Strepsils Natur kashel suhi i hripka

Leaflet attached to the packaging: patient information

Strepsils Natur dry cough and hoarseness, 10 mg, soft lozenges

Dry extract of Sisymbrium officinale herb (Sisymbrii officinalis herbae extractum siccum)

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement after 7 days or the patient feels worse, they should contact a doctor.

If symptoms persist during treatment or if side effects occur that are not listed in this leaflet, the patient should consult a doctor or pharmacist.

Table of contents of the leaflet

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

1. What is Strepsils Natur dry cough and hoarseness and what is it used for

Strepsils Natur dry cough and hoarseness is a traditional herbal medicine used to relieve symptoms of throat irritation, such as hoarseness and dry cough.

The medicine is a traditional herbal medicinal product for use in the specified indications, based on long-standing use.

The medicine is intended for use in adults, adolescents, and children over 6 years of age.

If there is no improvement after 7 days or the patient feels worse, they should contact a doctor.

2. Important information before taking Strepsils Natur dry cough and hoarseness

When not to take Strepsils Natur dry cough and hoarseness:

• if the patient is allergic to Sisymbrium officinale or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Patients should consult a doctor or pharmacist if symptoms persist during treatment or if side effects occur that are not listed in the leaflet.

If the patient experiences difficulty breathing, fever, or purulent sputum, they should immediately consult a doctor or pharmacist.

This medicine contains a flavoring substance with cinnamaldehyde. Cinnamaldehyde may cause allergic reactions.

Children

The use of Strepsils Natur dry cough and hoarseness in children under 6 years of age is not recommended due to the risk of choking on the lozenges and the lack of appropriate data.

Strepsils Natur dry cough and hoarseness with other medicines

No interactions have been reported. No studies on the interactions of this product with other medicines have been conducted. Patients should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

Strepsils Natur dry cough and hoarseness with food, drink, or alcohol

Interactions are not expected, however, there is a lack of available data.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult a doctor or pharmacist before taking this medicine.

Pregnancy

The safety of use during pregnancy has not been established. Due to the lack of sufficient data, the use of Strepsils Natur dry cough and hoarseness during pregnancy is not recommended.

Breastfeeding

It is not known whether the active substances or their metabolites pass into breast milk. A risk to newborns and (or) breastfed infants cannot be excluded. Therefore, Strepsils Natur dry cough and hoarseness should not be used during breastfeeding.

Driving and using machines

No functional disorders are expected, however, no studies on the effects of the preparation on the ability to drive and use machines have been conducted.

Strepsils Natur dry cough and hoarseness contains maltitol and sorbitol

This medicine contains 441 mg of liquid maltitol and 100 mg of liquid sorbitol in each lozenge. Sorbitol is a source of fructose. If the patient has previously been diagnosed with intolerance to some sugars or has a rare genetic disorder, hereditary fructose intolerance, they should consult a doctor before taking this medicine.

3. How to take Strepsils Natur dry cough and hoarseness

This medicine should always be taken exactly as described in this patient leaflet or as directed by a pharmacist. If in doubt, the patient should consult a doctor or pharmacist.

The recommended dose is:

• adolescents over 12 years of age, adults, and the elderly: 1 lozenge 10 to 12 times a day.

Use in children

• the recommended dose for children between 6 and 11 years of age is 1 lozenge 5 to 6 times a day.

The use of Strepsils Natur dry cough and hoarseness in children under 6 years of age is not recommended (see section 2, "Children").

Use in patients with renal and/or hepatic impairment

There is a lack of sufficient data to determine the recommended dose in patients with hepatic and/or renal impairment. Therefore, the use of lozenges containing Sisymbrium officinale is not recommended in these patient groups.

Method of administration

Dissolve the lozenge in the mouth, do not chew.

Duration of treatment

If symptoms worsen or persist for more than 1 week, the patient should consult a doctor or pharmacist (see also "Warnings and precautions").

Overdose of Strepsils Natur dry cough and hoarseness

No cases of overdose have been reported.

In the event of accidental ingestion of a double or triple dose of Strepsils Natur dry cough and hoarseness, no negative symptoms are expected to occur. The patient should continue taking the medicine as directed or as advised by a doctor. If a significantly larger dose than the recommended dose is taken, the patient should contact a doctor.

Missed dose of Strepsils Natur dry cough and hoarseness

The patient should not take a double dose to make up for a missed dose. The patient should continue treatment as directed in this leaflet or as advised by a doctor.

If the patient has any further questions on the use of this medicine, they should consult a doctor or pharmacist.

4. Possible side effects

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

If side effects occur, the patient should consult a doctor or pharmacist.

No side effects have been reported.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist.

Side effects can be reported directly to the Department of Post-Marketing Surveillance 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

Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information on the safety of this medicine can be gathered.

5. How to store Strepsils Natur dry cough and hoarseness

The medicine should be stored out of sight and reach of children.

Do not store above 25°C.

Do not use this medicine after the expiry date (EXP) stated on the carton and blister.

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 no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Strepsils Natur dry cough and hoarseness contains

One lozenge contains:

10 mg of dry extract of Sisymbrium officinale (L.) Scop. (Sisymbrium officinale herb) (6-8:1),

extract solvent: water.

Other ingredients:

maltodextrin, gum arabic (E414), liquid sorbitol, non-crystallizing (E420), liquid maltitol (E965), sucralose (E955), medium-chain triglycerides, purified water, corn starch, honey-lemon-vervain flavor (flavor contains cinnamaldehyde).

One lozenge contains 100 mg of sorbitol.

What Strepsils Natur dry cough and hoarseness looks like and contents of the pack

Strepsils Natur dry cough and hoarseness is a brownish, round, soft lozenge with a diameter of 16 mm in aluminum/PCV/PE/PVDC blisters.

The pack contains 10, 12, 20, 24, 30, 36, 40, or 48 soft lozenges.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Reckitt Benckiser (Poland) S.A.

ul. Okunin 1

• 05 – 100 Nowy Dwór Mazowiecki tel. (22) 211 26 92

Manufacturer

BOLDER Arzneimittel GmbH & Co. KG

Rheinische Allee 11

50858 Köln

Germany

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

Date of last revision of the leaflet: 12/2024