Pulnozin

Package Leaflet: Information for the Patient

Pulnozin, 50 mg/ml, Syrup

Carbocisteine

Read the Leaflet Carefully Before Using the Medication, as it Contains Important Information for the Patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Pulnozin and what is it used for
• 2. Important information before using Pulnozin
• 3. How to use Pulnozin
• 4. Possible side effects
• 5. How to store Pulnozin
• 6. Contents of the pack and other information

1. What is Pulnozin and what is it used for

Pulnozin, 50 mg/ml, syrup (hereinafter referred to as Pulnozin in this leaflet) contains the substance called carbocisteine. It belongs to a group of medicines called "mucolytics" used in the treatment of respiratory tract infections with excessive mucus production in the bronchi. It works by reducing the viscosity of mucus, making it easier to cough up. Pulnozin is used to treat respiratory system diseases with excessive production of thick and viscous mucus.

2. Important information before using Pulnozin

When not to use Pulnozin:

• if you are allergic to carbocisteine or any of the other ingredients of this medicine (listed in section 6);
• if you have active stomach or duodenal ulcer.

Warnings and precautions

Before starting to use Pulnozin, discuss it with your doctor or pharmacist. Be particularly careful when using Pulnozin:

• in patients with bronchial asthma with a history of bronchospasm;
• in patients with severe respiratory failure;
• in weakened patients. By reducing the cough reflex, there is a risk of respiratory tract obstruction due to increased secretions.

Using Pulnozin causes a decrease in mucus viscosity and removal of mucus through ciliary activity of the epithelium or through a cough reflex. Therefore, you should expect increased coughing and sputum production. Concurrent use of Pulnozin with anti-cough medications is not recommended. Since mucolytics can damage the gastric mucosa, caution should be exercised in people with a tendency to stomach and duodenal ulcers. Caution should be exercised in elderly patients and those using other medications that may cause gastrointestinal bleeding.

Children and adolescents

Do not use in children under 2 years of age.

Pulnozin and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, or have recently taken, and about the medicines you plan to take. When using Pulnozin, do not use anti-cough medications or medications that reduce bronchial mucus secretion, as they have opposite effects to carbocisteine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. Pregnancy: The use of Pulnozin is not recommended in pregnant women, especially during the first trimester, even though no teratogenic effect of carbocisteine has been demonstrated. Breastfeeding: The use of Pulnozin is not recommended during breastfeeding, as it is not known whether carbocisteine passes into breast milk.

Driving and using machines

The medicine has no or negligible influence on the ability to drive and use machines.

Pulnozin contains sucrose, sodium, and methyl parahydroxybenzoate

Pulnozin contains 2.9 g of sucrose per 5 ml dose, and 5.8 g and 8.7 g per 10 ml and 15 ml doses, respectively. This should be taken into account in patients with diabetes. If you have previously been diagnosed with intolerance to some sugars, you should consult your doctor before taking the medicine. The medicine contains methyl parahydroxybenzoate, which may cause allergic reactions (possible late reactions). The medicine contains up to 7 mg of sodium per 1 ml, which corresponds to 0.35% of the recommended daily sodium intake in the diet for adults.

3. How to use Pulnozin

Always use this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist. Regardless of whether the medicine is used in an adult or a child, the appropriate volume of syrup should be measured using the enclosed dosing device (oral syringe with a capacity of 5 ml) according to the general dosage. The oral syringe is scaled to 0.25 ml. One scale mark, 0.25 ml, corresponds to 12.5 mg of carbocisteine. How to use the syringe: Step 1: Check the marking on the side of the syringe to see how much to fill it with. Step 2: Press the syringe plunger all the way down. Then insert the end of the syringe into the bottle with the medicine. Step 3: Slowly pull the plunger until the syringe is filled to the correct mark. Make sure there are no large air bubbles in the syringe. If there are, empty the syringe and try again. Step 4: Place the end of the syringe in the mouth, against the cheek, and gently press the plunger to slowly release the medicine. After use, close the bottle with the cap. Rinse the syringe with warm water and let it dry. Store it out of the reach of children.

Use in adults

The usual daily dose for adults is 2250 mg in divided doses (15 ml of syrup, 3 times a day). After the mucolytic effect occurs (thinning of secretions), the dose can be reduced to 1500 mg per day (10 ml of syrup, 3 times a day).

Use in children and adolescents

Do not use in children under 2 years of age. From 2 to 5 years: 125 mg - 250 mg (2.5 ml to 5 ml of syrup) 2 times a day. From 6 to 12 years: 250 mg (5 ml of syrup) 3 times a day. After using the syrup, close the bottle tightly.

Using a higher dose of Pulnozin than recommended

In case of stomach pain, nausea, and vomiting, stop using Pulnozin and consult your doctor. If you have taken more than the recommended dose of Pulnozin, contact your doctor or pharmacist immediately.

Missing a dose of Pulnozin

Do not take a double dose to make up for a forgotten dose. If you miss a dose, take it as soon as possible. However, if it is close to the time for the next dose, skip the missed dose and take the next dose at the usual time. Then continue with your regular dosing schedule.

Stopping the use of Pulnozin

This does not apply. If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Pulnozin can cause side effects, although not everybody gets them. Uncommon (less than 1 in 100 people): Gastrointestinal disorders: nausea, vomiting, and diarrhea. Rare (less than 1 in 1000 people): Hypersensitivity reactions, such as hives and bronchospasm. Particular attention should be paid to patients with asthma due to the risk of bronchial constriction (bronchial muscle spasm leading to reduced airflow). In such cases, treatment should be discontinued. Headache, muscle pain, dizziness, urinary incontinence, palpitations, and shortness of breath. Very rare (less than 1 in 10,000 people): Allergic reactions, such as skin rash, gastrointestinal bleeding. Frequency not known (frequency cannot be estimated from the available data): Hypothyroidism, abdominal discomfort, muscle pain, bronchial secretion, Stevens-Johnson syndrome (blisters turning into ulcers on the mucous membranes of the mouth, eyes, genitals), erythema multiforme. Particular attention should be paid to patients with thyroid function disorders due to the risk of hypothyroidism.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products of 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 Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Pulnozin

Keep this medicine out of the sight and reach of children. Do not store above 25°C. Do not use this medicine after the expiry date which is stated on the packaging after "EXP:". The expiry date refers to the last day of that month. Shelf life after first opening the package: 3 months. If the syrup appears discolored or shows any other signs of deterioration, consult your pharmacist. 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 contains

• The active substance is carbocisteine. 5 ml of syrup contains 250 mg of carbocisteine.
• The other ingredients are: sucrose, caramel (E150), blackcurrant flavor Aroma grosella 63.2334, sodium hydroxide (to adjust pH), methyl parahydroxybenzoate (E218), purified water.

What Pulnozin looks like and contents of the pack

Pulnozin syrup is a clear amber liquid with a blackcurrant odor and sweet taste. Packaging: a bottle containing 200 ml or 300 ml of syrup, with an enclosed oral syringe (oral syringe with a capacity of 5 ml, scaled to 0.25 ml).

Marketing authorization holder and manufacturer

Marketing authorization holder Solinea Sp. z o.o. Elizówka, ul. Szafranowa 6 21-003 Ciecierzyn Poland Manufacturer: Laboratórios Basi - Indústria Farmacêutica, S.A Parque Industrial Manuel Lourenço Ferreira, Lotes 8, 15 e 16 3450-232 Mortágua PORTUGAL. Date of last revision of the leaflet:07.2023