Mukolina

Package Leaflet: Information for the User

MUKOLINA, 50 mg/ml, Syrup

Carbocisteinum

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in the package leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or further information, consult a pharmacist.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If after 4 to 5 days of treatment there is no improvement or the patient feels worse, consult a doctor.

Table of Contents of the Leaflet:

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

1. What is Mukolina and what is it used for

Mukolina syrup contains carbocisteine, which affects the secretions of the respiratory tract. The medicine reduces the viscosity of bronchial secretions, making them more fluid (mucolytic action), which facilitates expectoration and reduces the frequency of coughing attacks. This medicine is used for the symptomatic treatment of respiratory system diseases characterized by excessive production of thick and viscous secretions. If after 4 to 5 days of treatment there is no improvement or the patient feels worse, consult a doctor.

2. Important information before taking Mukolina

When not to take Mukolina

• if the patient is allergic to carbocisteine or any of the other ingredients of this medicine (listed in section 6),
• if the patient has active gastric or duodenal ulcer disease,
• in asthmatic status,
• in children under 6 years of age.

Warnings and precautions

Before taking Mukolina, discuss with your doctor or pharmacist if:

• the patient has a history of ulcer disease, as mucolytic agents may damage the gastric mucosa.

In case of abundant purulent secretions and fever, as well as in case of chronic bronchitis or lung disease and in patients with reduced ability to expectorate, a doctor's visit is necessary, who may prescribe other medicines. The treatment of patients with bronchial asthma should be carried out under close medical supervision due to the possibility of bronchospasm. If this symptom occurs, the administration of the medicine should be stopped immediately. Do not take the medicine before bedtime.

Children

Mukolina is not intended for use in children under 6 years of age.

Mukolina and other medicines

Tell your doctor or pharmacist about all medicines the patient is taking or has recently taken, as well as medicines the patient plans to take. Do not take carbocisteine simultaneously with cough suppressants and medicines that inhibit mucus secretion.

Mukolina with food and drink

Mukolina syrup should be taken after meals.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before taking this medicine. The use of the medicine during pregnancy is not recommended. It is not known whether carbocisteine passes into breast milk, therefore, the use of the medicine during breastfeeding is not recommended. There are no data on the effect of carbocisteine on fertility.

Driving and using machines

The medicine does not affect the ability to drive vehicles or operate machinery.

Mukolina contains methyl parahydroxybenzoate

The medicine may cause allergic reactions (possible late reactions) and exceptionally bronchospasm.

Mukolina contains sorbitol

The medicine contains 2.5 g of sorbitol in 5 ml of syrup, which corresponds to 22.5 g of sorbitol in the maximum recommended daily dose of the medicine (45 ml). Sorbitol may cause gastrointestinal discomfort and may have a mild laxative effect. The energy value is 2.6 kcal/g of sorbitol. Sorbitol is a source of fructose. If the patient (or their child) has previously been diagnosed with intolerance to some sugars or has been diagnosed with hereditary fructose intolerance, a rare genetic disease in which the patient's body does not break down fructose, the patient should consult a doctor before taking the medicine or giving it to their child.

Mukolina contains sodium

The medicine contains 32.07 mg of sodium (the main component of common salt) in 5 ml of syrup. The maximum recommended daily dose of this medicine contains 288.7 mg of sodium. This corresponds to 14.4% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to take Mukolina

This medicine should always be taken exactly as described in the package leaflet or as directed by a doctor or pharmacist. In case of doubt, consult a doctor or pharmacist. The medicine is taken orally. The appropriate volume of syrup should be measured using the measuring spoon provided with the medicine packaging. The medicine is usually taken as follows: Adults and adolescents over 12 years of age:Initially, a dose of 750 mg (15 ml of syrup) should be taken 3 times a day, and then, after achieving a beneficial effect (thinning of secretions, facilitation of expectoration), the dose should be reduced to 500 mg (10 ml of syrup) 3 times a day. Children from 6 to 12 years of age:250 mg (5 ml of syrup) 3 times a day. In children and adolescents, the daily dose of carbocisteine should not exceed 30 mg/kg of body weight. It is recommended that the child drink water after taking the dose. Elderly patients:The dosing recommended for adult patients should be used. Without a doctor's recommendation, the medicine should not be taken for more than 4 to 5 days. It is not recommended to take the medicine before bedtime.

Overdose of Mukolina

There are no reports of carbocisteine overdose cases. The most likely symptoms of overdose may be gastrointestinal disorders. In case of overdose, the doctor may perform gastric lavage and monitor the patient. If a higher dose of the medicine than recommended is taken, consult a doctor or pharmacist immediately.

Missed dose of Mukolina

A missed dose should be taken as soon as possible. Do not take a double dose to make up for a missed dose.

Stopping treatment with Mukolina

In case of any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Gastrointestinal disorders: Rarely (in less than 1 in 1000 people, but more than 1 in 10,000 people): nausea, diarrhea, Very rarely (in less than 1 in 10,000 people): gastrointestinal bleeding, stomach disorders, abdominal pain. Nervous system disorders: Single cases: headaches. Immune system disorders: In sensitive patients, inflammation of the mucous membrane of the mouth and nose may occur. Skin and subcutaneous tissue disorders: Very rarely (in less than 1 in 10,000 people): allergic reactions (skin rash, itching, urticaria). Frequency not known (frequency cannot be estimated from the available data): single cases of blistering skin reactions such as Stevens-Johnson syndrome have been reported.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of 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 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 Mukolina

Keep the medicine out of the sight and reach of children. Store in a temperature below 25°C, protected from light. Do not use this medicine after the expiry date stated on the carton and label. The expiry date refers to the last day of the month stated. Shelf life after first opening the package: 28 days. 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 Mukolina contains

• The active substance is carbocisteine. 5 ml of syrup contains 250 mg of carbocisteine.
• The other ingredients are: liquid crystallizing sorbitol 70% (E 420), glycerol (E 422), sodium hydroxide (E 524), methyl parahydroxybenzoate (E 218), powdered caramel, banana flavor, purified water.

What Mukolina looks like and contents of the pack

Bottle containing 120 ml or 200 ml of syrup. The bottle is made of brown glass, closed with an aluminum cap with a guarantee ring or a polypropylene cap with a foam seal and a polyethylene guarantee ring, in a cardboard box. A measuring spoon with a 2.5 ml and 5 ml scale is attached to the packaging.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Teva Pharmaceuticals Polska Sp. z o.o. ul. Emilii Plater 53 00-113 Warsaw tel.: (22) 345 93 00

Manufacturer:

Teva Operations Poland Sp. z o.o. ul. Mogilska 80 31-546 Kraków Date of last revision of the leaflet: