Mucofortin

Package Leaflet: Information for the Patient

Mucofortin, 600 mg, Effervescent Tablets

Acetylcysteine

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

This medicine should always be taken exactly as described in the package leaflet for the patient or as advised by a doctor, pharmacist, or nurse.

• Keep this 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 the leaflet, tell your doctor or pharmacist. See section 4.
• If after 5 days there is no improvement or you feel worse, contact a doctor.

Table of Contents of the Leaflet:

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

1. What is Mucofortin and what is it used for

Mucofortin effervescent tablets contain the active substance acetylcysteine, which reduces the viscosity of bronchial secretions and facilitates expectoration. Mucofortin is used as a short-term mucolytic agent to facilitate expectoration of bronchial secretions in patients with symptoms of respiratory tract infections associated with the common cold. If after 5 days there is no improvement or you feel worse, contact a doctor.

2. Important information before taking Mucofortin

When not to take Mucofortin:

• If you are allergic to acetylcysteine or any of the other ingredients of this medicine (listed in section 6). Symptoms of an allergic reaction may include: itching, hives, rash, bronchospasm (difficulty breathing), rapid heartbeat, and low blood pressure. If any of these symptoms occur, stop taking Mucofortin and contact a doctor.
• In status asthmaticus (difficulty breathing in asthma or obstructive pulmonary disease that does not respond to bronchodilators).
• If you have phenylketonuria (see "Mucofortin contains aspartame").
• In children under 2 years of age, as the active substance acetylcysteine may cause respiratory tract obstruction in children under 2 years of age (also see "Warnings and precautions" and "How to take Mucofortin").

Warnings and precautions

Before taking Mucofortin, discuss with your doctor or pharmacist if:

• you have or have had asthma (as the medicine may cause bronchospasm and difficulty breathing);
• you are elderly (over 65 years);
• you have or have had respiratory failure;
• you have had stomach or duodenal ulcers;
• you are allergic to histamine, as Mucofortin may cause symptoms of intolerance: headache, nasal congestion, itching.

Rarely, severe skin reactions have been observed with acetylcysteine, such as Stevens-Johnson syndrome and Lyell's syndrome. If you experience any skin or mucous membrane changes while taking Mucofortin, stop taking the medicine and contact a doctor immediately. Mucofortin may affect the results of some laboratory tests (salicylate determination by colorimetry and ketone determination in urine).

Children and adolescents

Due to the amount of active substance in Mucofortin, it should not be used in children and adolescents under 18 years of age.

Mucofortin and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.

• Do not take Mucofortin with cough suppressants, as they may weaken the cough reflex and make it difficult to expectorate the secretions thinned by Mucofortin.
• Acetylcysteine (the active substance of Mucofortin) may reduce the effectiveness of some antibiotics, especially semi-synthetic penicillins, tetracyclines, cephalosporins, and aminoglycosides. To avoid this, take Mucofortin 2 hours after taking the antibiotic. This does not apply to antibiotics such as amoxicillin, doxycycline, erythromycin, thiamphenicol, and cefuroxime. If in doubt, consult a doctor.
• Mucofortin may enhance the effect of nitroglycerin and other nitrates (medicines used in cardiovascular diseases and coronary heart disease). If you are taking nitroglycerin or another similarly acting nitrate medicine, consult a doctor before taking Mucofortin.
• Activated charcoal may reduce the effectiveness of Mucofortin.

If you are unsure whether you are taking any of the above medicines, ask your doctor or pharmacist.

Pregnancy and breastfeeding

If you are pregnant, breastfeeding, think you may be pregnant, or plan to have a baby, consult a doctor or pharmacist before taking this medicine. During pregnancy, Mucofortin should only be used in absolutely necessary cases and under close medical supervision. The doctor will decide whether to stop breastfeeding or stop taking Mucofortin, considering the benefits of breastfeeding for the baby and the benefits of treatment for the mother.

Driving and using machines

The effect of Mucofortin on the ability to drive and use machines is not known.

Mucofortin contains sodium

Mucofortin contains 183.4 mg of sodium (the main component of common salt) in each effervescent tablet. This corresponds to 9.17% of the maximum recommended daily intake of sodium by the WHO (2 g) in the diet of adults.

Mucofortin contains isomalt

This medicine contains isomalt (a sweetener). If you have been diagnosed with intolerance to some sugars, consult a doctor before taking the medicine.

