Patient Information Leaflet

Mucoflav, 50 mg/mL syrup
Carbocisteinum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by
the doctor or pharmacist.

Keep this leaflet, as you may need to read it again.
If you need advice or further information, please consult your pharmacist.
If you experience any side effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement or if you feel worse after 4 to 5 days of treatment, consult your doctor.

Contents of the leaflet

What Mucoflav is and what it is used for
Important information before taking Mucoflav
How to take Mucoflav
Possible side effects
How to store Mucoflav
Contents of the pack and other information

1. What Mucoflav is and what it is used for

Mucoflav contains carbocysteine as the active substance, which affects the composition of bronchial mucus. Carbocysteine makes the mucus less viscous and more fluid, thus facilitating its removal from the respiratory tract during coughing (so-called mucolytic action).
This medicine is used for symptomatic treatment of respiratory diseases associated with excessive production of thick and sticky mucus.
If there is no improvement after 4 to 5 days of treatment, or if you feel worse, consult your doctor.

2. Important information before using Mucoflav

When not to use Mucoflav

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

Warnings and precautions
Before starting treatment with Mucoflav, consult a doctor or pharmacist:

if the patient has previously had a peptic ulcer.

If there is abundant purulent sputum and fever, or in case of chronic bronchial or lung disease, as well as in patients with reduced ability to expectorate, a visit to a doctor is necessary, who may recommend additional or alternative treatment.
Treatment of patients with bronchial asthma should be conducted under strict medical supervision due to the risk of bronchospasm. If this symptom occurs, administration of the drug must be stopped immediately.
Children
Mucoflav is not intended for use in children under 6 years of age.
Mucoflav with other medicines
Inform the doctor or pharmacist about all medicines currently used or recently used, as well as any medicines the patient intends to take.
During treatment with Mucoflav, do not use antitussive medicines or drugs that reduce bronchial mucus secretion.
Mucoflav with food and drink
During treatment, it is recommended to drink increased amounts of fluids.
Pregnancy, breastfeeding and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
There are no data on the use of carbocysteine in pregnant women. The use of this medicine in pregnant women is not recommended.
It is unknown whether carbocysteine passes into breast milk. The medicine should not be used during breastfeeding.
There are no data on the effect of carbocysteine on fertility.
Driving and using machines
No studies have been conducted on the influence of carbocysteine on the ability to drive or operate machinery.
Mucoflav contains methyl parahydroxybenzoate (E 218)
This medicine may cause allergic reactions (including delayed-type reactions).
Mucoflav contains sodium
This medicine contains 33.55 mg of sodium (main component of table salt) in 5 mL of syrup. This corresponds to 1.68% of the maximum recommended daily dietary intake of sodium for adults.
Mucoflav contains sucrose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this 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.
If in doubt, consult a doctor or pharmacist.
This medicine is for oral use.
5 mL of medicine contains 250 mg of carbocysteine.
A syringe is supplied with the packaging to allow accurate measurement of the required volume of medicine.

Dosage
Children aged 6 to 12 years:
5 mL of medicine three times daily.
In children and adolescents, the daily dose of carbocysteine must not exceed 30 mg/kg body weight.
It is recommended that the child drinks water after taking the dose.

Adults and adolescents over 12 years of age:
Initially, use 15 mL of medicine three times daily. After the mucolytic effect (sputum-thinning effect) has occurred, reduce the dose to 10 mL of medicine three times daily.
Do not use the medicine for longer than 4 to 5 days without medical advice.
During treatment, increase fluid intake.
Do not take the medicine immediately before bedtime. The last dose should be taken no later than 4 hours before going to sleep.

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

Overdose of Mucoflav
There are no known cases of poisoning following overdose. The most likely symptoms of overdose would be gastrointestinal disturbances. There is no known antidote.
In case of ingestion of a higher than recommended dose, seek immediate medical advice from a doctor or pharmacist.

Missed dose of Mucoflav
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 will experience them.
If any of the adverse reactions listed below occur in the patient, stop using Mucoflav immediately and seek medical help at once:

Angioedema (severe allergic reaction) with swelling of the skin and/or mucous membranes, e.g. in the face, limbs, joints (frequency unknown – frequency cannot be determined from available data);
Stevens-Johnson syndrome (blisters progressing to erosions on the oral mucosa, conjunctiva, genital organs) (frequency unknown – frequency cannot be determined from available data).

Adverse reactions with unknown frequency (frequency cannot be determined from available data):

Headache;
Abdominal pain, diarrhoea, gastrointestinal bleeding, nausea and vomiting;
Skin allergic reactions, including erythematous rash, pruritus, urticaria, drug eruption.

Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform a 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
Adverse reactions may also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Mucoflav

Keep the medicine out of the sight and reach of children.
Store 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 stated month.
The shelf life after first opening the bottle is 3 months.
Medicines must 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 Packaging and Other Information

What Mucoflav contains

The active substance in Mucoflav is carbocysteine. Each mL of syrup contains 50 mg of carbocysteine.
Other ingredients are: sucrose, sodium hydroxide, methyl parahydroxybenzoate (E 218), caramel (E 150d), blackcurrant flavour consisting of propylene glycol E 1520, ethyl formate, isoamyl acetate, 4-(4-hydroxyphenyl)butan-2-one, 3-methylbutan-1-ol, bay leaf extract, acetic acid, 4-(2,6,6-trimethylcyclohex-1-ene-1-yl)-but-3-ene-2-one, purified water.

What Mucoflav looks like and contents of the pack
Mucoflav is a syrup. It is an amber-coloured liquid with a blackcurrant odour and sweet taste.
An amber glass type III bottle of 200 mL or 300 mL capacity, closed with a PP screw cap with an attached LDPE dosing connector, child-resistant closure, and an oral syringe of 5 mL capacity, with a PP cylinder and HDPE plunger, graduated every 0.25 mL, all contained in a cardboard box.
The pack contains 200 mL or 300 mL of syrup.

Marketing Authorisation 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