Package leaflet: Information for the patient

LISTEMUL 200 mg granules for oral solution

Acetylcysteine
Please read this leaflet carefully before 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 instructed you.

Keep this leaflet. You may need to read it again.
If you need more information or advice, 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 a short period of treatment.

Contents of this leaflet:

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

1. What LISTEMUL is and what it is used for

This medicinal product contains the active substance acetylcysteine, which belongs to a group of medicines called expectorants - mucolytics, used to help eliminate mucus from the respiratory tract.
LISTEMUL is indicated for the treatment of respiratory diseases characterised by increased production of thick and viscous mucus (viscous, dense hypersecretion).
Consult your doctor if you do not feel better or if you feel worse after short periods of treatment.

2. What you need to know before taking LISTEMUL

Do not take LISTEMUL

if you are allergic to acetylcysteine or to any of the other ingredients of this medicine (listed in section 6);
if you are pregnant or breastfeeding (see section “Pregnancy and breastfeeding”);
if the person taking this medicine is a child under 12 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before taking LISTEMUL.
Take this medicine with caution and always under medical supervision in the following cases:

if you suffer from a bronchial inflammatory disease called bronchial asthma. Stop taking the medicine if bronchial muscle contractions occur (bronchospasm);
if you have or have had a stomach or intestinal disorder called peptic ulcer, especially if you are taking other medicines that cause stomach problems (gastrolesive drugs) together with LISTEMUL.

This medicine may increase the volume of bronchial mucus (bronchial secretions), especially at the beginning of treatment. Therefore, if this occurs and you are unable to clear the bronchial secretions by coughing (expectorate), consult your doctor, who will advise you on a method to remove the mucus (postural drainage or bronchoaspiration).
If you notice a sulphur-like odour, do not be concerned, as this does not indicate deterioration of the preparation but is due to acetylcysteine.
Acetylcysteine may interfere with certain blood and urine tests (colorimetric assay for salicylate determination and tests for detecting ketones). Inform your doctor that you are taking this medicine before undergoing any laboratory tests.

Other medicines and LISTEMUL
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take this medicine if you are taking:

cough suppressants (antitussives), as they may lead to accumulation of mucus in the bronchi.

Take this medicine with caution and consult your doctor if you are taking any of the following medicines:

activated charcoal, used to treat digestive disorders or intestinal gas (meteorism), as it may reduce the effectiveness of LISTEMUL;
antibiotics taken by mouth, used to treat infections. Take these medicines at least two hours apart from LISTEMUL;
nitroglycerin, used for certain heart conditions. Concurrent use of this medicine with LISTEMUL may cause low blood pressure (hypotension) and headache (cephalalgia).

Do not mix the LISTEMUL solution with other medicines.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Take this medicine during pregnancy or while breastfeeding only if strictly necessary and under direct medical supervision.

Driving and using machines
DISSOLVIN does not affect the ability to drive vehicles or operate machinery.

LISTEMUL contains sucrose and sunset yellow (E 110)
This medicine contains sucrose (each dose of LISTEMUL contains 2.24 g of sucrose), a type of sugar. If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.
This medicine contains sunset yellow (E 110), a colouring agent. It may cause allergic reactions.

3. How to take LISTEMUL

Take this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Instructions for use of LISTEMUL: dissolve the contents of the sachet in a glass containing a little water, mixing with a teaspoon.
Take the medicine immediately after preparing the solution.
The recommended dose of LISTEMUL for adults is 1 sachet of 200 mg, 2–3 times daily.
The duration of treatment is 5 to 10 days for acute conditions. For chronic conditions, the doctor may extend the treatment duration up to 1 or more months.
This medicine is intended for use in adults only.
If you take more LISTEMUL than you should
Cases of overdose have not been reported. Symptoms of overdose may include nausea, vomiting, and diarrhoea.
If you have taken or ingested more than the prescribed amount of this medicine, inform your doctor immediately or go to the nearest hospital.
If you forget to take LISTEMUL
Do not take a double dose to make up for a missed dose.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur:

Uncommon (may affect up to 1 in 100 people)

allergic reactions (hypersensitivity);
headache (cephalalgia);
ringing in the ears (tinnitus);
increased heart rate (tachycardia);
vomiting, diarrhoea, inflammation of the mouth (stomatitis), abdominal pain, nausea;
skin irritations (urticaria, rash), swelling due to fluid accumulation around the mouth and eyes (angioedema), itching;
fever (pyrexia);
decrease in blood pressure.

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

bronchial muscle contractions (bronchospasm);
difficulty in breathing (dyspnoea);
digestive problems (dyspepsia).

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

severe allergic reactions (anaphylactic shock, anaphylactic/anaphylactoid reaction);
bleeding (haemorrhage).

Not known (frequency cannot be estimated from the available data)

bronchial occlusion (bronchial obstruction);
facial swelling (facial oedema).

Contact your doctor if you experience any of the following side effects:

skin lesions (Stevens-Johnson syndrome or Lyell’s syndrome). If you notice changes in the mucous membranes or skin, stop taking the medicine;
blood disorders (reduced platelet aggregation).

Reporting of side effects
If you experience any side effect, 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/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store LISTEMUL

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after Exp. The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from moisture.
Do not dispose of any medicine 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 LISTEMUL contains

The active substance is acetylcysteine: each sachet contains 200 mg of acetylcysteine.
The other components are: granular orange juice, orange flavour, saccharin, sunset yellow (E 110), sucrose.

Description of the appearance of LISTEMUL and contents of the pack
Carton containing 30 sachets of 3 g each.
Marketing Authorisation Holder
FG S.r.l. – Via San Rocco, 6 – 85033 EPISCOPIA (PZ)
Manufacturer
Mipharm S.p.A. – Via Bernardo Quaranta, 12 – 20139 MILANO