Pulnozin Iunior o smaku malinovim

Package Leaflet: Information for the User

PULNOZIN Junior Raspberry Flavor, 250 mg, Sucking Tablets

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 have any further questions, ask your doctor or pharmacist.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

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

The active substance of PULNOZIN Junior Raspberry Flavor is 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 (so-called mucolytic action).
PULNOZIN Junior Raspberry Flavor is used for symptomatic treatment of respiratory system diseases characterized by excessive production of thick and viscous mucus.

2. Important information before taking PULNOZIN Junior Raspberry Flavor

Raspberry Flavor

When not to take PULNOZIN Junior Raspberry Flavor:

Warnings and precautions

Before taking PULNOZIN Junior Raspberry Flavor, discuss it with your doctor or pharmacist.
Particular caution should be exercised when taking PULNOZIN Junior Raspberry Flavor:

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

Taking PULNOZIN Junior Raspberry Flavor causes a reduction in viscosity and removal of mucus, through ciliary activity of the mucosa or through a cough reflex. Therefore, increased coughing and expectoration should be expected. Concurrent use of PULNOZIN Junior Raspberry Flavor with antitussive medicines is not recommended.
Since mucolytics can damage the gastric mucosa, caution should be exercised in people with a tendency to stomach and duodenal ulcers. Caution should 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 of age.

PULNOZIN Junior Raspberry Flavor and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
When taking PULNOZIN Junior Raspberry Flavor, do not take antitussive medicines or medicines that reduce bronchial mucus secretion.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before taking this medicine.
This medicine is not recommended for use in pregnant women, especially during the first trimester, even though carbocisteine has not been shown to have a teratogenic effect.
This medicine is not recommended during breastfeeding, as it is not known whether carbocisteine passes into breast milk.
There are no data on the negative impact of oral carbocisteine on human fertility.

Driving and using machines

PULNOZIN Junior Raspberry Flavor does not affect the ability to drive and use machines.

PULNOZIN Junior Raspberry Flavor contains isomalt

One sucking tablet of PULNOZIN Junior Raspberry Flavor contains 225.90 mg of isomalt.
If you have previously been diagnosed with intolerance to some sugars, you should consult your doctor before taking the medicine. The energy value of 2.6 kcal/g isomalt.
The medicine may have a mild laxative effect.

3. How to take PULNOZIN Junior Raspberry Flavor

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
The medicine is for use on the oral mucosa.
One tablet contains 250 mg of carbocisteine.

Recommended dose

Adults and adolescents (12 years and older)

Carbocisteine is administered at a dose of 20-30 mg per kilogram of body weight per day, in 2-3 divided doses.
Chew or suck 3 tablets 3 times a day.
If long-term use is necessary, the daily dose should be reduced to 1.5 g, i.e., 3 tablets 2 times a day.

Use in children (6-11 years old)

Chew or suck 1 tablet 3 times a day.
Do not take the medicine before bedtime.

Taking a higher dose of PULNOZIN Junior Raspberry Flavor than recommended

There is no information on cases of carbocisteine overdose.
The most likely symptoms of PULNOZIN Junior Raspberry Flavor overdose may be gastrointestinal disorders.
If you have taken more than the recommended dose of PULNOZIN Junior Raspberry Flavor, consult your doctor or pharmacist immediately.

Missing a dose of PULNOZIN Junior Raspberry Flavor

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 questions about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Uncommon(less than 1 in 100 people):
Gastrointestinal disorders: nausea, vomiting, and diarrhea.
Rare(less than 1 in 1,000 people):
Headache, dizziness, urinary incontinence, palpitations, shortness of breath, hives, and bronchospasm, rash.
Very rare(less than 1 in 10,000 people):
Gastrointestinal bleeding.
Frequency of the following side effects is unknown(cannot be determined from available data):
Abdominal pain, gastric ulcers, abdominal discomfort, allergic skin reactions, itching, hives, angioedema, Stevens-Johnson syndrome, erythema multiforme, hypothyroidism, palpitations, edema, hemorrhoids, bronchial secretion, muscle pain.
If you experience any of these symptoms, consult your doctor, who will recommend reducing the dose or stopping the medicine.

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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store PULNOZIN Junior Raspberry Flavor

Store the medicine out of sight and reach of children.
Do not use this medicine after the expiration date (EXP) stated on the packaging.
The expiration date refers to the last day of the specified month.
There are no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste. Ask your 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 Junior Raspberry Flavor contains

• The active substance of the medicine is carbocisteine. Each sucking tablet contains 250 mg of carbocisteine.
• Other ingredients are: isomalt, microcrystalline cellulose, hydroxypropylcellulose, low-substituted, sodium alginate, magnesium stearate, calcium phosphate, raspberry flavor, sucralose E955

What PULNOZIN Junior Raspberry Flavor looks like and what the package contains

PULNOZIN Junior Raspberry Flavor is a white, round, flat sucking tablet with beveled edges.
Packaging:
PVC/PVDC/Aluminum blisters in a cardboard box.
PULNOZIN Junior Raspberry Flavor is available in packages containing 10, 20, 30, or 40 sucking tablets.
Not all package sizes may be marketed.

Marketing authorization holder:

Solinea Sp. z o.o.
Elizówka, ul. Szafranowa 6
21-003 Ciecierzyn
tel.: +48 81 463 48 82
[Solinea logo]

Manufacturer:

Mako Pharma Sp. z o.o.
ul. Kolejowa 231A
05-092 Dziekanów Polski
Medicofarma S.A.
ul. Tarnobrzeska 13
26-613 Radom
Date of leaflet approval:07.2023