Package leaflet: Information for the patient

Warning! Keep this leaflet! The information on the immediate packaging is in a foreign language.
Erdomed
300 mg, hard capsules
Erdosteinum
Please read the entire leaflet before taking the medicine, as it contains important information for the patient.

Keep this leaflet for future reference.
Consult your doctor or pharmacist if you have any further questions.
This medicine has been prescribed for a specific individual. Do not share it with others.
This medicine may harm another person, even if their symptoms appear identical.
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:

What Erdomed is and what it is used for
Important information before taking Erdomed
How to take Erdomed
Possible side effects
How to store Erdomed
Contents of the package 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 drugs known as mucolytics – agents that reduce the viscosity of bronchial secretions and facilitate expectoration.
Erdomed is indicated for secretolytic treatment in acute and chronic upper respiratory tract, bronchial, and lung diseases associated with abnormal mucus secretion and impaired mucus 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 reduced 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 must not be administered to children under 12 years of age.
Taking Erdomed with food and drink
Food and drink do not affect drug absorption.
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
No dosage adjustment is necessary 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 impaired respiratory function.
To avoid complications, antitussive and secretolytic (mucus-increasing) drugs should not be routinely combined, especially before bedtime.
Pregnancy, breastfeeding and effects on fertility
Consult a physician before taking this medicine. The decision to use the drug is made by a physician.
Driving and operating machinery
Erdomed has no influence on the ability to drive or operate machinery.
Excipients contained in Erdomed:
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 doctor. If in doubt, consult
the doctor or pharmacist.
The recommended dose for adults is:
1 capsule of 300 mg twice daily.
This medicine should not be taken before going to sleep.
Taking more Erdomed than recommended
No cases of overdose have been reported.
If you take more than the recommended dose of this medicine, consult a doctor immediately.
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 as scheduled and then continue 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 side effects

Like all medicines, Erdomed can cause side effects, although not everybody gets 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 side effects may occur in some individuals during treatment with Erdomed.
Reporting of side effects
If any side effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Side effects can also 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, phone: +48 22 4921301, fax: +48 22 4921309, website: https://smz.ezdrowie.gov.pl.
Reporting side effects helps to provide more information on the safety of this medicine.

5. How to store Erdomed
Keep this medicine out of 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 pack and other information

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

What Erdomed looks like and contents of the pack
The pack contains 10, 20 or 60 capsules in Al/PVC/PVDC blisters 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 - 60100 Ancona, Italy
Astrea Fontaine S.A.S.
Rue des Prés Potets, 21121 Fontaine-les-Dijon, France

Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw, Poland

Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw, Poland

Marketing authorisation number in the Czech Republic, country of export: 52/045/96-C
Parallel import authorisation number: 79/25