Erdomed Muko, 20 sachets

Important! Before use, read the leaflet, which contains indications, contraindications, data on side effects and dosage, as well as information on the use of the medicinal product, or consult a doctor or pharmacist, because any medicine used incorrectly poses a threat to your life or health.

ERDOMED MUKO, 225 mg, powder for oral suspension

Erdosteinum

Please read carefully read this leaflet before you start using this medicine because it contains important information for you.

Always use this medicine exactly as described in this leaflet or exactly as your doctor or pharmacist has told you.

Keep this leaflet so you can read it again if you need to.

If you need any advice or any more information, ask your pharmacist.

If you have any of the following side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. See section 4.

If you do not feel better or if you feel worse after 3 days, contact your doctor.

Table of contents of the leaflet:

What is Erdomed Muko and how purpose it is used

Important information before using Erdomed Muko

How to use Erdomed Muko

Possible side effects

How to store Erdomed Muko

Package contents and other information

1. What is Erdomed Muko and what is it used forErdomed Mukocontains the active substance erdosteine, which belongs to the group of mucolytic drugs that reduce the viscosity of mucus in the respiratory tract and facilitate its expectoration.

Erdomed Muko is used to dilute and facilitate expectoration of mucous secretions

from the respiratory tract, as an adjunct to the treatment of acute and chronic respiratory diseases, such as inflammation of the nose, sinuses, larynx, trachea, bronchi and lungs.

If you do not feel better or if you feel worse after 3 days, contact your doctor.

2. Important information before using Erdomed Muko

When not to use Erdomed Muko: if you are allergic to the active substance, any of the other ingredients of this medicine (listed in section 6), or to substances containing free SH groups (e.g. acetylcysteine);

if you suffer from liver dysfunction;

if you suffer from renal failure (creatinine clearance <25 ml/min);

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if you suffer from homocystinuria (a genetically determined metabolic disease involving the abnormal metabolism of the amino acid methionine);

in children under 12 years of age.

Warnings and precautions

Talk to your doctor or pharmacist before using Erdomed Muko.

If typical symptoms of hypersensitivity occur (rash, hives), stop treatment immediately.

Use with caution in patients with a weakened cough reflex or ciliary clearance disorders (due to the risk of accumulation of large amounts of mucus).

Children

The drug should not be administered to children under 12 years of age.

Other medicines and Erdomed Muko

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

No clinically significant, adverse interactions have been observed with other drugs used to treat respiratory tract infections and chronic obstructive pulmonary disease, such as: theophylline, drugs causing bronchial smooth muscle relaxation (corticosteroids), erythromycin, amoxicillin or cotrimoxazole.

After administration of erdosteine, an increase in the concentration of amoxicillin in the respiratory tract was demonstrated.

Erdomed Muko should not be used with antitussive medications, as they may weaken the cough reflex and make it difficult to expectorate thin secretions.

Erdomed Muko with food and drink

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

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine .

The drug is not recommended for use by pregnant or breastfeeding women.

Driving and using machines

Erdomed Muko has no effect on the ability to drive or use machines. operating machines.

Erdomed Muko contains sucrose, glucose (a component of maltodextrin), benzyl alcohol and sodium.

Sucrose

The medicine contains 3.5 g of sucrose in one sachet. This should be taken into account in patients with diabetes. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Glucose (part of maltodextrin)

If you have been told by your doctor that you have an intolerance to some sugars, should contact your doctor before taking this medicine.

Benzyl alcohol

The medicine 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 contact their doctor before taking the medicine, as large amounts of benzyl alcohol may accumulate in their body and cause side effects (so-called metabolic acidosis).

Sodium

This medicine contains less than 1 mmol (23 mg) sodium per sachet, i.e. essentially 'sodium-free'.

3. How to use Erdomed Muko

Always use this medicine exactly as described in this leaflet or as told by your doctor or pharmacist. If in doubt, please ask 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.

No dose adjustment is required in adults in case of exacerbations of chronic obstructive pulmonary disease (COPD).

Use of Erdomed Muko in patients with renal impairment

No dose adjustment is required in adults in case of moderate renal impairment (creatinine clearance >25 ml/min).

Use of Erdomed Muko in elderly patients

There is no need to change the dosage in patients over 65 years of age.

How to use

Sachet contents pour into approximately 120 ml (half a standard glass) of water at room temperature, stir if necessary to obtain a thin, cloudy suspension. Use orally, immediately after preparation, according to the above dosage schedule.

The medicine should not be used before going to bed because it may be difficult to expectorate thin secretions during sleep.

If after 3 days there is no improvement or the patient feels worse, contact your doctor.

If you take more Erdomed Muko than you should

No case of overdose has been reported.

If you take more than the recommended dose, contact your doctor immediately. .

If you forget to take Erdomed Muko

If you take your medicine regularly and a short time has passed since you should have taken the missed dose, take it as soon as possible. If it is almost time for your next dose, take it at the usual time.

Do not take a double dose to make up for a missed dose.

If you have any further questions on the use of 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.

The following side effects have been reported:

Common (1 to 10 users in 100): upper abdominal pain, nausea, headache.

Uncommon (1 to 10 users in 1,000): heartburn, constipation, diarrhea, dry mouth, dizziness, generally feeling unwell.

Rare (affects 1 to 10 in 10,000 people): loss of taste or dysgeusia, allergy symptoms: rash, hives, fever.

U Some people may experience other side effects while taking Erdomed Muko.

Reporting side effects

If you notice any side effects, talk to us. This includes any side effects not listed in this leaflet. doctor or pharmacist. Adverse reactions can be reported directly to the Department for Monitoring Adverse Reactions of Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Adverse reactions can also be reported to the responsible entity.

By reporting adverse reactions, you can collect more information about the safety of the drug.

5. How to store Erdomed Muko

Keep the medicine out of the sight and reach of children.

Store at a temperature below 25°C.

Do not use this medicine after the expiry date which is stated on the carton.

The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. Doing so will help protect the environment.

6. Package contents and other information

What Erdomed Muko contains

The active substance is erdosteine. One sachet contains 225 mg

The other ingredients are: sucrose, sodium carboxymethyl starch (type A), silicon dioxide, sucralose (E 955), anhydrous malic acid, orange flavor [corn maltodextrin, flavorings (including among others, citral, benzyl alcohol, linalool), α-tocopherol (E 307)].

What Erdomed Muko looks like and contents of the package

Erdomed Muko is a powder for preparation of a suspension. oral.

The immediate packaging of the drug is a sachet made of paper and aluminum/LDPE foil, containing 225 mg of erdosteine.

The cardboard box contains 10 or 20 sachets.

Patient leaflet in a form suitable for blind and partially sighted people available at the registered office of the MAH.

Important information about the medicine

This is a medicine. For safety, use it according to the leaflet included in the package. Do not exceed the maximum dose of the drug. If in doubt, consult your doctor or pharmacist.