Tantum verde mint flavor

Patient Information Leaflet

Tantum Verde Mint Flavour
3 mg, hard pastilles
Benzydamini hydrochloridum
Please read all of this leaflet carefully before using this medicine, because it contains
important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed by
your doctor or pharmacist.

• Keep this leaflet, so that you can read it again if necessary.
• If you need advice or further information, please 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, or if you feel worse, consult your doctor.

Contents of the leaflet

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

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

Tantum Verde Mint Flavour contains the active substance benzydamine, which belongs to the group of indole-type non-steroidal anti-inflammatory drugs (NSAIDs) for topical and general use.
Benzydamine has anti-inflammatory and analgesic properties and acts locally as a local anesthetic and antiseptic. The drug is well absorbed locally, achieving high concentrations in tissues affected by inflammation. The drug is generally well tolerated and is suitable for local treatment of inflammatory symptoms.
Lozenge for sucking.
Tantum Verde is used for the treatment of discomfort and symptoms (pain, redness, swelling) associated with inflammatory conditions of the mouth and throat.
If there is no improvement after 3 days, or if you feel worse, consult your doctor.

2. Important information before using Tantum Verde Smak miętowy

When not to use Tantum Verde Smak miętowy

• if the patient is allergic to benzydamine or to any of the other ingredients of this medicine (listed in section 6).
• in patients with phenylketonuria, as the medicine contains aspartame, a source of phenylalanine.

Warnings and precautions
Before starting treatment with Tantum Verde Smak miętowy, discuss it with your doctor or
pharmacist.

• It is not recommended to use this medicine if the patient is allergic 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 oral inflammation, such as ulceration, do not begin to improve within 3 days of using the medicine, consult a doctor, because in some patients oral ulceration may be a sign of another serious disease.

Tantum Verde Smak miętowy with other medicines
Tell your doctor or pharmacist about all medicines currently used or recently used,
as well as any medicines the patient plans to use.
Interactions between Tantum Verde Smak miętowy and other medicines have not been studied.

Pregnancy and breastfeeding
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.
Tantum Verde Smak miętowy should not be used during pregnancy unless absolutely
necessary and recommended by a doctor. If use is necessary, the lowest possible dose should be used for the shortest possible duration.
Tantum Verde Smak miętowy 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 Smak miętowy contains: aspartame (E 951), isomalt (E 953),
butylated hydroxyanisole (E 320), and fragrance allergens such as: benzyl alcohol (E 1519),
citral, citronellol, d-limonene, eugenol, geraniol, linalool (contained in lemon and mint flavouring
compositions).

Aspartame (E 951)
The medicine contains 3.5 mg of aspartame in each hard tablet. Aspartame is a source of phenylalanine. It may be harmful for patients with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to impaired excretion.

Isomalt (E 953)
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should
consult a doctor before taking this medicine.

Flavouring compositions
The medicine contains flavouring compositions with benzyl alcohol (E1519), citral,
citronellol, d-limonene, eugenol, geraniol, linalool, which may cause allergic reactions.
The medicine contains 0.000175 mg of benzyl alcohol in each hard tablet. Benzyl alcohol may
cause allergic reactions and mild local irritation.
Patients with liver or kidney disease should consult a doctor before using the medicine, as large amounts of benzyl alcohol may accumulate in their bodies and cause adverse effects (so-called metabolic acidosis).

Butylated hydroxyanisole (E 320)
The medicine may cause local skin reactions (e.g. contact dermatitis) or irritation of the eyes and mucous membranes.

3. How to use Tantum Verde Smak miętowy

This medicine should always be used exactly as described in this patient information 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 last longer than 7 days.
Use in children and adolescents
Due to its pharmaceutical form, this medicine should not be used in children under 6 years of age.
In children aged 6 to 11 years, the medicine should be used under supervision of an adult.
If the effect of the medicine appears too strong or too weak, consult a doctor.
Taking more than the recommended dose of Tantum Verde Smak miętowy
In case of accidental ingestion of too many tablets, contact a doctor immediately, taking the medicine packaging with you. The doctor will initiate appropriate management.
Very rarely, symptoms of overdose (excitement, convulsions, sweating, incoherence, 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 Smak miętowy
Do not take a double dose to make up for a missed dose.
If you have any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Allergic reactions of unknown frequency (frequency cannot be estimated from the available data)
may occur.
If any of the following symptoms occur, contact a doctor immediately:

• sudden swelling of the mouth or throat,
• difficulty breathing,
• rash or itching, especially if widespread over the body.

Uncommon adverse reactions (occurring in fewer than 1 in 100 people): skin reactions due to photosensitivity.
Rare adverse reactions (occurring in fewer than 1 in 1,000 people): burning or dryness in the mouth.
If these symptoms occur, they may be reduced by slowly drinking a glass of water in small sips.
Very rare adverse reactions (occurring in fewer than 1 in 10,000 people): laryngospasm, angioedema.
Adverse reactions of 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 or raised skin rash (urticaria), swelling of the face, lips, tongue, and (or) throat; such a reaction may be life-threatening,
• oral hypoaesthesia (localised loss of sensation in the oral mucosa).

Reporting of adverse reactions
If any adverse reactions occur, including any 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 at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +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 helps provide more information on the safety of this medicine.

5. How to store Tantum Verde Mint Flavour

Keep the medicine out of the sight and reach of children.
Store below 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Tantum Verde Mint Flavour contains

• The active substance is benzidamine hydrochloride. Each hard pastille contains 3 mg of benzidamine hydrochloride.
• The other ingredients are: isomalt (E 953), levomenthol, aspartame (E 951), monohydrate citric acid, mint flavouring composition PHL-008468 [containing, among others: benzyl alcohol (E 1519), citronellol, d-limonene, eugenol, geraniol, linalool], lemon flavouring composition PHL-008469 [containing, among others: butylated hydroxyanisole (E 320), benzyl alcohol (E 1519), citral, citronellol, d-limonene, geraniol, linalool], quinoline yellow (E 104), indigo carmine (E 132).

What Tantum Verde Mint Flavour looks like and contents of the pack
Green, mint-flavoured, biconvex hard pastilles.
Pastilles in PVC/PE/PVdC/Aluminium blisters or individually packed in paraffin-coated paper, then placed in aluminium-paper foil pouches, all contained in a cardboard box.
Each pack contains 20 or 30 hard pastilles.
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
Manufacturer:
PIERRE FABRE MEDICAMENT PRODUCTION
Site Diététique et Pharmacie
Zone Industrielle de la Coudette
32290 Aignan, France
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.