Patient Information Leaflet: Information for the User

MUCOATAC
600 mg, effervescent tablets
Acetylcysteinum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
This medicine should always be taken exactly as described in this patient leaflet or as directed by
your doctor or pharmacist.

Keep this leaflet, so that you can read it again if necessary.
If you need advice or further information, please consult your pharmacist.
If you experience any side effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 5 days, or if you feel worse, you should consult your doctor.

Table of Contents

What MUCOATAC is and what it is used for
Important information before taking MUCOATAC
How to take MUCOATAC
Possible side effects
How to store MUCOATAC
Contents of the pack and other information

1. What MUCOATAC is and what it is used for

Acetylcysteine, the active substance in MUCOATAC, liquefies mucus and mucopurulent secretions by breaking the disulfide bonds in mucus polypeptides in the respiratory tract.
MUCOATAC is used short-term as a mucolytic agent to thin respiratory secretions and facilitate expectoration in patients with symptoms of infection associated with the common cold.
If there is no improvement after 5 days, or if you feel worse, you should consult your doctor.

2. Information before using MUCOATAC

When not to use MUCOATAC:

if the patient is allergic to acetylcysteine or to any of the other ingredients of this medicine (listed in section 6);
in asthmatic conditions;
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 3. How to take MUCOATAC);
in children and adolescents under 18 years of age due to the amount of active substance.

Warnings and precautions
Before starting treatment with MUCOATAC, discuss this with your doctor or pharmacist.

Caution is advised when using MUCOATAC if the patient has or has had a history of gastric or duodenal ulcer, especially if they are also taking other medicines known to irritate the gastric mucosa.
Treatment of patients with bronchial asthma should be carried out under strict medical supervision due to the risk of bronchospasm. If this symptom occurs, administration of the medicine must be stopped immediately.
If large amounts of secretion are liquefied, especially in young children and very ill immobilized patients, suctioning should be made possible.
Acetylcysteine should not be administered to patients with reduced ability to expectorate unless respiratory physiotherapy is provided during treatment.
Caution is required when MUCOATAC is used long-term in patients with histamine intolerance, as symptoms such as headache, vasomotor rhinitis, and skin itching may occur.

Children and adolescents
Mucolytic medicines may cause airway obstruction in children under 2 years of age.
Due to the physiological characteristics of the respiratory tract in this age group, the ability to expectorate may be limited; therefore, mucolytic medicines should not be used in children under 2 years of age.
Due to the amount of active substance, MUCOATAC should not be used in children and adolescents under 18 years of age.

MUCOATAC with other medicines
Inform 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 take MUCOATAC together with cough suppressants, as this may lead to mucus accumulation due to reduced cough reflex.
Activated charcoal may reduce the effectiveness of MUCOATAC.
If it is necessary to take other medicines, including antibiotics, simultaneously, a 2-hour interval between administration of those medicines and MUCOATAC is recommended. This does not apply to loracarbef (a medicine used in infections).
Concomitant use of MUCOATAC and nitroglycerin (a medicine used in ischemic heart disease) causes significant arterial hypotension. Headache may also occur. If the patient is taking nitroglycerin, they should consult a doctor before taking MUCOATAC.
Concomitant use of MUCOATAC and carbamazepine (a medicine used in epilepsy treatment) may reduce carbamazepine blood levels and decrease its effectiveness.
MUCOATAC may affect the results of certain laboratory tests (colorimetric determination of salicylates and urinary ketone testing).
Mixing other medicines with the MUCOATAC solution is not recommended.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor before using this medicine.

Pregnancy
Use of MUCOATAC during pregnancy is not recommended. MUCOATAC may be administered during pregnancy only when absolutely necessary and under strict medical supervision.

Breastfeeding
It is not known whether MUCOATAC passes into human breast milk. Risk to the breastfed infant cannot be excluded. MUCOATAC should not be used if the patient is breastfeeding.

Fertility
There are no data on the effect of MUCOATAC on human fertility. Animal studies do not indicate harmful effects of acetylcysteine on fertility in humans when used at recommended doses.

Driving and operating machinery
The effect of MUCOATAC on the ability to drive and operate machinery is unknown.

MUCOATAC contains:

194.58 mg of sodium (a main component of table salt) in each effervescent tablet. This corresponds to 9.7% of the maximum recommended daily dietary sodium intake for adults,
contains sulfites. The sulfite content in the orange flavour is below 10 ppm (10 parts per million). The medicine may rarely cause severe hypersensitivity reactions and bronchospasm.

