Fluimucil Forte

Package Leaflet: Information for the User

Warning!

The leaflet must be kept. Information on the immediate packaging in a foreign language.

Fluimucil Forte Lysomucil 600 mg effervescent tablets)

600 mg, effervescent tablets

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

It is necessary to 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 a doctor or pharmacist.

• The leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any side effects not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.
• If there is no improvement or the patient feels worse after 5 days, they should contact their doctor.

Table of Contents of the Leaflet:

• 1. What is Fluimucil Forte and what is it used for
• 2. Important information before using Fluimucil Forte
• 3. How to use 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 respiratory tract infections associated with the common cold.
If there is no improvement or the patient feels worse after 5 days, they should consult their doctor.

2. Important information before using Fluimucil Forte

When not to use Fluimucil Forte

• if the patient is allergic to acetylcysteine or any of the other ingredients of this medicine (listed in section 6);
• in asthma;
• if the patient has phenylketonuria;
• in children under 2 years of age, as the active substance: acetylcysteine may cause respiratory tract obstruction in children under 2 years of age (see also section 3. How to use Fluimucil Forte).

Warnings and precautions

Before starting treatment with Fluimucil Forte, the patient should discuss it with their doctor or pharmacist.

• Caution is recommended when using Fluimucil Forte if the patient has or has had a stomach 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 aspiration.
• Acetylcysteine should not be administered to patients with reduced ability to cough, unless they are 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 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 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

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Fluimucil Forte 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 Fluimucil Forte.
If it is necessary to take other medicines, including antibiotics, at the same time, a 2-hour interval should be maintained 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 the patient is taking nitroglycerin, they should consult their 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).
Other medicines should not be mixed with the Fluimucil Forte solution.

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 or pharmacist before using this medicine.
Pregnancy
Fluimucil Forte should be avoided 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. Fluimucil Forte should not be used during breastfeeding.
Fertility
There are no data on the effect of Fluimucil Forte on fertility in humans. 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 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 its impaired excretion.
• 156.9 mg of sodium (in the form of sodium bicarbonate)in each effervescent 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 use Fluimucil Forte

This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor or pharmacist.
In case of doubt, a doctor or pharmacist should be consulted.
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, an increased amount of fluids should be consumed.
Treatment of acute conditions should not last more than 5 days.
Note:
The last dose of Fluimucil Forte should be taken no later than 4 hours before bedtime.
If the patient feels that the effect of Fluimucil Forte is too strong or too weak, they should consult their doctor.

Overdose of Fluimucil Forte

In case of overdose, 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, the patient should immediately consult their doctor or pharmacist.

Missed dose of Fluimucil Forte

A double dose should not be taken to make up for a missed dose.
In case of any further doubts about the use of this medicine, the patient should consult their 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, allergic 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 the face, throat, larynx, genitalia, and 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 the 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, the patient should stop taking the medicine and consult their doctor.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the patient should inform their doctor, pharmacist, or nurse. 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
Aleje Jerozolimskie 181C
02-222 Warsaw
tel.: + 48 (22) 49 21 301
fax: + 48 (22) 49 21 309
website: https://smz.ezdrowie.gov.pl
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Fluimucil Forte

The medicine should be stored out of sight and reach of children.
This medicine should not be used 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.
Note:
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. The patient should ask their 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 (excipients) 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 flavor and a possible sulfur smell, which is typical for the active substance contained in the medicine.
Available packs:
10 effervescent tablets, in 5 blisters Al/PE/PE/Al/PA of 2 tablets each, in a cardboard box.
For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Belgium, the country of export:

Zambon S.A.
Avenue Bourgmestre E. Demunter 3
1090 Brussels
Belgium

Manufacturer:

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

Parallel importer:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Belgian marketing authorization number: BE 150202

Parallel import authorization number: 93/13 Date of approval of the leaflet: 01.02.2023

[Information about the trademark]