Auropect

Package Leaflet: Information for the User

Auropect, 50 mg/mL, Syrup

Carbocisteine

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

This medicine should always be used exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist.

• Keep this package leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in this package leaflet, they should tell their doctor or pharmacist. See section 4.
• If after 4 to 5 days there is no improvement or the patient feels worse, they should contact their doctor.

Table of Contents of the Package Leaflet:

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

1. What is Auropect and what is it used for

Auropect syrup contains carbocisteine, which affects the secretion 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 there is no improvement or the patient feels worse, they should consult their doctor.

2. Important information before using Auropect

When not to use Auropect

• 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 starting treatment with Auropect, the patient should discuss it with their doctor or pharmacist if:

• the patient has a history of gastric 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. Treatment of patients with bronchial asthma should be carried out under close medical supervision due to the risk of bronchospasm. If this symptom occurs, the administration of the medicine should be stopped immediately. The medicine should not be taken before bedtime.

Children

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

Auropect and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. Carbocisteine should not be used simultaneously with cough suppressants and expectorant medicines.

Auropect with food and drink

Auropect syrup should be taken after meals.

Pregnancy, breastfeeding, and fertility

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

Driving and using machines

Auropect has no effect on the ability to drive vehicles or operate machinery.

Auropect contains methyl parahydroxybenzoate (E 218)

The medicine contains 1.5 mg of methyl parahydroxybenzoate in 1 mL of syrup. The medicine may cause allergic reactions (possible late reactions) and, exceptionally, bronchospasm.

Auropect contains sucrose

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine. The medicine contains 0.5775 g of sucrose in 1 mL of syrup, which corresponds to 25.99 g of sucrose in the maximum recommended daily dose of the medicine (45 mL). This should be taken into account in patients with diabetes.

Auropect contains propylene glycol

The medicine contains 0.057 mg of propylene glycol in each mL of syrup, which corresponds to 0.285 mg of propylene glycol in 5 mL of syrup.

Auropect contains sodium

The medicine contains between 11.3 mg and 11.666 mg of sodium (the main component of common salt) in 1 mL of syrup, which corresponds to between 0.565% and 0.5833% of the maximum daily dose of sodium recommended by the WHO for adults. The maximum recommended daily dose of this medicine contains 524.97 mg of sodium, which corresponds to 26.25% of the maximum recommended daily dose of sodium in the diet for adults.

3. How to use Auropect

This medicine should always be used exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist. The medicine is administered orally. The appropriate volume of syrup should be measured using the measuring spoon provided with the medicine packaging. The medicine is usually used as follows: Adults and adolescents over 12 years of age:Initially, a dose of 750 mg (15 mL of syrup) should be used 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 used for more than 4 to 5 days. The medicine should not be taken before bedtime.

Overdose of Auropect

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

Missed dose of Auropect

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

Stopping treatment with Auropect

In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

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

Reporting side effects

If side effects occur, including any possible side effects not listed in this package leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring 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, more information can be collected on the safety of the medicine.

5. How to store Auropect

The medicine should be stored out of sight and reach of children. Store in a temperature below 25°C. 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. Shelf life after first opening the package: 3 months. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Auropect contains

• The active substance of the medicine is carbocisteine. 5 mL of syrup contains 250 mg of carbocisteine. 1 mL of syrup contains 50 mg of carbocisteine.
• The other ingredients of the medicine are: methyl parahydroxybenzoate (E 218), caramel (E 150d), sucrose, blackcurrant flavor (propylene glycol, ethyl formate, isopentyl acetate, 4-(4-hydroxyphenyl)butan-2-one, 3-methylbutan-1-ol, blackcurrant bud extract (Ribes nigrum), acetic acid, 4-(2,6,6-trimethylcyclohex-1-en-1-yl)but-3-en-2-one), sodium hydroxide, purified water.

What Auropect looks like and contents of the pack

A 200 mL glass bottle with an HDPE cap and LDPE seal in a cardboard box. The bottle contains a clear, amber-colored syrup with a blackcurrant flavor and sweet taste. A measuring spoon (5 mL) is provided with the packaging, allowing the measurement of volumes of 1.25 mL, 2.5 mL, 3.75 mL, and 5 mL.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Aurovitas Pharma Polska Sp. z o.o. ul. Sokratesa 13D lokal 27 01-909 Warsaw e-mail: [email protected]

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 package leaflet: