Fluimucil Forte

Package Leaflet: Information for the User

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Fluimucil Forte(Lysomucil)
600 mg, effervescent tablets
Acetylcysteine
Fluimucil Forte and Lysomucil are different trade names for the same medicine.

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 the 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 ask your pharmacist.
• If you experience any side effects, including those not listed in the leaflet, you should tell your doctor or pharmacist. See section 4.
• If after 5 days there is no improvement or you feel worse, you should contact your doctor.

Table of Contents of the Leaflet:

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

1. What is Fluimucil Forte and what is it used for

Acetylcysteine, the active substance of Fluimucil Forte, thins mucus and mucopurulent secretions by breaking disulfide bonds in mucoproteins in the respiratory tract.
Fluimucil Forte is used for a short period as a mucolytic agent to facilitate expectoration in patients with symptoms of infection associated with a cold.
If after 5 days there is no improvement or you feel worse, you should contact your doctor.

2. Important information before taking Fluimucil Forte

When not to use Fluimucil Forte:

• if you are allergic to acetylcysteine or any of the other ingredients of this medicine (listed in section 6);
• in asthmatic status;
• if you have phenylketonuria;
• 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 take Fluimucil Forte).

Warnings and precautions

You should discuss with your doctor or pharmacist before starting to take Fluimucil Forte.

• Caution is recommended when using Fluimucil Forte if you have or have had stomach or duodenal ulcer, especially if you 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 case of liquefaction of large amounts of secretions, especially in small children and very ill bedridden patients, it is necessary to enable their aspiration.
• Acetylcysteine should not be administered to patients with reduced ability to cough, unless respiratory physiotherapy is provided during treatment.
• Caution is recommended 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, Fluimucil Forte should not be used in children and adolescents under 18 years of age.

Fluimucil Forte and other medicines

You should tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
Fluimucil Forte should not be used at the same time as cough suppressants, as this may lead to accumulation of secretions due to reduced cough reflex.
Activated charcoal may reduce the effect of Fluimucil Forte.
If it is necessary to take other medicines, including antibiotics, it is recommended to maintain a 2-hour interval between the administration of these medicines and Fluimucil Forte. This does not apply to loracarbef (a medicine used in infections).
Concomitant use of Fluimucil Forte and nitroglycerin (a medicine used in coronary heart disease) may cause significant hypotension. Headache may occur. If you are taking nitroglycerin, you should consult your doctor before taking Fluimucil Forte.
Concomitant use of Fluimucil Forte and carbamazepine (a medicine used in the treatment of epilepsy) may decrease carbamazepine levels in the blood and reduce its effectiveness.
Fluimucil Forte 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 Fluimucil Forte solution.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before using this medicine.
Pregnancy
It is recommended to avoid using Fluimucil Forte during pregnancy. During pregnancy, Fluimucil Forte may only be administered in cases where it is absolutely necessary and under close medical supervision.
Breastfeeding
It is not known whether Fluimucil Forte passes into breast milk. The risk to the breastfed child cannot be excluded. You should not use Fluimucil Forte if you are breastfeeding.
Fertility
There are no data on the effect of Fluimucil Forte on human fertility. Animal studies do not indicate any harmful effect of acetylcysteine on human fertility at the recommended doses.

Driving and using machines

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

What Fluimucil Forte contains

• 20 mg of aspartamein each 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.
• 156.9 mg of sodium(in the form of sodium bicarbonate) in each tablet (sodium is the main component of common salt). This corresponds to 7.8% of the maximum recommended daily intake of sodium in the diet of adults.

3. How to take Fluimucil Forte

This medicine should always be used exactly as described in the patient leaflet or as directed by your doctor or pharmacist.
In case of doubt, you should consult your doctor or pharmacist.
Fluimucil Forte should not be used for more than 5 days without consulting a doctor.
Recommended dose:

Adults

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

Use in children and adolescents

Due to the amount of active substance, Fluimucil Forte 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 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 Fluimucil Forte should be taken no later than 4 hours before bedtime.
If you feel that the effect of Fluimucil Forte is too strong or too weak, you should consult your doctor.

Overdose of Fluimucil Forte

In case of overdose of Fluimucil Forte, gastrointestinal symptoms such as nausea, vomiting, and diarrhea may occur.
There is no known antidote specific to acetylcysteine. Symptomatic treatment is used.
In case of overdose, you should immediately consult your doctor or pharmacist.

Missed dose of Fluimucil Forte

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, Fluimucil Forte 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 Fluimucil Forte:
Uncommon (less than 1 in 100 patients):

• hypersensitivity,
• headache,
• tinnitus,
• tachycardia (increased 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), pruritus,
• fever,
• hypotension.

Rare (less than 1 in 1000 patients):

• bronchospasm, dyspnea,
• gastritis.

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, severe skin reactions (Stevens-Johnson syndrome, Lyell syndrome) and changes in mucous membranes have been reported after using Fluimucil Forte. In most cases, at least one other medicine was likely to have contributed to the skin and mucous membrane changes.
In case of side effects, you should stop taking the medicine and contact your doctor.

Reporting side effects

If you experience any side effects, including those not listed in the leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Fluimucil Forte

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the month stated.
There are no special precautions for storage.
WARNING:
The possible presence of a sulfur smell is typical for the active substance contained in the medicine.
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 pack and other information

What Fluimucil Forte contains

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

What Fluimucil Forte looks like and contents of the pack

Fluimucil Forte is a white, round, effervescent tablet with a lemon odor and a possible sulfur smell, which is typical for the active substance contained in the medicine.
Packaging available:
10 effervescent tablets, in 5 blisters of 2 tablets, in a cardboard box.
To obtain more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Belgium, the country of export:

Zambon S.A./N.V, Avenue Bourgmestre E. Demunter 3, 1090 Brussels, Belgium

Manufacturer:

Zambon S.A./N.V, Avenue Bourgmestre E. Demunter 3, 1090 Brussels, Belgium
Zambon S.p.A., Via della Chimica 9, 36100 Vicenza, Italy

Parallel importer:

InPharm Sp. z o.o., ul. Strumykowa 28/11, 03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k., ul. Chełmżyńska 249, 04-458 Warsaw
Marketing authorization number in Belgium, the country of export:BE 150202
Parallel import authorization number:101/18
Date of leaflet approval: 13.12.2022
[Information about the trademark]