Nagardlan

Package Leaflet: Information for the User

Nagardlan

1.5 mg/mL, Solution for Oral Use

Benzydamine Hydrochloride

Read the Package Leaflet Carefully Before Using the Medication, as it Contains Important Information for the Patient.

This Medication Should Always be Used Exactly as Described in this Package Leaflet for the Patient or as Advised by a Doctor or Pharmacist.

• Keep this Package Leaflet, You May Need to Read it Again.
• If You Need Advice or Further Information, Consult a Pharmacist.
• If You Experience any Side Effects, Including those not Listed in this Package Leaflet, Tell Your Doctor or Pharmacist. See Section 4.
• If There is no Improvement or if You Feel Worse after 3 Days, Consult a Doctor.

Package Leaflet Contents

• 1. What is Nagardlan and What is it Used for
• 2. Important Information Before Using Nagardlan
• 3. How to Use Nagardlan
• 4. Possible Side Effects
• 5. How to Store Nagardlan
• 6. Package Contents and Other Information

1. What is Nagardlan and What is it Used for

Nagardlan Contains an Anti-Inflammatory Substance for Use in the Mouth and Throat.
Nagardlan Contains Benzydamine Hydrochloride, Which is Used for the Symptomatic Treatment of Pain and Irritation in the Mouth and Throat.
Nagardlan is Used for the Symptomatic Treatment of Pain and Inflammation of the Mouth and Throat in Adults and Adolescents Aged 12 Years and Older.
Nagardlan is a Ready-to-Use Solution and is Used Undiluted for Rinsing the Mouth and Throat. In Most Cases, Treatment with Nagardlan for Acute Symptoms of Inflammation Lasts Only a Few Days.
If There is no Improvement or if You Feel Worse after 3 Days, Consult a Doctor.

2. Important Information Before Using Nagardlan

When Not to Use Nagardlan

• If You are Allergic to Benzydamine Hydrochloride or any of the Other Ingredients of this Medication (Listed in Section 6). Nagardlan Solution Should not be Used in Children Under 12 Years of Age.

Warnings and Precautions

Before Starting to Use Nagardlan or if You Experience any of the Following Symptoms, Consult a Doctor or Pharmacist.
Using this Medication, Especially for a Long Time, may Cause Allergic Reactions. If this Happens or if You Experience any of the Listed Side Effects, Stop Using the Medication and Consult a Doctor.
Nagardlan Should be Used with Caution in Patients with a History of Asthma, as it may Cause Bronchospasm.
If Mouth and Throat Pain Worsens or Does not Improve Within 3 Days, You Should Consult a Dentist or Doctor.
Prolonged Use of the Medication may Affect the Bacterial Flora in the Mouth.
Benzydamine Hydrochloride is not Recommended for Patients with Hypersensitivity to Salicylic Acid or Other Painkillers Called NSAIDs (Non-Steroidal Anti-Inflammatory Drugs).

Children and Adolescents

Nagardlan Should not be Used in Children Under 12 Years of Age Due to Concerns About Safety and Efficacy.

Nagardlan and Other Medications

Tell Your Doctor or Pharmacist About all Medications You are Currently Taking or Have Recently Taken, as well as any Medications You Plan to Take.
No Interactions Between Nagardlan and Other Medications are Known.

Pregnancy, Breastfeeding, and Fertility

If You are Pregnant or Breastfeeding, Think You may be Pregnant or are Planning to Have a Baby, Consult a Doctor or Pharmacist Before Using this Medication.
The Doctor Will Decide Whether You Should Use Nagardlan.

Driving and Using Machines

Nagardlan Does not Affect the Ability to Drive or Use Machines.
Nagardlan Contains Methyl Parahydroxybenzoate.
This Medication Contains 1 mg/mL of Methyl Parahydroxybenzoate. Methyl Parahydroxybenzoate may Cause Allergic Reactions (Possible Late Reactions).

Nagardlan Contains Alcohol (Ethanol)

This Medicinal Product Contains 1.233 mg of Alcohol per 15 mL Dose, Which is Equivalent to 82.20 mg/mL of Solution (8% w/w).
The Amount of Alcohol in one Dose of this Medication is Equivalent to 100 mL of Beer or 13 mL of Wine.
The Amount of Alcohol in this Medication is Unlikely to Have an Effect on Adults and Adolescents, and its Effect in Children is Likely to be Minimal. It may Cause Some Effect in Younger Children, such as Drowsiness.
The Alcohol in this Medication may Affect the Way Other Medications Work. You Should Tell Your Doctor or Pharmacist if You are Taking Other Medications.
If You are Pregnant or Breastfeeding, You Should Consult a Doctor Before Using this Medication.
If You are Alcohol Dependent, You Should Consult a Doctor Before Using this Medication.

Nagardlan Contains Sodium

Nagardlan Contains Less than 1 mmol of Sodium (23 mg) per Dose (Spray), Which Means the Medication is Considered "Sodium-Free".

Nagardlan Contains Peppermint Flavor

Peppermint Flavor may Cause Hypersensitivity Reactions (Including Dyspnea) in Allergic Patients.

3. How to Use Nagardlan

This Medication Should Always be Used Exactly as Described in this Package Leaflet for the Patient or as Advised by a Doctor or Pharmacist. If You are in Doubt, Consult a Doctor or Pharmacist.

Adults and Adolescents Over 12 Years of Age

The Recommended Dose is 2-3 Times a Day (After Meals).
Using the Measuring Cup, Measure 15 mL of Undiluted Solution and Rinse the Mouth for 20-30 Seconds, and if the Inflammation is in the Throat, Rinse the Throat for the Same Amount of Time.
In Case of Severe Pain, More Frequent Use (Up to 5 Times a Day) of the Medication is Safe.
In Most Cases, Treatment with Nagardlan for Acute Symptoms of Inflammation Lasts Only a Few Days.
In Most Cases, the Therapeutic Goal, Which is the Disappearance of Inflammation Symptoms and Pain, Especially When Swallowing, is Achieved Within the First 2-4 Days of Treatment.
There are no Concerns About Prolonged Use in Cases of Mouth Inflammation During Radiotherapy. However, You Should Consider the Special Warnings for Long-Term Treatment, as it may Affect the Normal Bacterial Flora in the Mouth, and Long-Term Use may Lead to Allergic Reactions.
Do not Usethe Solution for Rinsing the Mouth and Throat Continuously for a Period Longer than 7 Days, Unless Advised by a Doctor or Dentist.

Elderly Patients

There are no Special Dosage Recommendations for Elderly Patients. If the Dentist or Doctor Does not Advise Otherwise, the Same Dosage as for Adult Patients Should be Used.
Method of Administration
For Use on the Mucous Membranes of the Mouth.
Nagardlan is Intended for Rinsing the Mouth and Throat and Should not be Swallowed. Therefore, Nagardlan can be Used for Rinsing if the Patient is Able to Withhold the Swallowing Reflex and Can Spit Out the Solution After Rinsing the Mouth or Throat.
Patients Should not Eat or Drink for 1 Hour After Using Nagardlan.
Instructions for Use

• 1. Opening the Bottle: Press the Cap Down (1) and Turn it Counterclockwise (2).

Using More than the Recommended Dose of Nagardlan

Accidental Ingestion of a Small Amount of Medication is not Harmful.
In Case of Incorrect Use (i.e., Swallowing a Larger Amount of Nagardlan), Side Effects such as Vomiting, Abdominal Pain, Sleep Disturbances, Restlessness, Anxiety, Seizures, Ataxia, Fever, Tachycardia, and Possible Respiratory Depression may Occur.
In Case of Ingestion of an Excessive Amount of Medication or Accidental Ingestion of a Large Amount of Medication, Consult a Doctor or Pharmacist Immediately.
The First Step in Treatment is to Try to Induce Vomiting. Symptomatic Treatment is Recommended in Case of Poisoning Symptoms (e.g., Respiratory Support, Gastric Lavage, etc.).

