033Q
BISOLMONUS 600 MG EFFERVESCENT TABLETS 10 TABLETS IN AL/PAP BLISTER
BISOLMONUS 600 MG EFFERVESCENT TABLETS 10 TABLETS IN AL/PAP BLISTER
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Description
Description
Bisolmonus 600 mg effervescent tablets
Acetylcysteine
Equivalent medicine
What is it and what is it for?
Acetylcysteine breaks down and thins thick mucus, making it watery and easier to cough up. 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.
Talk to your doctor if you do not feel better or if you 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 should not use this medicine.
Warnings and precautions
Talk to your doctor or pharmacist before taking Bisolmonus.
If you suffer from asthma or have a history of bronchospasm (narrowing/cramping of the airways), Bisolmonus should be used with particular caution, as treatment with Bisolmonus may aggravate this condition. If this occurs, consult a doctor immediately.
If you suffer from a stomach ulcer or have suffered from one in the past, you are advised to be especially careful, as Bisolmonus can irritate the stomach lining, especially if you take other medicines that irritate the stomach lining.
Very rare cases of serious hypersensitivity reactions with high fever, red marks on the skin, joint pain, and/or eye inflammation (Stevens-Johnson syndrome) and acute hypersensitivity reactions associated with fever and skin blistering or peeling (Lyell's syndrome) have been reported, which may be associated with the use of acetylcysteine. If you experience new changes in your skin or mucous membranes, consult a doctor immediately and stop taking Bisolmonus.
If you are unable to expel thin mucus effectively (e.g., elderly or frail patients with impaired cough reflex). You should be especially careful at the beginning of treatment, as the mucus secretion may increase in volume as it becomes thinner.
When you open the package, you may notice a slight sulfurous odor (rotten egg odor). This is a characteristic of the active ingredient and is normal. It does not indicate any abnormality in the medicine.
Children and adolescents
Bisolmonus may block the airways in children under 2 years of age, as their ability to clear mucus is limited. Therefore, Bisolmonus should 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 to the emergency department of a nearby hospital. These side effects are very rare (may affect up to 1 in 10,000 people):
• Shock (rapid reduction in blood pressure, paleness, agitation, weak pulse, clammy skin, reduced level of consciousness) due to sudden widening of blood vessels caused by 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 substance of this medicine and are uncommon (may affect up to 1 in 100 people):
• Tension due to cramps in the muscles of the airways (bronchospasms)
• Difficulty breathing, wheezing, or chest tightness (dyspnea)
Other side effects
Uncommon (may affect up to 1 in 100 people):
• Hypersensitivity reactions such as increased heart rate (tachycardia), itching, severely itchy and spotty skin rash (hives)
• Heachache
• Ringing in the ears (tinnitus)
• Inflammation of the mucous membrane in the mouth (stomatitis)
• Stomach ache (abdominal pain)
• Nausea, vomiting
• Diarrhea
• Fever (pyrexia)
• Reduction of 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 not known (frequency cannot be estimated from the available data)
• Facial swelling
If you develop gastric or intestinal ulcers, or have had them in the past, acetylcysteine may have an adverse effect on the gastrointestinal mucosa.
Reporting of side effects
If you experience 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.
033Q
BISOLMONUS 600 MG EFFERVESCENT TABLETS 10 TABLETS IN AL/PAP BLISTER
BISOLMONUS 600 MG EFFERVESCENT TABLETS 10 TABLETS IN AL/PAP BLISTER
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