Erdosol Muco

Package Leaflet: Information for the Patient

Erdosol Muco, 300 mg, Tablets

Erdostein

Read the Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

Erdosol Muco contains the active substance erdosteine, which belongs to the group of mucolytic drugs - reducing the viscosity of bronchial secretions and facilitating expectoration.
Erdosol Muco is recommended for the treatment of secretolytic therapy in acute and chronic upper respiratory tract diseases, bronchi and lungs with accompanying abnormal secretion and transport of mucous secretion.
It is also used for preventive treatment of seasonal exacerbations of chronic bronchitis.
Erdosol Muco is indicated for use in adults and adolescents over 12 years of age.

2. Important information before taking Erdosol Muco

When not to take Erdosol Muco:

Warnings and precautions

Before starting treatment with Erdosol Muco, discuss it with your doctor or pharmacist.
In case of typical symptoms of hypersensitivity (rash, urticaria), discontinue treatment 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 side effects can be reduced by using the smallest effective doses for as short a period as possible.
If no improvement occurs, the patient should consult a doctor who will consider discontinuing treatment.
No dose adjustment is required in adults with chronic obstructive pulmonary disease (COPD).

Children and adolescents

The medicine should not be given to children under 12 years of age.

Elderly patients

No dose adjustment is necessary in patients over 65 years of age.

Patients with renal impairment

Erdosol Muco should not be used in patients with renal impairment.
In patients with severe renal impairment, metabolites of erdosteine produced in the liver may accumulate.

Erdosol Muco and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
No interactions have been observed with other medicines used to treat respiratory infections and chronic obstructive pulmonary disease, such as: theophylline, drugs causing bronchial smooth muscle relaxation (corticosteroids), erythromycin, amoxicillin or cotrimoxazole.
After administration of erdosteine, an increase in amoxicillin concentration in the respiratory tract has been demonstrated.
Concomitant treatment with antitussive drugs may cause accumulation of large amounts of bronchial secretions, which may worsen the patient's condition in the course of the disease, e.g. due to decreased respiratory function.
To avoid complications, antitussive and secretolytic drugs (increasing secretion) should not be combined, especially before bedtime.

Erdosol Muco with food and drink

Food and drink do not affect the absorption of the medicine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
The use of the medicine is not recommended in pregnant or breastfeeding women.

Driving and using machines

Erdosol Muco has no influence on the ability to drive and use machines.

Erdosol Muco contains sodium

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

3. How to take Erdosol Muco

This medicine should always be taken exactly as directed by your doctor. If you are unsure, consult your doctor or pharmacist.
The recommended dose for adults and adolescents over 12 years of age is:
1 tablet of 300 mg twice a day.
The medicine should not be taken before bedtime.

Overdose of Erdosol Muco

If you have taken more than the recommended dose of the medicine, tell your doctor or pharmacist immediately.
No cases of overdose have been reported.

Missed dose of Erdosol Muco

Take the recommended dose as soon as possible, and then continue with the previous dosing schedule. If it is time for the next dose, take only one dose, and then continue with the recommended dosing schedule.
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, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Erdosol Muco can cause side effects, although not everybody gets them.
The following side effects have been reported:

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

In some individuals, other side effects may occur during treatment with Erdosol Muco.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Erdosol Muco

Keep the medicine out of the sight and reach of children.
There are no special precautions for storage.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Erdosol Muco contains

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

What Erdosol Muco looks like and contents of the pack

Erdosol Muco is a white, elongated tablet.
One pack of the medicine contains 10, 20 or 120 tablets, in a cardboard box with a leaflet.

Marketing authorization holder:

Solinea Sp. z o.o.
Elizówka, ul. Szafranowa 6
21-003 Ciecierzyn
e-mail: [email protected]
{Logo of the marketing authorization holder}

Manufacturer:

Mako Pharma Sp. z o.o.
Kolejowa 231A
05-092 Dziekanów Polski
Medicofarma S.A.
ul. Tarnobrzeska 13
26-613 Radom

Date of last revision of the leaflet: