Package leaflet: Information for the user

Auropect, 50 mg/mL, syrup
Carbocisteinum
Please read the entire 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 patient leaflet or according to the instructions provided by the doctor or pharmacist.

Keep this leaflet for future reference.
If advice or further information is needed, consult a pharmacist.
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 4 to 5 days, or if the patient feels worse, consult a doctor.

Table of contents:

What Auropect is and what it is used for
Important information before using Auropect
How to use Auropect
Possible side effects
How to store Auropect
Contents of the pack and other information

1. What Auropect is and what it is used for

Auropect syrup contains carbocisteine, which acts on respiratory tract secretions. The medicine reduces the viscosity of bronchial mucus, making it more fluid (mucolytic action), thus facilitating expectoration and reducing the frequency of coughing episodes.
This medicine is used for the symptomatic treatment of respiratory diseases associated with excessive production of thick and sticky mucus.
If there is no improvement after 4 to 5 days, or if the patient feels worse, consult a doctor.

2. Important information before using Auropect

When not to use Auropect

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

Warnings and precautions
Before starting treatment with Auropect, consult a doctor or pharmacist if:

the patient has previously suffered from peptic ulcer disease, as mucolytic agents may damage the gastric mucosa.

In case of abundant purulent sputum and fever, as well as in chronic bronchial or pulmonary disease and in patients with reduced ability to expectorate, a visit to a doctor is necessary, who may recommend additional treatment.
Treatment of patients with bronchial asthma should be conducted under strict medical supervision due to the risk of bronchospasm. If this symptom occurs, administration of the drug must be stopped immediately.
Do not take the medicine before going to sleep.

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

Auropect and other medicines
Inform your doctor or pharmacist about all medicines currently used or recently used, as well as any medicines you plan to use.
Do not take carbocysteine simultaneously with antitussive drugs or drugs that suppress mucus secretion.

Auropect with food and drink
Auropect syrup should be taken after meals.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or plans to become pregnant, she should consult a doctor or pharmacist before using this medicine.
The use of this medicine during pregnancy is not recommended.
It is unknown whether carbocysteine passes into breast milk; therefore, use of the medicine during breastfeeding is not recommended.
There is no data available regarding the effect of carbocysteine on fertility.

Driving and operating machinery
Auropect has no influence on the ability to drive or operate machinery.

Auropect contains methyl parahydroxybenzoate (E 218)
The medicine contains 1.5 mg of methyl parahydroxybenzoate per 1 mL of syrup. This may cause allergic reactions (including delayed-type reactions) and exceptionally bronchospasm.

Auropect contains sucrose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
The medicine contains 0.5775 g of sucrose per 1 mL of syrup, equivalent to 25.99 g of sucrose in the maximum recommended daily dose (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, equivalent to 0.285 mg of propylene glycol in 5 mL of syrup.

Auropect contains sodium
The medicine contains 11.3 mg to 11.666 mg of sodium (main component of table salt) per 1 mL of syrup, corresponding to 0.565% to 0.5833% of the WHO recommended maximum daily sodium intake of 2 g for adults.
The maximum recommended daily dose of this medicine contains 524.97 mg of sodium. This corresponds to 26.25% of the maximum recommended daily dietary sodium intake for adults.

3. How to use Auropect

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 use. The correct volume of syrup should be measured using the dosing spoon provided with the medicine pack.
The usual dosage is as follows:
Adults and adolescents over 12 years of age:
Initially, a dose of 750 mg (15 mL of syrup) should be taken three times daily. After achieving the desired therapeutic effect (thinning of secretions, easier expectoration), the dose should be reduced to 500 mg (10 mL of syrup) three times daily.
Children aged 6 to 12 years:
250 mg (5 mL of syrup) three times daily.
In children and adolescents, the daily dose of carbocysteine must not exceed 30 mg/kg body weight.
It is recommended that the child drinks water after taking the dose.
Elderly patients:
The dosage recommended for adult patients should be used.
Do not use this medicine for longer than 4 to 5 days without medical advice.
It is not recommended to take the medicine before going to sleep.
Taking more Auropect than recommended
There are no reported cases of carbocysteine overdose. The most likely symptoms of overdose may be gastrointestinal disturbances.
If an overdose is taken, consult a doctor or pharmacist immediately. In case of overdose, the doctor may perform gastric lavage and monitor the patient.
Missed dose of Auropect
If a dose is missed, take it as soon as possible. Do not take a double dose to make up for a missed dose.
Stopping Auropect
If you have any further doubts regarding 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 everybody will experience them.
Gastrointestinal disorders:
Uncommon (occurring in more than 1 in 10,000 people but less than 1 in 1,000 people): nausea,
diarrhea.
Very rare (occurring in less than 1 in 10,000 people): gastrointestinal bleeding, gastric disturbances, abdominal pain.
Central nervous system disorders:
Single cases: headache.
Immune system disorders:
In hypersensitive patients, inflammation of the mucous membranes of the mouth and nose may occur.
Skin and subcutaneous tissue disorders:
Very rare (occurring 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): isolated cases of blistering skin reactions such as Stevens-Johnson syndrome have been reported.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, patients should inform their doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Auropect

Keep the medicine out of sight and reach of children.
Store below 25°C.
Do not use this medicine after the expiry date stated on the cardboard box and bottle label.
The expiry date refers to the last day of the specified month.
Period of validity after first opening of the container – 3 months.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. Such measures help protect the environment.

6. Contents of the pack and other information

What Auropect contains

The active substance is carbocysteine. 5 mL of syrup contains 250 mg of carbocysteine. 1 mL of syrup contains 50 mg of carbocysteine.
The other ingredients are: methyl parahydroxybenzoate (E 218), caramel (E 150d), sucrose, gooseberry flavour (propylene glycol, ethyl formate, isoamyl acetate, 4-(4-hydroxyphenyl)butan-2-one, 3-methylbutan-1-ol, Barosma betulina leaf extract, 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 amber glass bottle closed with a HDPE screw cap and LDPE seal, contained in a cardboard box. The bottle contains a clear, amber-coloured syrup with a gooseberry odour and sweet taste. A measuring spoon (5 mL dosing spoon) is included in the pack, allowing measurement of volumes of 1.25 mL, 2.5 mL, 3.75 mL and 5 mL.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Aurovitas Pharma Polska Sp. z o.o.
Sokratesa 13D, local 27
01-909 Warsaw
email: [email protected]

Manufacturer:
Laboratórios Basi - Indústria Farmacêutica, S.A.
Parque Industrial Manuel Lourenço Ferreira, Lotes 8, 15 e 16
3450-232 Mortágua
Portugal