Mucoflav

Leaflet attached to the packaging: information for the user

Mucoflav, 50 mg/mL syrup

Carbocisteine

Please read carefully the contents of the leaflet 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.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including those not listed in this leaflet, the doctor or pharmacist should be informed. See section 4.
• If after 4 to 5 days of use there is no improvement or the patient feels worse, a doctor should be contacted.

Table of contents of the leaflet

• 1. What is Mucoflav and what is it used for
• 2. Important information before using Mucoflav
• 3. How to use Mucoflav
• 4. Possible side effects
• 5. How to store Mucoflav
• 6. Contents of the packaging and other information

1. What is Mucoflav and what is it used for

Mucoflav contains the active substance carbocisteine, which affects the composition of bronchial secretions. Carbocisteine makes the secretions less viscous and more fluid, making them easier to remove from the airways during coughing (mucolytic action). This medicine is used for the symptomatic treatment of respiratory system diseases characterized by excessive production of thick and viscous secretions. If after 4 to 5 days there is no improvement or the patient feels worse, a doctor should be consulted.

2. Important information before using Mucoflav

When not to use Mucoflav

• if the patient is allergic to carbocisteine or any of the other ingredients of this medicine (listed in section 6),
• in asthmatic status,
• if the patient has active gastric or duodenal ulcer disease,
• in children under 6 years of age.

Warnings and precautions

Before starting to use Mucoflav, the doctor or pharmacist should be consulted:

• if the patient has a history of ulcer disease.

In case of abundant purulent secretions and fever, as well as in case of chronic bronchitis or lung disease and in patients with reduced ability to cough up, a doctor's visit is necessary, who may prescribe other medicines. The treatment of patients with bronchial asthma should be carried out under close medical supervision due to the possibility of bronchospasm. In case of its occurrence, the administration of the medicine should be stopped immediately.

Children

Mucoflav is not intended for use in children under 6 years of age.

Mucoflav and other medicines

The doctor or pharmacist should be informed about all medicines currently or recently used by the patient, as well as about medicines that the patient plans to take. During the use of Mucoflav, cough suppressants or medicines that reduce bronchial mucus secretion should not be used.

Mucoflav with food and drink

During treatment, it is recommended to drink plenty of fluids.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before using this medicine. There are no data on the use of carbocisteine in pregnant women. The use of the medicine is not recommended in pregnant women. It is not known whether carbocisteine passes into breast milk. The medicine should not be used during breastfeeding. There are no data on the effect of carbocisteine on fertility.

Driving and using machines

No studies have been conducted on the effect of carbocisteine on the ability to drive and use machines.

Mucoflav contains methyl parahydroxybenzoate (E 218)

The medicine may cause allergic reactions (possible late reactions).

Mucoflav contains sodium

The medicine contains 33.55 mg of sodium (the main component of common salt) in 5 mL of syrup. This corresponds to 1.68% of the maximum recommended daily intake of sodium in the diet for adults.

Mucoflav contains sucrose

If the patient has previously been diagnosed with intolerance to some sugars, the patient should consult a doctor before taking the medicine. The medicine contains 2.89 g of sucrose in 5 mL of syrup. This should be taken into account in patients with diabetes.

3. How to use Mucoflav

This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist. In case of doubt, a doctor or pharmacist should be consulted. The medicine is for oral use. 5 mL of the medicine contains 250 mg of carbocisteine. A measuring syringe is attached to the packaging, which allows the correct volume of the medicine to be measured.

Dosage

Children from 6 to 12 years of age:
5 mL of the medicine 3 times a day. In children and adolescents, the daily dose of carbocisteine should not exceed 30 mg/kg body weight. It is recommended that the child drink water after taking the dose of the medicine. Adults and adolescents over 12 years of age:
Initially, a dose of 15 mL of the medicine should be used 3 times a day, and then after the mucolytic effect (thinning of secretions) occurs, the dose should be reduced to 10 mL of the medicine 3 times a day. Without a doctor's recommendation, the medicine should not be used for more than 4 to 5 days. During treatment, plenty of fluids should be consumed. The medicine should not be used before bedtime. The last dose should be taken no later than 4 hours before bedtime.

Use in children

Mucoflav is not intended for use in children under 6 years of age.

Use of a higher than recommended dose of Mucoflav

No cases of poisoning have been reported in case of overdose. The most likely symptoms of overdose may be gastrointestinal disorders. There is no antidote. In case of taking a higher dose of the medicine than recommended, a doctor or pharmacist should be consulted immediately.

Missing a dose of Mucoflav

A double dose should not be used to make up for a missed dose. In case of any further doubts about the use of this medicine, a doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If the patient experiences any of the following side effects, the use of Mucoflav should be stopped and medical help should be sought immediately:

• angioedema (severe allergic reaction) with skin and/or mucous membrane edema, e.g. in the face, limbs, joints (frequency not known - frequency cannot be estimated from available data);
• Stevens-Johnson syndrome (blisters turning into ulcers, on the mucous membranes of the mouth, eyes, genitals) (frequency not known - frequency cannot be estimated from available data).

Side effects with unknown frequency (frequency cannot be estimated from available data):

• headache;
• abdominal pain, diarrhea, gastrointestinal bleeding, nausea, and vomiting;
• skin allergic reactions, including rash, itching, urticaria, drug rash.

Reporting side effects

If any side effects occur, including those not listed in the leaflet, the doctor or pharmacist should be informed. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the 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, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Mucoflav

The medicine should be stored out of sight and reach of children. Store in a temperature below 25°C. Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month. The shelf life after opening the bottle is 3 months. Medicines should not be disposed of via wastewater or household waste. A pharmacist should be asked how to dispose of medicines that are no longer used. This will help protect the environment.

6. Contents of the packaging and other information

What Mucoflav contains

• The active substance of the medicine is carbocisteine. Each mL of syrup contains 50 mg of carbocisteine.
• The other ingredients are: sucrose, sodium hydroxide, methyl parahydroxybenzoate (E 218), caramel (E 150d), gooseberry flavor consisting of propylene glycol E 1520, ethyl formate, isopentyl acetate, 4-(4-hydroxyphenyl)butan-2-one, 3-methylbutan-1-ol, grapeseed oil extract, acetic acid, 4-(2,6,6-trimethylcyclohex-1-ene-1-yl)-but-3-ene-2-one, purified water.

What Mucoflav looks like and what the packaging contains

Mucoflav is a syrup. It is an amber liquid with a gooseberry smell and sweet taste. The bottle is made of orange glass type III with a capacity of 200 mL or 300 mL, closed with a PP cap with an LDPE insert, with a child-resistant closure, and a 5 mL oral syringe with a PP cylinder and an HDPE piston, graduated every 0.25 mL, placed in a cardboard box. The packaging contains 200 mL or 300 mL of syrup.

Marketing authorization holder

Biofarm Sp. z o.o., ul. Wałbrzyska 13, 60-198 Poznań, tel.: +48 61 66 51 500, fax: +48 61 66 51 505, e-mail: [email protected]

Manufacturer

Laboratórios Basi - Indústria Farmacêutica, S.A., Parque Industrial Manuel Lourenço Ferreira, Lotes 8, 15 e 16, 3450-232 Mortágua, Portugal

Date of last update of the leaflet: