Benzydamine neo-angin

Package leaflet: Information for the patient

Benzydamine neo-angin
1.5 mg/ml, oral spray, solution
Benzydamini hydrochloridum
Please read all of this leaflet carefully before using the medicine, because 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 so that you can read it again if necessary.
• If you need advice or further information, please contact your pharmacist.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 3 days, or if your condition worsens, consult your doctor.

Table of contents

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

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

Benzydamine neo-angin 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 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 and children over 6 years of age.

2. Important information before using Benzydamine neo-angin

When not to use Benzydamine neo-angin

• 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, 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 action (so-called NSAIDs).
• If the patient has or has ever had bronchial asthma or allergic diseases, as 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.
Oral and pharyngeal ulceration may be a symptom of more serious diseases.
If symptoms persist after 3 days or the patient feels worse, or if the patient has fever or
other symptoms, consult a doctor.
Prolonged use of the medicine may have a harmful effect on the bacterial flora of the oral cavity and may
cause irritation. In such a case, temporary discontinuation is necessary and medical advice should be sought.
The duration of treatment should not exceed 7 days.
Avoid contact of the medicine with the eyes.
Children
Use of Benzydamine neo-angin is not recommended in children who are unable to hold their breath
during aerosol administration.
Benzydamine neo-angin and 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 take.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Pregnancy
Do not use Benzydamine neo-angin 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 should not
be used during breastfeeding.
Fertility
There are no data on the effect of benzydamine on human fertility.
Driving and operating machinery
Benzydamine neo-angin has no effect or has a negligible effect on the ability to drive
and operate machinery.
Benzydamine neo-angin contains 13.22 mg of alcohol (ethanol) per dose

• 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 (delayed-type reactions possible) and, exceptionally, bronchospasm.
Benzydamine neo-angin contains macrogol glycerol hydroxystearate (derived from castor oil):
The medicine may cause gastrointestinal discomfort and diarrhoea.
Benzydamine neo-angin contains less than 1 mmol (23 mg) of sodium per dose, meaning 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 information leaflet, or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist. Benzydamine neo-angin 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. Place the nozzle into the mouth and direct the spray toward the affected area. Press the spray head with the index finger.

Before first use of Benzydamine neo-angin, press the spray button several times until a uniform mist is obtained.
During spraying, hold your breath.
Children: Do not use in children who are unable to hold their breath while using the spray.
Do not use this medicine immediately before eating or drinking.

Dosage:
Benzydamine neo-angin is usually used 2 to 6 times daily (no more frequently than every 1.5–3 hours):
For adults and children over 12 years of age, spray 4 to 8 doses per application. For children aged 6 to 12 years, spray 4 doses per application.
Unless otherwise prescribed by a doctor, elderly patients should use the adult dose.

Use of more than the recommended dose of Benzydamine neo-angin
If too much medicine is used or if a large amount of Benzydamine neo-angin is accidentally swallowed, contact your doctor or pharmacist immediately.
In case of overdose, vomiting may be induced as first aid.

Missed dose of Benzydamine neo-angin
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 doctor or pharmacist.

4. Possible adverse effects

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

• Allergic reactions (hypersensitivity)
• If any of the adverse effects 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, intense skin itching or raised skin rashes, swelling of the face, lips, tongue and (or) throat, which may potentially be life-threatening.

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse effects 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 effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps provide more information on the safety of the medicine.

5. How to store Benzydamine neo-angin

Keep this medicine out of 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 the medicinal product, do not use 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 required. Such measures help protect the environment.

6. Contents of the package 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 spray dose (0.17 ml) contains 0.255 mg of benzydamine hydrochloride.

Other ingredients are:
Glycerol 85%
Ethanol 96%
Macrogol glycerol hydroxystearate
Methyl 4-hydroxybenzoate (E 218)
Sodium saccharin (E 954)
Sodium hydrogen carbonate (E 500) for pH adjustment
Cherry flavour
Purified water

What Benzydamine neo-angin looks like and contents of the pack
Benzydamine neo-angin is packed in HDPE bottles with a polyethylene metering pump, containing 15 ml, 30 ml or 60 ml of cherry-flavoured solution. The pack consists of a cardboard box containing the bottle.

Pack sizes: 88 doses (15 ml), 176 doses (30 ml), 352 doses (60 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 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 orální sprej, roztok
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