Pulnozin muco junior with raspberry flavor

Package leaflet: Information for the user

PULNOZIN MUCO Junior raspberry-flavoured, 250 mg, effervescent tablets for oral administration
Carbocisteinum
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed by your
doctor, pharmacist, or nurse.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any side effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after 5 days of treatment, or if you feel worse, consult your doctor.

Leaflet contents

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

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

PULNOZIN MUCO Junior raspberry-flavoured 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, the mucus becomes easier to remove from the respiratory tract during coughing (so-called mucolytic action).

PULNOZIN MUCO Junior raspberry-flavoured is indicated for symptomatic treatment of respiratory diseases associated with excessive production of thick and sticky mucus in adults, adolescents, and children aged 6 years and older.
If there is no improvement after 5 days of treatment, or if you feel worse, consult your doctor.

2. Important information before using PULNOZIN MUCO Junior raspberry-flavoured

When not to use PULNOZIN MUCO 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 peptic ulcer disease of the stomach or duodenum.

Warnings and precautions
Before starting treatment with PULNOZIN MUCO Junior raspberry-flavoured,
discuss this with a doctor or pharmacist.
Exercise particular caution when using PULNOZIN MUCO 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 resulting from increased secretion.

Administration of PULNOZIN MUCO 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 sputum production may be expected. Concomitant use of PULNOZIN MUCO Junior raspberry-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
This medicine is not recommended for children under 6 years of age.

PULNOZIN MUCO Junior raspberry-flavoured and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently taken, or planned to be used by the patient.
During treatment with PULNOZIN MUCO Junior raspberry-flavoured, do not use antitussive medicines or agents 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 become pregnant, 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 the medicine is not recommended during breastfeeding.
There are no data regarding the effect of carbocysteine on fertility.

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

PULNOZIN MUCO Junior raspberry-flavoured contains isomalt
One PULNOZIN MUCO 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. The caloric value of isomalt is 2.3 kcal/g. The medicine may have a mild laxative effect.

3. How to use PULNOZIN MUCO Junior raspberry-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 is 3 lozenges to be sucked, taken 3 times daily.
• If symptoms improve, reduce the dose to 3 lozenges to be sucked, taken 2 times 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 (aged 6 to 11 years)
Chew or suck 1 tablet 3 times daily.
PULNOZIN MUCO Junior raspberry-flavoured is not recommended for children under 6 years of age.
If you take more PULNOZIN MUCO Junior raspberry-flavoured than you should
There is no information on cases of carbocysteine overdose.
The most likely symptoms of overdose with PULNOZIN MUCO Junior raspberry-flavoured may be gastrointestinal disturbances.
If you take more than the recommended dose of PULNOZIN MUCO Junior raspberry-flavoured, seek immediate medical advice from a doctor or pharmacist. Take the medicine packaging with you. This will allow the doctor to see which medicine has been taken.
If you forget to take PULNOZIN MUCO Junior raspberry-flavoured
Do not take a double dose to make up for a forgotten dose.
Take the next dose at the usual time.
If you have any further questions 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 the 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 (severe reactions affecting the skin and mucous membranes), hypothyroidism, palpitations, oedema, haemorrhoids, bronchial mucus secretion, muscle pain.
If any of these symptoms occur, medical advice should be sought; the doctor 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 a doctor, pharmacist, or nurse.
Adverse reactions can be reported directly to the Department of Monitoring of 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 to the marketing authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store PULNOZIN MUCO 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 instructions apply.
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 the medicine PULNOZIN MUCO Junior raspberry-flavoured contains

• The active substance is carbocysteine. Each pastille contains 250 mg of carbocysteine.
• The other ingredients are: isomalt, microcrystalline cellulose, low-substituted hydroxypropylcellulose, sodium alginate, magnesium stearate, calcium phosphate, raspberry flavour 052383 AP0551 [corn maltodextrin, glyceryl triacetate], sucralose (E955).

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