Tantum verde flavour honey-orange

Package leaflet: Information for the patient

Tantum Verde Smak miodowo-pomaranczowy
3 mg, hard pastilles
Benzydamini hydrochloridum
Read the following information 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 leaflet or as directed by
the doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse reactions, including those 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 your doctor.

Table of contents:

1. What Tantum Verde Smak miodowo-pomaranczowy is and what it is used for
2. Important information before taking Tantum Verde Smak miodowo-pomaranczowy
3. How to take Tantum Verde Smak miodowo-pomaranczowy
4. Possible side effects
5. How to store Tantum Verde Smak miodowo-pomaranczowy
6. Contents of the pack and other information

1. What Tantum Verde Smak miodowo-pomaranczowy is and what it is used for

Tantum Verde Smak miodowo-pomaranczowy 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 exerts local anaesthetic and antiseptic effects.
Tantum Verde Smak miodowo-pomaranczowy is a pastille for sucking, 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 your condition worsens, consult your doctor.

2. Important information before using Tantum Verde Smak miodowo-pomarańczowy

When not to use Tantum Verde Smak miodowo-pomaranczowy

• 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 Smak miodowo-pomaranczowy, discuss this with a doctor or pharmacist.

• It is not recommended to use the medicine 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 inflammation in the mouth, 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 medical condition.

Tantum Verde Smak miodowo-pomaranczowy and other medicines
Inform 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 miodowo-pomaranczowy 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 baby, she should consult a doctor or pharmacist before using this medicine.
Tantum Verde Smak miodowo-pomaranczowy should not be used 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 applied.
Tantum Verde Smak miodowo-pomaranczowy 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 miodowo-pomaranczowy contains isomalt, sunset yellow (E 110), and an orange-flavour composition containing citral, citronellol, d-limonene, geraniol, and linalool.

Isomalt
Isomalt is a type of sugar, which should be taken into account in patients with congenital intolerance to certain sugars (e.g. fructose). If a patient has previously been diagnosed with intolerance to certain sugars, he or she should consult a doctor before taking this medicine.

Sunset yellow (E 110)
This medicine contains sunset yellow and may cause allergic reactions.

Flavour composition
This medicine contains an orange flavour composition containing citral, citronellol, d-limonene, geraniol, and linalool, which may cause allergic reactions.

3. How to use Tantum Verde Honey-Orange 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 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 the supervision of an adult.

Overdose of Tantum Verde Honey-Orange Flavour
In case of accidental ingestion of too many tablets, seek medical advice immediately and take the medicine package 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 Honey-Orange Flavour
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 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.
You should immediately inform your doctor if any of the following symptoms occur:

• sudden swelling of the mouth or throat,
• difficulty breathing,
• rash or itching, especially if it affects 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.
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 or raised lumps on the skin, swelling of the face, lips, tongue, and (or) throat; such a reaction may be life-threatening,
• oral hypoaesthesia (localised loss of mucosal sensitivity in the oral cavity).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your 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, 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 to provide more information on the safety of the medicine.

5. How to store Tantum Verde Honey-Orange Flavour

Keep this medicine out of sight and reach of children.
Store the medicine 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 will help protect the environment.

6. Contents of the pack and other information

What Tantum Verde Honey-Orange Flavour contains

• The active substance in Tantum Verde Honey-Orange Flavour is benzidamine hydrochloride. Each hard lozenge contains 3 mg of benzidamine hydrochloride.
• The other ingredients are: isomalt (E 953), citric acid monohydrate, orange flavour PHL-013100 (containing, among others: citral, citronellol, d-limonene, geraniol, linalool), honey flavour 22 969 NF, levomenthol, potassium acesulfame, quinoline yellow (E 104), orange yellow (E 110).

What Tantum Verde Honey-Orange Flavour looks like and contents of the pack
Yellow-orange, biconvex lozenges.
Lozenges in PVC/PE/PVdC/Aluminium blisters or individually packed in paraffin-coated paper, then placed in PE/paper/Aluminium foil packets, all contained in a cardboard box.
Each pack contains 20 or 30 hard lozenges.

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
tel.: (22) 70 28 200
e-mail: [email protected]
Representative of the Marketing Authorisation Holder.