Mucopect Control

Package Leaflet: Information for the User

Mucopect Control, 375 mg, Hard Capsules

Carbocisteine

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in the package leaflet or as directed by a doctor or pharmacist.

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

Table of Contents of the Leaflet

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

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

Mucopect Control, 375 mg, hard capsules contain the active substance carbocisteine. It belongs to a group of medicines called "mucolytics". Its action is to reduce the viscosity of mucus (phlegm). This makes it easier to cough up the mucus.

Mucopect Control is used for the symptomatic treatment of respiratory diseases with excessive production of thick and viscous mucus.

If after 4 to 5 days of treatment there is no improvement or you feel worse, consult a doctor.

2. Important information before taking Mucopect Control

When not to take Mucopect Control:

• If you are allergic to carbocisteine or any of the other ingredients of this medicine (listed in section 6). Symptoms of an allergic reaction include: rash, difficulty swallowing or breathing, swelling of the face, lips, throat, or tongue.
• If you have stomach or duodenal ulcers.

Warnings and precautions

Before taking Mucopect Control, discuss it with your doctor or pharmacist if:

• you are elderly;
• you have had a stomach ulcer in the past;
• you are taking other medicines known to cause stomach bleeding.

In case of abundant purulent discharge and fever, as well as in case of chronic bronchitis or lung disease, and in patients with reduced ability to cough up mucus, a doctor's visit is necessary, who may prescribe other medicines.

Treatment of patients with 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.

Children and adolescents

Mucopect Control is not recommended for children and adolescents.

Mucopect Control and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.

Do not take cough suppressants or medicines that reduce mucus production in the bronchi while taking Mucopect Control.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor before taking this medicine.

Do not take this medicine during the first three months of pregnancy.

It is not known whether carbocisteine passes into breast milk. This medicine should not be taken during breastfeeding.

There is no data on the effect of carbocisteine on fertility.

Driving and using machines

There is no information on the effect of carbocisteine on the ability to drive and use machines.

3. How to take Mucopect Control

Take this medicine exactly as described in the package leaflet or as directed by a doctor or pharmacist. If you are unsure, consult a doctor or pharmacist.

Take the medicine orally.

If you feel that the effect of Mucopect Control is too strong or too weak, consult a doctor.

Recommended dose

Adults (including the elderly)

• The usual initial dose is two capsules taken three times a day.
• If the symptoms decrease, the dose can be reduced to one capsule taken four times a day.

Do not take the medicine for more than 4 to 5 days without consulting a doctor.

During treatment, drink plenty of fluids.

Do not take the medicine before bedtime. The last dose should be taken at least 4 hours before bedtime.

Use in children and adolescents

• Mucopect Control is not recommended for children and adolescents.

Overdose of Mucopect Control

In case of overdose, consult a doctor or pharmacist immediately. Take the package with you. This will help the doctor to know what medicine you have taken.

After taking too many Mucopect Control capsules, the patient will likely experience stomach upset (gastrointestinal disorders).

Missed dose of Mucopect Control

Do not take a double dose to make up for a missed dose.

Take the next dose at the usual time.

If you have any further doubts about taking this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Mucopect Control can cause side effects, although not everybody gets them.

Stop taking Mucopect Control and consult a doctor or go to the hospital immediately if:

• An allergic reaction occurs. It may manifest as: rash, difficulty swallowing or breathing, swelling of the face, lips, throat, or tongue.
• Bleeding wounds or blisters appear on the skin, including around the lips, eyes, mouth, nose, and genitals. These may also be accompanied by

flu-like symptoms and fever. This may be a condition known as "Stevens-Johnson syndrome".

• Blood is visible in the vomit or the patient passes black, tarry stools.

Consult a doctor or pharmacist if any of the following side effects worsen or last longer than a few days:

• Vomiting.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the 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.

Side effects can also be reported to the marketing authorization holder.

Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Mucopect Control

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton and blister after "EXP". The expiry date refers to the last day of the month stated.

Store in a temperature below 30°C.

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 Control contains

• The active substance is carbocisteine. Each hard capsule contains 375 mg of carbocisteine.
• The other ingredients are: maize starch, maize starch pregelatinised and magnesium stearate. Capsule shell: titanium dioxide (E171), yellow iron oxide (E172), and gelatin.

What Mucopect Control looks like and contents of the pack

Mucopect Control is a yellow hard capsule, size 0, containing a white or almost white powder.

Packaging:

PVC/PVDC/Aluminium blisters in a cardboard box.

or

PVC/PE.EVOH.PE/PCTFE/Aluminium blisters in a cardboard box.

Mucopect Control is available in packs containing 6, 18, or 30 hard capsules.

Not all pack sizes may be marketed.

Marketing authorization holder:

Adamed Pharma S.A.

Pieńków, ul. M. Adamkiewicza 6A

05-152 Czosnów, Poland

Manufacturer:

Adamed Pharma S.A.

ul. Marszałka J. Piłsudskiego 5

95-200 Pabianice, Poland

Chanelle Medical

Dublin Road, Laughrea,

Co. Galway, H62 FH90, Ireland

Akciju sabiedrība “GRINDEKS”

53 Krustpils iela,

LV-1057 Riga, Latvia

Date of last revision of the leaflet:January 2023