Benzydamine neo-angin honey-orange flavour

Patient Information Leaflet

Benzydamine neo-angin honey-orange flavour, 3 mg, hard pastilles
Benzydamini hydrochloridum
Please read this leaflet carefully before using the medicine, as it contains important information for you.
Always use this medicine exactly as described in this patient leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, please contact your pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 3 days, or if you feel worse, consult your doctor.

Leaflet Contents

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

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

Benzydamine neo-angin honey-orange flavour contains the active substance benzydamine hydrochloride, which belongs to the group of non-steroidal anti-inflammatory drugs (NSAIDs).

Benzydamine neo-angin honey-orange flavour is used for symptomatic local treatment of acute sore throat associated with typical signs of inflammation such as pain, redness or swelling in the mouth and throat.

Benzydamine neo-angin honey-orange flavour is indicated for use in adults, adolescents and children above 6 years of age.

If there is no improvement after 3 days, or if you feel worse, consult your doctor.

2. Important information before using Benzydamine neo-angin honey-orange flavour

When not to use Benzydamine neo-angin honey-orange flavour

• 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 honey-orange flavour, discuss this with a doctor or pharmacist:

• if the patient is allergic to salicylates (e.g. acetylsalicylic acid and salicylic acid) or other medicines used to treat fever, pain and inflammatory conditions (so-called NSAIDs).
• if the patient has bronchial asthma or has ever had it, as there is an increased risk of bronchospasm.
• if the patient develops an ulceration of the mouth or throat, which may be a sign of a more serious underlying disease. If symptoms such as sore throat do not improve or worsen within 3 days, or if the patient experiences severe pain, fever or other symptoms, medical advice should be sought. Prolonged use of hard pastilles may rarely cause hypersensitivity to the active substance or excipients. If hypersensitivity occurs, treatment should be discontinued.

Children and adolescents
Benzydamine neo-angin honey-orange flavour is not intended for children under 6 years of age.
Interaction of Benzydamine neo-angin honey-orange flavour with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or 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
Benzydamine neo-angin honey-orange flavour should not be used during pregnancy unless absolutely necessary and recommended by a doctor. If use is necessary, the lowest possible dose should be used for the shortest possible duration.
Breastfeeding
A risk to newborns and infants cannot be excluded. Benzydamine neo-angin honey-orange flavour should not be used during breastfeeding.
Fertility
There is no data available on the effect of benzydamine on fertility in humans.
Driving and operating machinery
Benzydamine neo-angin honey-orange flavour has no effect or has a negligible effect on the ability to drive and operate machinery.
Benzydamine neo-angin honey-orange flavour contains isomalt (E 953)
If the patient has been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
Benzydamine neo-angin honey-orange flavour contains aspartame (E 951)
This medicine contains 3.409 mg of aspartame (E 951) in each hard pastille. Aspartame (E 951) is a source of phenylalanine. It may be harmful to patients with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to impaired excretion.
Benzydamine neo-angin honey-orange flavour contains a flavouring agent containing
limonene (contained in peppermint essential oil). Limonene may cause allergic reactions.

3. How to use Benzydamine neo-angin honey-orange flavour

This medicine should always be used according to the instructions provided by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
Dosage
The recommended dose is:
Adults and adolescents aged 12 years and older:
1 tablet 3 times daily. Do not exceed the recommended dose.
Use in children
Children aged 6 to 11 years:
1 tablet 3 times daily. Do not exceed the recommended dose.
The medicine should be used under the supervision of an adult.
Children under 6 years of age:
Due to the pharmaceutical form, Benzydamine neo-angin honey-orange flavour should not be used in children under 6 years of age.
When treating with Benzydamine neo-angin honey-orange flavour, children must be able to suck the tablet in a controlled manner.
Duration of treatment
Treatment should be limited to a maximum of 7 days. If there is no improvement within 3 days or if symptoms worsen, consult your doctor.
Method of administration
The tablet should be slowly dissolved in the mouth.
Do not swallow or chew the tablets.
Use of a higher than recommended dose of Benzydamine neo-angin honey-orange flavour
If too many tablets have been taken, seek immediate medical advice from a doctor or pharmacist or go to the nearest hospital. In such cases, bring the medicine packaging with you, regardless of whether any tablets remain. Symptoms of overdose observed in children include excitement, seizures, sweating, movement coordination disorders (ataxia), tremor and vomiting. These symptoms occurred after oral intake of benzydamine doses approximately 100 times higher than the amount contained in one tablet.
Missed dose of Benzydamine neo-angin honey-orange flavour
Do not take a double dose to make up for a missed dose. Take the next dose at the usual time.
If you have any further questions about the use of this medicine, consult your doctor 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 1 out of 100 people):

• increased sensitivity of the skin to sunlight (photosensitivity) leading to rash or sunburn.

Rare (may occur in 1 out of 1,000 people):

• burning sensation,
• dryness of the mouth.

Very rare (may occur in 1 out of 10,000 people):

• symptoms such as difficulty breathing or swallowing,
• rash, itching, hives,
• swelling of the face, hands and feet, eyes, lips and/or tongue, dizziness (angioedema),
• difficulty breathing (laryngeal or bronchial spasm).

Unknown (frequency cannot be estimated from the available data):

• allergic reaction (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 feeling of pressure in the chest and (or) dizziness/fainting,
• severe itching of the skin or raised lumps on the skin,
• swelling of the face, lips, tongue and (or) throat, which may potentially be life-threatening,
• local loss of sensation in the mouth and around the mouth (oral hypoaesthesia).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. 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.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Benzydamine neo-angin smak miodowo-pomarańczowy

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 pack following EXP.
The expiry date refers to the last day of the stated month.
No special temperature storage conditions are required. Store in the original packaging to protect from light.
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 honey-orange flavour contains

• The active substance is benzylamine hydrochloride. Each hard pastille contains 3 mg of benzylamine hydrochloride (corresponding to 2.68 mg of benzylamine).
• Other ingredients are: isomalt (E 953), citric acid monohydrate, aspartame (E 951), peppermint essential oil (contains limonene), honey flavour, orange flavour, ammonium caramel (E 150c).

What Benzydamine neo-angin honey-orange flavour looks like and contents of the pack
Packaging
Brown, round hard pastilles, approximately 19 mm in diameter.
The original packaging contains 8, 10, 12, 16, 20, 24, 30, 40, or 48 hard pastilles in PVC/PVDC/aluminium foil blisters, packed in a cardboard box.
Hospital pack: 100 hard pastilles (5 x 20).
Not all pack sizes may be marketed.
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
12277 Berlin
Germany
This medicinal product is authorised in the European Economic Area countries under the following names:
Belgium: Orocalm goût Miel et Orange 3 mg pastilles / Orocalm Honing- en Sinaasappelsmaak 3 mg zuigtabletten / Orocalm mit Honig- und Orangengeschmack 3 mg Lutschtabletten
Czech Republic: Orocalm Med a Pomeranč
Luxembourg: Orocalm goût Miel et Orange 3 mg pastilles / Orocalm Honing- en Sinaasappelsmaak 3 mg zuigtabletten / Orocalm mit Honig- und Orangengeschmack 3 mg Lutschtabletten
Poland: Benzydamine neo-angin honey-orange flavour
Slovakia: Orocalm Med a Pomaranč