Tantum verde eucalyptus flavor

Package leaflet: Information for the user

Tantum Verde Eucalyptus Flavour
3 mg, hard pastilles
Benzydamini hydrochloridum
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the user.
This medicine should always be used according to the instructions provided in this patient leaflet or as directed by a physician or pharmacist.

• Keep this leaflet for future reference.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 3 days of treatment, or if symptoms worsen, consult a doctor.

Contents of the leaflet:

1. What Tantum Verde Eucalyptus Flavour is and what it is used for
2. Important information before using Tantum Verde Eucalyptus Flavour
3. How to use Tantum Verde Eucalyptus Flavour
4. Possible side effects
5. How to store Tantum Verde Eucalyptus Flavour
6. Contents of the pack and other information

1. What Tantum Verde Eucalyptus Flavour is and what it is used for

Tantum Verde Eucalyptus Flavour contains the active substance benzydamine, which belongs to the group of non-steroidal anti-inflammatory drugs (NSAIDs).
Benzydamine has anti-inflammatory and analgesic properties and acts locally as a local anaesthetic and antiseptic.
Tantum Verde Eucalyptus Flavour is a pastille for sucking, used to treat discomfort and symptoms (pain, redness, swelling) associated with inflammatory conditions of the mouth and throat in adults and children over 6 years of age.
If there is no improvement after 3 days of treatment, or if symptoms worsen, consult a doctor.

2. Important information before using Tantum Verde Eucalyptus Flavour

When not to use Tantum Verde Eucalyptus Flavour

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

Warnings and precautions
Before starting to use Tantum Verde Eucalyptus Flavour, discuss it with your doctor or pharmacist.

• Use of this medicine is not recommended if the patient has a history of allergy to acetylsalicylic acid (aspirin) or other non-steroidal anti-inflammatory drugs (NSAIDs).
• This medicine should be used with caution in patients who have had bronchial asthma, as it may cause breathing difficulties.
• If symptoms of inflammation in the mouth, e.g. ulceration, do not begin to improve within 3 days of using the medicine, consult your doctor, because in some patients oral ulceration may be a sign of another serious illness.

Tantum Verde Eucalyptus Flavour and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Interactions between Tantum Verde Eucalyptus Flavour and other medicines have not been studied.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should consult your doctor or pharmacist before using this medicine.
Do not use Tantum Verde Eucalyptus Flavour 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 used.
Tantum Verde Eucalyptus Flavour should not be used during breastfeeding.

Driving and operating machinery
Local application of benzydamine at recommended doses does not affect the ability to drive or operate machinery.

Tantum Verde Eucalyptus Flavour contains isomalt (a type of sugar), which should be taken into account in patients with congenital intolerance to certain sugars (e.g. fructose).
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.

3. How to use Tantum Verde Eucalyptus Flavour

This medicine should always be used according to the instructions in the patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Recommended dosage: 1 tablet 3 times daily.
The tablet should be sucked slowly. Do not swallow or chew. Do not exceed the recommended dose.
Continuous treatment should not exceed 7 days.
Use in children and adolescents
Due to the pharmaceutical form of the medicine, it should not be used in children under 6 years of age.
In children aged 6 to 11 years, the medicine should be used under adult supervision.
Accidental overdose of Tantum Verde Eucalyptus Flavour
In case of accidental ingestion of too many tablets, seek medical advice immediately, taking the medicine packaging with you. The doctor will initiate appropriate management.
Very rarely, symptoms of overdose (agitation, convulsions, sweating, incontinence, tremor, vomiting) have been reported in children after ingestion of medicines containing benzydamine in doses approximately one hundred times higher than the dose contained in a single tablet.
Missed dose of Tantum Verde Eucalyptus Flavour
Do not take a double dose to make up for a missed dose.
If you have any further doubts concerning the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Adverse reactions with unknown frequency (frequency cannot be estimated from the available data) are allergic reactions, which may be severe.
Immediately contact a doctor if any of the following symptoms occur:

• sudden swelling of the mouth or throat,
• difficulty breathing,
• rash or itching, especially if it involves the whole body.

Uncommon adverse reactions (occurring in less than 1 in 100 people): skin reactions due to photosensitivity.
Rare adverse reactions (occurring in less than 1 in 1,000 people): burning sensation or dryness in the mouth. If these symptoms occur, they can be reduced by slowly drinking a glass of water in small sips.
Very rare adverse reactions (occurring in less than 1 in 10,000 people): laryngospasm, angioedema.
Adverse reactions with unknown frequency (frequency cannot be estimated from the available data):

• premature closure of the ductus arteriosus in the fetus,
• allergic reaction (hypersensitivity),
• severe allergic reaction (anaphylactic shock) with symptoms such as: difficulty breathing, pain or tightness in the chest, and (or) dizziness/fainting, intense itching of the skin or raised skin lumps, swelling of the face, lips, tongue, and (or) throat; such a reaction may be life-threatening,
• oral hypoaesthesia (local loss of sensitivity of the oral mucosa).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor, pharmacist, or nurse. Adverse reactions 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 reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions contributes to enhancing the knowledge on the safety of the medicine.

5. How to store Tantum Verde Smak eukaliptusowy

Keep the medicine out of the sight and reach of children.
Blister
Store the medicine at a temperature not exceeding 30°C, in the original packaging to protect from light and moisture.
Packet
Store the medicine at a temperature not exceeding 25°C, in the original packaging.
Do not use this medicine after the expiry date stated on the carton.
The expiry date refers to the last day of the specified month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the package and other information

What Tantum Verde Eucalyptus Flavour contains

• The active substance in Tantum Verde Eucalyptus Flavour is benzidamine hydrochloride. Each hard tablet contains 3 mg of benzidamine hydrochloride.
• Other ingredients are: isomalt (E 593), eucalyptus oil, citric acid monohydrate, acesulfame potassium, levomenthol, quinoline yellow (E 104), indigo carmine (E 132).

What Tantum Verde Eucalyptus Flavour looks like and contents of the pack
Dark green, biconvex tablets.
Tablets in PVC/PE/PVdC/Aluminium blisters, in a cardboard box or individually packed in
paraffin-coated paper, then placed in PE/paper/Aluminium pouches, all contained in a cardboard
box.
Each package contains 20 or 30 hard tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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 Authorisation Holder
Angelini Pharma Polska Sp. z o.o.
Aleje Jerozolimskie 181B
02-222 Warsaw, Poland
tel.: (22) 70 28 200
e-mail: [email protected]
representative of the Marketing Authorisation Holder.