TONSINO 1.5 MG/ML Oral mucosal solution

Содержание инструкции

1. Tonsino 1.5 mg/ml oral mucosal spray, solution
   1. What is Tonsino and what is it used for
   2. What you need to know before you take Tonsino
   3. How to take Tonsino
   4. Possible side effects
   5. How to store Tonsino
   6. Contents of the pack and other information
2. Tonsino 1.5 mg/ml oral mucosa solution
   1. What is Tonsino and what is it used for
   2. What you need to know before you take Tonsino
   3. How to take Tonsino
   4. Possible side effects
   5. How to store Tonsino
   6. Contents of the pack and other information

Tonsino 1.5 mg/ml oral mucosal spray, solution

For adults, adolescents and children aged 2 years or older and with a body weight of at least 4
kg
benzydamine hydrochloride

Read this leaflet carefully before taking this medicine as 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.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist
• If any side effect occurs, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• Talk to your doctor if you do not feel better 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 you take Tonsino
• 3. How to take Tonsino
• 4. Possible side effects
• 5. How to store Tonsino
• 6. Contents of the pack and other information

1. What is Tonsino and what is it used for

Tonsino contains the active substance benzydamine 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 over and 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.
See your doctor if you do not notice any improvement or if your symptoms worsen after 3 days.

2. What you need to know before you take Tonsino

Do not takeTonsino
If you are allergic to benzydamine hydrochloride or to any of the other ingredients of this medicine (listed in section 6).
Tonsino must not be used in newborns and children under 2 years of age (due to the peppermint oil flavouring content).

Warnings and precautions
Talk to your doctor or pharmacist before taking Tonsino.
The use of benzydamine hydrochloride is not recommended in case of hypersensitivity to salicylic acid or to other painkillers called NSAIDs.
Tonsino should be used with caution if you have a history of asthma, as bronchospasm may occur.
The use of this medicine, particularly for prolonged periods, may cause sensitisation. If this happens, the medicine should be temporarily discontinued and you should contact your doctor.
If the pain in your mouth and throat worsens or does not improve within 3 days, you should contact your doctor or dentist who is treating you.
Prolonged use of the medicine may affect the bacterial flora in the mouth.

Children
Tonsino must not be used in newborns and children under 2 years of age for safety and efficacy reasons.

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

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine. Tonsino should only be used during pregnancy and breastfeeding if your doctor considers it necessary.

Driving and using machines
Tonsino does not or negligibly alters the ability to drive vehicles and operate machines.

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

Tonsino contains alcohol (ethanol)
This medicine contains 14.22 mg of ethanol (alcohol) in each spray, equivalent to 82.20 mg/ml of solution (8% w/w).
The amount in one spray of this medicine is equivalent to less than 1 ml of beer or 1 ml of wine. The small amount of alcohol in this medicine 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 oil flavouring
The peppermint oil flavouring may trigger hypersensitivity reactions (including dyspnoea) in sensitised patients.

3. How to take Tonsino

Take this medicine following exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have doubts, consult your doctor or pharmacist.
Dosage:
Tonsino is generally used 2-6 times a day.

Adults and adolescents starting from 12 years of age:
4-8 sprays at a time.

Children from 6 to 11 years:
4 sprays at a time.

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

Elderly patients:
Unless otherwise prescribed by the dentist or doctor, the dose specified for adults applies.
Method of administration
Oromucosal use.

Instructions for use:
Before the first use of Tonsino, the supplied throat adapter must be applied
to the pump and must not be removed. To ensure uniform atomization, before the first
application it is advisable to dispense the spray twice.
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
The involuntary ingestion of small quantities is harmless.
If you have ingested an excessive amount of medicine or have accidentally ingested a large
amount of medicine, contact your doctor or pharmacist immediately.
In case of improper use (i.e. if high quantities of Tonsino are ingested), side 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 you use too little Tonsino, the time before it starts to take effect may
be prolonged.
However, in this case the treatment may also not be successful.
If you forget to use Tonsino on one occasion, continue the treatment as recommended without
increasing the frequency or dose.

