Tantum verde lemon flavor

Package leaflet: Information for the patient

Tantum Verde Smak cytrynowy
3 mg, hard lozenges
Benzydamini hydrochloridum
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient information leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• 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 your condition worsens, consult a doctor.

Table of contents of the leaflet

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

1. What Tantum Verde Smak cytrynowy is and what it is used for

Tantum Verde Smak cytrynowy contains the active substance benzydamine, which belongs to the group of indole-type non-steroidal anti-inflammatory drugs (NSAIDs) for local 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. It is generally well tolerated and suitable for local treatment of inflammatory symptoms.
This is a lozenge for sucking.
The medicine is used to treat 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 a doctor.

2. Important information before using Tantum Verde Smak cytrynowy

When not to use Tantum Verde Smak cytrynowy:

• if the patient is allergic to benzydamine or 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 cytrynowy, discuss it with your doctor or pharmacist.

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

Tantum Verde Smak cytrynowy and other medicines
Tell your doctor or pharmacist about all medicines currently used, recently used, or planned for use.
Interactions between Tantum Verde Smak cytrynowy 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 become pregnant, she should consult a doctor or pharmacist before using this medicine.
Tantum Verde Smak cytrynowy should not be used during pregnancy unless absolutely necessary and prescribed by a doctor. If use is necessary, the lowest possible dose should be used for the shortest possible duration.
Tantum Verde Smak cytrynowy should not be used during breastfeeding.

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

Tantum Verde Smak cytrynowy contains: aspartame (E 951), isomalt (E 953), butylated hydroxyanisole (E 320), and fragrance allergens such as: benzyl alcohol ( ), citral, citronellol, d-limonene, eugenol, geraniol, and linalool (contained in the lemon and mint flavouring compositions).

Aspartame (E 951)
The medicine contains 3.26 mg of aspartame in each hard pastille. Aspartame is a source of phenylalanine. It may be harmful to 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, he or she should consult a doctor before taking the medicine.

Flavouring compositions
The medicine contains flavouring compositions with benzyl alcohol (E 1519), citral, citronellol, d-limonene, eugenol, geraniol, and linalool, which may cause allergic reactions.
The medicine contains 0.00052 mg of benzyl alcohol in each hard pastille. 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 (such as 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 Lemon Flavour

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 three 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, 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 adult supervision.
If the effect of the medicine appears too strong or too weak, consult a doctor.
Taking more Tantum Verde Lemon Flavour than recommended
In case of accidental ingestion of too many tablets, seek immediate medical advice and take 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 amount contained in a single tablet.
Missed dose of Tantum Verde Lemon 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 they do not occur in everyone.
Adverse reactions with unknown frequency (frequency cannot be estimated from the available data) are allergic reactions, which may be severe.
If any of the following symptoms occur, consult a doctor immediately:

• sudden swelling of the mouth or throat,
• difficulty breathing,
• rash or itching, especially if affecting the whole 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 with unknown frequency (frequency cannot be estimated from the available data):

• premature closure of the fetal ductus arteriosus,
• 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 (hives), 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 for 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 helps provide more information on the safety of the medicine.

5. How to store Tantum Verde Smak cytrynowy

Keep this medicine out of 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 month indicated.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Tantum Verde Lemon Flavour contains

• The active substance is benzidamine hydrochloride. Each hard tablet contains 3 mg of benzidamine hydrochloride.
• The other ingredients are: isomalt (E 593), citric acid monohydrate, lemon flavouring composition PHL-008469 [contains, among others: butylated hydroxyanisole (E 320), benzyl alcohol (E 1519), citral, citronellol, d-limonene, geraniol, linalool], mint flavouring composition PHL-008468 [contains, among others: benzyl alcohol (E 1519), citronellol, d-limonene, eugenol, geraniol, linalool], aspartame (E 951), quinoline yellow (E 104), indigo carmine (E 132).

What Tantum Verde Lemon Flavour looks like and contents of the pack
Yellow, biconvex hard tablets with a lemon flavour.
The tablets are packed in blisters made of PVC/PE/PVdC/Aluminium or individually packed in paraffin-coated paper, then placed in PE/paper/Aluminium foil pouches, all contained in a cardboard box.
Each package contains 20 or 30 hard tablets.

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]