Package leaflet: Information for the user

Auropect COMFORT, 375 mg, hard capsules
Carbocysteine
Please read all of this leaflet carefully before taking this medicine, because it contains important information for you.
This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist.

Keep this leaflet so that you can read it again if necessary.
If you need advice or further information, please contact your pharmacist.
If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor or pharmacist. See section 4.
If there is no improvement after 5 days or if your condition worsens, consult your doctor.

Contents of the leaflet

What Auropect COMFORT is and what it is used for
What you need to know before taking Auropect COMFORT
How to take Auropect COMFORT
Possible side effects
How to store Auropect COMFORT
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 carbocysteine. It belongs to a group of medicines known as mucolytics. It works by reducing the viscosity of mucus (phlegm), making it easier to cough up. Auropect COMFORT is used in respiratory diseases associated with excessive mucus production or abnormally thick mucus. This medicine is recommended for use in adults aged 18 years and over.
If there is no improvement after 5 days or if your condition worsens, consult your doctor.

2. Important information before taking Auropect COMFORT

When not to take Auropect COMFORT:

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

Do not take this medicine if any of the above apply to the patient. If in doubt, consult a doctor or pharmacist before taking Auropect COMFORT.

Warnings and precautions

Talk to a doctor or pharmacist before taking this medicine if:

the patient is elderly;
the patient has previously had stomach or intestinal ulcers;
the patient is taking other medicines known to cause gastrointestinal bleeding.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects she may be pregnant or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.

This medicine should not be taken during pregnancy or while breastfeeding.

Auropect COMFORT contains sodium

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

3. How to take Auropect COMFORT

This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
This medicine is for oral use. If you feel the medicine is too weak or too strong, do not adjust the dose yourself; instead, consult your doctor.
Adults and elderly patients
The recommended dose is two capsules three times daily. If symptoms improve, the dose should be reduced to one capsule four times daily.
Use in children
Auropect COMFORT is not recommended for use in children.
If there is no improvement after 5 days of treatment, or if the patient feels worse, medical advice should be sought.
Taking more Auropect COMFORT than recommended
If you have taken more capsules than recommended, seek immediate medical advice or go to the nearest emergency department. Take the medicine packaging with you. This will help the doctor identify which medicine has been taken. Taking too many capsules is likely to cause stomach upset (gastrointestinal disturbances).
If you forget to take Auropect COMFORT
If you miss a dose, do not worry. Wait and take the next dose at the usual time. Do not take a double dose to make up for the missed dose.
If you have any further questions about 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 everyone experiences them.
You must stop taking Auropect COMFORT and immediately consult a doctor or go to hospital if:

The patient experiences an allergic reaction. Symptoms may include: rash, difficulty swallowing or breathing, swelling of the lips, face, throat or tongue.
Blisters appear on the patient's skin or bleeding from the skin occurs, including around the lips, eyes, mouth, nose and genital organs. Flu-like symptoms and fever may also occur. This may be the so-called Stevens-Johnson syndrome.
Blood is visible in the patient's vomit or the patient passes black, tarry stools.

You should inform the doctor or pharmacist if any of the following adverse reactions become severe or last longer than a few days:

Nausea or vomiting.
Diarrhea.
Discomfort in the upper abdomen.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse reactions not listed in this leaflet, inform your 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: 22 49-21-301, fax: 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 to provide more information on the safety of this medicine.

5. How to store Auropect COMFORT

Store below 30°C.
Keep the medicine out of the 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 stated month.
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 Auropect COMFORT contains

The active substance is carbocysteine. Each hard capsule contains 375 mg of carbocysteine.
The other ingredients are: Capsule contents: mannitol, corn starch, sodium croscarmellose, sodium lauryl sulfate K12 grade, 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 homogeneous white powder. Both cylindrical parts of the capsule are opaque, matte yellow in color. The size of each capsule is approximately 19.4 ± 0.3 mm.
The capsules are packed in blisters made of transparent, rigid PVC/PVDC/Aluminum foil. Each blister contains 10 capsules.
Pack sizes: 20 and 30 hard capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Importer
Marketing Authorisation Holder:
Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lok. 27
01-909 Warszawa
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 medicinal product is authorised in the Member States of the European Economic Area under the following names:
Hungary: Lolimucin 375 mg kemény kapszula
Poland: Auropect COMFORT