Benzidamine neo-angin smak citrinovi

Package Leaflet: Information for the Patient

Benzydamine neo-angin lemon flavor, 3 mg, hard tablets

Benzydamine hydrochloride

Read the package 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 package leaflet for the patient, or as directed by a doctor or pharmacist.

• This package leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any side effects not listed in this package leaflet, the doctor or pharmacist should be informed. See section 4.
• If there is no improvement after 3 days or the patient feels worse, a doctor should be consulted.

Table of Contents of the Package Leaflet

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

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

Benzydamine neo-angin lemon flavor contains the active substance benzydamine hydrochloride, belonging to non-steroidal anti-inflammatory drugs (NSAIDs). Benzydamine neo-angin lemon flavor is used for symptomatic local treatment of acute throat pain with accompanying typical symptoms of inflammation, such as pain, redness or swelling in the mouth and throat. Benzydamine neo-angin lemon 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, a doctor should be consulted.

2. Important information before taking Benzydamine neo-angin lemon flavor

When not to take Benzydamine neo-angin lemon 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 lemon flavor, the doctor or pharmacist should be consulted:

• 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 or has had asthma, as there is an increased risk of bronchospasm.

if the patient has an oral and throat ulcer that may be a symptom of a more serious disease. 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, a doctor should be consulted. Prolonged use of hard tablets can rarely cause hypersensitivity to the active substance or excipients. If hypersensitivity occurs, treatment should be discontinued.

• if the patient has an oral and throat ulcer that may be a symptom of a more serious disease. 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, a doctor should be consulted. Prolonged use of hard tablets can rarely cause hypersensitivity to the active substance or excipients. If hypersensitivity occurs, treatment should be discontinued.

Benzydamine neo-angin lemon flavor and other medicines

The doctor or pharmacist should be informed about all medicines the patient is 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, thinks she may be pregnant, or plans to have a child, she should consult a 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 lemon flavor should not be used during pregnancy.

Breastfeeding

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

Benzydamine neo-angin lemon flavor contains isomalt (E 953)

If the patient has been told by the doctor that they have an intolerance to some sugars, the doctor should be consulted before taking this medicine.

Benzydamine neo-angin lemon flavor contains aspartame (E 951)

This medicine contains 3.409 mg of aspartame (E 951) per tablet. 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 elimination.

3. How to take Benzydamine neo-angin lemon flavor

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

Dosage

The recommended dose is:
Adults and adolescents:
1 tablet 3 times a day. Do not exceed the recommended dose.
Children aged 6 to 11 years:
1 tablet 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 lemon flavor should not be used in children under 6 years of age.
When treating with Benzydamine neo-angin lemon flavor, 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 after 3 days or symptoms worsen, a doctor should be consulted.

Method of administration

The tablet should be dissolved slowly in the mouth.
The tablets should not be swallowed or chewed.

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

In case of taking too many tablets, a doctor or pharmacist should be consulted immediately or the nearest hospital should be visited. In such cases, the medicine packaging should be taken along, regardless of whether there are still tablets 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 approximately 100 times higher than contained in one tablet.

Missing a dose of Benzydamine neo-angin lemon flavor

A double dose should not be taken to make up for a missed dose. The next dose should be taken at the usual time.
In case of any further doubts about the use of this medicine, a doctor or pharmacist should be consulted.

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, medical attention should be sought 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 feeling of 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 side effects occur, including any side effects not listed in this package leaflet, the doctor or pharmacist should be informed. Side effects can be reported directly to the Department of Post-Marketing Surveillance 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.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Benzydamine neo-angin lemon flavor

The medicine should be stored out of sight and reach of children.
This medicine should not be used 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 storage precautions for this medicine. Store in the original packaging to protect from light.
Medicines should not be disposed of via wastewater or household waste. A pharmacist should be asked how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Benzydamine neo-angin lemon flavor contains

• The active substance is benzydamine hydrochloride. Each hard tablet 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), quinoline yellow (E 104), peppermint essential oil, lemon flavor.

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

Hard tablets are yellow, round, and approximately 19 mm in diameter.
The original packaging contains 8, 10, 12, 16, 20, 24, 30, 40, 48 hard tablets in PVC/PVDC/aluminum blisters in a cardboard box.
Hospital packaging: 100 (5 x 20) hard tablets.
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 Citron 3 mg pastilles/ Orocalm Citroensmaak 3 mg zuigtabletten/ Orocalm mit Zitronengeschmack 3 mg Lutschtabletten
Czech Republic: Orocalm Citron
Luxembourg: Orocalm goût Citron 3 mg pastilles/ Orocalm Citroensmaak 3 mg zuigtabletten/ Orocalm mit Zitronengeschmack 3 mg Lutschtabletten
Poland: Benzydamine neo-angin lemon flavor
Slovakia: Orocalm Citrón

Date of last revision of the package leaflet: