Tonsino

Package leaflet: Information for the patient

Tonsino 1.5 mg/ml oral mucosa spray, solution

For adults, adolescents and children aged 2 years and older and with a body weight of at least 4 kg
benzidamine hydrochloride
Please read this leaflet carefully before using this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you to do.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice any improvement or if your symptoms worsen after 3 days.

Contents of this leaflet:

1. What Tonsino is and what it is used for
2. What you need to know before using Tonsino
3. How to use Tonsino
4. Possible side effects
5. How to store Tonsino
6. Contents of the pack and other information

1. What Tonsino is and what it is used for

Tonsino contains the active substance benzidamine hydrochloride and is an anti-inflammatory agent for the mouth and throat.
Tonsino is used for the symptomatic treatment of pain and irritation of the mouth and throat in adults, adolescents, and children aged 2 years and older with a body weight of at least 4 kg (see section 2).
Tonsino is a ready-to-use spray and is sprayed directly into the mouth and throat.
Consult your doctor if you do not notice any improvement or if your symptoms worsen after 3 days.

2. What you need to know before taking Tonsino

Do not take Tonsino
If you are allergic to benzidamine hydrochloride or to any of the other ingredients of this
medicinal product (listed in section 6).
Tonsino must not be used in neonates and children under 2 years of age (due to the
peppermint flavour content).

Warnings and precautions
Talk to your doctor or pharmacist before taking Tonsino.
The use of benzidamine hydrochloride is not recommended in case of hypersensitivity to acetylsalicylic acid or to other analgesics known as NSAIDs.
Tonsino should be used with caution if you have a history of asthma, as bronchospasm may occur.
The use of this medicinal product, particularly over prolonged periods, may lead to sensitization. If this occurs, the medicinal product should be temporarily discontinued and you should contact your doctor.
If mouth or throat pain worsens or does not improve within 3 days, you should contact your doctor or treating dentist.
Prolonged use of this medicinal product may affect the bacterial flora in the mouth.

Children
Tonsino must not be used in neonates and children under 2 years of age due to lack of safety and efficacy data.

Other medicines and Tonsino
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No interactions are known.

Pregnancy, breast-feeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breast-feeding, consult your doctor or pharmacist before taking this medicinal product. Tonsino should be used during pregnancy and breast-feeding only if considered necessary by your doctor.

Driving and using machines
Tonsino does not affect or affects negligibly the ability to drive and use machines.

Tonsino contains methyl parahydroxybenzoate
This medicinal product contains 1 mg/ml of methyl parahydroxybenzoate. Methyl parahydroxybenzoate may cause allergic reactions (including delayed-type reactions).

Tonsino contains alcohol (ethanol)
This medicinal product contains 14.22 mg of ethanol (alcohol) per spray, equivalent to 82.20 mg/ml of solution (8% w/w).
The amount in one spray of this medicinal product corresponds to less than 1 ml of beer or 1 ml of wine. The small amount of alcohol in this medicinal product will have no noticeable effects.

Tonsino contains sodium
Tonsino contains less than 1 mmol (23 mg) of sodium per spray, i.e. essentially “sodium-free”.

Tonsino contains peppermint flavour
Peppermint flavour may trigger hypersensitivity reactions (including dyspnoea) in sensitized individuals.

3. How to take Tonsino

Take this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Dosage:

Tonsino is generally used 2–6 times a day.

Adults and adolescents from 12 years of age: 4–8 sprays per dose.

Children from 6 to 11 years of age: 4 sprays per dose.

Children from 2 to 5 years of age with a body weight above 4 kg: Administer 1 spray for every 4 kg of body weight, up to a maximum of 4 sprays.

Elderly patients: Unless otherwise prescribed by the dentist or doctor, the dosage specified for adults should be applied.

Method of administration: Oromucosal use.

Instructions for use: Before first use of Tonsino, the throat adapter provided must be attached to the pump and must not be removed thereafter. To ensure uniform nebulization, prime the spray by releasing two test sprays before the first application.

The spray can be applied directly into the mouth and throat, but must not be swallowed.

Duration of treatment: In the vast majority of cases, treatment of acute inflammation with Tonsino requires only a few days.

If you take more Tonsino than you should: Inadvertent ingestion of small amounts is harmless.

If you have ingested an excessive amount of the medicine or accidentally swallowed a large quantity, contact your doctor or pharmacist immediately.

In case of misuse (i.e. if large amounts of Tonsino are swallowed), adverse effects such as vomiting, abdominal pain, sleep disturbances, restlessness, anxiety, spasms, ataxia, fever, tachycardia, and possible respiratory paralysis may occur.

If you forget to take Tonsino: If too low a dose of Tonsino is used, the time until onset of effect may be prolonged. In this case, treatment may also be ineffective.

If you forget to use Tonsino on one occasion, continue treatment as recommended without increasing the frequency or dose.

If you stop using Tonsino: If you discontinue treatment with Tonsino or stop using it prematurely, the desired effect may not be achieved, or your condition may worsen again. Consult your doctor or pharmacist if you wish to stop or suspend treatment.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Uncommon (may affect up to 1 in 100 people)

• Skin redness or sunburn due to increased sensitivity of the skin to sunlight.

Rare (may affect up to 1 in 1,000 people)

• Burning sensation in the mouth and dry mouth. If this occurs, sip a glass of water to reduce the effect.

Very rare (may affect up to 1 in 10,000 people)

• Sudden swelling of the mouth and throat or mucous membranes (angioedema).
• Breathing difficulties (laryngospasm).

Not known (frequency cannot be estimated from the available data)

• Allergic reactions (hypersensitivity reactions).

Signs of a severe allergic reaction (anaphylactic shock) may include dyspnea (difficulty breathing), chest pain, tightness in the chest, dizziness, feeling weak, intense itching of the skin, lumps felt on the skin, swelling of the face, lips, tongue and/or throat, and these may potentially be life-threatening.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at the following address: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tonsino

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle and the outer packaging, following
Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
The shelf life after first opening is 3 months.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Tonsino contains

• The active substance is: benzidamine hydrochloride. 1 mL of solution contains 1.5 mg of benzidamine hydrochloride. Each spray delivers 0.18 ± 0.01 mL of solution containing 0.269 mg of benzidamine hydrochloride.
• The other components are: methyl 4-hydroxybenzoate (E 218), ethanol (96%), glycerol (85%), sodium hydrogen carbonate, concentrated hydrochloric acid (for pH adjustment), polysorbate 20, sodium saccharin (E 954), purified water, peppermint flavour (containing: propylene glycol (E 1520), aromatic extracts), Quinoline Yellow (E 104), Patent Blue V (E 131).

Description of the appearance of Tonsino and contents of the pack
Oromucosal spray, solution
Tonsino is a clear green solution with a characteristic peppermint flavour and odour.
Colourless glass bottle (type III) closed with a metering pump and protective cap, packaged together with a throat adapter.
Tonsino is available in packs containing 30 mL of solution.
Each 30 mL bottle delivers 166 sprays.

Marketing Authorisation Holder and Manufacturer
Aristo Pharma GmbH
Wallenroder Straße 8-10
13435 Berlin
Germany

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Germany Tonsino Spray bei Halsschmerzen
Poland Nagardlan
Italy Tonsino

Patient Information Leaflet

Tonsino 1.5 mg/ml oral mucosal solution

Benzidamine hydrochloride
Read this leaflet carefully before taking this medicine because it contains
important information for you.

• Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.
• Keep this leaflet. You may need to read it again.
• If you need further information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice improvement or if your symptoms worsen after 3 days.

Contents of this leaflet:

1. What Tonsino is and what it is used for
2. What you need to know before taking Tonsino
3. How to take Tonsino
4. Possible side effects
5. How to store Tonsino
6. Package contents and other information

1. What Tonsino is and what it is used for

Tonsino is an anti-inflammatory agent for the mouth and throat. Tonsino contains benzidamine hydrochloride,
which is used for the symptomatic treatment of pain and irritation in the mouth and throat.
Tonsino is a ready-to-use solution and is used undiluted for rinsing or gargling the mouth and throat.
In the vast majority of cases, only a few days are needed to treat acute signs of inflammation with Tonsino.
Consult your doctor if you do not notice any improvement or if your symptoms worsen after 3 days.

2. What you need to know before taking Tonsino

Do not take Tonsino

• if you are allergic to benzidamine hydrochloride or to any of the excipients in this medicine (listed in section 6). Tonsino solution must not be used in children under 12 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before taking Tonsino if you have the following symptoms:
The use of this medicine, particularly for prolonged periods, may cause sensitization. If this
occurs, or if you experience any of the side effects listed, treatment with the medicine should be
temporarily discontinued and you must contact your doctor.
Tonsino should be used with caution if you have a history of asthma, as bronchospasm may occur.
If mouth or throat pain worsens or does not improve within 3 days, you must contact your doctor
or dentist. Prolonged use of the medicine may affect the bacterial flora in the mouth.
The use of benzidamine hydrochloride is not recommended if you are hypersensitive to salicylic acid or to other analgesics known as NSAIDs.
Children and adolescents
Tonsino must not be used in children under 12 years of age due to lack of safety and efficacy data.
“For individuals engaged in sports activities, the use of medicinal products containing ethyl alcohol may result in positive doping tests, depending on the alcohol concentration limits established by certain sports federations.”
Other medicines and Tonsino
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No interactions with other medicines have been observed.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine. Your doctor will decide whether you can use Tonsino.
Driving and using machines
Tonsino does not impair the ability to drive vehicles or operate machinery.
Tonsino contains methylparahydroxybenzoate
This medicine contains 15 mg of methylparahydroxybenzoate per 15 ml dose, equivalent to 1 mg/ml. Methylparahydroxybenzoate may cause local irritation.
Tonsino contains ethanol (alcohol)
This medicine contains 10.28 vol% ethanol (alcohol), up to 1,233 mg per 15 ml dose,
equivalent to 100 ml of beer or 13 ml of wine.
Harmful for individuals suffering from alcoholism. This should be taken into account in pregnant or breastfeeding women, children, and high-risk groups such as patients with liver disease or epilepsy.
The alcohol contained in this medicine may alter the effects of other medicines.
Consult your doctor or pharmacist if you are taking other medicines.
If you are pregnant or breastfeeding, consult your doctor or pharmacist before taking this
medicine.
If you are alcohol-dependent, consult your doctor or pharmacist before taking this medicine.

