Muccosinal

Leaflet attached to the packaging: patient information

Muccosinal, 600 mg, effervescent tablets

Acetylcysteine
For adults and adolescents over 14 years of age

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

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If after 4 to 5 days there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

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

1. What is Muccosinal and what is it used for

Muccosinal contains the active substance acetylcysteine, a mucolytic agent that reduces the viscosity of bronchial secretions and makes them easier to cough up.
Muccosinal is used to treat acute conditions in the course of respiratory diseases - in colds and chronic respiratory diseases with the production of thick mucus and difficulty coughing up in adults and adolescents over 14 years of age.
This medicine can be used without consulting a doctor only for the treatment of acute conditions. If the patient has chronic respiratory diseases, this medicine should only be used on the advice of a doctor.
If after 4-5 days there is no improvement or the patient feels worse, they should consult a doctor.

2. Important information before taking Muccosinal

When not to take Muccosinal

if the patient is allergic to acetylcysteine or any of the other ingredients of this medicine (listed in section 6);
if the patient has an acute asthma attack;
if the patient has an active stomach or duodenal ulcer;
due to the high content of the active substance, the medicine should not be used in children and adolescents under 14 years of age.

Warnings and precautions

Before taking Muccosinal, the patient should discuss it with their doctor or pharmacist if:
they have diabetes;
they have bronchial asthma;
they have currently or have had a stomach or duodenal ulcer in the past.
In very rare cases, after taking acetylcysteine, severe skin reactions (Stevens-Johnson syndrome, Lyell's syndrome) may occur. If the patient experiences skin or mucous membrane changes while taking acetylcysteine, they should immediately consult a doctor.
If the patient has a histamine intolerance, treatment with acetylcysteine should be as short as possible.
Taking acetylcysteine, especially at the beginning of treatment, may lead to thinning and thus an increase in the amount of bronchial secretions. If the patient is unable to cough up sufficiently, the doctor will perform the appropriate procedures (e.g. drainage and suction).
Muccosinal should not be used in patients with liver or kidney failure to prevent the formation of nitrogen compounds.

Children and adolescents

Muccosinal should not be used in children under 14 years of age. Other, more suitable pharmaceutical forms are available for children under 14 years of age.

Muccosinal and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Muccosinal and other medicines taken at the same time may interact with each other. Before taking Muccosinal and any over-the-counter medicine, the patient should consult their doctor.
Taking Muccosinal and cough suppressants (blocking the cough reflex) may reduce the cough reflex and cause a dangerous accumulation of secretions in the airways. The simultaneous use of Muccosinal and cough suppressants must be justified by important reasons and preceded by consultation with a doctor.
Taking acetylcysteine and activated charcoal may weaken the effect of acetylcysteine.
In the case of oral antibiotics (tetracyclines, semi-synthetic penicillins, aminoglycosides, and cephalosporins), Muccosinal should be taken at least 2 hours after taking the antibiotic. A 2-hour interval is recommended for other antibiotics (except for amoxicillin, doxycycline, erythromycin, thiamphenicol, cefuroxime, cefixime, and loracarbef).
Taking Muccosinal and medicines containing nitroglycerin may lead to increased vasodilation and inhibition of platelet aggregation.
Acetylcysteine may affect the results of salicylate tests by colorimetry and the results of ketone body tests in urine. If the patient is going to undergo such tests, they should inform the medical staff about taking a medicine containing acetylcysteine.

Muccosinal with food and drink

The effect of acetylcysteine on mucus is enhanced by increasing fluid intake. It is not recommended to dissolve Muccosinal with other medicines.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
Due to the fact that there is not enough experience with the use of acetylcysteine in pregnant women, Muccosinal may be used during pregnancy only if the doctor considers it absolutely necessary.
Breastfeeding
There is no data on the penetration of acetylcysteine into breast milk. Therefore, Muccosinal may be used during breastfeeding only if the doctor considers it absolutely necessary.

Driving and using machines

Muccosinal has no effect on the ability to drive and use machines or has a negligible effect.

