Mucofortin

Package leaflet: Information for the patient

Mucofortin, 600 mg, effervescent tablets
Acetylcysteinum
Please read the entire leaflet carefully before using this medicine, as it contains important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed by your
doctor, pharmacist, or nurse.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 5 days or if your symptoms worsen, consult your doctor.

Table of contents:

1. What Mucofortin is and what it is 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 Mucofortin is and what it is used for

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

2. Important information before taking Mucofortin

When not to take Mucofortin:

• If the patient is allergic to acetylcysteine or to any of the other ingredients of this medicine (listed in section 6). Symptoms of allergy may include: itching, urticaria, rash, bronchospasm (shortness of breath), rapid heartbeat, and low blood pressure. If any of these symptoms occur, stop using Mucofortin immediately and contact a doctor.
• During an asthmatic attack (shortness of breath due to bronchial asthma or obstructive lung disease that does not resolve despite using bronchodilators).
• If the patient has phenylketonuria (see section "Mucofortin contains aspartame").
• In children under 2 years of age, because the active substance acetylcysteine may cause airway obstruction in children under 2 years of age (see also section "Warnings and precautions" and "How to take Mucofortin").

Warnings and precautions
Before starting treatment with Mucofortin, discuss with your doctor or pharmacist if:

• the patient has suffered from or suffers from chronic bronchial asthma (because the medicine may cause bronchospasm and shortness of breath);
• the patient is elderly (over 65 years of age);
• the patient currently has or has previously had respiratory insufficiency;
• the patient has had or has a history of peptic ulcer disease of the stomach or duodenum;
• the patient is allergic to histamine, as Mucofortin may cause intolerance symptoms such as headache, rhinitis, or itching.

Very rarely, severe skin adverse reactions have been observed during treatment with acetylcysteine,
e.g. Stevens-Johnson syndrome and Lyell's syndrome. If any skin changes or mucosal lesions occur
during treatment with Mucofortin, discontinue use of the medicine immediately and contact a doctor.
Mucofortin may interfere with the results of certain laboratory tests (determination of salicylates by
colorimetric method and determination of ketones in urine).
Children and adolescents
Due to the amount of active substance, Mucofortin should not be used in children and adolescents
under 18 years of age.
Mucofortin with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently
taken, as well as any medicines the patient plans to take.

• Do not use Mucofortin with antitussive medicines, as they suppress the cough reflex and may impair the expectoration of mucus liquefied by Mucofortin.
• Acetylcysteine (the active substance in Mucofortin) may reduce the effectiveness of certain antibiotics, especially semi-synthetic penicillins, tetracyclines, cephalosporins, and aminoglycosides. To prevent this, Mucofortin should be taken at least 2 hours after taking an antibiotic. This does not apply to amoxicillin, doxycycline, erythromycin, thiamphenicol, or cefuroxime. In case of doubt, consult a doctor.
• Mucofortin may enhance the effect of nitroglycerin and other nitrates (medicines used in cardiovascular diseases and ischemic heart disease). If the patient is taking nitroglycerin or another nitrate medicine, medical advice should be sought before taking Mucofortin.
• Activated charcoal may reduce the effectiveness of Mucofortin.

If the patient is unsure whether they are taking any of the above-mentioned medicines, they should
consult their doctor or pharmacist.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become
pregnant, she should consult a doctor or pharmacist before using this medicine.
During pregnancy, Mucofortin may be administered only when strictly necessary and under close
medical supervision.
The doctor will decide whether to discontinue breastfeeding or discontinue treatment with Mucofortin,
taking into account the benefits of breastfeeding for the child and the benefits of treatment for the mother.
Driving and operating machinery
The effect of Mucofortin on the ability to drive and operate machinery is unknown.
Mucofortin contains sodium
Mucofortin contains 183.4 mg of sodium (the main component of table salt) in each effervescent tablet.
This corresponds to 9.17% of the maximum daily sodium intake of 2 g recommended by WHO in the
diet of adults.
Mucofortin contains isomalt
This medicine contains isomalt (a sweetening agent). If the patient has previously been diagnosed
with intolerance to certain sugars, the patient should consult a doctor before taking this 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 impaired excretion.

3. How to take Mucofortin

This medicine should always be taken exactly as described in the patient information leaflet or as advised by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The recommended dose is:
Adults
1 effervescent tablet once daily (corresponding to 600 mg of acetylcysteine once daily).
Use in children and adolescents
This medicine must not be used in children and adolescents under 18 years of age.
Method of administration
The medicine should be taken after a meal.
The tablet should be dissolved in half a glass of water and taken immediately after dissolving.
The prepared oral solution of Mucofortin must not be mixed with other medicines.
Warning: Do not take the medicine immediately before going to sleep due to difficulty in expectorating the liquefied secretions during sleep. The last dose of Mucofortin should be taken at least 4 hours before bedtime.
During treatment, it is recommended to drink increased amounts of fluids.
Duration of treatment
Without medical advice, Mucofortin should not be used for longer than 5 days.
Taking more Mucofortin than recommended
If you have taken too much medicine, contact your doctor or pharmacist immediately. Gastrointestinal symptoms such as nausea, vomiting, and diarrhoea may occur.
If you miss a dose of Mucofortin
If you are taking the medicine regularly and only a short time has passed since the missed dose, take it 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 a missed dose.
If you have any further doubts concerning the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicinal products, this medicine can cause adverse reactions, although not everybody will experience them.
Severe adverse reactions
Severe allergic reactions presenting as difficulty in breathing, low blood pressure, urticaria, rash, angioedema (swelling of the skin and/or mucous membranes, e.g. face, limbs, joints), itching, or hypersensitivity reactions are uncommon adverse reactions. There have been 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 or pseudo-anaphylactic reactions) following the use of Mucofortin.
If any of the above-mentioned adverse reactions occur, discontinue Mucofortin immediately and contact your doctor.
In case of skin or mucous membrane lesions, discontinue Mucofortin immediately and contact your doctor.
Uncommon (may occur in less than 1 in 100 people but more than 1 in 1,000 people):
hypersensitivity reactions, headache, tinnitus, increased heart rate (tachycardia), oral mucosal inflammation, vomiting, diarrhoea, abdominal pain, nausea, skin reactions: urticaria, rash, itching, angioedema, fever, low blood pressure.
Rare (may occur in less than 1 in 1,000 people but more than 1 in 10,000 people):
bronchospasm, dyspnoea, indigestion.
Very rare (may occur in less than 1 in 10,000 people):
severe allergic reactions (anaphylactic shock, anaphylactic reaction, pseudo-anaphylactic reaction), haemorrhage.
Frequency not known (frequency cannot be estimated from the available data):
facial swelling.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration 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: [email protected].
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Mucofortin

Keep the medicine out of sight and reach of children.
Store 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 specified month.
Do not use the medicine more than 28 days after first opening the container.
Medicines must 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.
• Other ingredients are: anhydrous citric acid, isomalt, sodium bicarbonate, ascorbic acid, aspartame (E 951), lemon flavouring.

What Mucofortin looks like and contents of the pack
Mucofortin is a white, round, flat effervescent tablet with bevelled edges.
Mucofortin is available in a container made of LDPE with a closure, containing a moisture-absorbing agent (silica gel), packed in a cardboard box which also contains the patient leaflet.
Pack size: 10 effervescent tablets
Marketing authorisation 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 further information, please contact the representative of the marketing authorisation holder.
Detailed information on Mucofortin is available at: www.urpl.gov.pl