Strepsils Natur kashel mokri

Package Leaflet: Information for the Patient

Strepsils Natur Wet Cough, 8.25 mg/ml, Syrup

Dry extract of ivy leaf
( Hederae helicisfolii extractum siccum)

Read the package leaflet carefully before using 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 those not listed in this package leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement after 7 days or if the patient feels worse, they should contact their doctor.

Table of Contents of the Package Leaflet

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

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

Strepsils Natur Wet Cough is a herbal medicinal product used as an expectorant in the case of productive cough (wet cough).
Strepsils Natur Wet Cough syrup is intended for adults, adolescents, and children over 2 years of age.
If there is no improvement after 7 days or if the patient feels worse, they should contact their doctor.

2. Important information before using Strepsils Natur Wet Cough

When not to use Strepsils Natur Wet Cough

• if the patient is allergic to dry extract of ivy leaf, to other plants of the Araliaceae family (the botanical family to which ivy belongs), or to any of the other ingredients of this medicine (listed in section 6). Do not give Strepsils Natur Wet Cough to children under 2 years of age, as it may worsen respiratory symptoms (e.g., shortness of breath, difficulty breathing, cough, or wheezing).

Warnings and precautions

Before starting to use Strepsils Natur Wet Cough, the patient should discuss it with their doctor or pharmacist:

• in patients with gastritis or gastric ulcer disease.

In case of shortness of breath, fever, or purulent or bloody sputum before or during the use of this medicine, the patient should consult their doctor or pharmacist.
In case of the first symptoms of a severe allergic reaction, the patient should stop using the medicine immediately and contact their doctor (see section 4).

Use in patients with renal or hepatic impairment

If the patient has renal or hepatic impairment, they should discuss it with their doctor or pharmacist before using Strepsils Natur Wet Cough syrup. No dosage recommendations have been established for these patients.

Children

Using the medicine in children under 2 years of age is contraindicated. See the section "When not to use Strepsils Natur Wet Cough".
Persistent or recurrent cough in children aged 2 to 4 years requires a medical diagnosis before starting treatment.

Strepsils Natur Wet Cough and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
No interactions of Strepsils Natur Wet Cough syrup with other medicines have been reported.
No interaction studies have been performed.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
Pregnancy
The safety of using the medicine during pregnancy has not been established. Due to the lack of sufficient data, the medicine should not be used during pregnancy.
Breastfeeding
It is not known whether the active substance or its metabolites pass into human milk. The risk to newborns and (or) breastfed infants cannot be excluded. Therefore, Strepsils Natur Wet Cough should not be used during breastfeeding.

Driving and using machines

No studies have been conducted on the effects of the medicine on the ability to drive and use machines.

Strepsils Natur Wet Cough contains sorbitol

This medicine contains up to 469 mg of sorbitol per 1 ml of syrup.
Sorbitol is a source of fructose. If the patient (or their child) has previously been diagnosed with intolerance to some sugars or has a rare genetic disorder, hereditary fructose intolerance, in which the patient's body does not break down fructose, they should consult their doctor before taking the medicine or giving it to their child.
Sorbitol may cause gastrointestinal discomfort and may have a mild laxative effect in children.

Strepsils Natur Wet Cough contains propylene glycol

This medicine contains 16.8 mg of propylene glycol per 2 ml, which corresponds to 8.4 mg/ml.

Strepsils Natur Wet Cough contains benzyl alcohol

This medicine contains 0.0038 mg of benzyl alcohol per 2 ml, which corresponds to 0.0019 mg/ml.
Benzyl alcohol may cause allergic reactions.
Administering benzyl alcohol to small children is associated with a risk of severe side effects, including respiratory disorders (so-called "gasping syndrome").
Do not give to small children (under 3 years of age) for more than a week without the advice of a doctor or pharmacist.
Pregnant or breastfeeding women should consult their doctor or pharmacist before using the medicine, as a large amount of benzyl alcohol may accumulate in their body and cause side effects (so-called metabolic acidosis).
Patients with liver or kidney disease should consult their doctor or pharmacist before using the medicine, as a large amount of benzyl alcohol may accumulate in their body and cause side effects (so-called metabolic acidosis).

3. How to use Strepsils Natur Wet Cough

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 their doctor or pharmacist.
The recommended dose is:
Adolescents over 12 years of age, adults, and the elderly:
6 ml of syrup twice a day (corresponding to 99 mg of dry extract of ivy leaf per day)
Children aged 6 to 11 years:
4 ml of syrup twice a day (corresponding to 66 mg of dry extract of ivy leaf per day)
Children over 2 to 5 years:
2 ml of syrup twice a day (corresponding to 33 mg of dry extract of ivy leaf per day).

