Fluimucil forte

Patient Information Leaflet

Warning! Keep this leaflet! The information on the immediate packaging is in a foreign language.
Fluimucil Forte (Lysomucil)
600 mg, effervescent tablets
Acetylcysteinum
Fluimucil Forte and Lysomucil are different brand 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 adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 5 days of treatment, or if you feel worse, consult your doctor.

Table of contents:

1. What Fluimucil Forte is and what it is used for
2. What you need to know 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 the polypeptides of respiratory mucus.
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 of treatment, 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, 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.
• In cases of liquefaction of large amounts of secretions, especially in young children and very ill immobilized patients, suctioning should be provided.
• Acetylcysteine should not be administered to patients with reduced ability to expectorate unless respiratory physiotherapy is ensured during treatment.
• Caution is required 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 medicines 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 medicines 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 about all medicines you are currently taking, have recently taken, or plan to take.
Do not take Fluimucil Forte together with antitussive medicines, as this may lead to accumulation of secretions 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 in infections).
Concomitant use of Fluimucil Forte and nitroglycerin (a medicine used in 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 interfere with the results of certain laboratory tests (colorimetric determination of salicylates and urine ketone testing).
Mixing other medicines with the 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 baby, she should consult a doctor or pharmacist before using this medicine.

Pregnancy
It is recommended to avoid using Fluimucil Forte during pregnancy. Fluimucil Forte may be administered during pregnancy only when absolutely necessary and under strict medical supervision.

Breastfeeding
It is unknown whether Fluimucil Forte passes into breast 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 human fertility when used at recommended doses.

Driving and operating machinery
The effect of the 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 improper 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.

3. How to use Fluimucil Forte

This medicine should always be used exactly as described in this patient information 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, an 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 advice from your doctor or pharmacist.

Missed dose of Fluimucil Forte
Do not take a double dose to make up for a missed dose.
If you have any further doubts concerning 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 experiences them.
In clinical studies, gastrointestinal disorders were the most frequently reported adverse reactions,
while hypersensitivity reactions occurred less frequently.
Adverse reactions that may occur during the use of Fluimucil Forte:

Uncommon (less than 1 in 100 patients):

• hypersensitivity,
• headache,
• tinnitus (ringing in the ears),
• tachycardia (increased heart rate),
• vomiting, diarrhoea, oral inflammation, 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, pseudoanaphylactic reaction),
• haemorrhage (bleeding).

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 the use of Fluimucil Forte. In most cases, at least one other medicinal product likely contributed to the development of skin and mucosal lesions.

If adverse reactions occur, treatment should be discontinued and a doctor should be consulted immediately.

Reporting of adverse reactions

If any adverse reactions 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 this medicine 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 stated month.
No special storage conditions are required.
WARNING:
The possible presence of a sulfur-like odor is typical for the active substance contained in the medicine.
Medicines must 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.

What Fluimucil Forte looks like and contents of the pack
Fluimucil Forte is white, round effervescent tablets with a lemon scent and a possible odour of sulphur,
which is typical for the active substance contained in the medicine.
Pack sizes available:
10 effervescent tablets in 5 blisters of 2 tablets, 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./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, Poland
Repackaged in:
InPharm Sp. z o.o. Services sp. k., ul. Chełmżyńska 249, 04-458 Warsaw, Poland
Marketing authorisation number in Belgium, country of export: BE 150202
Parallel import authorisation number: 101/18