Patient Information Leaflet

Mucopect Kids, 50 mg/mL, syrup
Carbocisteinum
Please read this leaflet carefully before taking this medicine, as it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by
your 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 adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
If there is no improvement or if you feel worse after 4 to 5 days of treatment, consult your doctor.

Table of contents

What Mucopect Kids is and what it is used for
What you need to know before taking Mucopect Kids
How to take Mucopect Kids
Possible side effects
How to store Mucopect Kids
Contents of the pack and other information

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

Mucopect Kids contains the active substance carbocisteine. It belongs to a group of substances known as "mucolytics", used in the treatment of respiratory diseases associated 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 symptomatic treatment of respiratory tract diseases associated with excessive production of thick and sticky mucus.
If there is no improvement or if you feel worse after 4 to 5 days of treatment, you should consult your doctor.

2. Important information before using Mucopect Kids

When not to take Mucopect Kids:

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

Warnings and precautions
Before starting to use Mucopect Kids, consult a doctor or pharmacist if:

the patient has had peptic ulcer disease in the past;
the patient has acute respiratory insufficiency;
the patient is debilitated. Weakened cough reflex is associated with the risk of airway obstruction due to increased secretion.

Mucolytic agents may damage the gastric mucosa; therefore, patients with a history of peptic ulcer disease should use this medicine with caution.
If copious purulent secretions and fever occur, or in case of chronic bronchial or lung disease, as well as in patients with reduced ability to expectorate, a doctor's visit is necessary, as additional or alternative treatment may be required.
Treatment of patients with bronchial asthma should be performed under strict medical supervision due to the risk of bronchospasm. If bronchospasm occurs, the drug should be discontinued immediately.
Do not take this medicine before going to sleep.

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

Mucopect Kids and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Do not use carbocysteine simultaneously with antitussive drugs or drugs that reduce secretion.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.

Pregnancy
Use of this medicine during pregnancy is not recommended.

Breastfeeding
Use of this medicine during breastfeeding is not recommended.
It is unknown whether carbocysteine passes into breast milk.

Fertility
There are no data on the effect of carbocysteine on fertility.

Driving and operating machinery
Carbocysteine has no effect or has negligible effect on the ability to drive and operate machinery.

Mucopect Kids contains sucrose
This medicine may be harmful to teeth. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
1 mL of Mucopect Kids contains 577.5 mg of sucrose. The adult dose, 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)
This medicine may cause allergic reactions (including delayed-type reactions).

3. How to use Mucopect Kids

This medicine should always be used exactly as described in this patient leaflet or as directed by
your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Measure the appropriate amount of medicine for the patient (child or adult) using the measuring spoon (a dosing spoon with a 5 mL capacity) according to the recommended dosage. The dosing spoon used for measuring the oral dose has a volume of 5 mL and graduations indicating 1.25 mL, 2.5 mL, 3.75 mL,
and 5.0 mL.
The usual way to use this medicine is 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 daily.
Once symptoms have improved, the dose should be reduced to 10 mL of syrup three times daily.
Children
Children aged 6 to 12 years: 5 mL of syrup three times daily.
After taking a dose of syrup, the bottle should be closed tightly.
Do not take the medicine before going to sleep. The last dose should be taken no later than 4 hours before bedtime.
Without a doctor's recommendation, do not use the medicine for longer than 4 to 5 days.
It is recommended to drink increased amounts of fluids while taking Mucopect Kids.
Taking more Mucopect Kids than recommended
There are no reports of carbocysteine overdose. The most likely symptoms of overdose may be gastrointestinal disturbances.
If you take more than the recommended dose, consult your doctor.
Missed dose of Mucopect Kids
Take the missed dose as soon as possible. Do not take a double dose to make up for a missed dose.
Stopping Mucopect Kids treatment
If you have any further doubts about using 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 allergic reactions, Stevens-Johnson syndrome (appearance of bleeding sores or blisters on the skin, including around the lips, eyes, mouth, nose and genital organs, as well as flu-like symptoms and fever), or blood in vomit or stool occur, treatment with this medicine should be discontinued and immediate medical advice should be sought from a doctor or at a hospital emergency department.

Rare (more than 1 in 10,000 people but less than 1 in 1,000 people): nausea, vomiting, diarrhoea.

Very rare (less than 1 in 10,000 people): gastrointestinal bleeding, gastric disturbances, abdominal pain, allergic reactions (skin rash, itching, urticaria).

Frequency unknown (frequency cannot be estimated from available data): headache, isolated cases of blistering skin disorders such as Stevens-Johnson syndrome, and in hypersensitive patients, inflammation of the mucous membranes of the mouth and nose may occur.

Reporting of adverse reactions

If any adverse reactions occur, including any not listed in this leaflet, inform a doctor, pharmacist or nurse. Adverse reactions can be reported directly to:

Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: 22 49-21-301
Fax: 22 49-21-309
Website: https://smz.ezdrowie.gov.pl

Adverse reactions can also be reported to the responsible entity.

Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Mucopect Kids

Keep this medicine 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 stated month.
The shelf life after first opening the bottle is 3 months.
Do not use this medicine if the syrup changes colour or shows any other signs of deterioration; in such a case, take it to the pharmacist, who will provide appropriate advice.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such measures 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.
Other ingredients are: methyl parahydroxybenzoate (E 218), caramel (E 150d), sucrose, blackcurrant flavour “Aroma grosella 63 2334” [propylene glycol, ethyl formate, isopentyl acetate, 4-(4-hydroxyphenyl)butan-2-one, 3-methylbutan-1-ol, buchu leaf (Barosma betulina) extract, 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-coloured syrup with a sweet blackcurrant flavour.
Orange glass bottle of type III (200 mL capacity), with a polyethylene (PE) screw cap and a polypropylene (PP) measuring spoon (5 mL capacity), graduated every 1.25 mL, in a cardboard box.
Pack size: 1 bottle containing 200 mL of syrup.
Marketing Authorisation 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, Poland
Laboratórios Basi - Indústria Farmacêutica, S.A.
Parque Industrial Manuel Lourenço Ferreira, Lotes 8, 15 e 16
3450-232 Mortágua, Portugal