3. How to use MUCOATAC

This medicine should always be used exactly as described in this patient information leaflet. If in
doubt, consult a doctor or pharmacist.
Do not use MUCOATAC for longer than 5 days without consulting a doctor.
Recommended dose:
Adults
1 effervescent tablet (600 mg) of MUCOATAC once daily.
Use in children and adolescents
Due to the amount of active substance, MUCOATAC should not be used in children and adolescents
under 18 years of age.
Method of administration:
Dissolve the tablet in half a glass of lukewarm water. The resulting solution is ready to drink.
The solution should be consumed immediately after preparation.
During treatment, increased fluid intake is recommended.
Treatment of acute conditions should not last longer than 5 days.
Note:
The last dose of MUCOATAC should be taken no later than 4 hours before bedtime.
If you feel that the effect of MUCOATAC is too strong or too weak, consult your doctor.
Use of a higher than recommended dose of MUCOATAC
If a higher than recommended dose of MUCOATAC is taken, gastrointestinal symptoms such as
nausea, vomiting, and diarrhoea may occur.
There is no known specific antidote for acetylcysteine. Symptomatic treatment should be used.
If a higher than recommended dose is taken, seek immediate advice from a doctor or pharmacist.
Missed dose of MUCOATAC
Do not take a double dose to make up for a missed dose.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
In clinical trials, gastrointestinal adverse reactions were most frequently reported,
while hypersensitivity reactions occurred less frequently.
Adverse reactions that may occur during treatment with MUCOATAC:
Uncommon (less than 1 in 100 patients):

hypersensitivity,
headache,
tinnitus (ringing in the ears),
tachycardia (increased heart rate),
vomiting, diarrhoea, stomatitis (inflammation of the mouth), abdominal pain, nausea,
urticaria, rash, angioedema (swelling of the skin and mucous membranes, most commonly affecting the face, throat, larynx, genital organs, or intestines), pruritus (itching),
fever,
hypotension (low blood pressure).

Rare (less than 1 in 1,000 patients):

bronchospasm, dyspnoea (shortness of breath),
dyspepsia.

Very rare (less than 1 in 10,000 patients):

severe allergic reactions (anaphylactic shock, anaphylactic reaction, pseudoanaphylactic reaction),
haemorrhage (bleeding).

Frequency not known (frequency cannot be estimated from available data):

facial swelling.

Very rare cases of severe skin reactions (Stevens-Johnson syndrome, Lyell's syndrome) and mucosal lesions have been reported following administration of acetylcysteine. In most cases, at least one other medicinal product likely contributed to the development of skin and mucosal lesions.
If adverse reactions occur, treatment should be discontinued and medical advice should be sought.
Reporting of adverse reactions
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to:
Department of Monitoring of 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,
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store MUCOATAC

Keep this medicine out of sight and reach of children.
There are no special requirements for storage. Store in the original container tightly closed
to protect from light and moisture.
Expiry date:
The shelf life after first opening the container is 3 months.
Do not use this medicine after the expiry date stated on the packaging after:
Expiry date (EXP) or on the label after: EXP:
Medicines must not be disposed of via the sewage system or household waste. Ask your
pharmacist how to dispose of medicines no longer required. These measures will help
protect the environment.

6. Contents of the pack and other information

What MUCOATAC contains

The active substance is acetylcysteine. Each effervescent tablet contains 600 mg of acetylcysteine.
The other ingredients are: citric acid, maltodextrin, sodium hydrogen carbonate, leucine, orange flavour (corn maltodextrin, gum arabic, ascorbic acid (E 300), butylhydroxyanisole (E 320)), sodium saccharin (E 954).

What MUCOATAC looks like and contents of the pack
MUCOATAC is white, round, flat effervescent tablets.
The container is a polypropylene tube with a polyethylene cap containing a moisture-absorbing substance (silica gel), packed in a cardboard box.
The pack contains 10 effervescent tablets.

Marketing Authorisation Holder
TACTICA Pharmaceuticals Sp. z o.o.
Królowej Jadwigi 148a/1a
30-212 Kraków
tel.: +48 889 388 538

Manufacturer
E-Pharma Trento S.p.A.
Frazione Ravina
Via Provina, 2
38123 Trento
Italy