Mucofortin contains aspartame

This medicine contains 39.9 mg of aspartame in each effervescent tablet. Aspartame is a source of phenylalanine. It may be harmful to patients with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to its impaired excretion.

3. How to take Mucofortin

This medicine should always be taken exactly as described in the package leaflet for the patient or as advised by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist. The recommended dose is:

Adults

1 effervescent tablet once a day (corresponding to 600 mg of acetylcysteine once a day).

Use in children and adolescents

The medicine should not be used in children and adolescents under 18 years of age. Method of administration: Take the medicine after a meal. Dissolve the tablet in half a glass of water and drink immediately after dissolution. Do not mix the prepared oral solution of Mucofortin with other medicines. Note: Do not take the medicine before bedtime due to difficulty in expectorating thinned secretions during sleep. The last dose of Mucofortin should be taken at least 4 hours before bedtime. During treatment, it is recommended to drink plenty of fluids. Duration of treatment: Without a doctor's recommendation, do not take Mucofortin for more than 5 days.

Taking a higher dose of Mucofortin than recommended

In case of taking too much medicine, contact a doctor or pharmacist immediately. Gastrointestinal symptoms such as nausea, vomiting, and diarrhea may occur.

Missing a dose of Mucofortin

If you are taking the medicine 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 the next dose at the usual time. Do not take a double dose to make up for the missed dose. If you have any further doubts about taking this medicine, consult a doctor or pharmacist.

4. Possible side effects

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

Severe side effects

Severe allergic reactionswith symptoms such as difficulty breathing, low blood pressure, hives, rash, angioedema (swelling of the skin and/or mucous membranes, e.g., face, limbs, joints), itching, or hypersensitivity reactions are uncommon side effects. There are very rare reports of severe skin reactions, such as Stevens-Johnson syndrome and Lyell's syndrome, as well as severe allergic reactions (anaphylactic shock, anaphylactic reactions, or pseudo-anaphylactic reactions) after taking Mucofortin.

If you experience any of the above side effects, stop taking Mucofortin and contact a doctor immediately.

If you experience any skin or mucous membrane changes, stop taking Mucofortin and contact a doctor immediately. Uncommon(may affect up to 1 in 100 people): hypersensitivity reactions, headache, tinnitus, increased heart rate (tachycardia), oral mucositis, vomiting, diarrhea, abdominal pain, nausea, skin changes: hives, rash, itching, angioedema, fever, low blood pressure. Rare(may affect up to 1 in 1,000 people): bronchospasm, difficulty breathing, dyspepsia. Very rare(may affect up to 1 in 10,000 people): severe allergic reactions (anaphylactic shock, anaphylactic reaction, pseudo-anaphylactic reaction), bleeding. Frequency not known(frequency cannot be estimated from the available data): facial swelling.

Reporting side effects

If you experience any side effects, including those not listed in the leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance 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, e-mail: ndl@urpl.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 medicine.

5. How to store Mucofortin

Keep the medicine out of the sight and reach of children. Store in a temperature below 25°C. Keep the container tightly closed to protect from light and moisture. Do not use this medicine after the expiry date stated on the packaging after "Expiry date:" or "EXP". The expiry date refers to the last day of the month stated. Do not use the medicine after 28 days of opening the container. 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 Mucofortin contains

• The active substance is acetylcysteine. One effervescent tablet contains 600 mg of acetylcysteine.
• The other ingredients are: anhydrous citric acid, isomalt, sodium bicarbonate, ascorbic acid, aspartame (E 951), lemon flavor.

What Mucofortin looks like and contents of the pack

Mucofortin is white, round, flat effervescent tablets with beveled edges. Mucofortin is available in a container with a LDPE closure, containing a desiccant (silica gel), in a cardboard box also containing a patient leaflet. Pack size: 10 effervescent tablets

Marketing authorization holder and manufacturer:

Natur Produkt Pharma Sp. z o.o. ul. Podstoczysko 30 07-300 Ostrów Mazowiecka Tel. +48 29 644 29 00 Fax. +48 29 745 39 95 (NP Pharma logo) For more detailed information, please contact the representative of the marketing authorization holder.

Date of last revision of the leaflet:

Detailed information about Mucofortin is available on the website: www.urpl.gov.pl