3. How to take Tonsino

Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
Adults and adolescents from 12 years of age:
The recommended dose is 2 to 3 times daily (after meals).
Using the dosing cap, pour 15 ml of undiluted solution to rinse the mouth for 20–30
seconds if the mouth is inflamed, or to gargle for the same duration if the throat is inflamed.
In case of severe pain, more frequent application (up to 5 times daily) is safe.
In the vast majority of cases, only a few days of treatment with Tonsino are needed to treat acute signs of
inflammation.
In most cases, the therapeutic goal—which is resolution of inflammatory signs and disappearance of pain,
especially during swallowing—is achieved within the first 2–4 days.
There are no concerns regarding prolonged use in cases of stomatitis during irradiation. However, special
precautions for long-term use must be considered, as long-term treatment may affect the normal bacterial
flora of the oral cavity, and prolonged use may lead to sensitization.
Do not use the mouthwash continuously for more than 7 days unless otherwise directed by your doctor or
dentist.
Elderly patients:
There are no special dosage recommendations for elderly patients. Unless otherwise
prescribed by the dentist or doctor, the dose specified for adults should be applied.
Method of administration
For oral use only.
Tonsino solution is intended for mouth and throat gargling and must not be swallowed. Therefore,
Tonsino solution may only be used for gargling if the patient is able to suppress the swallowing reflex and is able to spit out the solution after rinsing or gargling.
Do not eat or drink for up to 1 hour after using the product.
Instructions for use

1. Open the bottle: press down on the cap (1) and turn it counterclockwise (2).

If you take more Tonsino than you should
Inadvertent ingestion of small amounts is harmless.
In case of misuse (i.e., if larger amounts of Tonsino solution are swallowed), adverse effects such as
vomiting, abdominal pain, sleep disturbances, restlessness, anxiety, seizures, ataxia, fever, tachycardia, and possibly respiratory paralysis may occur.
If you have ingested an excessive amount of the medicine or accidentally swallowed a large amount,
contact your doctor or pharmacist immediately.
As an initial measure, induction of vomiting may be attempted. Symptomatic treatment is recommended if signs of poisoning occur (e.g., respiratory support, removal of poison by gastric pumping, etc.).
If you forget to take Tonsino
If too little Tonsino is used, the time until onset of effect may be prolonged. In this case, treatment may
also fail.
If you forget to use Tonsino on one occasion, continue treatment as recommended without increasing the frequency or dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Uncommon (may affect up to 1 in 100 people)

• Skin redness or sunburn due to increased sensitivity of the skin to sunlight

Rare (may affect up to 1 in 1,000 people)

• Burning sensation in the mouth and dryness of the mouth. If this occurs, sip a glass of water to reduce the effect.

Very rare (may affect up to 1 in 10,000 people)

• Sudden swelling of the mouth, throat or mucous membranes (angioedema).
• Breathing difficulties (laryngospasm).

Not known (frequency cannot be estimated from the available data)

• Allergic reactions (hypersensitivity reactions)

Methylparahydroxybenzoate may cause allergic reactions (including delayed reactions).
Signs of a severe allergic reaction (anaphylactic shock) may include dyspnea (difficulty breathing), chest pain, chest tightness, dizziness, feeling of weakness, intense skin itching, skin nodules that may be felt, swelling of the face, lips, tongue and/or throat, and these may potentially be life-threatening.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at the following website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse*.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tonsino

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp". The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light.
Once opened, the product should be used within 6 months.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Tonsino contains

• The active substance is Benzidamine hydrochloride. 1 mL contains 1.5 mg of benzidamine hydrochloride.
• The other ingredients are Methylparahydroxybenzoate (E 218), ethanol (96%), glycerol (85%), sodium hydrogen carbonate, hydrochloric acid (for pH adjustment), polysorbate 20, sodium saccharin, purified water, peppermint flavour (containing: propylene glycol (E 1520), aromatic extracts), Quinoline Yellow (E 104), Patent Blue V (E 131).

Description of the appearance of Tonsino and contents of the pack
Tonsino is a clear green solution with a characteristic peppermint flavour and odour, contained in a colourless glass bottle with a screw cap. The pack includes a measuring cup.
Pack sizes of 120 ml, 240 ml and 300 ml solution.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Aristo Pharma GmbH
Wallenroder Straße 8-10
13435 Berlin
Germany

This medicinal product is authorised in the Member States of the European Economic Area under the following names