Acetilcisteinum Flegamina

Package Leaflet: Information for the Patient

Acetylcysteinum Flegamina, 600 mg, Effervescent Tablets

Acetylcysteinum
For adults and adolescents over 14 years of age

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 directed by the doctor or pharmacist.

• The package leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, the pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the package leaflet, the doctor or pharmacist should be informed. See section 4.
• If there is no improvement after 4-5 days or if the patient feels worse, the doctor should be contacted.

Table of Contents of the Package Leaflet

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

1. What is Acetylcysteinum Flegamina and what is it used for

Acetylcysteinum Flegamina contains the active substance acetylcysteine, which is a mucolytic agent that thins stubborn mucus in the respiratory tract.
Acetylcysteinum Flegamina is indicated for adolescents over 14 years of age and adults to thin mucus and facilitate its expectoration in bronchitis caused by a cold with accompanying persistent respiratory secretion and reduced mucus transport.

2. Important information before taking Acetylcysteinum Flegamina

When not to take Acetylcysteinum Flegamina:

• if the patient is allergic to acetylcysteine or any of the other ingredients of this medicine (listed in section 6).

Due to the high content of the active substance, Acetylcysteinum Flegamina should not be taken by children under 14 years of age. For this patient group, medicines with appropriate potency are available.

Warnings and precautions

Before starting treatment with Acetylcysteinum Flegamina, the patient should discuss it with the doctor or pharmacist if

• the patient notices skin changes. There are very rare reports of severe skin reactions, such as Stevens-Johnson syndrome and Lyell's syndrome, associated with temporary administration of acetylcysteine. If new skin and mucous membrane changes occur, the doctor should be consulted immediately and the administration of acetylcysteine should be discontinued.
• -the patient has bronchial asthma.
• the patient has or has had stomach or duodenal ulcers, especially when taking other medicines that irritate the mucous membrane of the gastrointestinal tract.
• the patient has a histamine intolerance. Long-term use should be avoided in these patients, as Acetylcysteinum Flegamina affects histamine metabolism and may lead to intolerance symptoms (e.g., headache, nasal discharge, itching).
• the patient is unable to effectively cough up liquid secretions. Taking Acetylcysteinum Flegamina, especially at the beginning of treatment, may cause thinning of mucus, leading to an increase in the volume of bronchial secretions. If the patient is not able to cough up sufficiently, the doctor will take appropriate action.

Children and adolescents

Mucolytic agents may cause respiratory tract 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 up mucus may be limited. Therefore, mucolytic agents should not be taken by children under 2 years of age.

Acetylcysteinum Flegamina and other medicines

The doctor or pharmacist should be informed about all medicines the patient is taking or has recently taken, as well as any medicines the patient plans to take. This includes all medicines, including those bought without a prescription.
Interaction studies have been conducted only in adults.
The doctor or pharmacist should be informed about the use of any of the following medicines:

• Cough medicines (antitussives), as they may cause dangerous accumulation of secretions due to impaired cough reflex
• Activated charcoal, used to treat poisoning, may reduce the effect of acetylcysteine.
• Antibiotics used to treat bacterial infections, e.g., tetracycline, aminoglycosides, penicillins. Clinical studies have shown that acetylcysteine weakens the effect of antibiotics. For safety reasons, antibiotics should be taken separately, at intervals of at least two hours. This does not apply to medicines containing the active substance cefixime or loracarbef. These medicines can be taken simultaneously with acetylcysteine.
• Medicines used to treat angina pectoris attacks; chest, neck, and arm pressure (e.g., nitroglycerin).
• Concomitant use of acetylcysteine and nitroglycerin may enhance the vasodilating effect of nitroglycerin due to possible blood-thinning effects. If the doctor considers it necessary to treat with nitroglycerin and acetylcysteine simultaneously, the patient's low blood pressure (hypotension) will be monitored, which may be severe and cause headaches.
• Medicines used to treat epilepsy and nerve pain (carbamazepine). Concomitant use of acetylcysteine and carbamazepine may reduce the effectiveness of carbamazepine due to decreased carbamazepine serum levels.

Changes in laboratory test results
Acetylcysteine may affect salicylate tests.
Acetylcysteine may affect the results of ketone body tests in urine.
It is not recommended to dissolve Acetylcysteinum Flegamina with other medicines.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult her doctor or pharmacist before taking this medicine.
Pregnancy
Since there is not enough experience with the use of acetylcysteine in pregnant women, Acetylcysteinum Flegamina should be used during pregnancy only if the treating doctor considers it absolutely necessary.
Breastfeeding
There is no data on the excretion of acetylcysteine into human milk.
Therefore, Acetylcysteinum Flegamina should be used during breastfeeding only if the treating doctor considers it absolutely necessary.

Driving and using machines

There is no evidence that acetylcysteine has any effect on the ability to drive and use machines.

Acetylcysteinum Flegamina contains sodium

This medicine contains 150 mg of sodium (the main component of common salt) in each effervescent tablet.
This corresponds to 7.65% of the maximum recommended daily intake of sodium in the diet for adults. This should be taken into account in patients controlling their sodium intake.

Acetylcysteinum Flegamina contains aspartame

This medicine contains 20 mg of aspartame in each effervescent tablet.
Aspartame is a source of phenylalanine. It may be harmful to patients with phenylketonuria, a rare genetic disorder in which phenylalanine accumulates in the body due to its impaired excretion.

