Tantum Verde

Package Leaflet: Information for the Patient

Tantum Verde

1.5mg/ml, Oral and Pharyngeal Rinsing Solution

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 Patient Information Leaflet or as Directed by a Doctor or Pharmacist.

• Keep this Leaflet to be Able to Read it Again if Necessary.
• If Advice or Additional Information is Needed, Consult a Pharmacist.
• If the Patient Experiences any Undesirable Effects, Including any Possible Undesirable Effects not Listed in this Leaflet, they Should Inform their Doctor or Pharmacist. See Section 4.
• If there is no Improvement or the Patient Feels Worse after 7 Days, they Should Consult a Doctor.

Table of Contents of the Leaflet:

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

1. What is Tantum Verde and What is it Used for

Tantum Verde, an Oral and Pharyngeal Rinsing Solution, Contains the Active Substance Benzydamine, which Belongs to the Group of Indole Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) for Local and General Use.
Benzydamine is Characterized by its Anti-Inflammatory, Analgesic, Local Anesthetic, and Antiseptic Properties.
The Medication is Well Absorbed Locally, Reaching High Concentrations in the Inflamed Tissues.
It is Generally Well Tolerated and Suitable for Local Treatment of Inflammatory Symptoms.
The Medication is Used for the Mucous Membranes of the Mouth and Throat.
It is Used to Treat Symptoms (Pain, Redness, Swelling) Associated with Inflammation of the Mouth and Throat, such as Bacterial and Viral Infections, Mucositis after Radiotherapy, Post-Operative Conditions in Laryngology and Stomatology, and after Intubation.
If there is no Improvement or the Patient Feels Worse after 7 Days, they Should Consult a Doctor.

2. Important Information Before Using Tantum Verde

When Not to Use Tantum Verde

• If the Patient is Allergic to Benzydamine or any Other Component of this Medication (Listed in Section 6).

Warnings and Precautions

Before Starting to Use Tantum Verde, Consult a Doctor or Pharmacist.
Prolonged Use of Locally Acting Medications may Cause an Allergic Reaction.
In such a Case, the Medication Should be Discontinued and a Doctor Consulted, who will Advise on the Appropriate Course of Action.
Accidental Ingestion of Small Amounts of Tantum Verde Solution does not Pose a Health Risk.

Tantum Verde and Other Medications

Inform the Doctor or Pharmacist about all Medications Currently Being Used or Recently Used by the Patient, as well as any Planned Medications.
No Interactions of Tantum Verde with Other Medications are Known.

Pregnancy and Breastfeeding

If the Patient is Pregnant, Breastfeeding, Thinks they may be Pregnant, or Plans to Have a Child, they Should Consult a Doctor or Pharmacist Before Using this Medication.
The Doctor will Decide on the Possibility of Using the Medication in Pregnant or Breastfeeding Women.

Driving and Operating Machinery

The Medication does not Affect the Ability to Drive or Operate Machinery.
Tantum Verde ContainsMethyl Parahydroxybenzoate (E 218), Ethanol, Benzyl Alcohol (E 1519), Flavoring Composition, Polysorbate 20 (E 432), and Sodium.

• The Medication Contains a Flavoring Composition with Benzyl Alcohol (E 1519), Cinnamon Alcohol, Citral, Citronellol, Geraniol, Isoeugenol, Linalool, Eugenol, and d-Limonene.

Methyl Parahydroxybenzoate (E 218)

The Medication may Cause Allergic Reactions (Late-Type Reactions are Possible).

Ethanol

This Medication Contains 1200 mg of Alcohol (Ethanol) in a Single 15 ml Dose, which is Equivalent to 80 mg/ml of Solution (8% w/w).
The Amount of Alcohol in a Single Dose of this Medication is Equivalent to Less than 31 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 Unnoticeable.
However, it may Cause some Effect in Younger Children, such as Drowsiness.
Alcohol in this Medication may Interact with Other Medications.
If the Patient is Taking Other Medications, they Should Consult a Doctor or Pharmacist.
If the Patient is Pregnant or Breastfeeding, they Should Consult a Doctor or Pharmacist Before Using this Medication.
If the Patient is Alcohol-Dependent, they Should Consult a Doctor or Pharmacist Before Using this Medication.

Flavoring Composition

The Medication Contains a Flavoring Composition with Benzyl Alcohol (E 1519), Cinnamon Alcohol, Citral, Citronellol, Geraniol, Isoeugenol, Linalool, Eugenol, and d-Limonene, which may Cause Allergic Reactions.
The Medication Contains 2.1 mg of Benzyl Alcohol in each 15 ml Dose.
Benzyl Alcohol may Cause Allergic Reactions and Mild Local Irritation.
Pregnant or Breastfeeding Women Should Consult a Doctor Before Using the Medication, as a Large Amount of Benzyl Alcohol may Accumulate in their Body and Cause Undesirable Effects (Metabolic Acidosis).
Patients with Liver or Kidney Disease Should Consult a Doctor Before Using the Medication, as a Large Amount of Benzyl Alcohol may Accumulate in their Body and Cause Undesirable Effects (Metabolic Acidosis).

Polysorbate 20 (E 432)

Polysorbates may Cause Allergic Reactions.

Sodium

The Medication Contains Less than 1 mmol (23 mg) of Sodium per Dose, which means the Medication is Considered "Sodium-Free".

3. How to Use Tantum Verde

This Medication Should Always be Used Exactly as Described in this Patient Information Leaflet or as Directed by a Doctor or Pharmacist.
In Case of Doubt, Consult a Doctor or Pharmacist.
The Recommended Dosage is to Rinse the Mouth and Throat 2 to 3 Times a Day.
Use Approximately 15 ml of the Undiluted or Diluted Solution (with a Small Amount of Water) and Rinse the Mouth and Throat for 20 to 30 Seconds.
Do not Exceed the Recommended Dose.
Continuous Treatment Should not Exceed 7 Days, and any Extension Should be Decided by a Doctor.
It is not Recommended to Use the Tantum Verde Solution in Patients who have Difficulty Rinsing their Mouth and Throat Properly.
If the Patient Feels that the Medication is too Strong or too Weak, they Should Consult a Doctor.

Using a Higher Dose of Tantum Verde than Recommended

Overdose of the Medication is Unlikely due to the Low Concentration of the Active Substance and the Local Route of Administration.
However, in Case of Ingestion (e.g., by Children) of a Very Large Amount of Tantum Verde Solution, the Following Symptoms may Occur: Vomiting, Abdominal Pain, Anxiety, Fear, Seizures, Ataxia, Fever, Tachycardia, and Possible Respiratory Depression.
In Case of Using a Higher Dose than Recommended or Accidental Ingestion of a Large Amount of the Medication, Consult a Doctor or Pharmacist Immediately.

Missing a Dose of Tantum Verde

Do not Take a Double Dose to Make up for a Missed Dose.
In Case of any Further Doubts about Using this Medication, Consult a Doctor or Pharmacist.

4. Possible Undesirable Effects

Like all Medications, Tantum Verde can Cause Undesirable Effects, although not Everybody will Experience them.
Very Rarely(May Affect up to 1 in 10,000 Patients) and Frequency not Known(Frequency cannot be Estimated from the Available Data):

• Allergic Reaction (Hypersensitivity),
• Severe Allergic Reaction (Anaphylactic Shock), which may Include Symptoms such as Difficulty Breathing, Chest Pain or Tightness, and (or) Dizziness or Fainting, Severe Itching of the Skin or Hives, Swelling of the Face, Lips, Tongue, and (or) Throat, and which may be Life-Threatening,
• Burning Sensation of the Mucous Membranes, Dryness of the Mouth, Nausea, and Vomiting, Sensory Disturbances, Numbness, Dizziness, and Headaches, Rash.

Local Symptoms are Related to the Pharmacodynamic Effect of Benzydamine, which, among other Things, has a Local Anesthetic Effect.
Local Undesirable Effects are Usually Transient, Resolve Spontaneously, and Rarely Require Additional Treatment.
Benzydamine, when Used Locally, is Absorbed into the Circulation in Small Amounts, and therefore Systemic Undesirable Effects are Very Rare.
Dilution of the Medication usually Eliminates these Symptoms.

Reporting Undesirable Effects

If any Undesirable Effects Occur, including any Possible Undesirable Effects not Listed in this Leaflet, Inform a Doctor, Pharmacist, or Nurse.
Undesirable Effects can be Reported Directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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
Undesirable Effects can also be Reported to the Marketing Authorization Holder.
Reporting Undesirable Effects will Help to Gather more Information on the Safety of the Medication.

5. How to Store Tantum Verde

Store the Medication out of Sight and Reach of Children.
There are no Special Storage Instructions for the Medication.
Do not Use this Medication after the Expiration Date Stated on the Packaging.
The Expiration Date is the Last Day of the Specified Month.
Medications should not be Disposed of via Wastewater or Household Waste.
Ask a Pharmacist how to Dispose of Medications that are no Longer Needed.
This will Help Protect the Environment.

6. Package Contents and Other Information

What Tantum Verde Contains

• The Active Substance of the Medication is Benzydamine Hydrochloride.
  1 ml of the Solution Contains 1.5 mg of Benzydamine Hydrochloride.
• Other Ingredients are: Glycerol (E 422), Ethanol 96%, Methyl Parahydroxybenzoate (E 218), Peppermint Flavoring Composition (Containing, among others, Benzyl Alcohol (E 1519), Cinnamon Alcohol, Citral, Citronellol, Geraniol, Isoeugenol, Linalool, Eugenol, and d-Limonene), Saccharin, Sodium Bicarbonate, Polysorbate 20 (E 432), Quinoline Yellow 70% (E104), Patent Blue V 85% (E131), and Purified Water.

What Tantum Verde Looks Like and What the Package Contains

A Clear Solution with a Green Color and a Mint Flavor.
A Bottle made of Colorless Glass with a Polypropylene Cap and a Polypropylene Measuring Cup with a 15 ml and 30 ml Gradation, in a Cardboard Box.
1 Bottle – 120 ml
1 Bottle – 240 ml

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Angelini Pharma S.p.A.
Viale Amelia 70, 00181 Rome, Italy

Manufacturer:

Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A.
Via Vecchia del Pinocchio 22
60131 Ancona, Italy

Representative of the Marketing Authorization Holder

Angelini Pharma Polska Sp. z o.o.
Aleje Jerozolimskie 181B
02-222 Warsaw
tel. (22) 70 28 200
e-mail: [email protected]
A Patient Information Leaflet in a Version Suitable for the Visually Impaired and Blind is Available at the Representative's Office.

Date of the Last Update of the Leaflet: