Pulnozin with lemon flavour

Patient Information Leaflet

PULNOZIN lemon-flavoured, 750 mg, effervescent tablets
Carbocisteinum
Please read all of this leaflet carefully before taking this medicine, as it contains
important information for you.
This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, consult your doctor or pharmacist.
• If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents

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

1. What PULNOZIN lemon-flavoured is and what it is used for

The active substance in PULNOZIN lemon-flavoured 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 is more easily expelled from the respiratory tract during coughing (so-called mucolytic action).
PULNOZIN lemon-flavoured is used in the symptomatic treatment of respiratory diseases associated with excessive production of thick and sticky mucus.

2. Important information before using the medicine PULNOZIN lemon flavour

When not to use PULNOZIN lemon 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 treatment with PULNOZIN lemon flavour, discuss this with your
doctor or pharmacist.
Exercise particular caution when using PULNOZIN lemon 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 resulting from increased secretion volume.

Administration of PULNOZIN lemon flavour reduces the viscosity of mucus and facilitates its removal
through ciliary activity of the epithelium or via the cough reflex. Therefore, increased coughing and sputum production may be expected.
Concomitant use of PULNOZIN lemon flavour with antitussive medicines is not recommended.
Since mucolytics may damage the gastric mucosa, caution is advised 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 lemon flavour is not recommended for use in children and adolescents under 12 years of age.

PULNOZIN lemon flavour and other medicines
Inform your doctor or pharmacist about all medicines currently used or recently used, as well as any medicines planned for future use.
During treatment with PULNOZIN lemon flavour, do not use antitussive medicines or drugs that reduce bronchial mucus secretion.

Pregnancy, breastfeeding and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor before using this medicine.
Use in pregnancy is not recommended, especially during the first trimester, even though carbocysteine has not been shown to have teratogenic effects.
Use during breastfeeding is not recommended, as it is unknown whether carbocysteine passes into breast milk.
There are no data indicating a negative effect of orally administered carbocysteine on fertility in humans.

Driving and operating machinery
PULNOZIN lemon flavour has no influence on the ability to drive or operate machinery.

PULNOZIN lemon flavour contains isomalt
One PULNOZIN lemon flavour lozenge contains 679.10 mg of isomalt. If the patient has previously been diagnosed with intolerance to certain sugars, he or she should consult a doctor before taking this medicine. The caloric value of isomalt is 2.6 kcal/g.
The medicine may have a mild laxative effect.

3. How to use PULNOZIN lemon-flavoured

This medicine should always be used exactly as recommended by a doctor or pharmacist.
In case of doubt, consult a doctor or pharmacist.
This medicine is for oral mucosal use.
One tablet 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 – 3 doses.
Chew or suck one tablet three times a day.
If prolonged treatment is necessary, the daily dose should be reduced to 1.5 g, i.e. one tablet twice daily.
Do not use the medicine before going to sleep.
Use in children and adolescents
PULNOZIN lemon-flavoured is not recommended for use in children and adolescents under 12 years of age.
Taking more PULNOZIN lemon-flavoured than recommended
There is no information on cases of carbocysteine overdose.
The most likely symptoms of overdose with PULNOZIN lemon-flavoured may be gastrointestinal disturbances.
If more PULNOZIN lemon-flavoured has been taken than recommended, consult a doctor or pharmacist immediately.
Missed dose of PULNOZIN lemon-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 concerning the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, 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 1,000 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.
Frequency of the following adverse effects is unknown (cannot be estimated from available data):
Abdominal pain, gastric erosions, abdominal discomfort, skin allergic reactions, pruritus, urticaria, angioedema, Stevens-Johnson syndrome, erythema multiforme, 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 effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse.
Adverse effects 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.: +48 22 49-21-301
Fax: +48 22 49-21-309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store PULNOZIN lemon-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.
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 lemon-flavoured contains

• The active substance is carbocysteine. Each effervescent tablet contains 750 mg of carbocysteine.
• Other ingredients are: isomalt, microcrystalline cellulose, low-substituted hydroxypropyl cellulose, sodium alginate, magnesium stearate, calcium phosphate, lemon flavour, sucralose E955, mint flavour.

What PULNOZIN lemon-flavoured looks like and contents of the pack
PULNOZIN lemon-flavoured is a white, round, biconvex effervescent tablet with lemon flavour.
Packaging:
PVC/PVDC/Aluminium blisters in a cardboard box.
PULNOZIN lemon-flavoured is available in packs containing 10, 20, 30 or 40 effervescent tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Solinea Sp. z o.o.
Elizówka, Szafranowa 6
21-003 Ciecierzyn
tel.: +48 81 463 48 82
[logo Solinea]
Manufacturer:
Mako Pharma Sp. z o.o.
Kolejowa 231A
05-092 Dziekanów Polski
Medicofarma S.A.
Tarnobrzeska 13
26-613 Radom