Pulnozin o smaku limonki

Leaflet attached to the packaging: information for the user

PULNOZIN lemon flavor, 750 mg, lozenges

Carbocisteine

Please read carefully the contents of the leaflet before taking the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in the patient leaflet or as directed by the doctor or pharmacist.

• This leaflet should be kept in case it needs to be read again.
• In case of any doubts, the doctor or pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should inform the doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is PULNOZIN lemon flavor and what is it used for

The active substance of PULNOZIN lemon flavor is carbocisteine. This substance belongs to the 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 lemon flavor is used in the symptomatic treatment of respiratory system diseases characterized by excessive production of thick and viscous mucus.

2. Important information before taking PULNOZIN lemon flavor

When not to take PULNOZIN lemon 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 lemon flavor, the doctor or pharmacist should be consulted. Particular caution should be exercised when taking PULNOZIN lemon flavor:

• in patients with bronchial asthma with a history of 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 lemon flavor reduces the viscosity and removes mucus through ciliary activity of the epithelium or through the cough reflex. Therefore, increased coughing and expectoration should be expected. Concurrent use of PULNOZIN lemon flavor with anti-cough 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

PULNOZIN lemon flavor is not recommended for children and adolescents under 12 years of age.

PULNOZIN lemon flavor and other medicines

The doctor or pharmacist should be informed about all medicines currently or recently taken by the patient, as well as any medicines the patient plans to take. During the use of PULNOZIN lemon flavor, anti-cough medicines or medicines reducing bronchial mucus secretion should not be taken.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, or thinks they may be pregnant, or plans to have a child, they should consult a doctor before taking this medicine. PULNOZIN lemon flavor is not recommended during pregnancy, especially during the first trimester, even though no teratogenic effect of carbocisteine has been demonstrated. PULNOZIN lemon flavor 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 lemon flavor does not affect the ability to drive and use machines.

PULNOZIN lemon flavor contains isomalt

One lozenge of PULNOZIN lemon flavor contains 679.10 mg of isomalt. If the patient has previously been diagnosed with intolerance to some sugars, they should consult a doctor before taking the medicine. The energy value of 2.6 kcal/g of isomalt. The medicine may have a mild laxative effect.

3. How to take PULNOZIN lemon flavor

This medicine should always be used exactly as directed by the doctor or pharmacist. In case of doubts, the doctor or pharmacist should be consulted. The medicine is for use on the oral mucosa. One lozenge contains 750 mg of carbocisteine.

Recommended dose

Adults and adolescents (12 years and older)

Carbocisteine is administered in a dose of 20-30 mg per kilogram of body weight per day, divided into 2-3 doses. One lozenge should be chewed or sucked 3 times a day. If long-term use is necessary, the daily dose should be reduced to 1.5 g, i.e., 2 times a day, one lozenge. The medicine should not be taken before bedtime.

Use in children and adolescents

PULNOZIN lemon flavor is not recommended for children and adolescents under 12 years of age.

Taking a higher dose of PULNOZIN lemon flavor than recommended

There is no information on cases of carbocisteine overdose. The most likely symptoms of PULNOZIN lemon flavor overdose may be gastrointestinal disorders. In case of taking a higher dose of PULNOZIN lemon flavor than recommended, the doctor or pharmacist should be consulted immediately.

Missing a dose of PULNOZIN lemon 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. In case of any further doubts about the use of this medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, PULNOZIN lemon flavor 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. The 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, Stevens-Johnson syndrome, erythema multiforme, hypothyroidism, palpitations, edema, hemorrhoids, bronchial secretion, muscle pain. If such symptoms occur, the doctor should be consulted, who will recommend reducing the dose or discontinuing the medicine.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the doctor, pharmacist, or nurse should be informed. 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, more information can be collected on the safety of the medicine.

5. How to store PULNOZIN lemon 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 specified month. There are no special precautions for storage. Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What PULNOZIN lemon 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, lemon flavor, sucralose E955, peppermint flavor.

What PULNOZIN lemon flavor looks like and what the packaging contains

PULNOZIN lemon flavor is a white, round, biconvex lozenge with a lemon flavor. Packaging: PVC/PVDC/Aluminum blisters in a cardboard box. PULNOZIN lemon flavor is available in packs containing 10, 20, 30, or 40 lozenges. Not all pack 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, [logo Solinea]

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