Missing a Dose of Nagardlan

If You Use a Smaller Dose of Nagardlan than Recommended, the Time to Onset of Action may be Longer. However, in this Case, the Treatment may not be Successful.
If You Forget to Use Nagardlan Once, Continue the Treatment as Prescribed Without Increasing the Frequency of Use or Dose of the Medication.
If You Have any Further Doubts About Using this Medication, Consult a Doctor or Pharmacist.

4. Possible Side Effects

Like all Medications, 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 in the Mouth and Dryness of the Mouth. If You Experience this Side Effect, 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 Membranes (Angioedema).
• Difficulty Breathing (Laryngospasm).

Frequency Not Known(Frequency Cannot be Estimated from the Available Data)

• Allergic Reactions (Hypersensitivity Reactions).

Methyl Parahydroxybenzoate may Cause Allergic Reactions (Possible Late Reactions).
Symptoms of a Severe Allergic Reaction (Anaphylactic Shock) may Include: Shortness of Breath (Difficulty Breathing), Chest Pain, Tightness in the Chest, Dizziness, Weakness, Severe Itching of the Skin, Palpable Nodules on the Skin, Swelling of the Face, Lips, Tongue, and (or) Throat, Which may be Life-Threatening.

Reporting Side Effects

If You Experience any Side Effects, Including those not Listed in this Package Leaflet, Tell Your Doctor or Pharmacist, or Nurse. Side Effects can be Reported Directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 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 Authorization Holder.
Reporting Side Effects will Help to Gather More Information on the Safety of the Medication.

5. How to Store Nagardlan

Keep the Medication Out of Sight and Reach of Children.
Do not Use this Medication After the Expiration Date Stated on the Label and Carton After: "EXP". The Expiration Date is the Last Day of the Specified Month.
Store in the Original Packaging to Protect from Light.
After First Opening, the Medication Should be Used Within 6 Months.
Medications Should not be Disposed of via Wastewater or Household Waste. Ask Your Pharmacist How to Dispose of Medications that are no Longer Needed. This will Help Protect the Environment.

6. Package Contents and Other Information

What Nagardlan Contains

• The Active Substance of Nagardlan is Benzydamine Hydrochloride. 1 mL of Solution Contains 1.5 mg of Benzydamine Hydrochloride.
• The Other Ingredients are: Methyl Parahydroxybenzoate (E 218), Ethanol (96%), Glycerol (85%), Sodium Hydrogen Carbonate, Hydrochloric Acid, Concentrated (to Adjust pH), Polysorbate 20, Sodium Saccharin (E 954), Purified Water, Peppermint Flavor (Contains: Propylene Glycol (E 1520), Aromatic Extracts), Quinoline Yellow (E 104), Patent Blue V 85% (E 131).

What Nagardlan Looks Like and What the Package Contains

Nagardlan is a Clear, Green Solution with a Typical Peppermint Taste and Smell in a Clear, Glass Bottle (Type III) with a Cap in a Cardboard Box. The Package Contains a Measuring Cup.
Packages Contain 120 mL and 240 mL of Solution.
Not all Pack Sizes may be Marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Aristo Pharma Sp. z o.o.
Baletowa Street 30
02-867 Warsaw
Phone: +48 22 855 40 93

Manufacturer

Aristo Pharma GmbH
Wallenroder Strasse 8-10
13435 Berlin
Germany

This Medication is Authorized for Marketing in the Member States of the European Economic Area Under the Following Names:

Germany
Tonsino Gurgellösung bei Halsschmerzen
Italy
Tonsino
Spain
DRACOSAN
Poland
Nagardlan
Date of Last Revision of the Package Leaflet:November 2024