Strepsils na kashel

Package Leaflet: Information for the User

Strepsils for Cough, 375 mg, Hard Capsules

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 this package leaflet or as directed by a doctor or pharmacist.

• Keep this package 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 any not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If after 5 days there is no improvement or you feel worse, consult a doctor.

Table of Contents of the Package Leaflet

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

1. What is Strepsils for Cough and what is it used for

Strepsils for Cough, 375 mg, hard capsules contain a substance called carbocisteine. 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. Strepsils for Cough is used in respiratory diseases where too much mucus is produced or the mucus is too thick. If after 5 days there is no improvement or you feel worse, consult a doctor.

2. Important information before taking Strepsils for Cough

When not to take Strepsils for Cough:

• if you are allergic to carbocisteine 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 you have stomach or intestinal ulcers.

Do not take this medicine if any of the above applies to you. If in doubt, consult a doctor or pharmacist before taking Strepsils for Cough.

Warnings and precautions

Before taking this medicine, discuss it with your doctor or pharmacist if:

• you are elderly;
• you have had stomach or intestinal ulcers;
• you are taking other medicines known to cause stomach bleeding.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Taking this medicine is not recommended during pregnancy or breastfeeding.

Driving and using machines

This medicine has no or negligible influence on the ability to drive and use machines.

Strepsils for Cough contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per capsule, which means it is essentially 'sodium-free'.

3. How to take Strepsils for Cough

This medicine should always be taken exactly as described in the package leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist. This medicine should be taken orally. If you feel that the medicine is too weak or too strong, do not change the dose yourself, 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 and adolescents

Strepsils for Cough is not recommended for use in children and adolescents. If after 5 days there is no improvement or you feel worse, consult a doctor.

Overdose of Strepsils for Cough

If you have taken more capsules than recommended, consult a doctor or go to the hospital emergency department immediately. Take the package leaflet with you. This will help the doctor know what medicine you have taken. Taking too many capsules is likely to cause stomach upset (gastrointestinal disorders).

Missed dose of Strepsils for Cough

If you miss a dose, do not worry. Wait until it is time for your next dose. Do not take a double dose to make up for a missed dose. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Stop taking Strepsils for Cough and consult a doctor immediately or go to the hospital

if:

• you have an allergic reaction. Symptoms may include: rash, swallowing or breathing problems, swelling of the face, lips, throat or tongue;
• blisters appear on your skin or you have bleeding from the skin, including around the mouth, eyes, genitals, or anus. You may also have flu-like symptoms and fever. This could be a condition called Stevens-Johnson syndrome;
• you have blood in your vomit or black, tarry stools.

Tell your doctor or pharmacist if any of the following side effects get serious or last longer than a few days

: Frequency not known(frequency cannot be estimated from the available data):

• vomiting;
• diarrhea;
• nausea;
• discomfort in the upper and middle abdomen (epigastric discomfort);
• headache.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department for 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, you can help provide more information on the safety of this medicine.

5. How to store Strepsils for Cough

Store below 30°C. Keep this 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 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 package and other information

What Strepsils for Cough contains

• The active substance is carbocisteine. Each hard capsule contains 375 mg of carbocisteine.
• 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 Strepsils for Cough looks like and contents of the package

Strepsils for Cough 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 packaged in PVC/PVDC/Aluminum blisters in a cardboard box. Each blister contains 10 capsules. The pack sizes are 10, 20, or 30 hard capsules. Not all pack sizes may be marketed.

Marketing authorization holder

Reckitt Benckiser (Poland) S.A. ul. Okunin 1 05-100 Nowy Dwór Mazowiecki tel.: (22) 211 26 92

Manufacturer/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: info@alkaloid.si

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

Croatia BRONLES 375 mg hard capsules Bulgaria BRONLES 375 mg Capsules, hard Poland Strepsils na kaszel United Kingdom CARBOCISTEINE 375 mg Capsules, hard (Northern Ireland)

Date of last revision of the package leaflet:

02/2024