Package leaflet: Information for the user

Bisolmonus 600 mg effervescent tablets

Acetylcysteine
Generic medicine
Please read all of this leaflet carefully before you start 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 told you to do.

Keep this leaflet. You may need to read it again.
If you need more advice or information, consult your pharmacist.
If you experience any side effects, 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 8–10 days.

Contents of this leaflet:

What Bisolmonus is and what it is used for
What you need to know before taking Bisolmonus
How to take Bisolmonus
Possible side effects
How to store Bisolmonus
Contents of the pack and other information

1. What Bisolmonus is and what it is used for

Acetylcysteine breaks down and liquefies thick mucus, making it watery and easier to expel. Acetylcysteine is indicated in adults for the treatment of respiratory tract diseases in which reduction of bronchial secretion viscosity is required to facilitate expectoration, especially during episodes of acute bronchitis.
Consult your doctor if you do not feel better or if you feel worse after 8-10 days.

2. What you need to know before taking Bisolmonus

Do not take Bisolmonus

if you are allergic to acetylcysteine or to 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 may worsen this condition. In such a case, consult a doctor immediately.
If you have a stomach ulcer or have had one in the past, you are advised to exercise particular caution, as Bisolmonus may irritate the stomach lining, especially if you are taking other medicines that irritate the stomach lining.
Very rare cases of severe hypersensitivity reactions with high fever, red skin rashes, 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 syndrome), possibly related to the use of acetylcysteine, have been reported. If you develop new changes in the skin or mucous membranes, consult a doctor immediately and stop taking Bisolmonus.
If you are unable to effectively expel liquefied mucus (e.g. elderly or frail patients with impaired cough reflex), you should be particularly cautious. Especially at the beginning of treatment, mucus secretion may increase in volume as it becomes more fluid.
When opening the packaging, you may notice a slight sulfur-like odor (similar to rotten eggs). This is a property of the active ingredient and is normal. It does not indicate any defect in the medicine.

Children and adolescents
Bisolmonus may 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.

Other medicines and Bisolmonus
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
If you are using other medicines, do not dissolve them together with Bisolmonus.
If you need to take medicines to treat or prevent infections (antibiotics), it is advisable to take them two hours before or after taking Bisolmonus.
Bisolmonus may enhance the blood pressure-lowering effect of nitroglycerin (a medicine used to treat severe, painful chest sensations known as angina pectoris). Caution is required.
If you are taking activated charcoal (a medicine for traveler’s diarrhea), the effect of Bisolmonus may be reduced.
Acetylcysteine may bind to metallic salts such as gold, iron, and potassium salts, reducing their effectiveness in the body. Do not take these salts together with Bisolmonus, or maintain a time interval between administrations.

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 medicine.

Pregnancy
Data on the use of acetylcysteine in pregnant women are limited. Use acetylcysteine during pregnancy only if considered necessary by your doctor.

Breast-feeding
It is not known whether acetylcysteine is excreted in breast milk. If you are breast-feeding, consult your doctor before using acetylcysteine.

Fertility
Based on available data, there are no indications of potential effects of acetylcysteine on fertility.

Driving and using machines
Bisolmonus does not affect, or has a negligible effect on, the ability to drive vehicles or operate machinery.

Bisolmonus contains sodium, lactose and sorbitol
This medicine contains 6.03 mmol (or 138.8 mg) of sodium per dose. This should be taken into consideration in patients on a low-sodium diet.
This medicine contains lactose and sorbitol. If your doctor has informed you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.

3. How to take this medicine

Take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is:
Adults
Take one 600 mg effervescent tablet once daily.
Use in children
Bisolmonus must not be administered to children under 2 years of age and is not recommended in children and adolescents.
Dissolve the effervescent tablet in half a glass of water. Drink the solution immediately. The break line on the tablet is intended to facilitate breaking the tablet, making it dissolve more easily.
Do not take this medicine for longer than 8–10 days without consulting a doctor.
If you take more Bisolmonus than you should
If you have taken an excessive amount of Bisolmonus, contact your doctor or pharmacist immediately. You may experience nausea, vomiting, and diarrhoea.
If you forget to take Bisolmonus
If you have forgotten to take an effervescent tablet and it is almost time for your next dose, skip the forgotten tablet and continue as instructed in the section “How to take this medicine”. Do not take a double dose to make up for the forgotten tablet.

4. 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 department 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, pallor, agitation, weak pulse, clammy skin, reduced level of consciousness) due to sudden widening of blood vessels caused by a severe hypersensitivity to specific substances (anaphylactic shock).
Sudden accumulation of fluid in the skin and mucous membranes (e.g. throat or tongue), causing difficulty breathing and/or itching and skin 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 in this medicine and are uncommon (may affect up to 1 in 100 people):

Tightness due to spasms in the airway muscles (bronchospasm)
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 sensation, skin 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)
Decrease in 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):

Swelling of the face

If you develop gastric or intestinal ulcers, or have previously suffered from them, acetylcysteine may have an unfavourable effect on the gastrointestinal mucosa.
Reporting of side effects
If you get any side effects, 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: www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Bisolmonus

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after EXP. The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from moisture.
Laminated aluminium foil pack
No special storage conditions or temperature requirements are necessary.
Polypropylene tubes with polyethylene caps, containing a desiccant
Do not store above 30°C.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Bisolmonus contains

The active substance is acetylcysteine. Each effervescent tablet contains 600 mg of acetylcysteine.
The other components are citric acid, anhydrous, ascorbic acid, sodium citrate, sodium cyclamate, sodium saccharin, mannitol, sodium hydrogen carbonate, sodium carbonate, anhydrous, lactose, anhydrous, magnesium stearate and lemon flavour (composed of: natural lemon oil, natural/identical to natural lemon oil, mannitol (E421), maltodextrin, glucono delta-lactone (E575), sorbitol (E420), silica, anhydrous colloidal (E551)).

Description of the appearance of Bisolmonus and the contents of the pack
Bisolmonus are white, round effervescent tablets with a smooth surface, a score line on one side and a diameter of 20 mm.
Each effervescent tablet is individually sealed in an aluminium foil blister packed in a folding carton; alternatively, the tablets not individually sealed are packed in a polypropylene plastic bottle with polyethylene caps containing a desiccant with molecular sieve.
Pack sizes:
Cartons of 10 and 20 tablets.
Polypropylene bottles containing 10, 20 and 25 tablets.
Not all pack sizes may be marketed.
When opening the package, you may sometimes notice a slight odour of sulphur. This is normal and not harmful.

Marketing Authorisation Holder
Opella Healthcare Italy S.r.l.
Viale L. Bodio, 37/b
20158 Milano
Italy

Manufacturer
Hermes Pharma GmbH
Hans-Urmiller-Ring 52
82515 Wolfratshausen
Germany

This medicinal product is authorised in the EEA Member States under the following names:
Netherlands: Bisolaclar
Finland: Bisolaclar
Italy: Bisolmonus
Norway: Bisolaclar