Muccosinal contains lactose, sorbitol, and sodium

If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.
This medicine contains less than 40 mg of sorbitol in one 600 mg effervescent tablet.
This medicine contains approximately 138 mg (6 mmol) of sodium (the main component of common salt) in each effervescent tablet. This corresponds to 6.9% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to take Muccosinal

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.
The recommended dose for adults and adolescents over 14 years of age is 1 effervescent tablet (600 mg of acetylcysteine) per day. In adolescents, half a tablet should be taken twice a day.
The medicine should be taken after a meal, the tablet should be dissolved in half a glass of water. The solution should be consumed immediately after dissolving the tablet. Due to the fact that the medicine is stabilized with ascorbic acid, the solution should be drunk within 2 hours after preparation.
Without the advice of a doctor, Muccosinal should not be used for more than 4 to 5 days.
If the symptoms do not improve, or worsen, or side effects occur, the patient should consult their doctor about the possibility of re-taking acetylcysteine.

Taking a higher dose of Muccosinal than recommended

In case of overdose or accidental ingestion of an effervescent tablet by a child, the patient should consult a doctor. In case of overdose, gastrointestinal irritation (e.g. abdominal pain, nausea, vomiting, diarrhea) may occur.
However, serious side effects or symptoms of poisoning have not been observed even in extreme cases of overdose. If an overdose of Muccosinal is suspected, the patient should inform their doctor.

Missing a dose of Muccosinal

The patient should not take a double dose to make up for a missed dose, they should continue taking Muccosinal as described in the dosage schedule.
In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Muccosinal can cause side effects, although not everybody gets them.
The following side effects may occur during treatment with acetylcysteine.

Uncommon (may affect up to 1 in 100 people)

• allergic reactions (itching, hives, skin rash, rapid heartbeat, and low blood pressure)
• headache
• mouth inflammation, abdominal pain, nausea, vomiting, and diarrhea
• fever.

Rare (may affect up to 1 in 1,000 people)

• shortness of breath, bronchospasm - mainly in patients with hyperreactive airways in the case of bronchial asthma
• indigestion.

Very rare (may affect up to 1 in 10,000 people)

• anaphylactic reactions up to shock
• bleeding, partly related to hypersensitivity reactions.

If the patient experiences the first symptoms of hypersensitivity (see above), they should not take Muccosinal again. In such a case, they should contact their doctor.

Reporting side effects

If the patient experiences any side effects, including those not listed in the leaflet, they should inform their doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 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, it is possible to gather more information on the safety of the medicine.

5. How to store Muccosinal

The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiry date stated on the packaging after EXP.
The expiry date refers to the last day of the month indicated.
Polypropylene container:
The container should be kept tightly closed to protect from moisture. Do not store above 30°C.
Shelf life after first opening: 1 year
Soft blister:
There are no special precautions for storage conditions.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Muccosinal contains

• The active substance of Muccosinal is acetylcysteine. Each effervescent tablet contains 600 mg of acetylcysteine.
• The other ingredients are: anhydrous citric acid, ascorbic acid, sodium citrate, sodium cyclamate, sodium saccharin, mannitol, sodium bicarbonate, anhydrous sodium carbonate, anhydrous lactose, lemon flavor "AU" code 132 (consisting of natural lemon oils (code 5051), natural/identical to natural lemon oils (code
• 5023), mannitol, maltodextrin, gluconolactone, sorbitol (E 420), and anhydrous colloidal silica).

What Muccosinal looks like and contents of the packaging

Round, white tablets with a smooth surface and a dividing line on one side. The tablet can be divided into equal doses.
A polypropylene tablet container with a polyethylene cap and a desiccant, containing 10, 20, 25, 50, or 100 effervescent tablets, in a cardboard box.
Soft blister pack with aluminum/paper foil containing 10, 20, or 100 effervescent tablets, in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Dr. Max Pharma s.r.o.
Na Florenci 2116/15
Nové Město
110 00 Prague 1
Czech Republic

Manufacturer:

HERMES PHARMA GmbH
Hans-Urmiller-Ring 52
82515 Wolfratshausen
Germany

This medicine is authorized in the Member States of the European Economic Area under the following names:

Czech Republic
Acetylcysteine Dr.Max
Poland
Muccosinal
Slovakia
Acetylcysteine Dr.Max 600 mg
Date of last revision of the leaflet: