Erdosol Respiro

Package Leaflet: Information for the Patient

Erdosol Respiro, 225 mg, Tablets

Erdostein

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist.

• -Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If after 3 days there is no improvement or the patient feels worse, they should contact their doctor.

Table of Contents of the Leaflet

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

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

Erdosol Respiro contains the active substance erdosteine, which belongs to the group of mucolytic agents - reducing the viscosity of bronchial secretions and facilitating expectoration. Erdosol Respiro is used to thin and facilitate the expectoration of mucous secretions from the respiratory tract, as an adjunctive treatment for acute and chronic respiratory diseases, such as nasal, sinus, laryngeal, tracheal, bronchial, and pulmonary conditions. If after 3 days there is no improvement or the patient feels worse, they should consult their doctor. Erdosol Respiro is indicated for use in adults and adolescents over 12 years of age.

2. Important information before taking Erdosol Respiro

When not to take Erdosol Respiro:

• if the patient is allergic to the active substance or 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 impairment
• if the patient has homocystinuria (a genetically determined metabolic disorder characterized by 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 Respiro, the patient should discuss it with their doctor or pharmacist. In case of typical hypersensitivity symptoms (rash, urticaria), treatment should be discontinued immediately. The medicine should be used with caution in patients with weakened cough reflex or disorders of mucociliary 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 the shortest possible period. If there is no improvement, the patient should consult their 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 Respiro 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 Respiro and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. No interactions have been observed with other medicines used to treat respiratory infections and chronic obstructive pulmonary disease, such as theophylline, bronchodilators (corticosteroids), erythromycin, amoxicillin, or cotrimoxazole. After administration of erdosteine, an increase in amoxicillin concentration in the respiratory tract has been observed. Combined treatment with cough suppressants may cause accumulation of large amounts of bronchial secretions, which can worsen the patient's condition. To avoid complications, cough suppressants and expectorants should not be combined, especially before bedtime.

Erdosol Respiro 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, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine. The use of Erdosol Respiro is not recommended in pregnant or breastfeeding women.

Driving and using machines

Erdosol Respiro has no effect on the ability to drive and use machines.

Erdosol Respiro contains sodium

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

3. How to take Erdosol Respiro

This medicine should always be taken exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist. The recommended dose for adolescents over 12 years of age: 1 tablet 2 times a day. The recommended dose for adults: 1 tablet 2 or 3 times a day. The medicine should not be taken before bedtime. If after 3 days there is no improvement or the patient feels worse, they should consult their doctor.

Overdose of Erdosol Respiro

In case of overdose, the patient should immediately inform their doctor or pharmacist. No cases of overdose have been reported.

Missed dose of Erdosol Respiro

The patient should take the missed dose as soon as possible and then continue with the usual dosing schedule. If it is almost time for the next dose, the patient should skip the missed dose and continue with the regular dosing schedule. The patient should not take a double dose to make up for the missed dose. In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

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

• Frequent (in 1 to 10 out of 100 patients): abdominal pain, nausea, headache
• Uncommon (in 1 to 10 out of 1000 patients): heartburn, constipation, dry mouth, dizziness, general malaise, diarrhea
• Rare (in 1 to 10 out of 10,000 patients): loss of taste or taste disorders, allergic reactions: rash, urticaria, fever

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

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should inform their 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, phone: +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. By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Erdosol Respiro

The medicine should be stored out of sight and reach of children. There are no special precautions for storage. The medicine should not be used after the expiry date stated on the packaging. The expiry date refers to the last day of the month. Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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 Respiro contains

• The active substance of the medicine is erdosteine. One tablet contains 225 mg of erdosteine.
• The other ingredients are: colloidal anhydrous silica, anhydrous calcium hydrogen phosphate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, corn starch, sodium carboxymethylcellulose (type A), sucralose.

What Erdosol Respiro looks like and contents of the pack

Erdosol Respiro is a white, round, biconvex tablet. One pack of the medicine contains 10 or 20 tablets, in a cardboard box with a leaflet.

Marketing authorization holder:

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

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:05/2024