Pulnozin junior with raspberry flavor

Package leaflet: Information for the user

PULNOZIN Junior raspberry-flavoured, 250 mg, effervescent tablets
Carbocisteinum
Please read all of this leaflet carefully before taking this medicine because 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 further questions, please consult your doctor or pharmacist.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

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

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

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

2. Important information before using PULNOZIN Junior raspberry-flavoured

When not to use PULNOZIN Junior raspberry-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 Junior raspberry-flavoured, consult a doctor or pharmacist.

Exercise particular caution when using PULNOZIN Junior raspberry-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 caused by increased secretions.

Treatment with PULNOZIN Junior raspberry-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 expectoration may be expected. Concomitant use of PULNOZIN Junior raspberry-flavoured with antitussive medicines is not recommended.

Since mucolytics may damage the gastric mucosa, caution is advised in patients prone to 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

This medicine is not recommended for use in children under 6 years of age.

PULNOZIN Junior raspberry-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 plans to take.

During treatment with PULNOZIN Junior raspberry-flavoured, 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 baby, she should consult a doctor before using this medicine.

Use during pregnancy is not recommended, especially during the first trimester, even though no teratogenic effects of carbocysteine have been demonstrated.

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 human fertility.

Driving and operating machinery

PULNOZIN Junior raspberry-flavoured has no influence on the ability to drive or operate machinery.

PULNOZIN Junior raspberry-flavoured contains isomalt

One PULNOZIN Junior raspberry-flavoured lozenge contains 225.90 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: 2.6 kcal/g of isomalt.

The medicine may have a mild laxative effect.

3. How to use PULNOZIN Junior raspberry-flavoured

This medicine should always be used as directed by a doctor or pharmacist. If in
doubt, consult a doctor or pharmacist.
This medicine is for oral mucosa use.
One tablet contains 250 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 3 tablets three times daily.
If prolonged treatment is necessary, the daily dose should be reduced to 1.5 g, i.e. 3 tablets twice daily.
Use in children (aged 6 to 11 years)
Chew or suck 1 tablet three times daily.
Do not use the medicine before going to sleep.
Taking more PULNOZIN Junior raspberry-flavoured than recommended
There is no information available on cases of carbocysteine overdose.
The most likely symptoms of overdose with PULNOZIN Junior raspberry-flavoured may be gastrointestinal disturbances.
If more PULNOZIN Junior raspberry-flavoured has been taken than recommended, consult a doctor or pharmacist immediately.
Missed dose of PULNOZIN Junior raspberry-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 your doctor or pharmacist.

4. Possible adverse effects

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

Not common (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, bronchial mucus secretion, 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 adverse effects not listed in this leaflet, inform a 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
Phone: 22 49-21-301
Fax: 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 Junior raspberry-flavoured

Keep this medicine out of 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 required.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What PULNOZIN Junior raspberry-flavoured contains

• The active substance is carbocysteine. Each effervescent tablet contains 250 mg of carbocysteine.
• Other ingredients are: isomalt, microcrystalline cellulose, hydroxypropylcellulose, low-substituted, sodium alginate, magnesium stearate, calcium phosphate, raspberry flavour, sucralose E955.

What PULNOZIN Junior raspberry-flavoured looks like and contents of the pack
PULNOZIN Junior raspberry-flavoured is a white, round, flat effervescent tablet with bevelled edges.
Packaging:
PVC/PVDC/Aluminium blisters, in a cardboard box.
PULNOZIN Junior raspberry-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, 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