Pulnozin Muco Iunior o smaku malinovim

Package Leaflet: Information for the User

PULNOZIN MUCO Junior Raspberry Flavor, 250 mg, Sucking Tablets

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.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including those 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 Junior Raspberry Flavor and what is it used for
• 2. Important information before taking PULNOZIN MUCO Junior Raspberry Flavor
• 3. How to take PULNOZIN MUCO Junior Raspberry Flavor
• 4. Possible side effects
• 5. How to store PULNOZIN MUCO Junior Raspberry Flavor
• 6. Contents of the pack and other information

1. What is PULNOZIN MUCO Junior Raspberry Flavor and what is it used for

Indications
PULNOZIN MUCO Junior Raspberry 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 during coughing (mucolytic action).
PULNOZIN MUCO Junior Raspberry Flavor is used for the symptomatic treatment of respiratory system diseases characterized by excessive production of thick and viscous mucus in adults, adolescents, and children over 6 years old.
If there is no improvement or the patient feels worse after 5 days, they should contact their doctor.

2. Important information before taking PULNOZIN MUCO Junior Raspberry Flavor

Contraindications

When not to take PULNOZIN MUCO Junior Raspberry 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 to take PULNOZIN MUCO Junior Raspberry Flavor, the patient should discuss it with their doctor or pharmacist.
Particular caution should be exercised when taking PULNOZIN MUCO Junior Raspberry 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 Junior Raspberry Flavor can cause a reduction in mucus viscosity and removal, either through ciliary activity of the mucosa or through the cough reflex.
Therefore, increased coughing and expectoration should be expected. Concurrent use of PULNOZIN MUCO Junior Raspberry Flavor with antitussive drugs is not recommended.
As mucolytics may damage the gastric mucosa, caution should be exercised in patients with a history of gastric or duodenal ulcers. Caution should also be exercised in elderly patients and those taking other medicines that may cause gastrointestinal bleeding.

Children and adolescents

This medicine is not recommended for children under 6 years old.

PULNOZIN MUCO Junior Raspberry 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 Junior Raspberry Flavor, the patient should not take antitussive drugs or drugs that reduce bronchial mucus secretion.

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.
This medicine is not recommended during pregnancy, especially during the first trimester.
It is not known whether carbocisteine passes into breast milk. This medicine is not recommended during breastfeeding.
There is no data on the effect of carbocisteine on fertility.

Driving and using machines

PULNOZIN MUCO Junior Raspberry Flavor does not affect the ability to drive or operate machinery.

PULNOZIN MUCO Junior Raspberry Flavor contains isomalt

One sucking tablet of PULNOZIN MUCO Junior Raspberry Flavor contains 225.90 mg of isomalt. If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking this 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 Junior Raspberry 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 3 sucking tablets 3 times a day.
• If the symptoms decrease, the dose can be reduced to 3 sucking tablets 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 (6-11 years old)

One sucking tablet should be chewed or sucked 3 times a day.
PULNOZIN MUCO Junior Raspberry Flavor is not recommended for children under 6 years old.

Overdose of PULNOZIN MUCO Junior Raspberry Flavor

There is no information on cases of carbocisteine overdose.
The most likely symptoms of overdose of PULNOZIN MUCO Junior Raspberry Flavor are gastrointestinal disorders.
In case of overdose, the patient should immediately consult their doctor or pharmacist and take the package of the medicine with them. This will allow the doctor to know which medicine was taken.

Missed dose of PULNOZIN MUCO Junior Raspberry Flavor

A double dose should not be taken 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 Junior Raspberry 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, dyspnea, urticaria, and bronchospasm, rash.
Very rare side effects(less than 1 in 10,000 people):
Gastrointestinal bleeding.
Frequency not known(cannot be estimated from the available data):
Abdominal pain, gastric ulcers, abdominal discomfort, allergic skin reactions, itching, urticaria, 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 secretion, 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 those not listed in this leaflet, they should inform their doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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 to gather more information on the safety of this medicine.

5. How to store PULNOZIN MUCO Junior Raspberry Flavor

The medicine should be stored out of sight and reach of children.
This medicine should not be used after the expiry date (EXP) stated on the packaging.
The expiry date refers to the last day of the month.
There are no special precautions for storing the medicine.
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. Contents of the pack and other information

What PULNOZIN MUCO Junior Raspberry Flavor contains

• The active substance is carbocisteine. Each sucking tablet contains 250 mg of carbocisteine.
• The other ingredients are: isomalt, microcrystalline cellulose, hydroxypropylcellulose, low-substituted, sodium alginate, magnesium stearate, calcium phosphate, raspberry flavor 052383 AP0551 [corn maltodextrin, glycerol triacetate], sucralose (E955).

What PULNOZIN MUCO Junior Raspberry Flavor looks like and contents of the pack

PULNOZIN MUCO Junior Raspberry Flavor is a white, round, flat sucking tablet with beveled edges.
Packaging:
PVC/PVDC/Aluminum blisters in a cardboard box.
PULNOZIN MUCO Junior Raspberry Flavor is available in packs of 10, 20, 30, or 40 sucking tablets.
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 last revision of the leaflet: 09/2024