Asterdan

Package Leaflet: Information for the Patient

ASTERDAN, 300 mg, Tablets

Erdosteine

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet:

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

1. What is ASTERDAN and what is it used for

ASTERDAN contains the active substance erdosteine, which belongs to a group of mucolytic medicines

• that reduce the viscosity of bronchial secretions and facilitate expectoration. ASTERDAN is recommended for the treatment of secretory conditions in acute and chronic upper respiratory tract diseases, bronchi, and lungs with abnormal mucus secretion and transport. It is also used for the preventive treatment of seasonal exacerbations of chronic bronchitis. ASTERDAN is indicated for use in adults and adolescents over 12 years of age.

2. Important information before taking ASTERDAN

When not to take ASTERDAN:

• if you are allergic (hypersensitive) to the active substance, to substances containing free -SH groups or to any of the other ingredients of this medicine (listed in section 6)
• if you have liver function disorders
• if you have renal failure
• if you have homocystinuria (especially in patients on a methionine-free diet)
• in children under 12 years of age.

Warnings and precautions

In case of typical symptoms of hypersensitivity (rash, urticaria), treatment should be discontinued immediately.
Use with caution in patients with impaired 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 doctor will consider discontinuing 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 ASTERDAN with food and drink

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

Taking ASTERDAN in patients with renal impairment

In patients with severe renal impairment, erdosteine metabolites produced in the liver may accumulate.

Taking ASTERDAN in elderly patients

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

ASTERDAN and other medicines

Tell your doctor about all medicines you are taking or have recently taken, as well as any medicines you 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 co-trimoxazole.
After administration of erdosteine, an increase in amoxicillin concentration in the respiratory tract has been demonstrated.
Combination therapy with cough suppressants (antitussives) may cause accumulation of large amounts of bronchial secretions, which can worsen the patient's condition in the course of the disease, e.g., due to decreased respiratory function.
To avoid complications, do not routinely combine cough suppressants and secretolytic medicines (which increase secretion), especially before bedtime.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.
The decision to use the medicine is made by the doctor.

Driving and using machines

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

3. How to take ASTERDAN

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose for adults and adolescents over 12 years of age is:
1 tablet of 300 mg twice a day.
Do not take the medicine before bedtime.

Overdose of ASTERDAN

No cases of overdose have been reported.
If you have taken more than the recommended dose of the medicine, seek medical attention immediately.

Missed dose of ASTERDAN

Take the prescribed dose as soon as possible, and then continue with the usual dosing schedule. If it is time for the next dose, take only one dose and 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 taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

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

Some people may experience other side effects while taking ASTERDAN.

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 Post-Marketing Surveillance of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw, tel. +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.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store ASTERDAN

Store in a temperature below 25°C, in the original packaging to protect from moisture.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after: "EXP".
The expiry date refers to the last day of the month.
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 ASTERDAN contains

• The active substance is erdosteine. One tablet contains 300 mg of erdosteine.
• The other ingredients are: microcrystalline cellulose (type 102), magnesium stearate, silica, colloidal anhydrous, microcrystalline cellulose (type 101), povidone K-25.

What ASTERDAN looks like and contents of the pack

ASTERDAN is a white or cream-white, round tablet with beveled edges.
PVC/PVDC/Aluminum or OPA/Aluminum/PVC/Aluminum blister pack in a cardboard box.
The pack contains 10 or 20 tablets in blisters.

Marketing authorization holder and manufacturer

Polfarmex S.A.
Józefów 9
99-300 Kutno
Poland (Poland)
Tel.: 24 357 44 44
Fax: 24 357 45 45
e-mail: polfarmex@polfarmex.pl

Date of last revision of the leaflet: