Fluimucil forte

PACKAGE LEAFLET: INFORMATION FOR THE USER

Warning! Keep the leaflet, information on the outer packaging in a foreign language!
Fluimucil Forte (Lysomucil)
600 mg, effervescent tablets
Acetylcysteinum
Fluimucil Forte and Lysomucil are different trade names for the same medicine.
Please read this leaflet carefully 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 a doctor or pharmacist.

• Keep this leaflet for future reference.
• If you need advice or further information, please consult your pharmacist.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If there is no improvement after 5 days, or if you feel worse, consult your doctor.

Table of contents of the leaflet:

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

Acetylcysteine, the active substance in Fluimucil Forte, liquefies mucus and mucopurulent secretions by breaking disulfide bonds in mucus polypeptides in the respiratory tract.
Fluimucil Forte is used short-term as a mucolytic agent to thin respiratory secretions and facilitate expectoration in patients with symptoms of infection associated with the common cold.
If there is no improvement after 5 days, or if you feel worse, consult your doctor.

2. Important information before using Fluimucil Forte

When not to use Fluimucil Forte

• if the patient is allergic to acetylcysteine or to any of the other ingredients of this medicine (listed in section 6);
• in asthmatic conditions;
• if the patient has phenylketonuria;
• in children under 2 years of age, as the active substance acetylcysteine may cause airway 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, discuss this with your doctor or pharmacist.

• Caution is advised when using Fluimucil Forte in patients with current or past history of gastric or duodenal ulcer disease, 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 strict medical supervision due to the risk of bronchospasm. If this symptom occurs, administration of the medicine must be stopped immediately.
• If large amounts of secretions are liquefied, especially in young children and very ill immobilized patients, suctioning should be made available.
• Acetylcysteine should not be administered to patients with reduced ability to expectorate unless respiratory physiotherapy is provided during treatment.
• Caution is advised when Fluimucil Forte is used long-term in patients with histamine intolerance, as symptoms such as headache, vasomotor rhinitis, and skin itching may occur.

Children and adolescents
Mucolytic agents may cause airway 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
Tell your doctor or pharmacist if you are currently taking, have recently taken, or might take any other medicines.
Do not take Fluimucil Forte together with antitussive medicines, as this may lead to mucus retention due to suppression of the cough reflex.
Activated charcoal may reduce the effectiveness of Fluimucil Forte.
If it is necessary to take other medicines simultaneously, including antibiotics, a 2-hour interval between administration of these medicines and Fluimucil Forte is recommended. This does not apply to loracarbef (a medicine used for infections).
Concomitant use of Fluimucil Forte and nitroglycerin (a medicine used for ischemic heart disease) may cause significant arterial hypotension. Headache may also occur. If the patient is taking nitroglycerin, medical advice should be sought before taking Fluimucil Forte.
Concomitant use of Fluimucil Forte and carbamazepine (a medicine used in epilepsy treatment) may reduce carbamazepine blood levels and decrease its efficacy.
Fluimucil Forte may affect the results of certain laboratory tests (colorimetric determination of salicylates and urinary ketone testing).
Mixing other medicines with Fluimucil Forte solution is not recommended.

Pregnancy, breastfeeding and fertility

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.

Pregnancy
Use of Fluimucil Forte during pregnancy is not recommended. Fluimucil Forte may be administered during pregnancy only if absolutely necessary and under strict medical supervision.

Breastfeeding
It is not known whether Fluimucil Forte passes into human milk. Risk to the breastfed infant cannot be excluded. Fluimucil Forte should not be used if the patient is breastfeeding.

Fertility
There are no data on the effect of Fluimucil Forte on fertility in humans. Animal studies do not indicate harmful effects of acetylcysteine on fertility in humans when used at recommended doses.

Driving and operating machinery
The effect of this medicine on the ability to drive and operate machinery is unknown.

Fluimucil Forte contains:

• 20 mg of aspartame in 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 impaired excretion.
• 156.9 mg of sodium (contained in sodium bicarbonate) in each tablet (sodium is the main component of table salt). This corresponds to 7.8% of the maximum recommended daily dietary sodium intake for adults.
• Glucose (component of the lemon flavouring). If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to use Fluimucil Forte

This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist.
If in doubt, consult your doctor or pharmacist.
Do not use Fluimucil Forte for longer than 5 days without consulting a doctor.

Recommended dose:
Adults
1 effervescent tablet (600 mg) of Fluimucil Forte once daily.

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 consumed immediately after preparation.
During treatment, increased fluid intake is recommended.
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, consult your doctor.

Taking more Fluimucil Forte than recommended
If you take more Fluimucil Forte than recommended, gastrointestinal symptoms such as nausea, vomiting, and diarrhoea may occur.
There is no known specific antidote for acetylcysteine. Symptomatic treatment should be administered.
If you have taken more than the recommended dose, seek immediate medical advice from your doctor or pharmacist.

Missing a dose of Fluimucil Forte
Do not take a double dose to make up for a missed dose.
If you have any further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
In clinical studies, gastrointestinal disorders were the most commonly reported adverse reactions,
while hypersensitivity reactions occurred less frequently.
Adverse reactions that may occur during treatment with Fluimucil Forte:
Uncommon (less than 1 in 100 patients):

• hypersensitivity,
• headache,
• tinnitus (ringing in the ears),
• tachycardia (increased heart rate),
• vomiting, diarrhoea, oral mucositis, abdominal pain, nausea,
• urticaria, rash, angioedema (swelling of the skin and mucous membranes, most commonly affecting: face, throat, larynx, genital organs, intestines), itching,
• fever,
• hypotension (low blood pressure).

Rare (less than 1 in 1,000 patients):

• bronchospasm, dyspnoea (shortness of breath),
• dyspepsia.

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

• severe allergic reactions (anaphylactic shock, anaphylactic reaction, anaphylactoid reaction),
• haemorrhage.

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

• facial swelling.

Very rare cases of severe skin reactions (Stevens-Johnson syndrome, Lyell's syndrome) and mucosal lesions have been reported following administration of Fluimucil Forte. In most cases, at least one other medicinal product was likely involved in causing the skin and mucosal lesions.
If adverse reactions occur, treatment should be discontinued and medical advice should be sought.
Reporting of adverse reactions
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Fluimucil Forte

Keep the medicine out of the 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 stated month.
No special storage conditions are required for this medicine.
Note:
The presence of a sulphur-like odour is typical for the active substance contained in the medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Fluimucil Forte contains

• The active substance is acetylcysteine. One effervescent tablet contains 600 mg of acetylcysteine.
• Other ingredients are: citric acid, sodium hydrogen carbonate (contains sodium), aspartame, lemon flavour (contains glucose).

What Fluimucil Forte looks like and contents of the pack
Fluimucil Forte is white, round effervescent tablets with a lemon odour and a possible odour of sulphur, which is typical for the active substance contained in the medicine.
Available pack sizes:
10 effervescent tablets in blisters, in a cardboard box.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Belgium, 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:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing authorisation number in Belgium, country of export: BE150202
Parallel import authorisation number: 66/20