BISOLMONUS*10 EFF TABS 600MG

Bisolmonus 600 mg effervescent tablets
Acetylcysteine
Equivalent medicinal product

What it is and what it is used for
Acetylcysteine breaks down and thins thick mucus, making it watery and easy to expel. Acetylcysteine is indicated in adults for the treatment of respiratory diseases where it is necessary to reduce the viscosity of bronchial secretions to facilitate expectoration, especially during periods of acute bronchitis.

Consult your doctor if you do not feel better or feel worse after 8-10 days.

What you need to know before taking the medicine
Do not take Bisolmonus
- if you are allergic to acetylcysteine or any of the other ingredients of this medicine (listed in section 6).
- Children under 2 years of age must not use this medicine.

Warnings and precautions
Talk to your doctor or pharmacist before taking Bisolmonus.

If you suffer from asthma or have previously experienced episodes of bronchospasm (narrowing/cramping of the airways), Bisolmonus should be taken with particular caution as treatment with Bisolmonus could worsen this condition. In such a case, consult a doctor immediately.

If you suffer from a stomach ulcer or have suffered from one in the past, it is advisable to pay particular attention, as Bisolmonus can irritate the stomach lining, especially if you are using other medicines that irritate the stomach lining.

Very rare cases of severe hypersensitivity reactions with fever (high), red marks on the skin, joint pain and/or eye inflammation (Stevens-Johnson syndrome) and acute hypersensitivity reactions associated with fever and blisters on the skin or skin peeling (Lyell's syndrome) have been reported, which could be associated with the use of acetylcysteine. If you experience new changes in the skin or mucous membranes, consult a doctor immediately and stop taking Bisolmonus.

If you are unable to effectively expel fluid mucus (e.g., elderly or fragile patients with impaired cough reflex). Especially at the beginning of treatment, you must pay particular attention, as the secretion of mucus can increase in volume as it becomes more fluid.

When you open the package, you may notice a slight sulfur smell (smell of rotten eggs). This is a property of the active ingredient and is normal. It does not indicate any anomaly in the medicine.

Children and adolescents
Bisolmonus can block the airways in children under 2 years of age, as their ability to expel mucus is limited. For this reason, Bisolmonus must not be used in children under 2 years of age.

Bisolmonus is not suitable for children and adolescents.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you experience any of the following very serious side effects, stop using Bisolmonus immediately and contact your doctor, or go immediately to the emergency room of a nearby hospital. These side effects are very rare (may affect up to 1 in 10,000 people):
• Shock (rapid drop in blood pressure, paleness, agitation, weak pulse, clammy skin, reduced state of consciousness) due to sudden widening of blood vessels due to severe hypersensitivity to specific substances (anaphylactic shock).
• Sudden accumulation of fluid in the skin and mucous membranes (e.g., throat or tongue) with difficulty breathing and/or itching and rash, often due to an allergic reaction (angioedema).

Contact your doctor if you experience any of the following side effects. These side effects are part of a hypersensitivity reaction to the active ingredient of this medicine and are uncommon effects (may affect up to 1 in 100 people):
• Tightness due to cramps in the airway muscles (bronchospasms)
• Difficulty breathing, shortness of breath or chest tightness (dyspnoea)

Other side effects

Uncommon (may affect up to 1 in 100 people):
• Hypersensitivity reactions such as increased heart rate (tachycardia), itching, rash with severe itching and appearance of spots (urticaria)
• Headache
• Ringing in the ears (tinnitus)
• Inflammation of the mucous membrane in the mouth (stomatitis)
• Stomach ache (abdominal pain)
• Nausea, vomiting
• Diarrhoea
• Fever (pyrexia)
• Reduced blood pressure

Rare (may affect up to 1 in 1,000 people)
• Impaired digestion with heartburn (dyspepsia)

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

Frequency unknown (frequency cannot be estimated from the available data)
• Facial swelling

If you develop stomach or intestinal ulcers, or if you have suffered from them in the past, acetylcysteine may have an unfavourable effect on the gastrointestinal mucous membrane.

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.