Strepsils natur for cough

Package leaflet: Information for the user

Strepsils Natur wet cough, 8.25 mg/ml, syrup
Dry extract of ivy leaves
(Hederae helicis folii extractum siccum)
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by
a doctor or pharmacist.

• 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 adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 7 days of treatment, or if your symptoms worsen, consult your doctor.

Contents of the leaflet

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

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

Strepsils Natur wet cough is a herbal medicinal product used as an expectorant in productive (wet) cough.
Strepsils Natur wet cough syrup is intended for adults, adolescents, and children above 2 years of age.
If there is no improvement after 7 days of treatment, or if you feel worse, you should consult your doctor.

2. Important information before using Strepsils Natur kaszel mokry

When not to use Strepsils Natur kaszel mokry

• if the patient is allergic to dry extract of ivy leaf, to other plants from the family Araliaceae (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 kaszel mokry to children under 2 years of age, as it may worsen respiratory symptoms (e.g. shortness of breath, breathing difficulties, cough or wheezing).

Warnings and precautions
Before starting treatment with Strepsils Natur kaszel mokry, consult your doctor or
pharmacist:

• in patients with gastric mucosal inflammation or peptic ulcer disease.

If shortness of breath, fever, or purulent or bloody sputum occurs before or during
treatment with this medicine, consult your doctor or pharmacist.
In case of first signs of a severe allergic reaction, discontinue use immediately and
contact your doctor (see section 4).
Use in patients with renal and/or hepatic impairment
If the patient has impaired kidney or liver function, consult your doctor or pharmacist before using Strepsils Natur kaszel mokry syrup. Dosage recommendations in these patients have not been established.
Children
Use of this medicine is contraindicated in children under 2 years of age. See section "When not to use Strepsils Natur kaszel mokry".
Persistent or recurrent cough in children aged 2 to 4 years requires medical diagnosis before starting treatment.
Strepsils Natur kaszel mokry and other medicines
Inform your doctor or pharmacist about all medicines currently used or recently used, as well as any medicines the patient intends to use.
No interactions of Strepsils Natur kaszel mokry syrup with other medicines have been reported.
No studies on interactions have been conducted.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a
child, she should consult a doctor or pharmacist before using this medicine.
Pregnancy
Safety during pregnancy has not been established. Due to insufficient data, this medicine should not be used during pregnancy.
Breastfeeding
It is unknown whether the active substance or its metabolites pass into human milk. Risk to newborns and/or breastfed infants cannot be excluded. Therefore, Strepsils Natur kaszel mokry should not be used during breastfeeding.
Driving and operating machinery
No studies have been conducted on the influence on the ability to drive or operate machinery.
Strepsils Natur kaszel mokry contains sorbitol
This medicine contains up to 469 mg of sorbitol per 1 ml of syrup.
Sorbitol is a source of fructose. If intolerance to certain sugars has previously been diagnosed in the patient (or their child), or if hereditary fructose intolerance, a rare genetic disorder in which the patient's body cannot break down fructose, has been diagnosed, the patient should consult a doctor before taking the medicine or giving it to a child.
Sorbitol may cause gastrointestinal discomfort and may have a mild laxative effect in children.
Strepsils Natur kaszel mokry contains propylene glycol
This medicine contains 16.8 mg of propylene glycol in each 2 ml, equivalent to 8.4 mg/ml.
Strepsils Natur kaszel mokry contains benzyl alcohol
This medicine contains 0.0038 mg of benzyl alcohol in each 2 ml, equivalent to 0.0019 mg/ml.
Benzyl alcohol may cause allergic reactions.
Administration of benzyl alcohol to young children is associated with risk of severe adverse reactions including respiratory disorders (so-called "gasping syndrome").
Do not administer to young children (under 3 years of age) for longer than one week without medical or pharmacist recommendation.
Pregnant or breastfeeding women should consult a doctor or pharmacist before using this medicine, as large amounts of benzyl alcohol may accumulate in their body and cause adverse effects (so-called metabolic acidosis).
Patients with liver or kidney disease should consult a doctor or pharmacist before using this medicine, as large amounts of benzyl alcohol may accumulate in their body and cause adverse effects (so-called metabolic acidosis).

3. How to use Strepsils Natur kaszel mokry

This medicine should always be taken exactly as described in this patient leaflet or as advised by your
doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Recommended dose:
Adolescents over 12 years of age, adults and elderly people:
6 ml of syrup twice daily (corresponding to 99 mg of dry ivy leaf extract per day)
Children aged 6 to 11 years:
4 ml of syrup twice daily (corresponding to 66 mg of dry ivy leaf extract per day)
Children aged above 2 to 5 years:
2 ml of syrup twice daily (corresponding to 33 mg of dry ivy leaf extract per day).
Use in children
Persistent or recurrent cough in children aged 2 to 4 years requires medical diagnosis before
starting treatment.
Use in children under 2 years of age is contraindicated (see section "When not to use Strepsils Natur kaszel mokry").
Use in patients with renal and/or hepatic impairment
See section 2.
Method of administration
For oral use.
Use the provided measuring device graduated at 2 ml and 4 ml.
A 6 ml dose is recommended using a full measure (4 ml) plus half a measure (2 ml).
Shake the bottle well before use.
Duration of treatment
If there is no improvement after 7 days, if symptoms worsen, or if symptoms persist, consult your doctor.
Overdose of Strepsils Natur kaszel mokry
Taking more than the recommended dose may cause nausea, vomiting, diarrhoea, and agitation.
If you take more Strepsils Natur kaszel mokry syrup than you should, contact your doctor.
Missed dose of Strepsils Natur kaszel mokry
Do not take a double dose to make up for a forgotten 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 product may cause adverse reactions, although not everybody will experience them.
Adverse reactions that may occur during treatment with Strepsils Natur kaszel mokry syrup:
Frequency unknown (cannot be estimated from available data):

• gastrointestinal reactions such as nausea, vomiting, and diarrhoea
• allergic reactions such as urticaria, skin rash, dyspnoea, and anaphylactic reaction.

If symptoms of a severe allergic reaction occur, discontinue use of the medicine immediately and
contact a doctor.
If any other adverse reactions occur that are not listed above, consult a doctor or pharmacist.
Reporting of adverse reactions
If any adverse effects occur, including any adverse effects 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,
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 marketing authorisation holder. By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Strepsils Natur kaszel mokry

Keep the medicine out of the sight and reach of children.
No special storage conditions are required for the medicine kept 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 stated month.
Expiry date after first opening of the bottle: 3 months.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Strepsils Natur kaszel mokry contains

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

What Strepsils Natur kaszel mokry looks like and contents of the pack
Strepsils Natur kaszel mokry syrup is a brown, opalescent liquid with a sweet taste; a slight sediment may occur.
The syrup is contained in a brown glass bottle with a white screw cap made of plastic (polyethylene). The bottle is packed in a cardboard box together with a measuring spoon (made of polypropylene, marked with graduations at 2 ml and 4 ml).
Pack sizes: 100 ml or 200 ml.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Reckitt Benckiser (Poland) S.A.
ul. Okunin 1
05 – 100 Nowy Dwór Mazowiecki
tel. (22) 211 26 92

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

This medicinal product is authorised in the European Economic Area under the following names:
Austria StrepHustan Efeu Hustenlöser Sirup
Belgium Streptuss klimop siroop
Streptuss lierre grimpant sirop
Streptuss Efeu Sirup
StrepTuss Ivy 8.25 mg/ml syrup
Bulgaria СтрепТус Бръшлян 8.25 mg/ml сироп
Croatia Streptusan bršljan sirup
Czech Republic Strevox s břečťanem sirup
Denmark StrepHost Muco
Estonia Dobenhustil
Finland Streptus Dry
France LIERRE GRIMPANT RECKITT HEALTHCARE, sirop
Greece StrepCough Ivy
Spain Streptos hiedra 8,25 mg/ml jarabe
Netherlands Streptuss klimop siroop
Iceland StrepHost Muco
Lithuania Hostastrep 8,25 mg/ml sirupas
Latvia Dobenhustil sīrups
Germany Dobendan Hustenlöser
Norway Strepmuco Sirup
Portugal StrepTosse Tosse Produtiva
Romania StrepTuss iederă 8,25 mg/ml sirop
Slovakia Strevox s brečtanom 8,25 mg/ml sirup
Slovenia Bršljan Streptusan sirup
Sweden Strepmuco Sirap
Hungary StrepTuss borostyán 8,25 mg/ml szirup
Italy Benactuss Tosse grassa