Pulnozin o smaku harnei pozhehki

Package Leaflet: Information for the User

PULNOZIN Blackcurrant Flavor, 750 mg, Sucking Tablets

Carbocisteinum

Read the Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is PULNOZIN Blackcurrant Flavor and what is it used for

The active substance of PULNOZIN Blackcurrant 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 Blackcurrant 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 Blackcurrant Flavor

When not to take PULNOZIN Blackcurrant Flavor:

• if you are allergic to the active substance - carbocisteine or any of the other ingredients of this medicine (listed in section 6);
• if you have active stomach or duodenal ulcer.

Warnings and precautions

Before taking PULNOZIN Blackcurrant Flavor, discuss it with your doctor or pharmacist. Be particularly careful when taking PULNOZIN Blackcurrant Flavor:

• in patients with bronchial asthma with a history of 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 Blackcurrant Flavor causes a reduction in viscosity and removal of mucus, through ciliary activity of the mucosa or through a cough reflex. Therefore, you should expect increased coughing and sputum production. Concurrent use of PULNOZIN Blackcurrant Flavor with antitussive drugs 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 also be exercised in elderly patients and those taking other medications that may cause gastrointestinal bleeding.

Children and adolescents

PULNOZIN Blackcurrant Flavor is not recommended for use in children and adolescents under 12 years of age.

PULNOZIN Blackcurrant Flavor and other medicines

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before taking this medicine. It is not recommended to take the medicine during pregnancy, especially during the first trimester. It is not recommended to take during breastfeeding, as it is not known whether carbocisteine passes into breast milk. There are no data on the negative effect of carbocisteine administered orally on human fertility.

Driving and using machines

PULNOZIN Blackcurrant Flavor has no effect on the ability to drive and use machines.

PULNOZIN Blackcurrant Flavor contains isomalt

One sucking tablet of PULNOZIN Blackcurrant Flavor contains 679.10 mg of isomalt. If you have previously been diagnosed with intolerance to some sugars, you should consult your doctor before taking the medicine. The caloric value is 2.3 kcal/g isomalt. The medicine may have a mild laxative effect.

3. How to take PULNOZIN Blackcurrant Flavor

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist. The medicine is for use on the oral mucosa. One sucking tablet 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. Initial dose: chew or suck 1 tablet 3 times a day. In case of prolonged use, the daily dose should be reduced to 1.5 g, i.e., 1 tablet 2 times a day. Do not take the medicine before bedtime.

Use in children and adolescents

PULNOZIN Blackcurrant Flavor is not recommended for use in children and adolescents under 12 years of age.

Overdose of PULNOZIN Blackcurrant Flavor

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

Missed dose of PULNOZIN Blackcurrant 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 on the use of this medicine, ask 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 1000 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 not known(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 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, please 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 Blackcurrant Flavor

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the 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 no longer required. This will help protect the environment.

6. Contents of the pack and other information

What PULNOZIN Blackcurrant Flavor contains

• The active substance is carbocisteine. Each sucking tablet contains 750 mg of carbocisteine.
• The other ingredients are: isomalt, microcrystalline cellulose, low-substituted hydroxypropylcellulose, sodium alginate, magnesium stearate, calcium phosphate, blackcurrant flavor 502009 AP0560 containing starch, maltodextrin, triacetin, triethyl citrate, sucralose (E 955), peppermint flavor SD0627 containing natural peppermint oil, natural spearmint oil, menthol, maltodextrin, propylene glycol 1,2.

What PULNOZIN Blackcurrant Flavor looks like and contents of the pack

PULNOZIN Blackcurrant Flavor is a white, round, biconvex sucking tablet with a blackcurrant flavor. Packaging: PVC/PVDC/Aluminum blisters in a cardboard box. PULNOZIN Blackcurrant 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, 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 last revision of the leaflet: February 2024