Erdomed Muko
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Package Leaflet: Information for the Patient
ERDOMED MUKO, 225 mg, Powder for Oral Suspension
Erdostein
Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.
This Medication Should Always be Used Exactly as Described in this Package Leaflet or as Directed by a Doctor or Pharmacist.
- Keep this Package Leaflet, You May Need to Read it Again.
- If You Need Advice or Further Information, Consult a Pharmacist.
- If You Experience any Side Effects, Including those not Listed in this Package Leaflet, Tell Your Doctor or Pharmacist. See Section 4.
- If After 3 Days There is no Improvement or You Feel Worse, Contact a Doctor.
Package Leaflet Contents:
- 1. What is Erdomed Muko and What is it Used for
- 2. Important Information Before Taking Erdomed Muko
- 3. How to Take Erdomed Muko
- 4. Possible Side Effects
- 5. How to Store Erdomed Muko
- 6. Package Contents and Other Information
1. What is Erdomed Muko and What is it Used for
Erdomed Muko Contains the Active Substance Erdostein, Which Belongs to the Group of Mucolytic Medications, Reducing the Viscosity of Mucus in the Airways and Facilitating its Expectoration. Erdomed Muko is Used to Thin and Facilitate the Expectoration of Mucous Secretions from the Airways, as a Supportive Medication in the Treatment of Acute and Chronic Respiratory Tract Disorders, Such as Inflammatory Conditions of the Nose, Sinuses, Larynx, Trachea, Bronchi, and Lungs. If After 3 Days There is no Improvement or You Feel Worse, Consult a Doctor.
2. Important Information Before Taking Erdomed Muko
When Not to Take Erdomed Muko:
- If You are Allergic to the Active Substance, any of the Other Ingredients of this Medication (Listed in Section 6), or to Substances Containing Free SH Groups (e.g., Acetylcysteine);
- If You Have Liver Function Disorders;
- If You Have Renal Impairment (Creatinine Clearance <25 ml min);< li>
- If You Have Homocystinuria (a Genetically Determined Metabolic Disorder Characterized by Abnormal Metabolism of the Amino Acid Methionine);
- In Children Under 12 Years of Age.
Warnings and Precautions
Before Starting Treatment with Erdomed Muko, Discuss it with Your Doctor or Pharmacist. In Case of Typical Hypersensitivity Symptoms (Rash, Urticaria), Discontinue Treatment 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).
Children
This Medication Should Not be Given to Children Under 12 Years of Age.
Erdomed Muko and Other Medications
Tell Your Doctor or Pharmacist About all Medications You are Currently Taking or Have Recently Taken, as well as any Medications You Plan to Take. No Clinically Significant, Adverse Interactions Have Been Observed with Other Medications Used in the Treatment of Respiratory Tract Infections and Chronic Obstructive Pulmonary Disease, Such as Theophylline, Muscle Relaxants (Corticosteroids), Erythromycin, Amoxicillin, or Cotrimoxazole. After Administration of Erdostein, an Increase in Amoxicillin Concentration in the Airways Has Been Observed. Erdomed Muko Should Not be Used with Cough Suppressants, as They May Weaken the Cough Reflex and Make it Difficult to Expectorate Thinned Secretions.
Erdomed Muko with Food and Drink
Food and Drink Do Not Affect the Absorption of the Medication.
Pregnancy and Breastfeeding
If You are Pregnant or Breastfeeding, Think You May be Pregnant or are Planning to Have a Baby, Consult Your Doctor or Pharmacist Before Taking this Medication. It is Not Recommended to Use this Medication During Pregnancy or Breastfeeding.
Driving and Using Machines
Erdomed Muko Does Not Affect the Ability to Drive and Use Machines.
Erdomed Muko Contains Sucrose, Glucose (as Part of Maltodextrin), Benzyl Alcohol, and Sodium.
Sucrose
The Medication Contains 3.5 g of Sucrose in One Sachet. This Should be Taken into Account in Patients with Diabetes. If You Have Previously Been Diagnosed with Intolerance to Some Sugars, You Should Consult Your Doctor Before Taking the Medication.
Glucose (as Part of Maltodextrin)
If You Have Previously Been Diagnosed with Intolerance to Some Sugars, You Should Consult Your Doctor Before Taking the Medication.
Benzyl Alcohol
The Medication Contains 0.01 mg of Benzyl Alcohol in Each Sachet. Benzyl Alcohol May Cause Allergic Reactions. Pregnant or Breastfeeding Women and Patients with Liver or Kidney Disease Should Consult Their Doctor Before Taking the Medication, as Large Amounts of Benzyl Alcohol May Accumulate in Their Body and Cause Side Effects (So-called Metabolic Acidosis).
Sodium
The Medication Contains Less than 1 mmol (23 mg) of Sodium per Sachet, Which Means the Medication is Considered "Sodium-Free".
3. How to Take Erdomed Muko
This Medication Should Always be Used Exactly as Described in this Package Leaflet or as Directed by a Doctor or Pharmacist. If You Have any Doubts, Consult Your Doctor or Pharmacist. Recommended Dose
Use in Children from 12 Years of Age
1 Sachet 2 Times a Day.
Use in Adults
1 Sachet 2 or 3 Times a Day. Dose Adjustment is Not Required in Adults in Case of Exacerbations of Chronic Obstructive Pulmonary Disease (COPD).
Use of Erdomed Muko in Patients with Renal Impairment
Dose Adjustment is Not Required in Adults with Moderate Renal Impairment (Creatinine Clearance >25 ml/min).
Use of Erdomed Muko in the Elderly
No Dose Adjustment is Necessary in Patients Over 65 Years of Age.
Method of Administration
Pour the Contents of the Sachet into Approximately 120 ml (Half a Standard Glass) of Water at Room Temperature, and Stir if Necessary to Obtain a Thin, Turbid Suspension. Take Orally, Immediately After Preparation, According to the Above Dosing Schedule. The Medication Should Not be Taken Before Bedtime Due to Difficulty in Expectoring Thinned Secretions During Sleep. If After 3 Days There is no Improvement or You Feel Worse, Consult a Doctor.
Overdose of Erdomed Muko
No Cases of Overdose Have Been Reported. In Case of Overdose, Consult a Doctor Immediately.
Missed Dose of Erdomed Muko
If the Medication is Taken Regularly and it is Almost Time for the Next Dose, Take the Missed Dose as Soon as Possible. If it is Almost Time for the Next Dose, Take it at the Usual Time. Do Not Take a Double Dose to Make Up for the Missed Dose. If You Have any Further Questions About the Use of this Medication, Consult Your Doctor or Pharmacist.
4. Possible Side Effects
Like all Medications, this Medication can Cause Side Effects, Although not Everybody Gets Them. The Following Side Effects Have Been Reported:
- Frequent (in 1 to 10 out of 100 Patients): Abdominal Pain, Nausea, Headache.
- Uncommon (in 1 to 10 out of 1000 Patients): Heartburn, Constipation, Diarrhea, Dry Mouth, Dizziness, General Malaise.
- Rare (in 1 to 10 out of 10,000 Patients): Loss of Taste or Taste Disorders, Allergic Symptoms: Rash, Urticaria, Fever.
In Some People, Other Side Effects May Occur During Treatment with Erdomed Muko.
Reporting Side Effects
If You Experience any Side Effects, Including those not Listed in this Package Leaflet, Tell Your Doctor or Pharmacist. Side Effects can be Reported Directly to the Department of Adverse Reaction Monitoring 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. Side Effects can also be Reported to the Marketing Authorization Holder. By Reporting Side Effects, You can Help Provide More Information on the Safety of this Medication.
5. How to Store Erdomed Muko
Keep this Medication out of the Sight and Reach of Children. Store in a Temperature Below 25°C. Do Not Use this Medication After the Expiration Date Stated on the Packaging. The Expiration Date Refers to the Last Day of the Specified Month. Medications Should Not be Disposed of via Wastewater or Household Waste. Ask Your Pharmacist How to Dispose of Medications that are no Longer Needed. This will Help Protect the Environment.
6. Package Contents and Other Information
What Erdomed Muko Contains
- The Active Substance of the Medication is Erdostein. One Sachet Contains 225 mg of Erdostein.
- Other Ingredients are: Sucrose, Sodium Carboxymethylcellulose (Type A), Silicon Dioxide, Sucralose (E 955), Anhydrous Apple Acid, Orange Flavor [Corn Maltodextrin, Flavoring Substances (Including, Among Others, Citral, Benzyl Alcohol, Linalool), α-Tocopherol (E 307)].
What Erdomed Muko Looks Like and What the Package Contains
Erdomed Muko is a Powder for Oral Suspension. The Immediate Packaging of the Medication is a Sachet Made of Paper and Aluminum/LDPE Foil, Containing 225 mg of Erdostein. The Carton Contains 10 or 20 Sachets.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Angelini Pharma Polska Sp. z o.o.
Aleje Jerozolimskie 181B
02-222 Warsaw
tel. (22) 70 28 200
email: [email protected]
Manufacturer:
Fine Food & Pharmaceuticals N.T.M. S.p.A
Via Grignano, 43
24041 Brembate (BG)
Italy
Date of Last Revision of the Package Leaflet: 01.07.2021
A Package Leaflet for the Visually Impaired and Blind is Available at the Marketing Authorization Holder's Headquarters.
- Country of registration
- Active substance
- Prescription requiredNo
- Manufacturer
- ImporterFine Food & Pharmaceuticals NTM S.P.A.
- This information is for reference only and does not constitute medical advice. Always consult a licensed doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
- Alternatives to Erdomed MukoDosage form: Tablets, 300 mgActive substance: erdosteineManufacturer: Polfarmex S.A.Prescription requiredDosage form: Powder, 35 mg/mlActive substance: erdosteineManufacturer: Fulton Medicinali S.p.A. Zeta Farmaceutici S.p.A.Prescription requiredDosage form: Capsules, 300 mgActive substance: erdosteinePrescription required
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