Pulnozin Muco o smaku harnei pozhehki

Leaflet attached to the packaging: information for the user

PULNOZIN MUCO blackcurrant flavor, 750 mg, lozenges

Carbocisteinum

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

This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor, pharmacist, or nurse.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.
• If there is no improvement or the patient feels worse after 5 days, they should contact their doctor.

Table of contents of the leaflet

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

1. What is PULNOZIN MUCO blackcurrant flavor and what is it used for

Indications
PULNOZIN MUCO blackcurrant flavor contains the active substance carbocisteine. This substance belongs to a group of medicines called "mucolytics", and its action is to reduce the viscosity of mucus (phlegm). This makes it easier to remove mucus from the airways when coughing (mucolytic action).
PULNOZIN MUCO blackcurrant flavor is used for the symptomatic treatment of respiratory system diseases characterized by excessive production of thick and sticky mucus in adults and adolescents over 12 years of age.
If there is no improvement or the patient feels worse after 5 days, they should consult their doctor.

2. Important information before taking PULNOZIN MUCO blackcurrant flavor

Contraindications

When not to take PULNOZIN MUCO blackcurrant flavor:

• if the patient is allergic to the active substance - carbocisteine or any of the other ingredients of this medicine (listed in section 6);
• if the patient has active gastric or duodenal ulcer disease.

Warnings and precautions

Before starting treatment with PULNOZIN MUCO blackcurrant flavor, the patient should discuss it with their doctor or pharmacist.
Particular caution should be exercised when taking PULNOZIN MUCO blackcurrant flavor:

• in patients with a history of bronchial asthma with bronchospasm;
• in patients with severe respiratory failure;
• in weakened patients. Due to the reduced cough reflex, there is a risk of airway obstruction due to increased secretions.

Taking PULNOZIN MUCO blackcurrant flavor can cause a reduction in mucus viscosity and its removal through ciliary activity of the mucosa or through the cough reflex. Therefore, increased coughing and expectoration should be expected. Concurrent use of PULNOZIN MUCO blackcurrant flavor with antitussive medicines is not recommended.
Since mucolytics can damage the gastric mucosa, caution should be exercised in patients with a history of stomach or duodenal ulcers. Caution should also be exercised in elderly patients and those taking other medicines that may cause gastrointestinal bleeding.

Children and adolescents

PULNOZIN MUCO blackcurrant flavor is not recommended for use in children and adolescents under 12 years of age.

PULNOZIN MUCO blackcurrant flavor 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.
While taking PULNOZIN MUCO blackcurrant flavor, the patient should not take antitussive medicines or medicines that reduce mucus production in the airways.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before taking this medicine.
PULNOZIN MUCO blackcurrant flavor is not recommended during pregnancy, especially during the first trimester.
It is not known whether carbocisteine passes into breast milk. PULNOZIN MUCO blackcurrant flavor is not recommended during breastfeeding.
There is no data on the effect of carbocisteine on fertility.

Driving and using machines

PULNOZIN MUCO blackcurrant flavor has no effect on the ability to drive or operate machinery.

PULNOZIN MUCO blackcurrant flavor contains isomalt

One lozenge of PULNOZIN MUCO blackcurrant flavor contains 679.10 mg of isomalt. If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine. The energy value is 2.3 kcal/g of isomalt. The medicine may have a mild laxative effect.

3. How to take PULNOZIN MUCO blackcurrant flavor

This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.
The medicine is for use on the oral mucosa.

Recommended dose

Adults and adolescents (12 years and older)

• The initial dose is: 1 lozenge 3 times a day.
• If the symptoms decrease, the dose can be reduced to 1 lozenge 2 times a day.

The medicine should not be taken before bedtime.
Medicines containing carbocisteine should not be used for more than 5 days without consulting a doctor.

Use in children and adolescents

PULNOZIN MUCO blackcurrant flavor is not recommended for use in children and adolescents under 12 years of age.

Taking a higher dose of PULNOZIN MUCO blackcurrant flavor than recommended

There is no information on cases of carbocisteine overdose.
The most likely symptoms of PULNOZIN MUCO blackcurrant flavor overdose may be gastrointestinal disorders.
In case of taking a higher dose of PULNOZIN MUCO blackcurrant flavor than recommended, the patient should immediately consult their doctor or pharmacist. They should take the medicine packaging with them, so the doctor knows which medicine was taken.

Missing a dose of PULNOZIN MUCO blackcurrant flavor

The patient should not take a double dose to make up for a missed dose.
The next dose should be taken at the usual time.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, PULNOZIN MUCO blackcurrant flavor can cause side effects, although not everybody gets them.
Uncommon side effects(less than 1 in 100 people):
Gastrointestinal disorders: nausea, vomiting, and diarrhea.
Rare side effects(less than 1 in 1000 people):
Headache, dizziness, urinary incontinence, palpitations, shortness of breath, hives, and bronchospasm, rash.
Very rare side effects(less than 1 in 10,000 people):
Gastrointestinal bleeding.
Frequency of the following side effects is unknown(cannot be estimated from the available data):
Abdominal pain, gastric ulcers, abdominal discomfort, allergic skin reactions, itching, hives, angioedema (severe allergic reaction causing facial or throat swelling), Stevens-Johnson syndrome, erythema multiforme (severe skin and mucous membrane reactions), hypothyroidism, palpitations, edema, hemorrhoids, bronchial secretions, muscle pain.
If such symptoms occur, the patient should consult their doctor, who will recommend reducing the dose or stopping the medicine.

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department for Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 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 gather more information on the safety of this medicine.

5. How to store PULNOZIN MUCO blackcurrant flavor

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date (EXP) stated on the packaging.
The expiry date refers to the last day of the given month.
There are no special precautions for storing the medicine.
Medicines should not be disposed of via wastewater or household waste containers. 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 PULNOZIN MUCO blackcurrant flavor contains

• The active substance of the medicine is carbocisteine. Each lozenge contains 750 mg of carbocisteine.
• The other ingredients are: isomalt, microcrystalline cellulose, hydroxypropylcellulose, low-substituted, sodium alginate, magnesium stearate, calcium phosphate, blackcurrant flavor 502009 AP0560 [corn maltodextrin, glycerol triacetate (E1518), triethyl citrate (E1505), flavoring substances], sucralose (E955), peppermint flavor SD0627 [natural peppermint oil, natural spearmint oil, menthol, maltodextrin, arabic gum (E414), propylene glycol (E1520)].

What PULNOZIN MUCO blackcurrant flavor looks like and what the package contains

PULNOZIN MUCO blackcurrant flavor is a white, round, biconvex lozenge with a blackcurrant flavor.
Packaging:
PVC/PVDC/Aluminum blisters in a cardboard box.
PULNOZIN MUCO blackcurrant flavor is available in packages containing 10, 20, 30, or 40 lozenges.
Not all pack sizes may be marketed.

Marketing authorization holder:

Solinea Sp. z o.o.
Elizówka, Szafranowa 6
21-003 Ciecierzyn
tel.: +48 81 463 48 82
{logo of the marketing authorization holder}

Manufacturer:

Mako Pharma Sp. z o.o.
Kolejowa 231A
05-092 Dziekanów Polski
Medicofarma S.A.
Tarnobrzeska 13
26-613 Radom

Date of the last update of the leaflet: 09.2024