Erdomed

Package Leaflet: Information for the Patient

ERDOMED

300 mg, capsules

Erdostein

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

• Keep this leaflet, you may need to read it again.
• In case of any further questions, consult a doctor or pharmacist.
• This medicine has been prescribed to you by a doctor, do not pass it on to others.
• The medicine may harm another person, even if their symptoms are the same.
• If any of the side effects get worse or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

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

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

Erdomed contains the active substance erdosteine, which belongs to a group of mucolytic agents - reducing the viscosity of bronchial secretions and facilitating expectoration. Erdomed 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 mucus. It is also used for preventive treatment of seasonal exacerbations of chronic bronchitis.

2. Important information before taking Erdomed

When not to take Erdomed:

• in children under 12 years of age.

Warnings and precautions

In case of typical symptoms of hypersensitivity (rash, urticaria), treatment should be stopped immediately. Use with caution in patients with weakened cough reflex or disorders of 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 the shortest possible period. If there is no improvement, the doctor will consider stopping treatment. No dose adjustment is required in adults with chronic obstructive pulmonary disease (COPD).

Children

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

Taking Erdomed with food and drink

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

Taking Erdomed in patients with kidney function disorders

In patients with severe kidney failure, erdosteine metabolites produced in the liver may accumulate.

Taking Erdomed in elderly patients

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

Other medicines and Erdomed

No interactions have been observed with other medicines used to treat respiratory infections and chronic obstructive pulmonary disease, such as theophylline, smooth muscle relaxants (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 (antitussives) may cause accumulation of large amounts of bronchial secretions, which can worsen the patient's condition. To avoid complications, do not routinely combine cough suppressants and secretolytic agents (increasing secretion), especially before bedtime.

Pregnancy, breastfeeding, and fertility

Before taking the medicine, consult a doctor. The decision to use the medicine is made by the doctor.

Driving and using machines

Erdomed does not affect the ability to drive and use machines.

Erdomed contains the following excipients:

povidone, microcrystalline cellulose, magnesium stearate, gelatin, titanium dioxide (E171), yellow iron oxide (E172), indigotine (E132).

3. How to take Erdomed

Take this medicine always as directed by your doctor. If you are not sure, consult your doctor or pharmacist. The recommended dose for adults is: 1 capsule of 300 mg twice a day. Do not take the medicine before bedtime.

Taking a higher dose of Erdomed than recommended.

No cases of overdose have been reported. If you have taken more than the recommended dose, consult a doctor immediately.

Missing a dose of Erdomed:

Take the prescribed 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 the missed dose. If you have any further questions about taking this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Erdomed can cause side effects, although not everybody gets them.

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

In some people, other side effects may occur during treatment with Erdomed.

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, 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. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Erdomed

Keep the medicine out of the sight and reach of children. Store in a temperature below 25°C. Do not take Erdomed after the expiry date stated on the carton. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Erdomed contains

The active substance is erdosteine. One capsule contains 300 mg of erdosteine. The other ingredients are: povidone, microcrystalline cellulose, magnesium stearate, gelatin, titanium dioxide (E171), yellow iron oxide (E172), indigotine (E132).

What Erdomed looks like and contents of the pack

The pack contains 10, 20, or 60 capsules in PVC/PVdC/Aluminum blisters in a cardboard box. Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder: Angelini Pharma Polska Sp. z o.o., Aleje Jerozolimskie 181B, 02-222 Warsaw, email: [email protected]. Manufacturer: Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A., Via Vecchia del Pinocchio, 22, 60131 Ancona, Italy; Astrea Fontaine, Rue des Prés Potets, 21121 Fontaine-les-Dijon, France.

Date of last revision of the leaflet: September 2024