MUCOPECT CONTROL

Package leaflet: Information for the user

Mucopect Control, 375 mg, hard capsules
Carbocisteinum
Please read all of this leaflet carefully before taking this medicine, because
it contains important information for the patient.
This medicine should always be taken exactly as described in the patient leaflet
or as advised by the 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 the patient experiences any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform the doctor or pharmacist. See section 4.
• If there is no improvement or if the patient feels worse after 4 to 5 days, contact the doctor.

Contents of the leaflet

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

Mucopect Control 375 mg, hard capsules contains an active substance called
carbocisteine. It belongs to a group of medicines known as "mucolytics". Its action
consists in reducing the viscosity of mucus (phlegm). As a result, mucus becomes easier to cough up.
Mucopect Control is used for symptomatic treatment of respiratory diseases
associated with excessive production of thick and sticky mucus.
If there is no improvement or if the patient feels worse after 4 to 5 days of treatment, contact the doctor.

2. Important information before using MUCOPECT CONTROL

When not to take MUCOPECT CONTROL:

• If the patient is allergic to carbocysteine or to any of the other ingredients of this medicine (listed in section 6). Symptoms of allergy include: rash, difficulty in swallowing or breathing, swelling of the lips, face, throat or tongue.
• If the patient has gastric or intestinal ulcers.

Warnings and precautions
Before starting to use MUCOPECT CONTROL, consult a doctor or pharmacist if:

• the patient is elderly;
• the patient has a history of peptic ulcer disease;
• the patient is taking other medicines known to cause gastrointestinal bleeding.

If there is abundant purulent sputum and fever, or in case of chronic bronchial or lung disease, as well as in patients with reduced ability to expectorate, a visit to the doctor is necessary, as additional or alternative treatment may be required.
Treatment of patients with bronchial asthma should be carried out under strict medical supervision due to the risk of bronchospasm. If this symptom occurs, administration of the medicine must be stopped immediately.

Children and adolescents
MUCOPECT CONTROL is not recommended for children and adolescents.

MUCOPECT CONTROL and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned to be used by the patient.
During treatment with MUCOPECT CONTROL, cough suppressants or drugs reducing bronchial mucus secretion should not be used.

Pregnancy, breastfeeding and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor before using this medicine.
This medicine should not be taken during the first three months of pregnancy.
It is unknown whether carbocysteine passes into breast milk. The medicine should not be used during breastfeeding.
There are no data regarding the effect of carbocysteine on fertility.

Driving and operating machinery
There is no information available on the influence of carbocysteine on the ability to drive vehicles or operate machinery.

3. How to take MUCOPECT CONTROL

This medicine should always be taken exactly as described in this patient leaflet
or as advised by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The medicine is taken orally.
If you feel that the effect of MUCOPECT CONTROL is too strong or too weak,
consult your doctor.
Recommended dose
Adults (including elderly people)

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

Do not use the medicine for longer than 4 to 5 days without medical advice.
During treatment, drink plenty of fluids.
Do not take the medicine before going to bed. The last dose should be taken no later than
4 hours before bedtime.
Use in children and adolescents

• MUCOPECT CONTROL is not recommended for children and adolescents.

If you take more MUCOPECT CONTROL than recommended
If you take more MUCOPECT CONTROL than recommended, contact your doctor or pharmacist immediately.
Take the medicine package with you. This will help the doctor identify which medicine has been taken.
Taking too many MUCOPECT CONTROL capsules may likely cause stomach upset (gastrointestinal disturbances).
If you forget to take MUCOPECT CONTROL
Do not take a double dose to make up for a forgotten dose.
Take the next dose at the usual time.
If you have any further doubts about the use of 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.
You must stop taking Mucopect Control and immediately consult a doctor or go to the emergency room if:

• An allergic reaction has occurred. It may manifest as rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue.
• Bleeding skin lesions or blisters appear, including around the lips, eyes, mouth, nose, and genital organs. Flu-like symptoms and fever may also occur.

This may be the so-called "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 adverse reactions worsen or persist for more than a few days:

• Vomiting.

Reporting adverse reactions
If any adverse symptoms occur, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, phone: 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 provide more information on the safety of this medicine.

5. How to store MUCOPECT CONTROL

Keep this medicine out of 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 stated month.
Store below 30°C.
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 Control contains

• The active substance is carbocysteine. Each hard capsule contains 375 mg of carbocysteine.
• The other ingredients are: maize starch, pregelatinized maize starch 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 yellow hard capsules of size 0, containing 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 Authorisation 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 sabiedríba “GRINDEKS”
53 Krustpils iela,
LV-1057 Riga, Latvia