Mucoatac

Leaflet attached to the packaging: information for the user

MUCOATAC

600 mg, effervescent tablets

Acetylcysteine

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

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

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult your 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 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 MUCOATAC and what is it used for
• 2. Important information before using MUCOATAC
• 3. How to use MUCOATAC
• 4. Possible side effects
• 5. How to store MUCOATAC
• 6. Contents of the packaging and other information

1. What is MUCOATAC and what is it used for

Acetylcysteine, the active substance of MUCOATAC, thins mucus and mucopurulent secretions by breaking disulfide bonds in mucoproteins in the respiratory tract. MUCOATAC is used as a short-term expectorant to facilitate the expulsion of respiratory secretions in patients with symptoms of infection associated with a cold. If after 5 days there is no improvement or the patient feels worse, they should consult their doctor.

2. Important information before using MUCOATAC

When not to use MUCOATAC:

• if the patient is allergic to acetylcysteine or any of the other ingredients of this medicine (listed in section 6);
• in asthmatic status;
• in children under 2 years of age, as the active substance: acetylcysteine may cause respiratory obstruction in children under 2 years of age (see also section 3. How to use 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, you should discuss it with your doctor or pharmacist.

• Caution is recommended 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 close medical supervision due to the possibility of bronchospasm. If this symptom occurs, the administration of the medicine should be stopped immediately.
• In the event of liquefaction of large amounts of secretions, especially in small children and very ill bedridden patients, it is necessary to enable their suction.
• Acetylcysteine should not be administered to patients with reduced ability to cough, unless the patient is provided with respiratory physiotherapy during treatment.
• Caution should be exercised if the medicine is used for a long time in patients with histamine intolerance, as they may experience symptoms such as headache, vasomotor rhinitis, skin itching.

Children and adolescents

Mucolytic agents may cause respiratory obstruction in children under 2 years of age. Due to the physiological characteristics of the respiratory tract in this age group, the ability to cough may be limited, therefore mucolytic agents 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 and other medicines

You should 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. MUCOATAC should not be used at the same time as cough suppressants, as this may lead to retention of secretions due to reduced cough reflex. Activated charcoal may reduce the effect of MUCOATAC. If it is necessary to take other medicines, including antibiotics, at the same time, it is recommended to maintain a 2-hour interval between the administration of these medicines and MUCOATAC. This does not apply to loracarbef (a medicine used in infections). Concurrent use of MUCOATAC and nitroglycerin (a medicine used in coronary heart disease) can cause significant hypotension. Headache may also occur. If the patient is taking nitroglycerin, they should consult their doctor before taking MUCOATAC. Concurrent use of MUCOATAC and carbamazepine (a medicine used in the treatment of epilepsy) may decrease carbamazepine levels in the blood and reduce its effectiveness. MUCOATAC may affect the results of some laboratory tests (salicylate determination by colorimetry and ketone determination in urine). It is recommended not to mix other medicines with the solution of MUCOATAC.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before using this medicine. Pregnancy It is recommended to avoid using MUCOATAC during pregnancy. During pregnancy, MUCOATAC may only be administered in cases where it is absolutely necessary and under close medical supervision. Breastfeeding It is not known whether MUCOATAC passes into breast milk. The risk to the breastfed child 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 any harmful effect of acetylcysteine on human fertility when used at the recommended doses.

Driving and using machines

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

MUCOATAC contains:

• 194.58 mg of sodium (the main component of common salt) in each effervescent tablet. This corresponds to 9.7% of the maximum recommended daily intake of sodium in the diet of adults,
• contains sulfites. The sulfite content in the orange flavor is less than 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 leaflet. In case of doubt, you should consult your doctor or pharmacist. MUCOATAC should not be used for more than 5 days without consulting a doctor. The recommended dose is:

Adults

1 effervescent tablet (600 mg) of MUCOATAC once a day.

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 cool water. The resulting solution is ready to drink. The solution should be drunk immediately after preparation. During treatment, you should drink an increased amount of fluids. 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, you should consult your doctor.

Using a higher dose of MUCOATAC than recommended

In the event of using a higher dose of MUCOATAC than recommended, gastrointestinal symptoms such as nausea, vomiting, and diarrhea may occur. There is no known antidote specific to acetylcysteine. Symptomatic treatment is used. In the event of using a higher dose of the medicine, you should immediately consult your doctor or pharmacist.

Missing a dose of MUCOATAC

You should not take a double dose to make up for a missed dose. In case of any further doubts about the use of this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, MUCOATAC can cause side effects, although not everybody gets them. In clinical trials, the most commonly reported side effects were related to the stomach and intestines, and less frequently, hypersensitivity reactions. Side effects that may occur when using MUCOATAC:

Uncommon (less than 1 in 100 patients):

• hypersensitivity,
• headache,
• tinnitus,
• tachycardia (accelerated heart rate),
• vomiting, diarrhea, stomatitis, abdominal pain, nausea,
• urticaria, rash, angioedema (swelling of the skin and mucous membranes, which most often affects: face, throat, larynx, genitals, intestines), itching,
• fever,
• hypotension.

Rare (less than 1 in 1000 patients):

• bronchospasm, dyspnea,
• indigestion.

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

• severe allergic reactions (anaphylactic shock, anaphylactic reaction, pseudo-anaphylactic reaction),
• hemorrhage.

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

• facial edema.

Very rarely, there have been reports of severe skin reactions (Stevens-Johnson syndrome, Lyell's syndrome) and changes in mucous membranes after using acetylcysteine. In most cases, at least one other medicine was likely to have contributed to the skin and mucous membrane changes. If side effects occur, you should stop taking the medicine and consult your doctor.

Reporting side effects

If you experience any side effects, including those not listed in the leaflet, you should inform your doctor or pharmacist. Side effects can be reported directly to: Department of Monitoring of Adverse Reactions to Medicinal Products, 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 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 MUCOATAC

The medicine should be stored out of sight and reach of children. There are no special precautions for storage. Store in the original packaging, tightly closed, to protect from light and moisture. Shelf life: Shelf life after first opening the container 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 should not be disposed of via wastewater or household waste. You should ask your 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 MUCOATAC contains

• The active substance of MUCOATAC is acetylcysteine. One effervescent tablet contains 600 mg of acetylcysteine.
• The other ingredients are: citric acid, maltodextrin, sodium bicarbonate, leucine, orange flavor (corn maltodextrin, gum arabic, ascorbic acid (E 300), butylhydroxyanisole (E 320)), sodium saccharin (E 954).

What MUCOATAC looks like and what the packaging contains

MUCOATAC is white, round, flat tablets. A polypropylene tube-shaped container with a polyethylene cap, containing a desiccant (silica gel), in a cardboard box. The packaging contains 10 effervescent tablets.

Marketing authorization holder

TACTICA Pharmaceuticals Sp. z o.o. ul. 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

Date of last revision of the leaflet: