PULNOZIN MUCO BLACKCURRANT FLAVOR

Package leaflet: Information for the user

PULNOZIN MUCO blackcurrant flavour, 750 mg, effervescent tablets for oral use
Carbocisteinum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
Always use this medicine exactly as described in this patient leaflet or as your doctor,
pharmacist, or nurse has advised.

• Keep this leaflet. You may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after 5 days, or if you feel worse, consult your doctor.

Contents of the leaflet

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

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

PULNOZIN MUCO blackcurrant flavour contains an active substance called carbocisteine. This substance belongs to a group of medicines known as "mucolytics" and works by reducing the viscosity of mucus (phlegm). As a result, mucus is more easily expelled from the respiratory tract during coughing (so-called mucolytic effect).

PULNOZIN MUCO blackcurrant flavour is used symptomatically in the treatment of respiratory diseases associated with excessive production of thick and sticky mucus in adults and adolescents aged 12 years and older.

If there is no improvement after 5 days, or if you feel worse, consult your doctor.

2. Information before using PULNOZIN MUCO blackcurrant flavour

When not to use PULNOZIN MUCO blackcurrant flavour:

• 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 to use PULNOZIN MUCO blackcurrant flavour, discuss this with a doctor or pharmacist.
Exercise particular caution when using PULNOZIN MUCO blackcurrant flavour:

• 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 caused by increased secretion.

Administration of PULNOZIN MUCO blackcurrant flavour reduces mucus viscosity and facilitates mucus elimination through ciliary activity of the epithelium or via the cough reflex. Therefore, increased coughing and sputum production may be expected. Concomitant use of PULNOZIN MUCO blackcurrant flavour with antitussive medicines is not recommended.
Since mucolytics may damage the gastric mucosa, caution should be exercised in patients with a tendency to develop gastric or duodenal ulcers. Caution is also advised in elderly patients and in those taking other medicines that may cause gastrointestinal bleeding.
Children and adolescents
PULNOZIN MUCO blackcurrant flavour is not recommended for use in children and adolescents under 12 years of age.
PULNOZIN MUCO blackcurrant flavour and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines planned for use.
During treatment with PULNOZIN MUCO blackcurrant flavour, do not use antitussive medicines or drugs that reduce bronchial mucus secretion.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor before using this medicine.
Use of this medicine is not recommended in pregnant women, especially during the first trimester.
It is unknown whether carbocysteine passes into breast milk. Use of this medicine is not recommended during breastfeeding.
There are no data on the effect of carbocysteine on fertility.
Driving and operating machinery
PULNOZIN MUCO blackcurrant flavour has no effect on the ability to drive or operate machinery.
PULNOZIN MUCO blackcurrant flavour contains isomalt
One PULNOZIN MUCO blackcurrant flavour 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: 2.3 kcal/g of isomalt. The medicine may have a mild laxative effect.

3. How to use PULNOZIN MUCO blackcurrant flavoured

This medicine should always be used exactly as described in this patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
This medicine is for oral mucosal use.
Recommended dose
Adults and adolescents (aged 12 years and older)

• Initial dose: 1 lozenge three times daily.
• If symptoms improve, reduce the dose to 1 lozenge twice daily.

Do not use the medicine before going to sleep.
Medicines containing carbocysteine should not be used for longer than 5 days without consulting a doctor.
Use in children and adolescents
PULNOZIN MUCO blackcurrant flavoured is not recommended for use in children and adolescents under 12 years of age.
Taking more PULNOZIN MUCO blackcurrant flavoured than recommended
There is no information available on cases of carbocysteine overdose.
The most likely symptoms of overdose with PULNOZIN MUCO blackcurrant flavoured are gastrointestinal disturbances.
If more PULNOZIN MUCO blackcurrant flavoured has been taken than recommended, seek immediate advice from a doctor or pharmacist. Take the medicine package with you. This will allow the doctor to identify which medicine has been taken.
Missed dose of PULNOZIN MUCO blackcurrant flavoured
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 doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.

Uncommon adverse reactions (less frequent than in 1 out of 100 people):
Gastrointestinal disorders: nausea, vomiting, and diarrhoea.

Rare adverse reactions (less frequent than in 1 out of 1,000 people):
Headache, dizziness, urinary incontinence, palpitations, dyspnoea, urticaria and bronchospasm, rash.

Very rare adverse reactions (less frequent than in 1 out of 10,000 people):
Gastrointestinal bleeding.

Frequency of the following adverse reactions is unknown (cannot be estimated from available data):
Abdominal pain, gastric erosions, abdominal discomfort, skin allergic reactions, pruritus, urticaria, angioedema (a severe allergic reaction causing swelling of the face or throat), Stevens-Johnson syndrome, erythema multiforme (serious reactions affecting the skin and mucous membranes), hypothyroidism, palpitations, oedema, haemorrhoids, bronchorrhoea, muscle pain.

If any of these symptoms occur, consult a doctor, who may recommend reducing the dose or discontinuing the medicine.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions 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 at 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 directly to the marketing authorization holder.
By reporting adverse reactions, additional information on the safety of this medicine can be collected.

5. How to store PULNOZIN MUCO blackcurrant flavour

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 instructions apply 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. Package contents and other information

What PULNOZIN MUCO blackcurrant flavour contains

• The active substance is carbocysteine. Each pastille contains 750 mg of carbocysteine.
• Other ingredients are: isomalt, microcrystalline cellulose, hydroxypropylcellulose, low-substituted, sodium alginate, magnesium stearate, calcium phosphate, blackcurrant flavour 502009 AP0560 [corn maltodextrin, glyceryl triacetate (E1518), triethyl citrate (E1505), flavouring substances], sucralose (E955), mint flavour SD0627 [natural peppermint oil, natural green mint oil, menthol, maltodextrin, gum arabic (E414), propylene glycol (E1520)].

What PULNOZIN MUCO blackcurrant flavour looks like and contents of the pack
PULNOZIN MUCO blackcurrant flavour is white, round, biconvex pastilles with blackcurrant flavour.

Packaging:
PVC/PVDC/Aluminium blisters in a cardboard box.
PULNOZIN MUCO blackcurrant flavour is available in packs containing 10, 20, 30 or 40 pastilles.
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 of the marketing authorisation holder}

Manufacturer:
Mako Pharma Sp. z o.o.
ul. Kolejowa 231A
05-092 Dziekanów Polski
Medicofarma S.A.
ul. Tarnobrzeska 13
26-613 Radom