Erdosol respiro

Package leaflet: Information for the patient

Erdosol Respiro, 225 mg, tablets
Erdosteinum
Please read this leaflet carefully before taking 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 doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, please 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 your condition worsens, consult your doctor.

Table of contents

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

Erdosol Respiro contains the active substance erdosteine, which belongs to a group of medicines
called mucolytics – agents that reduce the viscosity of bronchial secretions and facilitate expectoration.
Erdosol Respiro is used to liquefy and facilitate the expectoration of mucus from the respiratory tract,
as an adjunctive treatment in acute and chronic respiratory disorders, such as inflammatory conditions
of the nose, paranasal sinuses, larynx, trachea, bronchi, and lungs.
If there is no improvement after 3 days or if your condition worsens, consult your doctor.
Erdosol Respiro is indicated for use in adults and adolescents above 12 years of age.

2. Important information before using Erdosol Respiro

When not to use Erdosol Respiro:

• 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 liver function disorders
• if the patient has renal failure
• 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 Respiro, 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).
The risk of adverse reactions can be reduced by using the lowest 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 Respiro must not be given 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 Respiro must not be used in patients with impaired renal function.
In patients with severe renal failure, metabolites of erdosteine formed in the liver may accumulate.

Erdosol Respiro and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
No interactions have been observed with other medicines used in the treatment of respiratory tract infections and chronic obstructive pulmonary disease (COPD), 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.
Concomitant use with antitussive medicines (cough suppressants) may lead to accumulation of large amounts of bronchial secretions, which may worsen 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 sleep.

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, 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
Erdosol Respiro has no influence on the ability to drive or operate machinery.

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

3. How to use Erdosol Respiro

This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Recommended dose for adolescents over 12 years of age:
1 tablet twice daily.
Recommended dose for adults:
1 tablet two or three times daily.
This medicine should not be taken before going to sleep. If there is no improvement after 3 days, or if the patient feels worse, consult a doctor.
Taking more Erdosol Respiro than recommended
If more than the recommended dose is taken, inform a doctor or pharmacist immediately.
No cases of overdose have been reported.
Missing a dose of Erdosol Respiro
Take the missed dose as soon as possible, then continue according to the prescribed schedule. If it is almost time for the next dose, take only one dose and continue with the prescribed dosing regimen.
Do not take a double dose to make up for a missed dose.
If there are any further doubts regarding the use of this medicine, consult a 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, constipation, dryness of the mouth, dizziness, general malaise, diarrhoea
• Rare (in 1 to 10 out of 10,000 patients): loss of taste or taste disturbances, allergic symptoms: rash, urticaria, fever

Other adverse reactions may occur in some individuals during treatment with Erdosol Respiro.
Reporting of adverse reactions
If any adverse effects occur, including any adverse effects 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, tel.: +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 authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Erdosol Respiro

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 will help protect the environment.

6. Contents of the packaging and other information

What Erdosol Respiro contains

• The active substance 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 corn starch, sodium carboxymethyl starch (type A), sucralose.

What Erdosol Respiro looks like and contents of the pack
Erdosol Respiro is a white, round, biconvex tablet.
One pack contains 10 or 20 tablets in a cardboard box with a leaflet.
Marketing Authorisation Holder:
{Logo of the marketing authorisation 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