STREPSILS FOR COUGH

Package leaflet: information for the user

Strepsils na kaszel, 375 mg, hard capsules
Carbocisteinum
Please read this leaflet carefully before taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this patient leaflet or as your doctor or pharmacist has instructed.

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

Leaflet contents

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

1. What Strepsils na kaszel is and what it is used for

Strepsils na kaszel, 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. Strepsils na kaszel is used in respiratory diseases where excessive mucus is produced or when the mucus is too thick.
If there is no improvement after 5 days or if your condition worsens, consult your doctor.

2. Important information before taking Strepsils na kaszel

When not to take Strepsils na kaszel:

• if the patient is allergic to carbocisteine or 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. If in doubt, consult a doctor or pharmacist before taking Strepsils na kaszel.

Warnings and precautions

Before starting to take this medicine, discuss with a doctor or pharmacist 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.

The use of this medicine is not recommended during pregnancy or while breastfeeding.

Driving and operating machinery

This medicine has no effect or negligible effect on the ability to drive and operate machinery.

Strepsils na kaszel contains sodium

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

3. How to take Strepsils na kaszel

This medicine should always be taken exactly as described in the patient leaflet or as advised by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
This medicine should be taken orally. If you feel the medicine is too weak or too strong, do not adjust the dose yourself, but consult your doctor.
Adults and elderly patients
The recommended dose is two capsules three times a day. If symptoms improve, reduce the dose to one capsule four times a day.
Use in children and adolescents
Strepsils na kaszel is not recommended for use in children and adolescents.
If there is no improvement after 5 days, or if the patient feels worse, consult a doctor.
Taking more than the recommended dose of Strepsils na kaszel
If more capsules have been taken than recommended, seek immediate medical advice from a doctor or go to a hospital 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).
Missing a dose of Strepsils na kaszel
If a dose is missed, do not worry. Wait until it is time to take the next dose. Do not take a double dose to make up for a 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 should stop taking Strepsils na kaszel and consult a doctor immediately
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.

Tell a doctor or pharmacist if any of the following adverse reactions
become severe or persist for more than a few days:
Frequency unknown (frequency cannot be estimated from the available data):

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

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse effects not listed
in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions
can be reported directly to the Department of Monitoring of Adverse Drug Reactions 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
Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions helps to gather more information on the safety of the medicine.

5. How to store Strepsils na kaszel

Store below 30°C.
Keep the medicine in a place 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 stated month.
Medicines must 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 na kaszel contains

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

What Strepsils na kaszel looks like and contents of the pack
Strepsils na kaszel is a hard gelatin capsule filled with a homogeneous white powder. Both cylindrical parts of the capsule are opaque, matt yellow in colour. The size of each capsule is approximately 19.4 ± 0.3 mm.
The capsules are packed in blisters made of PVC/PVDC/Aluminium, contained in a cardboard box. Each blister contains 10 capsules.
Pack sizes: 10, 20 or 30 hard capsules.
Not all pack sizes may be marketed.

Marketing Authorisation 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: [email protected]

This medicinal product is authorised in the member states of the European Economic Area under the following names:
Croatia – BRONLES 375 mg tvrde kapsule
Bulgaria – BRONLES 375 mg Capsules, hard
Poland – Strepsils na kaszel
United Kingdom – CARBOCISTEINE 375 mg Capsules, hard
(Northern Ireland)
02/2024