Package leaflet: Information for the patient

Mucopect, 50 mg/mL, syrup
Carbocisteinum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
If the patient experiences any adverse reactions, including any not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents

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

1. What Mucopect is and what it is used for
Mucopect contains an active substance called carbocisteine. It belongs to a group of substances known as "mucolytics", used in the treatment of respiratory diseases associated with excessive mucus secretion in the bronchi.
Carbocisteine reduces the viscosity of mucus (phlegm), making it easier to remove from the airways during coughing.
Mucopect is used for symptomatic treatment of respiratory tract diseases associated with excessive production of thick and sticky mucus.

2. Important information before taking Mucopect

When not to take Mucopect:

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

Warnings and precautions
Before starting treatment with Mucopect, consult your doctor or pharmacist if:

the patient has previously experienced asthma or bronchospasm;
the patient has acute respiratory failure;
the patient is debilitated. Weakened cough reflex may lead to risk of airway obstruction due to increased mucus secretion.

Mucolytic agents may damage the gastric mucosa; therefore, patients with a history of peptic ulcer disease should use them with caution.
Do not take this medicine immediately before going to sleep.
Children
Mucopect is not recommended for children under 2 years of age.
Mucopect and other medicines
Tell your doctor or pharmacist about any other medicines the patient is currently taking, has recently taken, or plans to take.
Do not take carbocisteine simultaneously with antitussive (cough suppressant) medicines or agents that reduce mucus 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 her 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 carbocisteine passes into breast milk.
Fertility
There is no data available on the effect of carbocisteine on fertility.
Driving and operating machinery
Carbocisteine has no effect or negligible effect on the ability to drive and operate machinery.
Mucopect contains sucrose
This medicine may have harmful effects on teeth. If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.
1 mL of Mucopect contains 577.5 mg of sucrose. The adult dose of 15 mL of syrup contains 8.7 g of sucruise. This should be taken into account in patients with diabetes.
Mucopect contains methyl 4-hydroxybenzoate (E218)
This medicine may cause allergic reactions (including delayed-type reactions).

3. How to use Mucopect

This medicine should always be used as directed by the physician. If in doubt, consult
your doctor or pharmacist.
Using the measuring spoon (a measuring spoon with a volume of 5 mL), measure the amount of medicine appropriate
for the patient (child or adult) according to the recommended dosage. The measuring spoon used for
measuring the oral dose has a volume of 5 mL and markings indicating 1.25 mL, 2.5 mL, 3.75 mL,
and 5.0 mL.
The usual dosage 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. After
symptom relief, the dose should be reduced to 10 mL of syrup three times daily.
Children
Children aged 2 to 5 years: 1.25 mL to 2.5 mL of syrup four times daily.
Children aged 6 to 12 years: 5 mL of syrup three times daily.
This medicine is not recommended for children under 2 years of age.
After administering a dose of syrup, close the bottle tightly.
Taking more Mucopect than recommended
There have been no reports of carbocisteine overdose. The most likely symptoms of overdose may be
gastrointestinal disturbances.
If an overdose has been taken, consult a doctor.
Missed dose of Mucopect
If a dose is missed, take it as soon as possible. Do not take a double dose to make up for a
missed dose.
Stopping Mucopect
If you have any further questions 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 occur, 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 development of flu-like symptoms and fever), or blood in vomit or stool, discontinue use of the medicine immediately and consult a doctor or go to a hospital emergency department.
Rare (more than 1 in 10,000 people, but less than 1 in 1,000 people): nausea, vomiting, and diarrhoea.
Very rare (less than 1 in 10,000 people): gastrointestinal bleeding, gastric disturbances, abdominal pain, allergic reactions (skin rash, itching, urticaria).
Frequency not known
(frequency cannot be estimated from the available data): headache, isolated cases of bullous skin inflammation such as Stevens-Johnson syndrome, in hypersensitive patients inflammation of the mucous membranes of the oral cavity and nose may occur.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your 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 marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Mucopect

Keep the 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 specified 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 required. This will help protect the environment.

6. Contents of the pack and other information

What Mucopect contains

The active substance is carbocysteine. 1 mL of syrup contains 50 mg of carbocysteine.
The 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 (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 looks like and contents of the pack
Carbocysteine is a transparent, amber-coloured syrup with a sweet, blackcurrant taste.
Orange glass bottle of type III (200 mL capacity), with a PE cap, supplied with a PP measuring spoon (5 mL capacity), graduated every 1.25 mL, packed 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