Mucopect Kids

Leaflet attached to the packaging: patient information

Mucopect Kids, 50 mg/mL, syrup

Carbocisteine

Read the leaflet carefully before taking 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
the doctor or pharmacist.

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

Table of contents of the leaflet

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

1. What is Mucopect Kids and what is it used for

Mucopect Kids contains the active substance carbocisteine. It belongs to a group of substances called
"mucolytics", used to treat respiratory diseases with excessive mucus production in the bronchi.
Carbocisteine reduces the viscosity of mucus (phlegm), making it easier to expel from the airways during coughing.
Mucopect Kids is used for the symptomatic treatment of respiratory diseases with excessive production of thick and viscous secretions.
If there is no improvement or the patient feels worse after 4 to 5 days of treatment, the doctor should be consulted.

2. Important information before taking Mucopect Kids

When not to take Mucopect Kids:

• if the patient is allergic to carbocisteine or any of the other ingredients of this medicine (listed in section 6);
• if the patient has stomach or duodenal ulcers.

Warnings and precautions

Before starting treatment with Mucopect Kids, the doctor or pharmacist should be consulted if:

• the patient has a history of peptic ulcer disease.
• the patient has acute respiratory failure.
• the patient is weakened. Weakened cough reflex is associated with the risk of airway obstruction due to increased secretions.

Mucolytic agents may damage the gastric mucosa, so patients with a history of peptic ulcer disease should use them with caution.
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 secretions, a doctor's visit is necessary, who may prescribe other medications.
Treatment of patients with bronchial asthma should be carried out under close medical supervision due to the possibility of bronchospasm. If this symptom occurs, the administration of the medicine should be stopped immediately.
The medicine should not be taken before bedtime.

Children

Mucopect Kids is not indicated for children under 6 years of age.

Mucopect Kids and other medicines

The doctor or pharmacist should be informed about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Carbocisteine should not be used simultaneously with antitussive medicines and expectorant medicines.

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 taking this medicine.
Pregnancy
It is not recommended to use the medicine during pregnancy.
Breastfeeding
It is not recommended to use the medicine during breastfeeding.
It is not known whether carbocisteine passes into breast milk.
Fertility
There is no data on the effect of carbocisteine on fertility.

Driving and using machines

Carbocisteine has no influence or negligible influence on the ability to drive and use machines.

Mucopect Kids contains sucrose

The medicine may have a harmful effect on teeth. If the patient has previously been diagnosed with intolerance to some sugars, the patient should consult a doctor before taking the medicine.
1 mL of Mucopect Kids contains 577.5 mg of sucrose. The dose intended for adults, i.e., 15 mL of syrup, contains 8.7 g of sucrose. This should be taken into account in patients with diabetes.

Mucopect Kids contains methyl parahydroxybenzoate (E218)

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

3. How to take Mucopect Kids

This medicine should always be used exactly as described in this patient leaflet or as directed by
the doctor or pharmacist. In case of doubt, the doctor or pharmacist should be consulted.
Using a measuring cup (a 5 mL measuring spoon), the amount of medicine suitable for the patient (child or adult) should be measured according to the recommended dosage. The measuring spoon used to measure the oral dose has a volume of 5 mL and is graduated to indicate 1.25 mL, 2.5 mL, 3.75 mL, and 5.0 mL.
Usually, the medicine is used as follows:
Adults and adolescents over 12 years of age
The dose for adults and adolescents over 12 years of age is: 15 mL of syrup three times a day.
After the symptoms have subsided, the dose should be reduced to 10 mL of syrup three times a day.
Children
Children aged 6 to 12 years: 5 mL of syrup three times a day.
After taking the dose of syrup, the bottle should be tightly closed.
The medicine should not be taken before bedtime. The last dose should be taken no later than 4 hours before bedtime.
Without the doctor's recommendation, the medicine should not be used for more than 4 to 5 days.
It is recommended to drink plenty of fluids while taking Mucopect Kids.

Taking a higher dose of Mucopect Kids than recommended

There are no reports of carbocisteine overdose. The most likely symptoms of overdose may be gastrointestinal disorders.
In case of taking a higher dose of the medicine than recommended, the doctor should be consulted.

Missing a dose of Mucopect Kids

A missed dose should be taken as soon as possible. A double dose should not be taken to make up for a missed dose.

Stopping treatment with Mucopect Kids

In case of any further doubts about the use of the medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
In case of allergic reactions, Stevens-Johnson syndrome (appearance of bleeding wounds or blisters on the skin, including around the lips, eyes, mouth, nose, and genitals, as well as symptoms of a cold and fever) and gastrointestinal bleeding, the use of the medicine should be stopped and a doctor or hospital should be consulted immediately.
Rare (more than 1 in 10,000 people, but less than 1 in 1,000 people):nausea, vomiting, and diarrhea.
Very rare (less than 1 in 10,000 people):gastrointestinal bleeding, stomach disorders, abdominal pain, allergic reactions (skin rash, itching, urticaria).
Frequency not known (frequency cannot be estimated from the available data):headaches, single cases of bullous skin rash such as Stevens-Johnson syndrome, in sensitive patients, inflammation of the mucous membrane of the mouth and nose may occur.

Reporting side effects

If any side effects occur, including any not listed in this leaflet, the doctor, pharmacist, or nurse should be informed. 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
Aleje Jerozolimskie 181C
02-222 Warsaw
Phone: 22 49-21-301
Fax: 22 49-21-309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Mucopect Kids

The medicine should be stored out of sight and reach of children.
Do not store above 25°C.
Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of the month.
The shelf life after opening the bottle is 3 months.
Do not use this medicine if the syrup has changed color or shows any other signs of spoilage; it should be taken to a pharmacist who will provide appropriate advice.
Medicines should not be disposed of via wastewater or household waste. The 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 Mucopect Kids contains

• The active substance is carbocisteine. 1 mL of syrup contains 50 mg of carbocisteine.
• The other ingredients are: methyl parahydroxybenzoate (E 218), caramel (E 150d), sucrose, blackcurrant flavor "Aroma grosella 63 2334" [propylene glycol, ethyl formate, isoamyl acetate, 4-(4-hydroxyphenyl)butan-2-one, 3-methylbutan-1-ol, Buchu leaf extract (Barosma betulina), acetic acid, 4-(2,6,6-trimethylcyclohex-1-ene-1-yl)-but-3-ene-2-one], sodium hydroxide, and purified water.

What Mucopect Kids looks like and contents of the pack

Carbocisteine is a clear, amber-colored syrup with a sweet, blackcurrant flavor.
A brown glass type III bottle (200 mL), with a PE cap, with a 5 mL measuring spoon made of PP, in a cardboard box.
Pack size: 1 bottle containing 200 mL of syrup.

Marketing authorization holder:

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów, Poland

Manufacturer:

Adamed Pharma S.A.
ul. Marszałka Józefa Piłsudskiego 5
95-200 Pabianice
Laboratórios Basi - Indústria Farmacêutica, S.A.
Parque Industrial Manuel Lourenço Ferreira, Lotes 8, 15 e 16
3450-232 Mortágua, Portugal

Date of last revision of the leaflet: