Erdosol muco

Package leaflet: Information for the patient

Erdosol Muco, 300 mg, tablets
Erdosteinum
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What Erdosol Muco is and what it is used for
2. Important information before taking Erdosol Muco
3. How to take Erdosol Muco
4. Possible side effects
5. How to store Erdosol Muco
6. Contents of the pack and other information

1. What Erdosol Muco is and what it is used for

Erdosol Muco contains the active substance erdosteine, which belongs to a group of medicines
called mucolytics – reducing the viscosity of bronchial secretions and facilitating expectoration.
Erdosol Muco is indicated for secretolytic treatment in acute and chronic diseases of the upper
respiratory tract, bronchi and lungs associated with impaired secretion and mucus transport.
It is also used for the prophylactic treatment of seasonal exacerbations of chronic bronchitis.
Erdosol Muco is indicated for use in adults and adolescents above 12 years of age.

2. Important information before using Erdosol Muco

When not to use Erdosol Muco:

• if the patient is allergic to the active substance or to 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 impaired liver function
• if the patient has renal insufficiency
• if the patient has homocystinuria (a genetically determined metabolic disorder involving abnormal metabolism of the amino acid methionine) (especially in patients on a methionine-free diet)
• in children under 12 years of age.

Warnings and precautions
Before starting treatment with Erdosol Muco, discuss it with a 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).
The risk of adverse reactions can be reduced by using the smallest effective doses for the shortest possible duration.
If no improvement occurs, the patient should consult a doctor, who may consider discontinuing treatment.
Dose adjustment is not required in adults with chronic obstructive pulmonary disease (COPD).

Children and adolescents
Erdosol Muco should not be administered to children under 12 years of age.

Elderly patients
There is no need to modify the dosage in patients aged over 65 years.

Patients with renal impairment
Erdosol Muco should not be used in patients with impaired renal function.
In patients with severe renal insufficiency, metabolites of erdosteine formed in the liver may accumulate.

Erdosol Muco and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines planned for future use.
No interactions have been observed 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.
After administration of erdosteine, increased concentrations of amoxicillin in the respiratory tract have been demonstrated.
Combination therapy with antitussive medicines (cough suppressants) may lead to accumulation of large amounts of bronchial secretions, potentially worsening the patient's condition, for example by impairing respiratory function.
To avoid complications, antitussive and secretolytic (mucus-increasing) medicines should not be combined, especially before going to sleep.

Erdosol Muco with food and drink
Food and drink do not affect the absorption of the medicine.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Use of this medicine is not recommended in pregnant or breastfeeding women.

Driving and operating machinery
Erdosol Muco has no influence on the ability to drive or operate machinery.

Erdosol Muco contains sodium
Erdosol Muco contains less than 1 mmol (23 mg) of sodium per tablet; therefore, the medicine is considered "sodium-free".

3. How to use Erdosol Muco

This medicine should always be used according to the doctor's instructions. In case of doubts, consult
your doctor or pharmacist.
The recommended dose for adults and adolescents over 12 years of age is:
1 tablet of 300 mg twice daily.
This medicine should not be taken before going to bed.
Taking more than the recommended dose of Erdosol Muco
If you take more than the recommended dose, inform your doctor or pharmacist immediately.
No cases of overdose have been reported.
Missed dose of Erdosol Muco
Take the missed dose as soon as possible, then continue with the usual dosing schedule.
If it is almost time for the next dose, take only one dose as scheduled and continue with the recommended dosing regimen.
Do not take a double dose to make up for a missed dose.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The following adverse reactions 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
• Rare (in 1 to 10 out of 10,000 patients): loss of taste or taste disturbances, constipation, dry mouth, dizziness, malaise, diarrhoea, allergic reactions: rash, urticaria, fever.

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

5. How to store Erdosol Muco

Keep this medicine out of the sight and reach of children.
No special storage instructions are required for this medicine.
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 help protect the environment.

6. Contents of the pack and other information

What Erdosol Muco contains

• The active substance is erdosteine. Each tablet contains 300 mg of erdosteine.
• The other ingredients are: colloidal anhydrous silica, anhydrous calcium hydrogen phosphate, magnesium stearate, microcrystalline cellulose, pregelatinized maize starch, sodium carboxymethyl starch (type A), sucralose.

What Erdosol Muco looks like and contents of the pack
Erdosol Muco is in the form of white, elongated tablets.
One pack contains 10, 20 or 120 tablets in a cardboard box with a leaflet.
Marketing Authorisation Holder:
Solinea Sp. z o.o.
Elizówka, Szafranowa 6
21-003 Ciecierzyn
e-mail: [email protected]
{Logo of the marketing authorisation holder}
Manufacturer:
Mako Pharma Sp. z o.o.
Kolejowa 231A
05-092 Dziekanów Polski
Medicofarma S.A.
Tarnobrzeska 13
26-613 Radom