Fluimucil Forte

Leaflet attached to the packaging: 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 Lysomucilare different trade names for the same drug.

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

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist.

• You should keep this leaflet, so that you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell 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 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 packaging 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 after 5 days there is no improvement or the patient feels worse, they should consult their doctor.

2. Important information before taking Fluimucil Forte

When not to take 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 take 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 taking 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 severely ill bedridden patients, it is necessary to enable their aspiration.
• Acetylcysteine should not be administered to patients with reduced ability to expectorate, 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, 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 expectorate 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 tell 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 taken 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 effectiveness of Fluimucil Forte. If it is necessary to take other medicines, including antibiotics, 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). Concurrent use of Fluimucil Forte and nitroglycerin (a medicine used in coronary heart disease) may cause significant hypotension. Headache may also occur. If the patient is taking nitroglycerin, they should consult their doctor before taking Fluimucil Forte. Concurrent use of Fluimucil Forte and carbamazepine (a medicine used in 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 solution of Fluimucil Forte.

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 taking this medicine. Pregnancy It is recommended to avoid taking 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. A risk to the breastfed child cannot be excluded. Fluimucil Forte should not be taken if the patient is breastfeeding. Fertility There are no data on the effects of Fluimucil Forte on human fertility. Animal studies do not indicate any harmful effects 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.
• Glucose(a component of lemon flavor). If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

3. How to take Fluimucil Forte

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist. Fluimucil Forte should not be taken 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, the patient 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 the patient feels that the effect of Fluimucil Forte is too strong or too weak, they should consult their doctor.

Taking a higher dose of Fluimucil Forte than recommended

If a higher dose of Fluimucil Forte than recommended is taken, gastrointestinal symptoms such as nausea, vomiting, and diarrhea may occur. There is no known antidote specific to acetylcysteine. Symptomatic treatment is used. If a higher dose of the medicine than recommended is taken, the patient should immediately consult their doctor or pharmacist.

Missing a dose of Fluimucil Forte

A double dose should not be taken to make up for a missed dose. If the patient has any further doubts about taking this medicine, they 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 taking 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, genitals, and 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),
• bleeding.

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

• facial edema.

Very rarely, severe skin reactions (Stevens-Johnson syndrome, Lyell's syndrome) and changes in the mucous membranes have been reported after taking Fluimucil Forte. In most cases, at least one other medicine was likely to have contributed to the skin and mucous membrane changes. If side effects occur, 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 tell their 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. By reporting side effects, more information can be collected 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 taken 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 packaging 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 (contains glucose).

What Fluimucil Forte looks like and what the packaging contains

Fluimucil Forte is white, round, effervescent tablets with a lemon smell and a possible sulfur smell, which is typical for the active substance contained in the medicine. Available packaging: 10 effervescent tablets, in 5 blisters of 2 tablets, 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 N.V., Avenue Bourgmestre E. Demunter 3, 1090 Brussels, Belgium

Manufacturer:

Zambon N.V., Avenue Bourgmestre E. Demunter 3, 1090 Brussels, Belgium Zambon S.p.A., Via della Chimica 9, 36100 Vicenza, Italy Parallel importer: PharmaVitae Sp. z o.o. Sp. k., ul. E. Orzeszkowej 3/35, 59-820 Leśna Repackaged by: Pharma Innovations Sp. z o.o., ul. Jagiellońska 76, 03-301 Warsaw Synoptis Industrial Sp. z o.o., ul. Szosa Bydgoska 58, 87-100 Toruń LABOR Pharmaceutical-Chemical Enterprise Sp. z o.o., ul. Długosza 49, 51-162 Wrocław CEFEA Sp. z o.o. Sp. komandytowa, ul. Działkowa 56, 02-234 Warsaw SHIRAZ PRODUCTIONS Sp. z.o.o., ul. Tymiankowa 24/28, 95-054 Ksawerów Medezin Sp. z o.o., ul. Zbąszyńska 3, 91-342 Łódź CANPOLAND JOINT-STOCK COMPANY, ul. Beskidzka 190, 91-610 Łódź Belgian marketing authorization number, the country of export: BE150202 Parallel import authorization number: 381/17 Date of leaflet approval: 17.10.2022
[Information about the trademark]