Fluimucil muko

Patient Information Leaflet

Fluimucil Muko
200 mg, effervescent granules for oral solution
Acetylcysteine
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
Always use this medicine exactly as described in this patient leaflet or as your
doctor or pharmacist has advised.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, please contact 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 your condition worsens, consult your doctor.

Leaflet Contents:

1. What Fluimucil Muko is and what it is used for
2. What you need to know before taking Fluimucil Muko
3. How to take Fluimucil Muko
4. Possible side effects
5. How to store Fluimucil Muko
6. Contents of the pack and other information

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

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

2. Important information before using Fluimucil Muko

When not to use Fluimucil Muko

• 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 Muko).

Warnings and precautions
Before starting treatment with Fluimucil Muko, discuss this with your doctor or pharmacist.

• Caution is advised when using Fluimucil Muko if the patient has or has had gastric or duodenal ulcer disease in the past, 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 performed to remove the secretions.
• Acetylcysteine should not be administered to patients with reduced ability to expectorate unless respiratory physiotherapy is provided during treatment.
• Caution is required when Fluimucil Muko 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 Muko should not be used in children under 7 years of age.

Fluimucil Muko with other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Do not use Fluimucil Muko simultaneously with antitussive medicines, as this may lead to mucus retention due to reduced cough reflex.
Activated charcoal may reduce the effectiveness of Fluimucil Muko.
If it is necessary to take other medicines, including antibiotics, at the same time, a 2-hour interval between administration of these medicines and Fluimucil Muko is recommended. This does not apply to loracarbef (a medicine used for infections).
Concomitant use of Fluimucil Muko and nitroglycerin (a medicine used in ischemic heart disease) may cause significant arterial hypotension. Headache may also occur. If the patient is taking nitroglycerin, they should consult their doctor before taking Fluimucil Muko.
Concomitant use of Fluimucil Muko and carbamazepine (a medicine used in epilepsy treatment) may reduce blood levels of carbamazepine and decrease its effectiveness.
Fluimucil Muko may affect the results of certain laboratory tests (colorimetric determination of salicylates and urine ketone testing).
Mixing other medicines with the Fluimucil Muko 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 her doctor or pharmacist before using this medicine.

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

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

Fertility
There are no data on the effect of Fluimucil Muko 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 Muko contains:

• 25 mg of aspartame in each sachet (1 g of granules). 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.
• Sucrose (β-carotene component). If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.
• Less than 1 mmol (23 mg) of sodium per sachet (β-carotene component), meaning the medicine is considered "sodium-free".
• Glucose and lactose (orange flavour components). If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.
• 662.7 mg of sorbitol in each sachet (1 g of granules). Sorbitol is a source of fructose. If the patient (or their child) has previously been diagnosed with intolerance to certain sugars or hereditary fructose intolerance—a rare genetic disorder in which the body does not metabolize fructose—the patient should consult their doctor before taking the medicine or giving it to their child.

3. How to use Fluimucil Muko

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

Recommended dose
Children aged 7 to 14 years
1 sachet of Fluimucil Muko (200 mg) twice daily.

Adults and children over 14 years of age
1 sachet of Fluimucil Muko (200 mg) 2 to 3 times daily.

Method of administration:
Dissolve the contents of one sachet in half a glass of lukewarm water; stir with a spoon if necessary.
The resulting solution is ready to drink. The solution should be consumed immediately after preparation.
During treatment, increase fluid intake.

Note:
The last dose of Fluimucil Muko should be taken no later than 4 hours before bedtime.
If you feel that the effect of Fluimucil Muko is too strong or too weak, consult your doctor.

Taking more medicine than recommended
If more Fluimucil Muko than recommended is taken, gastrointestinal symptoms such as nausea, vomiting, and diarrhoea may occur.
There is no known specific antidote for acetylcysteine. Symptomatic treatment should be administered.
If an overdose has been taken, seek immediate advice from a doctor or pharmacist.

Missed dose of Fluimucil Muko
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 can cause adverse reactions, although they do not occur in everyone.
In clinical trials, 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 Muko:
Uncommon (less than 1 in 100 patients):

• hypersensitivity,
• headache,
• tinnitus,
• tachycardia (increased heart rate),
• vomiting, diarrhoea, stomatitis, 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.

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, pseudoanaphylactic 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 the use of Fluimucil Muko. In most cases, at least one other medicinal product was likely involved in the development of skin and mucosal lesions.
If adverse reactions occur, discontinue use of the medicine and contact your doctor.
Reporting of adverse reactions
If any adverse symptoms occur, including any possible adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to:
Department of Monitoring of Adverse Drug Reactions, 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,
e-mail: [email protected]
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Fluimucil Muko

Keep the 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.
Store Fluimucil Muko below 30°C.
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 packaging and other information

What Fluimucil Muko contains

• The active substance is acetylcysteine. Each sachet (1 g of granules) contains 200 mg of acetylcysteine.
• Other ingredients: aspartame, β-carotene (contains sucrose and less than 1 mmol (23 mg) of sodium), orange flavour (contains glucose and lactose), sorbitol.

What Fluimucil Muko looks like and contents of the pack
Fluimucil Muko is a yellow granule with an orange odour and a possible odour of sulphur,
which is typical for the active substance contained in the medicine.
Available pack sizes:
20 sachets of 1 g granules in a cardboard box.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
ZAMBON S.p.A.
Via Lillo del Duca, 10
20091 Bresso (MI), Italy
Manufacturer:
ZAMBON S.p.A.
Via Della Chimica, 9
36100 Vicenza, Italy
Representative of the Marketing Authorisation Holder:
Komtur Polska Sp. z o.o.
Plac Farmacji 1, 02-699 Warsaw
tel. (22) 566 26 00
e-mail: [email protected]
The package leaflet in an accessible format for blind or partially sighted persons is available at the representative's office of the Marketing Authorisation Holder.