Auropect Comfort

Package Leaflet: Information for the User

Auropect COMFORT, 375 mg, Hard Capsules

Karbocysteine

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 this package leaflet for the patient or as directed by a doctor or pharmacist.

• This package leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in this package leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement after 5 days or the patient feels worse, they should contact their doctor.

Table of Contents of the Package Leaflet

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

1. What Auropect COMFORT is and what it is used for

Auropect COMFORT, 375 mg, hard capsules contain a substance called karbocysteine. It belongs to a group of medicines called mucolytics. Its action is to reduce the viscosity of mucus (phlegm). This makes it easier to cough up the mucus. Auropect COMFORT is used in respiratory diseases where too much mucus is produced or the mucus is too thick. This medicine is recommended for use in adults and adolescents over 18 years of age. If there is no improvement after 5 days or the patient feels worse, they should contact their doctor.

2. Important information before taking Auropect COMFORT

When not to take Auropect COMFORT:

• if the patient is allergic to karbocysteine or any of the other ingredients of this medicine (listed in section 6). Symptoms of an allergic reaction include: rash, swallowing or breathing problems, swelling of the face, lips, throat, or tongue.
• if the patient has stomach or intestinal ulcers.

This medicine should not be taken if any of the above points apply to the patient. In case of doubt, the patient should consult a doctor or pharmacist before taking Auropect COMFORT.

Warnings and precautions

Before starting to take this medicine, the patient should discuss it with their doctor or pharmacist if:

• The patient is elderly;
• The patient has had stomach or intestinal ulcers;
• The patient is taking other medicines known to cause stomach bleeding.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine. This medicine should not be taken during pregnancy and breastfeeding.

Auropect COMFORT contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per capsule, which means it is considered "sodium-free".

3. How to take Auropect COMFORT

This medicine should always be taken 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 a doctor or pharmacist. This medicine should be taken orally. If the patient feels that the medicine is too weak or too strong, they should not change the dose themselves but consult a doctor.

Adults and the elderly

The recommended dose is two capsules three times a day. If the symptoms decrease, the dose can be reduced to one capsule four times a day.

Use in children

Auropect COMFORT is not recommended for use in children. If there is no improvement after 5 days or the patient feels worse, they should contact their doctor.

Taking more than the recommended dose of Auropect COMFORT

In case of taking more capsules than recommended, the patient should immediately consult a doctor or go to the hospital emergency department. They should take the package of the medicine with them. This will allow the doctor to know which medicine the patient has taken. Taking too many capsules will likely cause stomach upset (gastrointestinal disorders).

Missing a dose of Auropect COMFORT

In case of missing a dose, the patient should not worry. They should wait until it is time for the next dose. They should not take a double dose to make up for the missed dose. In case of any further doubts about taking this medicine, the patient should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The patient should stop taking Auropect COMFORT and immediately consult a doctor or go to the hospital if:

they experience:

• An allergic reaction. Symptoms may include: rash, swallowing or breathing problems, swelling of the face, lips, throat, or tongue.
• Blisters on the skin or bleeding from the skin, including the areas around the lips, eyes, mouth, nose, and genitals. They may also experience symptoms similar to flu and fever. This may be a condition known as Stevens-Johnson syndrome.
• Blood in their vomit or black, tarry stools.

The patient should tell their doctor or pharmacist if any of the following side effects become serious or last longer than a few days:

they experience:

• Nausea (feeling sick) or vomiting.
• Diarrhea.
• Discomfort in the upper abdomen.

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in this package leaflet, they should inform their 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.: 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, more information can be gathered on the safety of the medicine.

5. How to store Auropect COMFORT

Store in a temperature below 30°C. The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the carton and blister after: EXP. The expiry date refers to the last day of the month stated. 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 COMFORT contains

• The active substance is karbocysteine. Each hard capsule contains 375 mg of karbocysteine.
• The other ingredients are: Capsule content: mannitol, maize starch, croscarmellose sodium, sodium lauryl sulfate K12, colloidal anhydrous silica, and magnesium stearate. Capsule shell: gelatin; iron oxide red (E172); titanium dioxide (E171); and iron oxide yellow (E172).

What Auropect COMFORT looks like and contents of the pack

Auropect COMFORT is a hard gelatin capsule filled with a uniform white powder. Both cylindrical parts of the capsule are matte yellow and opaque. The size of each capsule is approximately 19.4 ± 0.3 mm. The capsules are packed in blisters of transparent, hard PVC/PVDC/Aluminum foil. Each blister contains 10 capsules. Pack sizes: 20 and 30 hard capsules. Not all pack sizes may be marketed.

Marketing authorization holder and importer

Marketing authorization holder:
Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lok. 27
01-909 Warsaw
Poland
e-mail: [email protected]
Importer:
Alkaloid-INT d.o.o., Šlandrova ulica 4, 1231 Ljubljana-Črnuče, Slovenia
Tel.: +386 1 300 42 90
Fax: +386 1 300 42 91
e-mail: [email protected]

This medicine is authorized in the Member States of the European Economic Area under the following names:

Hungary
Lolimucin 375 mg hard capsule
Poland
Auropect COMFORT

Date of last revision of the package leaflet: 07/2024