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 brand names of the same medicine.
Please read all of this leaflet carefully before taking this medicine, because 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 so that it can be read again if necessary.
• If advice or further information is needed, consult a pharmacist.
• If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. See section 4.
• If there is no improvement after 5 days, or if the patient feels worse, contact a doctor.

Contents of the leaflet:

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 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 the patient feels worse, consult a 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 asthmatic conditions;
• if the patient has phenylketonuria;
• in children under 2 years of age, because the active substance acetylcysteine may cause airway 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, 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.
• If large amounts of secretion are liquefied, especially in young children and very ill immobilized patients, suctioning should be made possible.
• 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 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 about any medicines the patient is currently taking, has recently taken, or plans to take.
Do not use Fluimucil Forte simultaneously with antitussive medicines, as this may lead to accumulation 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, simultaneously, 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 severe 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 effectiveness.
Fluimucil Forte may affect 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 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 breast milk. Risk to the breastfed infant 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 harmful effects of acetylcysteine on human fertility when used at recommended doses.

Driving and operating machinery
The effect of Fluimucil Forte on the ability to drive or operate machinery is unknown.

Fluimucil Forte contains:

• 20 mg of aspartame per 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 (from sodium hydrogen carbonate) per tablet (sodium is the main component of table salt). This corresponds to 7.8% of the maximum recommended daily sodium intake in the adult diet.
• Glucose (component of the lemon flavour). 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 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, 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 the effect of Fluimucil Forte is too strong or too weak, consult your doctor.

Overdose of Fluimucil Forte
If you take more than the recommended dose of Fluimucil Forte, gastrointestinal symptoms such as nausea, vomiting, and diarrhea may occur.
There is no known specific antidote for acetylcysteine. Symptomatic treatment should be administered.
In case of overdose, seek immediate medical advice from a 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 regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine may cause adverse reactions, although not everybody experiences them.
In clinical trials, gastrointestinal disorders were the most frequently 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,
• 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), pruritus,
• fever,
• hypotension (low blood pressure).

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

• bronchospasm, dyspnoea,
• dyspepsia.

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

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

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

• facial swelling.

Very rarely, 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 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 effects occur, including any possible adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can also be reported directly to:
Department of Monitoring Adverse Drug Reactions
Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 4921 301
Fax: +48 22 4921 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 instructions are required for this medicine.
Note:
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 in use. This 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.
• The 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.
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, 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 in:
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 Przedsiębiorstwo Farmaceutyczno-Chemiczne 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 SPÓŁKA AKCYJNA, ul. Beskidzka 190, 91-610 Łódź
Marketing Authorisation number in Belgium, the country of export: BE150202
Parallel Import Licence number: 381/17