Tantum verde duo

Package leaflet: Information for the patient

Tantum Verde Duo, 1.5 mg/ml + 5 mg/ml, oral spray, solution
Benzydamini hydrochloridum + Cetylpyridinii chloridum
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, tell 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 Duo is and what it is used for
2. Important information before using Tantum Verde Duo
3. How to use Tantum Verde Duo
4. Possible side effects
5. How to store Tantum Verde Duo
6. Contents of the pack and other information

1. What Tantum Verde Duo is and what it is used for

Tantum Verde Duo contains the active substances: benzydamine hydrochloride and cetylpyridinium chloride, which act locally on the mouth and throat as an anti-inflammatory (reducing inflammation), analgesic (relieving pain), and antiseptic (fighting infections).
Tantum Verde Duo is used in adults (including elderly people), adolescents, and children aged over 6 years, for the short-term, adjunctive local anti-inflammatory, analgesic, and antiseptic treatment of irritations of the throat, mouth, and gums, gingivitis, pharyngitis (sore throat), and before and after tooth extraction.
If there is no improvement after 3 days or if you feel worse, consult your doctor.

2. Important information before using Tantum Verde Duo

When not to use Tantum Verde Duo

• If the patient is allergic to benzydamine hydrochloride, cetylpyridinium chloride, or any of the other ingredients of this medicine (listed in section 6).
• This medicine must not be used in children under 6 years of age.

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

• Do not use this medicine for longer than 7 days. If symptoms worsen or do not improve after 3 days, or if new symptoms occur, consult your doctor (see section 3).
• The use of topical medicines such as Tantum Verde Duo, especially over a prolonged period, may cause sensitization (allergic reactions). In such a case, treatment should be discontinued and medical advice sought.
• Avoid contact with the eyes.
• Tantum Verde Duo should not be used in combination with detergents (anionic compounds), such as those present in toothpastes. Therefore, do not use this medicine immediately before or after brushing teeth.
• If the patient is allergic to salicylates (e.g. acetylsalicylic acid and salicylic acid) or other anti-inflammatory painkillers known as non-steroidal anti-inflammatory drugs (NSAIDs), this medicine should not be used, as benzydamine hydrochloride also belongs to the group of non-steroidal anti-inflammatory drugs.
• If the patient has or has ever had bronchial asthma, the use of this medicine should be discussed with a doctor or pharmacist. In such cases, caution is advised.

Children and adolescents
This medicine should not be given to children under 6 years of age, as the pharmaceutical form (oral cavity spray) is not suitable for use in this age group.
Tantum Verde Duo with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or might take in the future.
Do not use this medicine together with other antiseptic medicines (products used to combat infections).
Tantum Verde Duo with food and drink
Do not use Tantum Verde Duo together with milk, as milk reduces its effectiveness.
Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
Do not use Tantum Verde Duo during pregnancy unless absolutely necessary and recommended by a doctor. If use is necessary, use the lowest possible dose for the shortest possible time.
Discuss breastfeeding with your doctor; the doctor will decide whether breastfeeding should be discontinued or treatment with Tantum Verde Duo should be stopped.
Driving and operating machinery
Tantum Verde Duo has no effect on the ability to drive or operate machinery.
Tantum Verde Duo contains macrogolglycerol hydroxystearate, which may cause skin reactions.
Tantum Verde Duo contains flavouring with allergens (benzyl alcohol, cinnamyl alcohol, citral, citronellol, geraniol, isoeugenol, d-limonene, linalool and eugenol). These may cause allergic reactions.
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. the medicine is considered "sodium-free".

3. How to use Tantum Verde Duo

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 your doctor or pharmacist.
Dosing
Do not exceed the recommended dose.

• Adults (including elderly) and adolescents over 12 years of age: The recommended dose is 1–2 sprays. Repeat the dose 3 to 5 times daily. Maintain an interval of at least 2 hours between doses.
• Children aged 6 to 12 years

The recommended dose is 1 spray. Repeat the dose 3 to 5 times daily. Maintain an interval of at least 2 hours between doses.
Tantum Verde Duo must not be used in children under 6 years of age.
Method of administration
Turn the nozzle tip and press the spray button 1–2 times, as shown in the picture:

At first use, press the pump button at least four times until a consistent spray is obtained.
Do not inhale the spray. Hold your breath while spraying.
For best results, do not use Tantum Verde Duo immediately before or after tooth brushing (see section “Warnings and precautions”).
Duration of treatment
Do not use this medicine for longer than 7 days without consulting a doctor. If symptoms worsen or do not improve after 3 days, consult a doctor.
Inform your doctor if symptoms recur or if you notice any changes in your condition.
If you use more Tantum Verde Duo than you should
If you use more than the recommended dose of Tantum Verde Duo, contact your doctor immediately or go to the nearest hospital.
If you forget to use Tantum Verde Duo
Do not use a double dose to make up for a missed dose.
If you have any further questions about 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 everybody gets them.
If any of the following adverse reactions occur in the patient, STOP using this medicine and
contact a doctor immediately:

• Hypersensitivity (allergic reactions), including anaphylactic reaction (severe allergic reaction), urticaria, photosensitivity, and bronchospasm (narrowing of the airways, causing serious breathing difficulties).

Very rare (may affect up to 1 in 10,000 people):
Local irritation or burning sensation in the mouth or throat.
Frequency not known (frequency cannot be estimated from the available data):
Numbness of the oral mucosa (reduced sensation in the mouth).
The above adverse reactions are usually transient. Following the instructions provided in this patient leaflet
can help reduce the risk of adverse reactions occurring.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this
leaflet, inform a doctor or pharmacist. Adverse reactions can be reported
directly to the Department of Monitoring Adverse Reactions of Medicinal Products at 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.
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Tantum Verde Duo

Keep the medicine out of sight and reach of children.
There are no special requirements regarding storage temperature.
Store in the original packaging to protect from light.
Do not use this medicine after the expiry date stated on the bottle and carton after: EXP. The expiry date refers to the last day of the stated month. The expiry date applies to the product stored in its original, undamaged packaging and kept under proper storage conditions.
Do not use this medicine more than 12 months after first opening the bottle.
Do not use this medicine if the bottle seal is broken.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. Such measures help protect the environment.
It is important to always keep the medicine information available. Therefore, keep the carton and the package leaflet supplied with the medicine.

6. Contents of the pack and other information

What Tantum Verde Duo contains

• The active substances are: benzydamine hydrochloride and cetylpyridinium chloride. 1 ml of the oral aerosol solution contains 1.5 mg of benzydamine hydrochloride and 5 mg of cetylpyridinium chloride.
• Other components are: glycerol (E422), sodium saccharin (E954), citric acid monohydrate, sodium citrate, macrogolglycerol hydroxystearate, peppermint flavour ( containing allergens: benzyl alcohol, cinnamyl alcohol, citral, citronellol, geraniol, isoeugenol, d-limonene, linalool, and eugenol) , purified water.

What Tantum Verde Duo looks like and contents of the pack
Tantum Verde Duo is a clear, colourless to slightly yellow solution with a pH range of 5.0–6.2.
Each pack contains one plastic bottle (HDPE) with a capacity of 15 ml, equipped with a pump (PE/PP) for non-aerosol dosing, a dispenser with housing (PP), and a folding tube (PE). The bottle contains 15 ml of solution, and the spray pump is set to deliver a dose of 100 microlitres.
15 ml of oral aerosol solution is sufficient for approximately 150 doses.
The bottle is packaged in lithographed cardboard boxes together with the package leaflet.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Angelini Pharma Polska Sp. z o.o.
Al. Jerozolimskie 181B
02-222 Warsaw
tel.: (22) 70 28 200
e-mail: [email protected]

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

This medicinal product is authorised in the European Economic Area countries under the following names:
Austria: Tantum Verde Protect 1.5 mg/ml + 5 mg/ml Spray zur Anwendung in der Mundhöhle, Lösung
Czech Republic: TANTUM VERDE DUO
Germany: Tantum Verde duo 1.5 mg/ml + 5 mg/ml Spray zur Anwendung in der Mundhöhle, Lösung
Hungary: Tantum Verde Duo 1.5 mg/ml + 5 mg/ml szájnyálkahártyán alkalmazott oldatos spray
Italy: TANTUM VERDE ANTISETTICO E ANTINFIAMMATORIO
Poland: TANTUM VERDE DUO
Portugal: TANTUM VERDE DUO
Romania: TANTUM VERDE DUO 1.5 mg/ml + 5 mg/ml spray bucofaringian, soluție
Slovakia: TANTUM VERDE DUO