data on the effect of benzydamine on fertility in humans.
Driving and operating machinery
Benzydamine neo-angin forte has no effect or negligible effect on the ability to drive and operate machinery.
Benzydamine neo-angin forte contains 13.22 mg of alcohol (ethanol) in each dosage 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:
This medicine may cause allergic reactions (including delayed-type reactions) and, very rarely, bronchospasm.
Benzydamine neo-angin forte contains macrogolglycerol hydroxystearate
(derived from castor oil):
This medicine may cause gastrointestinal disturbances and diarrhoea.
Benzydamine neo-angin forte contains less than 1 mmol (23 mg) of sodium per dosage unit, meaning 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 patient leaflet or as directed by a
physician or pharmacist. If in doubt, consult a physician or pharmacist.
Benzydamine neo-angin forte is intended for use in the oral cavity 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 spray toward the affected area. Press the spray head with the index finger.

Before the first use of Benzydamine neo-angin forte, press the pump several times until a uniform spray is obtained.
Hold your breath while spraying the medicine.
Do not use this medicine immediately before eating or drinking.
Dosage:
Benzydamine neo-angin forte is usually administered 2 to 6 times daily (no more frequently than every 1.5–3 hours): 2 to 4 sprays per application.
Unless otherwise prescribed by a physician, elderly patients should use the recommended adult doses.
Use of more than the recommended dose of Benzydamine neo-angin forte
If too much medicine is used or if a large amount of Benzydamine neo-angin forte is accidentally swallowed, contact a physician or pharmacist immediately.
In case of overdose, vomiting may be induced as a first aid measure.
Missed dose of Benzydamine neo-angin forte
Do not use a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, consult your physician or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Not very common (may occur in up to 1 in 100 people):
Photosensitivity (skin becomes more sensitive than usual to sunlight, causing itchy, red, scaly rash, sometimes with blisters)
Rare (may occur in up to 1 in 1,000 people):
Itching and dry mouth.
Numbness of the mouth and throat (this is within the scope of action of this medicine and resolves quickly).
Nausea.
Vomiting.
Very rare (may occur in up to 1 in 10,000 people):
Breathing or swallowing difficulties (laryngospasm or bronchospasm)
Painful subcutaneous mucosal swelling (angioedema)
Frequency not known

• Allergic reactions (hypersensitivity)
• If any of the adverse reactions listed below occur, seek medical help immediately. Severe allergic reaction (anaphylactic shock), the symptoms of which may include difficulty breathing, chest pain or a feeling of pressure in the chest and (or) dizziness/fainting, severe skin itching or raised skin rashes, swelling of the face, lips, tongue and (or) throat, which

may potentially be life-threatening.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in the package leaflet, inform a doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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 on the safety of the medicine can be collected.

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 (EXP) refers to the last day of the stated month.
After first opening, do not use the medicinal product for longer than 6 months.
Medicines must not be disposed of via wastewater 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 Benzydamine neo-angin forte contains:
The active substance is benzylamine hydrochloride.
1 ml of oral spray solution contains 3 mg of benzylamine hydrochloride.
A single dose of the spray (0.17 ml) contains 0.51 mg of benzylamine hydrochloride.
The other ingredients are:
Glycerol 85%
Ethanol 96%
Macrogol glycerol hydroxystearate
Methyl 4-hydroxybenzoate (E 218)
Sodium saccharin (E 954)
Sodium bicarbonate (E 500) for pH adjustment
Cherry flavour
Purified water

What Benzydamine neo-angin forte looks like and contents of the pack
Benzydamine neo-angin forte is packed in HDPE bottles with a polyethylene metering pump, containing 15 ml or 30 ml of solution with cherry taste and odour. Complete with a cardboard carton.
Pack sizes: 88 doses (15 ml), 176 doses (30 ml)
Not all pack sizes may be marketed.

Marketing Authorisation Holder
M.C.M. Klosterfrau Healthcare Sp. z o.o.
Hrubieszowska 2
01-209 Warsaw
Poland

Manufacturer
Pharmex Advanced Laboratories S.L.
Ctra. A-431 Km. 19, Almodóvar del Río,
14720, Córdoba
Spain
Laboratorio 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 authorised in the European Economic Area member states 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