Package leaflet: Information for the patient

ERDOMED MUKO, 225 mg, powder for oral suspension
Erdosteinum
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by
the physician or pharmacist.

Keep this leaflet for future reference.
If you need advice or further information, consult your pharmacist.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 3 days, or if symptoms worsen, consult your doctor.

Table of contents:

What Erdomed Muko is and what it is used for
Important information before taking Erdomed Muko
How to take Erdomed Muko
Possible side effects
How to store Erdomed Muko
Contents of the pack and other information

1. What Erdomed Muko is and what it is used for

Erdomed Muko contains the active substance erdosteine, which belongs to a group of medicines called mucolytics that reduce the viscosity of mucus in the respiratory tract and facilitate its expectoration.
Erdomed Muko is used to liquefy and help expel mucus secretions from the respiratory tract, as an adjunctive treatment in acute and chronic respiratory disorders, such as inflammatory conditions of the nose, sinuses, larynx, trachea, bronchi, and lungs.
If there is no improvement after 3 days, or if the patient feels worse, medical advice should be sought.

2. Important information before using Erdomed Muko

When not to use Erdomed Muko:

if the patient is allergic to the active substance, any of the other ingredients of this medicine (listed in section 6), or to substances containing free SH groups (e.g., acetylcysteine);
if the patient has liver function disorders;
if the patient has renal failure (creatinine clearance <25 ml/min);
if the patient has homocystinuria (a genetically determined metabolic disorder involving abnormal metabolism of the amino acid methionine);
in children under 12 years of age.

Warnings and precautions
Before starting treatment with Erdomed Muko, discuss this with your doctor or pharmacist.
If typical symptoms of hypersensitivity occur (rash, urticaria), treatment must be discontinued immediately.
Use with caution in patients with weakened cough reflex or impaired ciliary clearance (due to the risk of accumulation of large amounts of mucus).
Children
This medicine should not be given to children under 12 years of age.
Erdomed Muko and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
Clinically significant adverse interactions with other medicines used in the treatment of respiratory tract infections and chronic obstructive pulmonary disease, such as theophylline, bronchodilators (corticosteroids), erythromycin, amoxicillin, or co-trimoxazole, have not been observed.
Following administration of erdosteine, increased concentrations of amoxicillin in the respiratory tract have been demonstrated.
Erdomed Muko should not be used with antitussive medicines, as they may suppress the cough reflex and impair expectoration of liquefied secretions.
Erdomed Muko with food and drink
Food and drink do not affect absorption of the medicine.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Use of this medicine is not recommended in pregnant or breastfeeding women.
Driving and operating machinery
Erdomed Muko has no influence on the ability to drive or operate machinery.
Erdomed Muko contains sucrose, glucose (as part of maltodextrin), benzyl alcohol, and sodium.
Sucrose
The medicine contains 3.5 g of sucrose per sachet. This should be taken into account in patients with diabetes.
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact a doctor before taking the medicine.
Glucose (as part of maltodextrin)
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact a doctor before taking the medicine.
Benzyl alcohol
The medicine contains 0.01 mg of benzyl alcohol per sachet. Benzyl alcohol may cause allergic reactions. Pregnant or breastfeeding women and patients with liver or kidney disease should contact a doctor before using the medicine, as large amounts of benzyl alcohol may accumulate in their bodies and cause adverse effects (so-called metabolic acidosis).
Sodium
The medicine contains less than 1 mmol (23 mg) of sodium per sachet, meaning the medicine is considered "sodium-free".

3. How to use Erdomed Muko

This medicine should always be used exactly as described in this patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.

Recommended dosage
Use in children from 12 years of age
1 sachet twice daily.

Use in adults
1 sachet two or three times daily.
Dose adjustment is not required in adults during exacerbations of chronic obstructive pulmonary disease (COPD).

Use of Erdomed Muko in patients with renal function impairment
Dose adjustment is not required in adults with moderate renal impairment (creatinine clearance >25 ml/min).

Use of Erdomed Muko in elderly patients
There is no need to modify the dosage in patients over 65 years of age.

Method of administration
Empty the contents of one sachet into approximately 120 ml (half a standard glass) of water at room temperature and, if necessary, stir until a thin, cloudy suspension is obtained. Administer orally immediately after preparation, according to the dosing regimen outlined above.

This medicine should not be taken before going to bed due to difficulty in expectorating the liquefied secretions during sleep.

If there is no improvement after 3 days of treatment or if the patient's condition worsens, consult a doctor.

Overdose of Erdomed Muko
No cases of overdose have been reported.
In case of ingestion of a dose higher than recommended, seek immediate medical advice from a doctor.

Missed dose of Erdomed Muko
If the medicine is taken regularly and only a short time has passed since the missed dose, it should be taken as soon as possible. If the next dose is approaching, take the next dose at the usual time.

Do not take a double dose to make up for a missed dose.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like any medicine, this medicine can cause adverse effects, although not everyone experiences them.
The following adverse effects have been reported:

Common (in 1 to 10 out of 100 patients): abdominal pain, nausea, headache.
Uncommon (in 1 to 10 out of 1,000 patients): heartburn, constipation, diarrhoea, dry mouth, dizziness, general malaise.
Rare (in 1 to 10 out of 10,000 patients): loss of taste sensation or taste disturbances, allergic reactions: rash, urticaria, fever.

Other adverse effects may occur in some individuals during treatment with Erdomed Muko.
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel. + 48 22 49 21 301, fax: + 48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Adverse effects can also be reported to the Marketing Authorisation Holder.
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Erdomed Muko

Keep this medicine out of the sight and reach of children.
Store below 25°C.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the packaging and other information

What Erdomed Muko contains

The active substance is erdosteine. Each sachet contains 225 mg of erdosteine.
The other ingredients are: sucrose, sodium carboxymethyl starch (type A), silicon dioxide, sucralose (E 955), anhydrous malic acid, orange flavour [corn maltodextrin, flavouring substances (including, among others, citral, benzyl alcohol, linalool), α-tocopherol (E 307)].

What Erdomed Muko looks like and contents of the pack
Erdomed Muko is a powder for oral suspension.
The immediate packaging of the medicine is a sachet made of paper and aluminium/LDPE foil, containing 225 mg of erdosteine.
Carton packs contain 10 or 20 sachets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Angelini Pharma Polska Sp. z o.o.
Aleje Jerozolimskie 181B
02-222 Warsaw
tel. (22) 70 28 200
email: [email protected]

Manufacturer:
Fine Food & Pharmaceuticals N.T.M. S.p.A
Via Grignano, 43
24041 Brembate (BG)
Italy
of the marketing authorisation holder.