Pulnozin muco lemon flavour

Package leaflet: Information for the user

PULNOZIN MUCO lemon 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, so 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, 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.

Leaflet contents

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

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

PULNOZIN MUCO lemon flavour contains an active substance called carbocisteine.
This substance belongs to a group of medicines known as "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 effect).
PULNOZIN MUCO lemon flavour is used for symptomatic 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. Important information before using PULNOZIN MUCO lemon-flavoured

When not to use PULNOZIN MUCO lemon-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 MUCO lemon-flavoured, consult your doctor or pharmacist.
Exercise special caution when using PULNOZIN MUCO lemon-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. PULNOZIN MUCO lemon-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 MUCO lemon-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 recommended in elderly patients and in those taking other medications that may cause gastrointestinal bleeding.
Children and adolescents
PULNOZIN MUCO lemon-flavoured is not recommended for use in children and adolescents under 12 years of age.
PULNOZIN MUCO lemon-flavoured and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
During treatment with PULNOZIN MUCO lemon-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 child, she should consult a doctor before using this medicine.
Use of this medicine during pregnancy is not recommended, especially during the first trimester.
It is unknown whether carbocysteine passes into breast milk. Use of this medicine during breastfeeding is not recommended.
There are no data available regarding the effect of carbocysteine on fertility.
Driving and operating machinery
PULNOZIN MUCO lemon-flavoured has no influence on the ability to drive or operate machinery.
PULNOZIN MUCO lemon-flavoured contains isomalt
One PULNOZIN MUCO lemon-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. The caloric value of isomalt is 2.3 kcal/g.
The medicine may have a mild laxative effect.

3. How to use PULNOZIN MUCO lemon-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 your doctor or pharmacist.
This medicine is for oral mucosa use.
Recommended dose
Adults and adolescents (aged 12 years and older)

• Initial dose: 1 lozenge 3 times daily.
• If symptoms improve, reduce the dose to 1 lozenge 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 and adolescents
PULNOZIN MUCO lemon-flavoured is not recommended for children and adolescents under 12 years of age.
Taking more than the recommended dose of PULNOZIN MUCO lemon-flavoured
There is no information on cases of carbocysteine overdose.
The most likely symptoms of overdose with PULNOZIN MUCO lemon-flavoured may be gastrointestinal disturbances.
If more than the recommended dose of PULNOZIN MUCO lemon-flavoured has been taken, seek immediate advice from a doctor or pharmacist. Take the medicine packaging with you. This will allow the doctor to see which medicine has been taken.
Missed dose of PULNOZIN MUCO 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 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 experiences them.
Uncommon adverse reactions (occur in fewer than 1 in 100 people):
Gastrointestinal disorders: nausea, vomiting, and diarrhoea.
Rare adverse reactions (occur in fewer than 1 in 1,000 people):
Headache, dizziness, urinary incontinence, palpitations, dyspnoea, urticaria, and bronchospasm, rash.
Very rare adverse reactions (occur in fewer than 1 in 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, itching, urticaria, angioedema (serious 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, bronchial mucus secretion, muscle pain.
If any of these symptoms occur, consult a doctor who will advise reducing the dose or discontinuing the medicine.
Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your 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 provide more information on the safety of the medicine.

5. How to store PULNOZIN MUCO 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 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.
Such measures will help protect the environment.

6. Contents of the pack and other information

What PULNOZIN MUCO lemon-flavoured contains

• The active substance is carbocysteine. Each pastille contains 750 mg of carbocysteine.
• The other ingredients are: isomalt, microcrystalline cellulose, low-substituted hydroxypropyl cellulose, sodium alginate, magnesium stearate, calcium phosphate, lemon flavour SD1820 [gum arabic, maltodextrin, triacetin], sucralose (E 955), mint flavour SD0627 [gum arabic, maltodextrin, propylene glycol 1,2]. What PULNOZIN MUCO lemon-flavoured looks like and contents of the pack
  PULNOZIN MUCO lemon-flavoured is white, round, biconvex pastilles with lemon flavour.

Pack presentation:
PVC/PVDC/Aluminium blisters in a cardboard box.
PULNOZIN MUCO lemon-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