Acetylcysteinum Flegamina contains sucrose and glucose (maltodextrin component)

If the patient has previously been diagnosed with intolerance to some sugars, the patient should contact the doctor before taking the medicine.

3. How to take Acetylcysteinum Flegamina

This medicine should always be taken exactly as described in the package leaflet for the patient, or as directed by the doctor or pharmacist or nurse. In case of doubt, the doctor or pharmacist or nurse should be consulted.
The following instructions should be followed, unless the doctor has prescribed a different dosage regimen. The instructions for use must be followed, otherwise Acetylcysteinum Flegamina will not work properly.
Method and duration of administration
The effervescent tablet should be dissolved in a glass of water and then the contents of the entire glass should be drunk.
Acetylcysteinum Flegamina should be taken after a meal.

If the symptoms worsen or do not improve after 4-5 days, the doctor should be consulted.
If the patient feels that the effect of Acetylcysteinum Flegamina is too strong or too weak, the doctor or pharmacist should be consulted.

Overdose of Acetylcysteinum Flegamina

Overdose may cause gastrointestinal irritation (e.g., abdominal pain, nausea, vomiting, diarrhea). So far, no serious adverse reactions indicating poisoning have been observed, even after significant overdose of acetylcysteine tablets. In case of suspected overdose of Acetylcysteinum Flegamina, the doctor should be informed.

Missed dose of Acetylcysteinum Flegamina

A double dose should not be taken to make up for a missed tablet. The medicine should be continued as described in the instructions for use.
In case of further doubts about the use of this medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If the patient experiences any of the following very rare (may occur less than 1 in 10,000 people) symptoms, the patient should stop taking Acetylcysteinum Flegamina and seek medical help immediately:

• severe skin reactions, such as Stevens-Johnson syndrome and Lyell's syndrome associated with temporary administration of acetylcysteine*. Symptoms include rash, swallowing or breathing problems, swelling of the lips, face, throat, or tongue. *In most reported cases, at least one other pharmaceutical substance was taken, which could potentially enhance the described effect on the skin and mucous membranes.

The following side effects may occur:

Uncommon (may occur less than 1 in 100 people):

• hypersensitivity reactions
• headache
• ringing in the ears (tinnitus)
• rapid heartbeat
• vomiting, diarrhea, oral mucositis, abdominal pain, nausea
• allergic reactions: hives, itching, rash, skin and mucous membrane swelling
• fever
• low blood pressure

Rare (may occur less than 1 in 1,000 people):

• shortness of breath, bronchospasm - mainly in patients with hyperreactive airways in bronchial asthma
• heartburn

Very rare (may occur less than 1 in 10,000 people):

• hypersensitivity reactions up to anaphylactic shock
• bleeding

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

• water accumulation in the face (facial edema)

The doctor should be consulted immediately and the use of Acetylcysteinum Flegamina should be discontinued if new skin and mucous membrane changes occur.
Acetylcysteinum Flegamina should not be continued.
Various studies have confirmed a decrease in platelet aggregation (clumping of certain blood components) during acetylcysteine administration. The clinical significance of this effect is still unclear.
Measures
Acetylcysteinum Flegamina should be discontinued at the first signs of hypersensitivity reactions (see above). In such cases, the doctor should be consulted.

Reporting side effects

If side effects occur, including any side effects not listed in the package leaflet, the doctor or pharmacist should be informed. Side effects can be reported directly to the Department for Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Acetylcysteinum Flegamina

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 container and carton after:
“Expiry date” or “EXP”. The expiry date refers to the last day of the month.
Storage conditions
The medicine should not be stored at temperatures above 25°C.
The container should be kept tightly closed to protect from moisture.
Shelf life after first opening of the container: 12 months.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of medicines that are no longer used. This will help protect the environment.

6. Contents of the pack and other information

What Acetylcysteinum Flegamina contains

• The active substance is: acetylcysteine. 1 effervescent tablet contains 600 mg of acetylcysteine.
• The other ingredients are: citric acid, sodium bicarbonate, adipic acid, povidone K-25, aspartame (E 951), lemon flavor (contains maltodextrin, sucrose, gum arabic (E 414), triacetin (E 1518), alpha-tocopherol (E 307)).

What Acetylcysteinum Flegamina looks like and contents of the pack

White to yellowish, round, effervescent tablets, flat on both sides and smooth, with a lemon flavor.
The effervescent tablets are packaged in polypropylene tubes with a white polyethylene cap, containing a desiccant (60% molecular sieve and 40% silica gel).
Acetylcysteinum Flegamina is available in packs of 10 effervescent tablets.

Marketing authorization holder:

Teva B.V., Swensweg 5, 2031GA Haarlem, Netherlands

Manufacturer:

Merckle GmbH, Graf-Arco Str. 3, 89079 Ulm, Germany
To obtain more detailed information about the medicine and its names in other EU member states, the representative of the marketing authorization holder should be contacted: Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warsaw, tel.: (22) 345 93 00.

This medicine is authorized in EU member states under the following names:

Germany:
NAC AbZ 600 mg Brausetabletten
Spain:
Notus Mucus 600mg comprimidos efervescentes sabor limón
Finland:
Mucoratio 600 mg poretabletti
Poland:
Acetylcysteinum Flegamina

Date of last revision of the package leaflet: March 2024