Patient Information Leaflet

Nagardlan
1.5 mg/mL, oral spray, solution
For adults, adolescents and children aged 2 years and older with body weight of at least 4 kg
Benzydamini hydrochloridum
Please read this leaflet carefully before using the medicine, as 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
physician or pharmacist.

Keep this leaflet, as you may need to read it again.
If you need advice or further information, please consult your pharmacist.
If the patient experiences any adverse reactions, including any not listed in this leaflet, inform a physician or pharmacist. See section 4.
If there is no improvement after 3 days, or if the patient feels worse, consult a physician.

Table of contents

What Nagardlan is and what it is used for
Important information before using Nagardlan
How to use Nagardlan
Possible side effects
How to store Nagardlan
Contents of the pack and other information

1. What Nagardlan is and what it is used for

Nagardlan contains the active substance benzydamine hydrochloride and is an anti-inflammatory agent for use in the mouth and throat.
Nagardlan is used for the symptomatic treatment of pain and inflammation in the mouth and throat in adults, adolescents and children aged 2 years and older with body weight of at least 4 kg (see section 2).
Nagardlan is a ready-to-use spray and is applied directly into the mouth and throat.
If there is no improvement after 3 days, or if the patient feels worse, consult a physician.

2. Important information before using Nagardlan

When not to use Nagardlan
Do not use Nagardlan if the patient is allergic to benzidamine hydrochloride or any of the other
components of this medicine (listed in section 6).
Nagardlan must not be used in children under 2 years of age, because the product contains
peppermint flavour.

Warnings and precautions
Before starting treatment with Nagardlan, consult a doctor or pharmacist.
The use of benzidamine hydrochloride is not recommended in patients with hypersensitivity to
salicylic acid or other pain-relieving medicines known as NSAIDs (non-steroidal anti-inflammatory drugs).
Nagardlan should be used with caution in patients with a history of asthma, as bronchospasm may occur.
The use of this medicine, especially long-term, may lead to sensitization. If this occurs, the medicine should be discontinued and the patient should contact a doctor.
If pain in the mouth and throat worsens or does not improve within 3 days, the patient should contact a dentist or physician.
Prolonged use of the medicine may affect the bacterial flora of the oral cavity.

Children and adolescents
Nagardlan must not be used in children under 2 years of age due to insufficient data on safety and efficacy in this age group.

Nagardlan with other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned to be used.
No interactions between Nagardlan and other medicines are known.

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.
Nagardlan should not be used 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 applied.

Driving and operating machinery
Nagardlan has no effect or has a negligible effect on the ability to drive and operate machinery.

Nagardlan contains methyl parahydroxybenzoate
This medicine contains 1 mg/mL of methyl parahydroxybenzoate. Methyl parahydroxybenzoate
may cause allergic reactions (including delayed-type reactions).

Nagardlan contains alcohol (ethanol)
This medicinal product contains 14.22 mg of alcohol (ethanol) per dose (spray), equivalent to 82.20 mg/mL of solution (8% w/w).
The amount of alcohol in one dose of this medicine is equivalent to less than 1 ml of beer or 1 ml of wine.
The small amount of alcohol in this medicine will not cause noticeable effects.

Nagardlan contains sodium
Nagardlan contains less than 1 mmol of sodium (23 mg) per dose (spray), meaning the medicine is considered "sodium-free".

Nagardlan contains peppermint flavour
Peppermint flavour may cause hypersensitivity reactions (including dyspnoea) in sensitized patients.

3. How to use Nagardlan

This medicine should always be used exactly as described in this patient leaflet or as directed by
a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Dosage
Nagardlan is usually administered 2 to 6 times daily.
Adults and adolescents aged 12 years and older
4 to 8 doses (sprays) per administration.
Children aged 6 to 11 years
4 doses (sprays).
Children aged 2 to 5 years weighing at least 4 kg
1 dose (spray) per 4 kg of body weight, up to a maximum of 4 sprays.
Elderly patients
Unless otherwise advised by a dentist or doctor, the dosage should be the same as for adults.
Method of administration
For application to the oral mucosa.
Instructions for use
Before first use of Nagardlan, attach the provided throat applicator to the pump and leave it attached.
Before first use, press the spray pump twice to prime the device and ensure a consistent mist during subsequent dosing.
The aerosol may be used directly into the mouth and throat, but should not be swallowed.
Duration of treatment
In the vast majority of cases, treatment of acute inflammatory symptoms with Nagardlan lasts only a few days.
Use of a higher than recommended dose of Nagardlan
Accidental swallowing of a small amount of the medicine is not harmful.
If a large amount of the medicine is swallowed accidentally or in excess, contact a doctor or pharmacist immediately.
In case of incorrect use (i.e. swallowing excessive amounts of Nagardlan), adverse effects may occur such as: vomiting, abdominal pain, sleep disturbances, restlessness, anxiety, seizures, ataxia, fever, tachycardia, and potentially respiratory center dysfunction.
Missed dose of Nagardlan
If a patient uses a lower than recommended dose of Nagardlan, the onset of action may be delayed. In this case, treatment may also be ineffective.
If a patient forgets to use Nagardlan once, continue treatment as recommended, without increasing the frequency or dose.
Stopping the use of Nagardlan
If a patient stops treatment with Nagardlan or discontinues use prematurely, the desired effect may not be achieved, or the patient's condition may worsen again. Consult a doctor or pharmacist if the patient wishes to discontinue or stop treatment early.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Not common (may affect up to 1 in 100 patients)

Redness or sunburn caused by skin hypersensitivity to sunlight.

Rare (may affect up to 1 in 1,000 patients)

Burning sensation in the mouth and dry mouth. If this side effect occurs, drink a glass of water to help reduce it.

Very rare (may affect up to 1 in 10,000 patients)

Sudden swelling of the mouth, throat or mucous membranes (angioedema).
Breathing difficulties (laryngospasm).

Frequency not known (frequency cannot be estimated from the available data)

Allergic reactions (hypersensitivity reactions).

Symptoms of a severe allergic reaction (anaphylactic shock) may include: shortness of breath
(difficulty breathing), chest pain, chest tightness, dizziness, feeling of weakness, intense itching,
skin hives, swelling of the face, lips, tongue and (or) throat, which may potentially be life-threatening.

Reporting of side effects

If any side effects occur, including any side effects not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can also be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C,
02-222 Warsaw,
tel.: 22 49-21-301,
fax: 22 49-21-309.
Website: https://smz.ezdrowie.gov.pl

Side effects can also be reported to the Marketing Authorisation Holder.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Nagardlan

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label of the bottle and carton after: "EXP". The expiry date refers to the last day of the stated month.
No special storage instructions apply.
After first opening, the medicine should be used within 3 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 will help protect the environment.

6. Contents of the package and other information

What Nagardlan contains
The active substance is benzidamine hydrochloride. 1 mL of solution contains 1.5 mg of benzidamine hydrochloride. One dose (spray) delivers 0.18 mL ± 0.01 mL of solution containing 0.269 mg of benzidamine hydrochloride.

Other ingredients include: methyl parahydroxybenzoate (E 218), ethanol (96%), glycerol (85%), sodium hydrogen carbonate, hydrochloric acid, concentrated (for pH adjustment), polysorbate 20, sodium saccharin (E 954), purified water, peppermint flavour, quinoline yellow (E 104), patent blue V (E 131).

What Nagardlan looks like and contents of the pack
Nagardlan is a clear green solution with a characteristic peppermint taste and odour.
The bottle is made of colourless type III glass with a dosing pump made of LDPE/POM/PP/EVA/stainless steel, a PP cap, and a PP/POM applicator, all contained in a cardboard box.
Nagardlan is available in bottles containing 30 mL of solution.
Each 30 mL bottle contains 166 doses (sprays).

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Aristo Pharma Sp. z o.o.
Baletowa 30
02-867 Warsaw
Tel.: +48 22 855 40 93

Manufacturer
Aristo Pharma GmbH
Wallenroder Strasse 8-10
13435 Berlin
Germany

This medicinal product is authorised in the European Economic Area under the following names:
Germany Tonsino
Italy Tonsino
Poland Nagardlan