Fluimucil forte

Package Leaflet: Information for the User

Fluimucil Forte

600 mg, Effervescent Tablets

Acetylcysteine

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

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

• Keep this leaflet, you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If you experience any side effects, including those not listed in the leaflet, tell your doctor or pharmacist. See section 4.
• If after 5 days there is no improvement or you feel worse, contact your 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 pack 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 as a short-term 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 you feel worse, consult your doctor.

2. Important information before taking Fluimucil Forte

When not to take Fluimucil Forte

• if you are allergic to acetylcysteine or any of the other ingredients of this medicine (listed in section 6);
• in asthma attacks;
• if you have 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 taking Fluimucil Forte, discuss it with your doctor or pharmacist.

• Caution is advised when taking Fluimucil Forte if you have or have had stomach or duodenal ulcers, especially if you are also taking other medicines known to irritate the stomach lining.
• Treatment of patients with bronchial asthma should be under close medical supervision due to the risk of bronchospasm. If this symptom occurs, the administration of the medicine should be stopped immediately.
• In case of liquefaction of large amounts of secretions, especially in small children and bedridden patients, it is necessary to ensure their aspiration.
• Acetylcysteine should not be administered to patients with reduced ability to cough, unless they are provided with respiratory physiotherapy during treatment.
• Caution is advised 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 cough 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 all medicines you are taking or have recently taken, as well as any medicines you 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 effect 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 occur. If you are taking nitroglycerin, consult your 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). It is recommended not to mix other medicines with the Fluimucil Forte solution.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, consult your doctor or pharmacist before taking this medicine. Pregnancy It is recommended to avoid taking Fluimucil Forte during pregnancy. Fluimucil Forte may be administered during pregnancy only 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 you are breastfeeding. Fertility There are no data on the effect 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.
• About 157 mg of sodium(in the form of sodium bicarbonate) in each tablet (sodium is the main component of common salt). This corresponds to 7.9% of the maximum recommended daily intake of sodium in the diet of adults.
• Glucose(a component of the lemon flavor). If you have previously been diagnosed with intolerance to some sugars, you should consult your doctor before taking the medicine.

3. How to take Fluimucil Forte

This medicine should always be taken exactly as described in the package leaflet or as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist. Do not take Fluimucil Forte for more than 5 days without consulting your 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 water. The resulting solution is ready to drink. The solution should be drunk immediately after preparation. During treatment, you 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 you feel that the effect of Fluimucil Forte is too strong or too weak, consult your doctor.

Overdose of Fluimucil Forte

In case of overdose, gastrointestinal symptoms such as nausea, vomiting, and diarrhea may occur. There is no known antidote specific to acetylcysteine. Symptomatic treatment is used. In case of overdose, consult your doctor or pharmacist immediately.

Missed 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 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, hypersensitivity 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, 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),
• hemorrhage.

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

• facial edema.

Very rarely, severe skin reactions (Stevens-Johnson syndrome, Lyell syndrome) and changes in 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 you experience any side effects, stop taking the medicine and consult your doctor.

Reporting side effects

If you experience any side effects, including those not listed in the leaflet, tell your doctor or pharmacist. Side effects can be reported directly to: Department for 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, e-mail: [email protected] Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this 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 month. 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. Ask your pharmacist how to dispose of medicines no longer required. 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 bicarbonate (contains sodium), aspartame, lemon flavor (contains glucose).

What Fluimucil Forte looks like and contents of the pack

Fluimucil Forte is white, round, lemon-flavored tablets with a possible sulfur smell, which is typical for the active substance contained in the medicine. Available packs: 10 effervescent tablets, in 5 blisters of 2 tablets, in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization 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 authorization holder:

Plac Farmacji 1, 02-699 Warsaw tel. (22) 566 26 00 e-mail: [email protected] The leaflet in a format suitable for the blind or visually impaired is available at the representative of the marketing authorization holder.

Date of last revision of the leaflet: