Mucopect

Leaflet attached to the packaging: patient information

Mucopect, 50 mg/mL, syrup

Carbocisteine

Read the leaflet carefully before taking the medicine, as it contains

important information for the patient.

• This leaflet should be kept, so that it can be read again if necessary.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed specifically for one person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

1. What is Mucopect and what is it used for

Mucopect contains the active substance carbocisteine. It belongs to a group of substances called "mucolytics", used in the treatment of respiratory diseases characterized by excessive mucus production in the bronchi.
Carbocisteine reduces the viscosity of mucus (phlegm), making it easier to expel from the airways during coughing.
Mucopect is used for the symptomatic treatment of respiratory diseases characterized by excessive production of thick and viscous secretions.

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 stomach or duodenal ulcers.

Warnings and precautions

Before starting treatment with Mucopect, the patient should discuss it with their doctor or pharmacist if:

• the patient has a history of asthma and bronchospasm.
• 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.
The medicine should not be taken before bedtime.

Children

Mucopect is not indicated for children under 2 years of age.

Mucopect and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Carbocisteine should not be taken simultaneously with cough suppressants and expectorants.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, or thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
It is not recommended to take the medicine during pregnancy.
Breastfeeding
It is not recommended to take 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 contains sucrose

The medicine may have a harmful effect on teeth. If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking the medicine.
1 mL of Mucopect contains 577.5 mg of sucrose. The recommended dose 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 contains methyl parahydroxybenzoate (E218)

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

3. How to take Mucopect

This medicine should always be taken according to the doctor's recommendations. In case of doubts, the patient should consult their doctor or pharmacist.
Using a measuring cup (a 5 mL measuring spoon), the patient should measure the amount of medicine corresponding to their dose (child or adult) according to the recommended dosage. The measuring spoon used to measure the oral dose has a volume of 5 mL and a scale indicating 1.25 mL, 2.5 mL, 3.75 mL, and 5.0 mL.
Usually, the medicine is taken as follows:
Adults and adolescents over 12 years old
The dose for adults and adolescents over 12 years old 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 from 2 to 5 years old: 1.25 mL to 2.5 mL of syrup four times a day.
Children from 6 to 12 years old: 5 mL of syrup three times a day.
This medicine is not indicated for children under 2 years of age.
After taking the dose, the bottle should be tightly closed.

Taking a higher dose of Mucopect 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 patient should consult their doctor.

Missing a dose of Mucopect

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

Stopping treatment with Mucopect

In case of any further doubts about taking the medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Mucopect 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 influenza and fever), and blood in vomit or stool, the patient should stop taking the medicine and immediately consult their doctor or go to the hospital emergency room.
Rarely(more often than 1 in 10,000 people, but less often than 1 in 1,000 people): nausea, vomiting, and diarrhea.
Very rarely(less often 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 blistering skin reactions such as Stevens-Johnson syndrome, in hypersensitive patients, oral and nasal mucositis may occur.

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, the patient should inform their doctor, pharmacist, or nurse. 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

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 stated.
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 deterioration; it should be taken to a pharmacist who will provide appropriate advice.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Mucopect 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, gooseberry 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 looks like and what the package contains

Carbocisteine is a clear, amber-colored syrup with a sweet, gooseberry flavor.
A type III orange glass bottle (200 mL), with a PE cap, with a 5 mL measuring spoon made of PP, scaled every 1.25 mL, in a cardboard box.
Package 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: