TONSINO*OS SOL 240ML1.5MG/ML

Tonsino 1.5 mg/ml oral mucosa solution
Benzydamine hydrochloride

What it is and what it is 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 used for the symptomatic treatment of pain and irritation of the mouth and throat in adults and adolescents from 12 years of age.

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 feel better or if you feel worse after 3 days.

What you need to know before taking the medicine
Do not take Tonsino:
- 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
Consult your doctor or pharmacist before taking Tonsino or if you experience the following symptoms:
The use of this medicine, especially for prolonged periods, can cause sensitization. If this happens, or if you experience any of the listed side effects, 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 mouth and throat pain worsens or does not improve within 3 days, you should contact your doctor or dentist. Prolonged use of the medicine can affect the bacterial flora in the 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 due to safety and efficacy.

For those engaged in sports activities, the use of medicines containing ethyl alcohol may result in positive anti-doping tests in relation to the alcohol concentration limits indicated by some sports federations.

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 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);
• Difficulty breathing (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, chest tightness, dizziness, feeling weak, severe skin itching, nodules 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, including any not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazionireazioni-avverse.
By reporting side effects you can help provide more information on the safety of this medicine.