Pulnozin with blackcurrant flavor

Package leaflet: Information for the user

PULNOZIN blackcurrant flavour, 750 mg, effervescent tablets
Carbocisteinum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents

1. What PULNOZIN blackcurrant flavour is and what it is used for
2. What you need to know before taking PULNOZIN blackcurrant flavour
3. How to take PULNOZIN blackcurrant flavour
4. Possible side effects
5. How to store PULNOZIN blackcurrant flavour
6. Contents of the pack and other information

1. What PULNOZIN blackcurrant flavour is and what it is used for

The active substance in PULNOZIN blackcurrant flavour is carbocisteine. This substance
belongs to a group of medicines called "mucolytics", which work by reducing the viscosity
of mucus (phlegm). As a result, mucus secretion is more easily removed from the respiratory tract
during coughing (so-called mucolytic effect).
PULNOZIN blackcurrant flavour is used for symptomatic treatment of respiratory diseases
associated with excessive production of thick and sticky mucus.

2. Information before using PULNOZIN blackcurrant-flavoured

When not to use PULNOZIN blackcurrant-flavoured:

• if the patient is allergic to the active substance - carbocysteine, or to 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 blackcurrant-flavoured, consult your doctor or pharmacist.
Exercise special caution when using PULNOZIN blackcurrant-flavoured:

• in patients with bronchial asthma and a history of bronchospasm;
• in patients with severe respiratory insufficiency;
• in debilitated patients. Due to reduced cough reflex, there is a risk of airway obstruction resulting from increased secretions.

Administration of PULNOZIN blackcurrant-flavoured reduces the viscosity of mucus and facilitates its removal via ciliary activity of the epithelium or through the cough reflex. Therefore, increased coughing and sputum production should be expected. Concomitant use of PULNOZIN blackcurrant-flavoured with antitussive medicines is not recommended.
Since mucolytics may damage the gastric mucosa, caution should be exercised in patients with a predisposition to gastric or duodenal ulcers. Caution is also advised in elderly patients and in those taking other medications that may cause gastrointestinal bleeding.
Children and adolescents
PULNOZIN blackcurrant-flavoured is not recommended for use in children and adolescents under 12 years of age.
PULNOZIN blackcurrant-flavoured and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient intends to take.
During treatment with PULNOZIN blackcurrant-flavoured, antitussive medicines or drugs reducing bronchial mucus secretion should not be used.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor before using this medicine.
Use during pregnancy is not recommended, especially during the first trimester.
Use during breastfeeding is not recommended, as it is unknown whether carbocysteine passes into breast milk.
There are no data on negative effects of orally administered carbocysteine on fertility in humans.
Driving and operating machinery
PULNOZIN blackcurrant-flavoured has no effect on the ability to drive or operate machinery.
PULNOZIN blackcurrant-flavoured contains isomalt
One PULNOZIN blackcurrant-flavoured lozenge contains 679.10 mg of isomalt.
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine. Calorific value of isomalt is 2.3 kcal/g.
The medicine may have a mild laxative effect.

3. How to use PULNOZIN blackcurrant-flavoured

This medicine should always be used exactly as directed by a doctor or pharmacist.
In case of doubt, consult a doctor or pharmacist.
Medicine for oral mucosa use.
One lozenge contains 750 mg of carbocysteine.
Recommended dose
Adults and adolescents (aged 12 years and older)
Carbocysteine should be administered at a dose of 20–30 mg per kilogram of body weight per day, divided into 2 to 3 doses.
Initial dose: chew or suck 1 tablet three times daily.
If prolonged treatment is necessary, the daily dose should be reduced to 1.5 g, i.e. 1 tablet twice daily.
Do not take this medicine before going to sleep.
Use in children and adolescents
PULNOZIN blackcurrant-flavoured is not recommended for use in children and adolescents under 12 years of age.
Taking more PULNOZIN blackcurrant-flavoured than recommended
There is no information available on cases of carbocysteine overdose.
The most likely symptoms of overdose with PULNOZIN blackcurrant-flavoured may be gastrointestinal disturbances.
If more PULNOZIN blackcurrant-flavoured has been taken than recommended, consult a doctor or pharmacist immediately.
Missed dose of PULNOZIN blackcurrant-flavoured
Do not take a double dose to make up for a missed dose.
Take the next dose at the usual time.
In case of any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Uncommon (less frequent than in 1 out of 100 people):
Gastrointestinal disorders: nausea, vomiting, and diarrhoea.
Rare (less frequent than in 1 out of 1000 people):
Headache, dizziness, urinary incontinence, palpitations, dyspnoea, urticaria, and bronchospasm, rash.
Very rare (less frequent than in 1 out of 10,000 people):
Gastrointestinal bleeding.
The frequency of the following adverse reactions is unknown (cannot be estimated from the available data):
Abdominal pain, gastric erosions, discomfort in the abdominal cavity, skin allergic reactions, pruritus, urticaria, angioedema, Stevens-Johnson syndrome, erythema multiforme, hypothyroidism, palpitations, oedema, haemorrhoids, bronchorrhoea, muscle pain.
If any of these symptoms occur, you should consult a doctor who will recommend reducing the dose or discontinuing the medicine.
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, inform your doctor, pharmacist, or nurse.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store PULNOZIN blackcurrant-flavoured

Keep this medicine out of the 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 stated month.
No special storage conditions are required for this medicine.
Medicines must 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 package and other information

What Pulnozin with blackcurrant flavour contains

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

What Pulnozin with blackcurrant flavour looks like and contents of the pack
Pulnozin with blackcurrant flavour is a white, round, biconvex effervescent tablet with blackcurrant flavour.
Packaging:
PVC/PVDC/Aluminium blisters, in a cardboard carton.
Pulnozin with blackcurrant flavour is available in packages containing 10, 20, 30 or 40 effervescent tablets.
Not all pack sizes may be marketed.
Marketing Authorisation 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