Package leaflet: Information for the patient

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.
Erdomed
300 mg, hard capsules
Erdosteine
Read the entire leaflet before taking the medicine, as it contains important information for the patient.

Keep this leaflet, so that you can read it again if necessary.
Consult your doctor or pharmacist if you have any further questions.
This medicine has been prescribed for a specific individual. Do not pass it on to others.
The medicine may harm another person, even if their symptoms are the same.
If any of the adverse effects worsen or if any adverse effects occur, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

What Erdomed is and what it is used for
What you need to know before taking Erdomed
How to take Erdomed
Possible side effects
How to store Erdomed
Contents of the pack and other information

1. What Erdomed is and what it is used for

Erdomed contains the active substance erdosteine, which belongs to a group of medicines called mucolytics –
these reduce the viscosity of bronchial secretions and facilitate expectoration.
Erdomed is indicated for secretolytic treatment in acute and chronic diseases of the upper respiratory tract,
bronchi and lungs associated with impaired mucus secretion and transport. It is also used for the prophylactic treatment of seasonal exacerbations of chronic bronchitis.

2. Important information before taking Erdomed

When not to use Erdomed:

if the patient is allergic (hypersensitive) to the active substance, to any of the excipients, or to substances containing free SH groups
if the patient has liver function disorders
if the patient has renal failure
if the patient has homocystinuria (especially in patients on a methionine-free diet)
in children under 12 years of age.

Warnings and precautions
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 minimized by using the lowest effective doses for the shortest possible duration. If no improvement occurs, the physician will consider discontinuing treatment.
Dose adjustment is not required in adults with chronic obstructive pulmonary disease (COPD).
Children
Erdomed should not be administered to children under 12 years of age.
Taking Erdomed with food and drink
Food and drink do not affect the absorption of the medicine.
Use of Erdomed in patients with renal impairment
In patients with severe renal failure, metabolites of erdosteine formed in the liver may accumulate.
Use of Erdomed in elderly patients
There is no need to modify the dosage in patients over 65 years of age.
Other medicines and Erdomed
No interactions have been observed with other drugs 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.
Concomitant use with drugs that suppress the cough reflex (antitussives) may lead to accumulation of large amounts of bronchial secretions, which may worsen the patient's condition, e.g. due to deterioration of respiratory function.
To avoid complications, antitussive and secretolytic (mucus-increasing) drugs should not be routinely combined, especially before bedtime.
Pregnancy, breastfeeding and fertility
Consult a physician before taking this medicine. The decision on use during pregnancy is made by the physician.
Driving and operating machinery
Erdomed has no influence on the ability to drive or operate machinery.
Erdomed contains the following excipients:
povidone, microcrystalline cellulose, magnesium stearate, gelatin, titanium dioxide (E 171), yellow iron oxide (E 172), indigotine (E 132).

3. How to take Erdomed

This medicine should always be taken exactly as directed by the physician. In case of doubt, consult
your doctor or pharmacist.
The recommended dose for adults is:
1 capsule of 300 mg twice daily.
Do not take this medicine before going to bed.
Taking more Erdomed than you should.
No cases of overdose have been reported.
If you have taken more than the recommended dose, seek immediate medical advice.
Missing a dose of Erdomed:
Take the missed dose as soon as possible, then continue taking the medicine as before. If it is almost 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, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, Erdomed may cause adverse reactions, although not everyone experiences them.

Common (in 1 to 10 out of 100 patients): stomach discomfort, 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, general malaise, diarrhoea, allergic reactions: rash, urticaria, fever

Other adverse reactions may occur in some individuals during treatment with Erdomed.
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 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
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store the medicine Erdomed

Keep the medicine out of the sight and reach of children.
Store below 25°C.
Do not use Erdomed after the expiry date stated on the packaging.
Medicines must 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 package and other information

What Erdomed contains
The active substance is erdosteine. One hard capsule contains 300 mg of erdosteine.
Other ingredients of the medicine are: povidone, microcrystalline cellulose, magnesium stearate, gelatin, titanium dioxide (E 171), yellow iron oxide (E 172), indigotine (E 132).

What Erdomed looks like and contents of the pack
The pack contains 10 or 20 or 60 capsules in Al/PVC/PVDC blisters, packed in a cardboard box.
For more detailed information, please contact the Marketing Authorisation Holder or the parallel importer.

Marketing Authorisation Holder in the Czech Republic, country of export:
Angelini Pharma Česká republika s.r.o.
Palachovo náměstí 799/5
625 00 Brno
Czech Republic

Manufacturer:
Aziende Chimiche Riunite Angelini Francesco
ACRAF S.p.A.
Via vecchia del Pinocchio, 22
60131 Ancona
Italy

Astrea Fontaine S.A.S.
Rue des Prés Potets
21121 Fontaine-les-Dijon
France

Parallel importer:
Medezin Sp. z o.o.
Zbąszyńska 3 Street
91-342 Łódź
Poland

Repackaged in:
Medezin Sp. z o.o.
Zbąszyńska 3 Street
91-342 Łódź
Poland

Marketing Authorisation Number in the Czech Republic, country of export: 52/045/96-C
Parallel Import Authorisation Number: 274/25