BENZYDAMINE NEO-ANGIN LEMON FLAVOR

Patient Information Leaflet

Benzydamine neo-angin lemon flavour, 3 mg, hard lozenges
Benzydamini hydrochloridum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
This medicine should always be used exactly as described in this patient 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 adverse 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.

Contents of the leaflet

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

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

Benzydamine neo-angin lemon flavour contains the active substance benzydamine hydrochloride,
which belongs to the group of non-steroidal anti-inflammatory drugs (NSAIDs).
Benzydamine neo-angin lemon flavour is used for local symptomatic treatment of acute sore throat
accompanied by typical inflammatory signs such as pain, redness, or swelling in the mouth and throat.
Benzydamine neo-angin lemon flavour is indicated for use in adults, adolescents, and children aged
6 years and older.
If there is no improvement after 3 days, or if you feel worse, you should contact your doctor.

2. Important information before using Benzydamine neo-angin lemon flavour

When not to use Benzydamine neo-angin lemon flavour

• if the patient is allergic to benzydamine hydrochloride or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting to use Benzydamine neo-angin lemon flavour, consult 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 inflammation (so-called NSAIDs).
• if the patient has or has ever had bronchial asthma, as there is an increased risk of bronchospasm.
• if the patient develops ulceration of the mouth or throat, which may be a sign of more serious underlying disease. If symptoms such as sore throat do not improve or worsen within 3 days, or if the patient experiences particularly severe pain, fever or other symptoms, medical advice should be sought. Prolonged use of hard pastilles may rarely lead to hypersensitivity to the active substance or excipients. If hypersensitivity occurs, treatment should be discontinued.

Children and adolescents
Benzydamine neo-angin lemon flavour is not intended for children under 6 years of age.
Benzydamine neo-angin lemon flavour and other medicines
Inform 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 have a child, she should consult a doctor or pharmacist before using this medicine.
Pregnancy
Benzydamine neo-angin lemon 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 lemon 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 lemon flavour has no effect or negligible effect on the ability to drive and operate machinery.
Benzydamine neo-angin lemon 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 lemon flavour contains aspartame (E 951)
This medicine contains 3.409 mg of aspartame (E 951) per 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 lemon flavour contains a flavouring agent containing limonene
(contained in peppermint essential oil). Limonene may cause allergic reactions.

3. How to use Benzydamine neo-angin lemon flavour

This medicine should always be used as directed by a doctor or pharmacist. If in doubt,
consult a 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 supervision of an adult.
Children under 6 years of age:
Due to the pharmaceutical form, Benzydamine neo-angin lemon flavour should not be
used in children under 6 years of age.
When treating with Benzydamine neo-angin lemon 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
symptoms worsen, consult a doctor.
Method of administration
The tablet should be slowly dissolved in the mouth.
Do not swallow or chew the tablets.
Use of more than the recommended dose of Benzydamine neo-angin lemon flavour
If too many tablets have been taken, contact a doctor or pharmacist immediately or go to the nearest hospital. In such cases, take the medicine packaging along, regardless of whether any tablets remain. Symptoms of overdose observed in children include agitation, seizures, sweating, coordination disturbances (ataxia), tremor and vomiting. These occurred after oral intake of benzydamine doses approximately 100 times higher than the amount contained in one tablet.
Missed dose of Benzydamine neo-angin lemon 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 effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

Not common (may occur in 1 out of 100 people):

• increased sensitivity of the skin to sunlight (photosensitivity) causing 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),
• breathing difficulties (laryngeal or bronchial spasm).

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

• allergic reaction (hypersensitivity).

• If any of the following adverse effects occur, seek immediate medical help. A serious allergic reaction (anaphylactic shock), the symptoms of which may include:

• difficulty breathing,

• chest pain or tightness 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 paraesthesia).

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

5. How to store Benzydamine neo-angin smak cytrynowy

Keep the 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.
There are no special storage temperature requirements for this medicine. Store in the
original packaging to protect from light.
Medicines must not be disposed of via the sewage system or household waste. Ask your
pharmacist how to dispose of medicines no longer required. These measures will help
protect the environment.

6. Contents of the pack and other information

What Benzydamine neo-angin lemon flavour contains

• The active substance is benzidamine hydrochloride. Each hard pastille contains 3 mg of benzidamine hydrochloride (equivalent to 2.68 mg of benzidamine).
• Other ingredients are: isomalt (E 953), citric acid monohydrate, aspartame (E 951), quinoline yellow (E 104), peppermint essential oil (contains limonene), lemon flavour.

What Benzydamine neo-angin lemon flavour looks like and contents of the pack
Yellow, 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 (5 x 20) hard pastilles.
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 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 smak cytrynowy
Slovakia: Orocalm Citrón