Use in children

Persistent or recurrent cough in children aged 2 to 4 years requires a medical diagnosis before starting treatment.
Using the medicine in children under 2 years of age is contraindicated (see the section "When not to use Strepsils Natur Wet Cough").

Use in patients with renal or hepatic impairment

See section 2.

Method of administration

Oral administration.
The patient should use the included measuring cup with a 2 ml and 4 ml scale.
A dose of 6 ml is recommended using the full measuring cup (4 ml) + half of the measuring cup (2 ml).
The bottle should be shaken before use.

Duration of use

If there is no improvement after 7 days or if the patient feels worse, or if the symptoms have not resolved, they should contact their doctor.

Taking a higher dose of Strepsils Natur Wet Cough than recommended

Taking a higher dose than recommended may cause nausea, vomiting, diarrhea, and excitement.
In case of taking a higher dose of Strepsils Natur Wet Cough syrup than recommended, the patient should contact their doctor.

Missing a dose of Strepsils Natur Wet Cough

The patient should not take a double dose to make up for a missed dose.
In case of any further doubts about using this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects that may occur when using Strepsils Natur Wet Cough syrup:
Frequency not known (cannot be estimated from the available data):

• gastrointestinal reactions, such as nausea, vomiting, and diarrhea
• allergic reactions, such as hives, skin rash, shortness of breath, and anaphylactic reaction.

In case of the first symptoms of a severe allergic reaction, the patient should stop using the medicine immediately and contact their doctor.
In case of other side effects not listed above, the patient should consult their doctor or pharmacist.

Reporting side effects

If the patient experiences any side effects, including those not listed in this package leaflet, they should inform their doctor or pharmacist.
Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, Medical Devices, and Biocidal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw,
phone: +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 can be collected on the safety of the medicine.

5. How to store Strepsils Natur Wet Cough

The medicine should be stored out of sight and reach of children.
There are no special precautions for storage of the medicine in its original packaging.
After first opening: do not store above 25°C.
Do not use this medicine after the expiry date (EXP) stated on the packaging. The expiry date refers to the last day of the month.
Shelf life after first opening the bottle: 3 months.
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 package and other information

What Strepsils Natur Wet Cough contains

• The active substance is dry extract of ivy leaf. Each 1 ml of the medicine contains 8.25 mg of extract (in the form of dry extract) from Hedera helixL., folium (ivy leaf) (4-8:1). Extraction solvent: ethanol 30% (m/m).
• The other ingredients are: liquid sorbitol (non-crystallizing) (E420), potassium sorbate (E202), xanthan gum (E415), citric acid (E330), natural honey-thyme flavor [flavor contains propylene glycol (E1520) and benzyl alcohol (E1519)], purified water.

What Strepsils Natur Wet Cough looks like and what the package contains

Strepsils Natur Wet Cough syrup is a brown, opalescent liquid with a sweet taste; a small sediment may be present.
The syrup is in a brown glass bottle with a white plastic cap (polyethylene).
The bottle is packaged in a cardboard box with an included measuring cup (made of polypropylene, with a 2 ml and 4 ml scale).
Package sizes: 100 ml or 200 ml.
Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Reckitt Benckiser (Poland) S.A.
Okunin 1

• 05 – 100 Nowy Dwór Mazowiecki phone: (22) 211 26 92

Manufacturer

Phytopharm Klęka S.A.
Klęka 1
63-040 Nowe Miasto nad Wartą
Poland

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

Austria
StrepHustan Efeu Hustenlöser Sirup
Belgium
Streptuss klimop siroop
Bulgaria
StrepTuss Active Naturals Ivy 8.25 mg/ml syrup
СтрепТус Актив Нечъралс Бръшлян 8.25 mg/ml сироп
Croatia
Streptusan bršljan sirup
Czech Republic
Strevox s břečťanem
Denmark
StrepHost Muco
Estonia
DobenHustil
Finland
Streptus Dry
France
STREPSILS EXPECTORANT LIERRE 8,25 mg/ml, sirop
Greece
StrepCough Ivy
Spain
Streptos hiedra 8,25 mg/ml jarabe
Netherlands
Streptuss klimop siroop
Iceland
StrepHost Muco
Lithuania
Starkspept
Latvia
Dobenhustil
Germany
Dobendan Hustenlöser
Norway
Strepmuco
Portugal
Streptosse Active Naturals Tosse Produtiva
Romania
StrepTuss iederă 8,25 mg/ml sirop
Slovakia
Strevox s brečtanom
Slovenia
Bršljan Streptusan sirup
Sweden
Strepmuco
Hungary
StrepTuss borostyán 8,25 mg/ml szirup
Italy
Benactuss Tosse Grassa
Date of last revision of the package leaflet:12/2024