Nagardlan

Package Leaflet: Information for the User

Nagardlan

1.5 mg/mL, oral spray, solution

For adults, adolescents, and children from 2 years of age and weighing at least 4 kg

Benzydamine hydrochloride

Read all of this leaflet carefully before using this medicine because it contains important information for you.

This medicine must always be used exactly as described in this leaflet for the patient or as directed by your doctor or pharmacist.

• You should keep this leaflet, you may need to read it again.
• If you have any further questions, ask your pharmacist.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
• If after 3 days there is no improvement or you feel worse, you should contact your doctor.

Contents of the pack

• 1. What is Nagardlan and what is it used for
• 2. Before you use Nagardlan
• 3. How to use Nagardlan
• 4. Possible side effects
• 5. How to store Nagardlan
• 6. Contents of the pack and other information

1. What is Nagardlan and what is it used for

Nagardlan contains the active substance benzydamine hydrochloride and is an anti-inflammatory for use in the mouth and throat. Nagardlan is used for the symptomatic treatment of pain and inflammation of the mouth and throat in adults, adolescents, and children from 2 years of age and weighing at least 4 kg (see section 2). Nagardlan is a ready-to-use spray and is applied directly to the mouth and throat. If after 3 days there is no improvement or you feel worse, you should contact your doctor.

2. Before you use Nagardlan

When not to use Nagardlan

If you are allergic to benzydamine hydrochloride or any of the other ingredients of this medicine (listed in section 6). Nagardlan must not be used in children under 2 years of age because the medicine contains peppermint flavor.

Warnings and precautions

Before using Nagardlan, you should discuss it with your doctor or pharmacist. Benzydamine hydrochloride is not recommended in patients with hypersensitivity to salicylic acid or other painkillers called NSAIDs (non-steroidal anti-inflammatory drugs). Nagardlan should be used with caution in patients with a history of asthma, as it may cause bronchospasm. The use of this medicine, especially for a long time, may cause an allergic reaction. If this happens, the medicine should be discontinued and you should contact your doctor. If the pain in the mouth and throat worsens or does not improve within 3 days, you should contact your dentist or doctor. Long-term use of the medicine may affect the bacterial flora in the mouth.

Children and adolescents

Nagardlan must not be used in children under 2 years of age due to the lack of sufficient data on safety and efficacy in this age group.

Nagardlan and other medicines

You should tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take. There are no known interactions between Nagardlan and other medicines.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. Nagardlan should only be used during pregnancy and breastfeeding if your doctor considers it necessary.

Driving and using machines

Nagardlan has no or negligible influence on the ability to drive and use machines. Nagardlan contains methyl parahydroxybenzoate. This medicine contains 1 mg/mL methyl parahydroxybenzoate. Methyl parahydroxybenzoate may cause allergic reactions (which may be delayed). The medicine also contains ethanol (see section 2).

Nagardlan contains alcohol (ethanol)

This medicinal product contains 14.22 mg of alcohol (ethanol) in each dose (spray), which is 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 have a noticeable effect.

Nagardlan contains sodium

Nagardlan contains less than 1 mmol of sodium (23 mg) per dose (spray), which means the medicine is essentially sodium-free.

Nagardlan contains peppermint flavor

Peppermint flavor may cause hypersensitivity reactions (including dyspnea) in sensitive patients.

3. How to use Nagardlan

This medicine must always be used exactly as described in this leaflet for the patient or as directed by your doctor or pharmacist. If you are unsure, you should ask your doctor or pharmacist. Dosage Nagardlan is usually used 2 to 6 times a day.

Adults and adolescents from 12 years of age

Each time 4 to 8 doses (sprays).

Children from 6 to 11 years of age

4 doses (sprays)

Children from 2 to 5 years of age and weighing at least 4 kg

1 dose (spray) per 4 kg of body weight, up to a maximum of 4 sprays.

Elderly patients

Unless your dentist or doctor has told you otherwise, you should use the same dose as for adults. Method of administration For use on the mucous membrane of the mouth. Instructions for use Before the first use of Nagardlan, you should attach the supplied applicator to the spray pump and leave it in place. Before the first use, you should press the spray pump twice to ensure a uniform spray during subsequent use. The spray can be applied directly to the mouth and throat but should not be swallowed. Duration of treatment In most cases, treatment of acute inflammatory symptoms with Nagardlan only lasts a few days.

Using more than the recommended dose of Nagardlan

Accidental ingestion of a small amount of medicine is not harmful. If you swallow more than the recommended dose or accidentally swallow a large amount of medicine, you should contact your doctor or pharmacist immediately. In case of incorrect use (i.e., swallowing a larger amount of Nagardlan), side effects such as vomiting, stomach pain, sleep disturbances, restlessness, anxiety, convulsions, ataxia, fever, tachycardia, and possible respiratory disorders may occur.

Missing a dose of Nagardlan

If you use less than the recommended dose of Nagardlan, the time to onset of action may be longer. However, in this case, the treatment may also not be effective. If you forget to use Nagardlan once, you should continue the treatment as directed, without increasing the frequency of use or dose of the medicine.

Stopping the use of Nagardlan

If you stop using Nagardlan or stop using it too early, the desired effect may not be achieved, or your condition may worsen again. You should contact your doctor or pharmacist if you want to stop the treatment or stop using the medicine too early. If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Nagardlan can cause side effects, although not everybody gets them. Uncommon(may affect up to 1 in 100 people)

• Redness or sunburn due to skin hypersensitivity to sunlight.

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

• Burning sensation in the mouth and dry mouth. If you experience this side effect, you should drink a glass of water to reduce it.

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

• Sudden swelling of the mouth and throat or mucous membrane (angioedema).
• Difficulty breathing (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: difficulty breathing (shortness of breath), chest pain, tightness in the chest, dizziness, weakness, severe itching of the skin, palpable skin nodules, swelling of the face, lips, tongue, and/or throat, which may potentially be life-threatening.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in the contact details below. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Nagardlan

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiry date refers to the last day of that month. There are no special storage conditions for this medicine. After first opening, the medicine should be used within 3 months. Medicines should not be disposed of via wastewater 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 Nagardlan contains

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

• The other ingredients are: methyl parahydroxybenzoate (E 218), ethanol (96%), glycerol (85%), sodium hydrocarbonate, hydrochloric acid, concentrated (for pH adjustment), polysorbate 20, sodium saccharin (E 954), purified water, peppermint flavor, 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 smell. The spray pump is made of LDPE/POM/PP/EVA/stainless steel, with a PP cap and a PP/POM applicator, in a cardboard box. Nagardlan is available in bottles containing 30 mL of solution. Each bottle of 30 mL contains 166 doses (sprays).

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Aristo Pharma Sp. z o.o.
ul. Baletowa 30
02-867 Warszawa
tel.: +48 22 855 40 93

Manufacturer

Aristo Pharma GmbH
Wallenroder Strasse 8-10
13435 Berlin
Germany

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Germany
Tonsino
Italy
Tonsino
Poland
Nagardlan

Date of last revision of the leaflet: