Benzidamine neo-angin smak miodovo-pomaranihovi

Leaflet attached to the packaging: patient information

Benzydamine neo-angin honey-orange flavor, 3 mg, hard lozenges

Benzydamine hydrochloride

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken 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 the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement after 3 days or the patient feels worse, they should contact a doctor.

Table of contents of the leaflet

• 1. What is Benzydamine neo-angin honey-orange flavor and what is it used for
• 2. Important information before taking Benzydamine neo-angin honey-orange flavor
• 3. How to take Benzydamine neo-angin honey-orange flavor
• 4. Possible side effects
• 5. How to store Benzydamine neo-angin honey-orange flavor
• 6. Package contents and other information

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

what it is used for
Benzydamine neo-angin honey-orange flavor contains the active substance benzydamine hydrochloride, which belongs to non-steroidal anti-inflammatory drugs (NSAIDs).
Benzydamine neo-angin honey-orange flavor is used for the symptomatic local treatment of acute sore throat with accompanying typical symptoms of inflammation, such as pain, redness, or swelling in the mouth and throat.
Benzydamine neo-angin honey-orange flavor is indicated for use in adults, adolescents, and children over 6 years of age.
If there is no improvement after 3 days or the patient feels worse, they should contact a doctor.

2. Important information before taking Benzydamine neo-angin honey-orange flavor

honey-orange flavor

When not to take Benzydamine neo-angin honey-orange flavor

• 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 treatment with Benzydamine neo-angin honey-orange flavor, the patient should discuss it with their doctor or pharmacist:

• if the patient has an allergy to salicylates (e.g., acetylsalicylic acid and salicylic acid) or other medicines used to treat fever, pain, and inflammation (so-called NSAIDs).
• if the patient has asthma, as there is an increased risk of bronchospasm.
• if the patient has oral and throat ulcers, which may be a symptom of more serious diseases. If symptoms such as sore throat do not improve or worsen within 3 days, or the patient experiences severe pain, has a fever, or other symptoms, they should contact a doctor. Prolonged use of hard lozenges can rarely cause hypersensitivity to the active substance or excipients. If hypersensitivity occurs, treatment should be discontinued.

Benzydamine neo-angin honey-orange flavor and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.

Pregnancy

There are no data or only limited data on the use of benzydamine in pregnant women. Benzydamine neo-angin honey-orange flavor should not be used during pregnancy.

Breastfeeding

A risk to newborns and infants cannot be excluded. Benzydamine neo-angin honey-orange flavor 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 honey-orange flavor has no or negligible influence on the ability to drive and use machines.

Benzydamine neo-angin honey-orange flavor contains isomalt (E 953)

If the patient has intolerance to some sugars, they should consult their doctor before taking the medicine.

Benzydamine neo-angin honey-orange flavor contains aspartame (E 951)

This medicine contains 3.409 mg of aspartame (E 951) per lozenge. 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 its impaired excretion.

3. How to take Benzydamine neo-angin honey-orange flavor

This medicine should always be taken exactly as directed by a doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.

Dosage

The recommended dose is:
Adults and adolescents
1 lozenge 3 times a day. Do not exceed the recommended dose.
Children aged 6 to 11 years:
1 lozenge 3 times a day. Do not exceed the recommended dose.
The medicine should be used under adult supervision.
Children under 6 years of age:
Due to the pharmaceutical form, Benzydamine neo-angin honey-orange flavor should not be used in children under 6 years of age.
When treating with Benzydamine neo-angin honey-orange flavor, children must be able to suck the lozenge in a controlled manner.

Duration of treatment

Treatment should be limited to a maximum of 7 days. If there is no improvement after 3 days or symptoms worsen, the patient should contact a doctor.

Method of administration

The lozenge should be dissolved slowly in the mouth.
Lozenges should not be swallowed or chewed.

Taking a higher dose of Benzydamine neo-angin honey-orange flavor than recommended

In case of taking too many lozenges, the patient should immediately contact a doctor or pharmacist or go to the nearest hospital. In such cases, the patient should have the medicine packaging with them, regardless of whether there are still lozenges in it. Symptoms of overdose reported in children include agitation, convulsions, sweating, coordination disorders (ataxia), tremors, and vomiting. They occurred after oral administration of benzydamine doses about 100 times higher than those contained in one lozenge.

Missing a dose of Benzydamine neo-angin honey-orange flavor

The patient should not take a double dose to make up for a missed dose. The next dose should be taken at the usual time.
If the patient has any further doubts about taking this medicine, they should consult their 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):

• skin hypersensitivity to sunlight (phototoxicity) causing rash or sunburn.

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

• burning sensation,
• dry mouth.

Very rare(may affect up to 1 in 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).

Not known(frequency cannot be estimated from the available data):

• allergic reaction (hypersensitivity).
• If any of the following side effects occur, the patient should seek medical attention 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 hives,
• swelling of the face, lips, tongue, and/or throat, which can potentially be life-threatening,
• local numbness in the mouth and around the mouth (oral hypoesthesia).

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Medicinal Product Monitoring 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, it is possible to gather more information on the safety of this medicine.

5. How to store Benzydamine neo-angin honey-orange flavor

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after EXP.
The expiry date refers to the last day of the month.
There are no special precautions for storage temperature. Store in the original packaging to protect from light.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Benzydamine neo-angin honey-orange flavor contains

• The active substance is benzydamine hydrochloride. Each hard lozenge contains 3 mg of benzydamine hydrochloride (equivalent to 2.68 mg of benzydamine).
• The other ingredients are: isomalt (E 953), citric acid monohydrate, aspartame (E 951), peppermint essential oil, honey flavor, orange flavor, caramel ammonia (E 150c).

What Benzydamine neo-angin honey-orange flavor looks like and what the package contains

Brown-colored hard lozenges, round, approximately 19 mm in diameter.
The original packaging contains 8, 10, 12, 16, 20, 24, 30, 40, 48 hard lozenges in PVC/PVDC/aluminum blisters in a cardboard box.
Hospital packaging: 100 (5 x 20) hard lozenges.
Not all pack sizes may be marketed.

Marketing authorization 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 authorized in the Member States of the European Economic Area 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 flavor
Slovakia: Orocalm Med a Pomaranč
Date of last revision of the leaflet:December 2024