If you stop taking Tonsino
If you stop treatment with Tonsino or prematurely discontinue the use of Tonsino, the desired effect
may not be achieved or may lead to a new worsening of the
condition. Consult your doctor or pharmacist if you wish to stop or discontinue treatment.
If you have any further questions on the use of this medicine, ask 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)

• Redness or sunburn due to increased skin sensitivity to sunlight.

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

• Burning 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 and throat or mucous membranes (angioedema).
• Difficulty breathing (laryngospasm).

Not known(frequency cannot be estimated from available data)

• Allergic reactions (hypersensitivity reactions).

The signs of a severe allergic reaction (anaphylactic shock) can include shortness of breath (difficulty
breathing), chest pain, a feeling of tightness in the chest, dizziness, a feeling of weakness, intense
skin itching, lumps that can be felt on the skin, swelling of the face, lips, tongue and/or throat and
these can be potentially life-threatening.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist.
You can also report side effects directly through the national reporting system
at: 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 which is stated on the bottle and the packaging after
Exp. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
The shelf life after first opening is 3 months.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Tonsino contains

• The active ingredient is: benzydamine hydrochloride. 1 mL of solution contains 1.5 mg of benzydamine hydrochloride. Each spray delivers 0.18 ± 0.01 ml of solution containing 0.269 mg of benzydamine hydrochloride.
• The other ingredients are: methyl parahydroxybenzoate (E 218), ethanol (96 %), glycerol (85 %), sodium hydrogen carbonate, concentrated hydrochloric acid (for pH adjustment), polysorbate 20, sodium saccharin (E 954), purified water, peppermint aroma (contains: 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 typical taste and odour of peppermint aroma.
Colourless glass bottle (type III) closed with a dosing pump and protective cap and packaged
together with a throat adapter.
Tonsino is available in packs of 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 with the
following denominations:
Germany Tonsino Spray bei Halsschmerzen
Poland Nagardlan
Italy Tonsino

Tonsino 1.5 mg/ml oral mucosa solution

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

• Take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• 4.
• See a doctor if you do not feel better 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. Contents of the pack and other information

1. What is Tonsino and what is it used for

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

2. What you need to know before you take Tonsino

Do not takeTonsino

• if you are allergic to benzydamine hydrochloride or any of the other ingredients of this medicine (listed in section 6). Tonsino solution should 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:
Use of this medicine, particularly for prolonged periods, may cause sensitization. If this
happens, or if you experience any of the undesirable effects listed, the medicine should be
temporarily discontinued and you should contact your doctor.
Tonsino should be used with caution if you have a history of asthma, as bronchospasm may occur.
If the pain in your mouth and throat worsens or does not improve within 3 days, you should contact your doctor
or dentist who is treating you. Prolonged use of the medicine may affect the bacterial flora in
your mouth.
The use of benzydamine hydrochloride is not recommended if you are hypersensitive to salicylic acid or
other pain relievers called NSAIDs.

Children and adolescents
Tonsino should not be used in children under 12 years of age for safety and
efficacy reasons.
“For those who engage in sports, the use of medicines containing ethyl alcohol may result in positive
doping tests in relation to the alcohol concentration limits indicated by certain sports federations.”

Other medicines and Tonsino
Tell 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, suspect you may be pregnant or are planning a pregnancy, or if you are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine. The doctor
will decide whether you can use Tonsino

Driving and using machines
Tonsino does not alter the ability to drive vehicles and use machines

Tonsino contains Methylparahydroxybenzoate
This medicine contains 15 mg of methylparahydroxybenzoate in each 15 ml dose, which is equivalent to 1
mg/ml. Methylparahydroxybenzoate may cause local irritation.

Tonsino contains ethanol (alcohol)
This medicine contains 10.28 vol % of ethanol (alcohol) up to 1,233 mg per 15 ml dose,
equivalent to 100 ml of beer or 13 ml of wine.
Harmful for those suffering from alcoholism. Should be considered 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.
Talk to your doctor or pharmacist if you are taking other medicines.
If you are pregnant or breastfeeding, talk to your doctor or pharmacist before taking this
medicine.
If you are dependent on alcohol, talk to your doctor or pharmacist before taking this medicine.

3. How to take Tonsino

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, ask your doctor or pharmacist.

Adults and adolescents starting from 12 years of age:
The recommended dose is 2 to 3 times a day (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 and gargle for the same time if the throat is inflamed.
In case of severe pain, more frequent application (up to 5 times a day) is safe.
In the vast majority of cases, only a few days are needed to treat the acute signs of
inflammation with Tonsino.
In most cases, the therapeutic goal, which is the resolution of the signs of inflammation and
the disappearance of pain, especially during swallowing, is achieved within the first 2 - 4 days.
There are no concerns about prolonged use in case of stomatitis during irradiation. However, the
special warnings for long-term use must be considered as long-term treatment may affect the normal oral bacterial flora and use for
prolonged periods may cause sensitization.
Do not use the mouthwash continuously for more than 7 days, unless told to do so by your doctor or
dentist.

Elderly patients:
There are no special recommendations regarding the dose in elderly patients. Unless otherwise
prescribed by the dentist or doctor, the dose specified for adults applies.
Method of administration
For oral use only.
Tonsino solution is intended for gargling in the mouth and throat and must not be swallowed. Therefore,
Tonsino solution can only be used for gargling if it is possible to suppress the swallowing reflex and if you are able to spit out the solution after rinsing or gargling.
Do not eat or drink for 1 hour after using the product.
Instructions for use

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

If you take more Tonsino than you should
Ingestion of small amounts unintentionally is harmless.
With incorrect use (i.e. if larger quantities of Tonsino solution are ingested), side effects such as vomiting, abdominal pain, sleep disturbances, restlessness, anxiety,
convulsions, ataxia, fever, tachycardia and possibly respiratory paralysis may occur.
If you have ingested an excessive amount of medicine or have accidentally ingested a large amount
of medicine, contact your doctor or pharmacist immediately.
As a first measure, you could try to induce vomiting. Symptomatic treatment is recommended if signs of poisoning occur (e.g. respiratory support, removal of
the poison by pumping the stomach, etc.).

If you forget to take Tonsino
If you use too little Tonsino, the time before it starts to take effect may be
prolonged. However, even in this case the treatment may not succeed.
If you forget to use Tonsino on one occasion, continue the treatment as recommended without
increasing the frequency or dose.
If you have any further questions on the use of this medicine, ask 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)

• Redness or sunburn due to increased sensitivity of the skin to sunlight

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

• Burning in the mouth and dryness of the oral mucosa. 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).
• Difficulty breathing (laryngospasm).

Not known(frequency cannot be estimated from available data)

• Allergic reactions (hypersensitivity reactions)

Methylparahydroxybenzoate may cause allergic reactions (including delayed ones).
Signs of a severe allergic reaction (anaphylactic shock) may include shortness of breath (difficulty
breathing), chest pain, tightness in the chest, dizziness, feeling of weakness, severe itching of the
skin, lumps that can be felt on the skin, swelling of the face, lips, tongue and/or throat and
these can be potentially life-threatening.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist or nurse. You can also report side effects directly
through the national reporting system reported Website
web: 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 which is stated on the pack after Exp. The expiry date refers to the last day of that month.
Store in the original package to protect the medicine from light.
Once opened, the product must be used within 6 months.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Tonsino contains

• The active ingredient 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 aroma (contains: 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 typical taste and odor of peppermint aroma in a
colorless glass bottle with a screw cap. The pack includes a measuring cup.
Packs with 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 denominations