Strepsils natur for dry cough and hoarseness

Package leaflet: Information for the patient

Strepsils Natur dry cough and hoarseness, 10 mg, soft pastilles
Dry extract of horehound herb
(Sisymbrii officinalis herbae 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 used exactly as described in this patient leaflet, or as directed by
the physician 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 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 you feel worse, you should contact your doctor.

If symptoms persist during treatment, or if adverse reactions occur which are not listed in this package leaflet, seek advice from your doctor or pharmacist.

Contents of the leaflet

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

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

Strepsils Natur dry cough and hoarseness is a traditional herbal medicinal product used to relieve symptoms of throat irritation, such as hoarseness and dry cough.
This medicine is a traditional herbal medicinal product intended for use in specific indications based exclusively on long-standing use.
This medicine is intended for use in adults, adolescents, and children aged 6 years and above.
If there is no improvement after 7 days of treatment, or if you feel worse, you should contact your doctor.

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

When not to use Strepsils Natur dry cough and hoarseness:

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

Warnings and precautions
Consult a doctor or pharmacist if symptoms persist during treatment or if adverse reactions not listed in the package leaflet occur.
If shortness of breath, fever or purulent sputum occur, consult a doctor or pharmacist immediately.
This medicine contains a flavouring substance with cinnamaldehyde. Cinnamaldehyde may cause allergic reactions.

Children
Use of Strepsils Natur dry cough and hoarseness in children under 6 years of age is not recommended due to the risk of swallowing the lozenges and lack of adequate data.

Strepsils Natur dry cough and hoarseness with other medicines
No interactions have been reported. No studies on interactions of this product with other medicines have been conducted. Inform your doctor or pharmacist about all medicines currently used or recently used, as well as any medicines planned for future use.

Strepsils Natur dry cough and hoarseness with food, drink or alcohol
Interactions are not expected; however, no data are available.

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, use of Strepsils Natur dry cough and hoarseness during pregnancy is not recommended.

Breastfeeding
It is not known whether active substances or their metabolites pass into human milk. 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 operating machinery
No functional disturbances are expected; however, no studies have been conducted on the effect of this medicine on the ability to drive or operate machinery.

Strepsils Natur dry cough and hoarseness contains maltitol and sorbitol
This medicine contains 441 mg of liquid maltitol and 100 mg of liquid sorbitol per lozenge. Sorbitol is a source of fructose. If intolerance to certain sugars has previously been diagnosed in the patient or hereditary fructose intolerance, a rare genetic disorder involving impaired fructose metabolism, consult a doctor before administering or taking this medicine.

3. How to use Strepsils Natur dry cough and hoarseness

This medicine should always be taken exactly as described in this patient information leaflet or as advised by
your pharmacist. If in doubt, consult your doctor or pharmacist.
Recommended dose:

• adolescents over 12 years of age, adults and elderly patients: 1 tablet 10 to 12 times daily.

Use in children

• recommended dose for children aged 6 to 11 years: 1 tablet 5 to 6 times daily.

Not recommended for children under 6 years of age (see section 2. "Children").
Use in patients with impaired kidney and/or liver function
There are insufficient data to determine the recommended dose in patients with impaired liver and/or
kidney function. Therefore, the use of tablets containing Sisymbrium herb (hedge mustard herb) is not
recommended in these patient groups.
Method of administration
Dissolve the tablet in the mouth; do not chew.
Duration of use
If symptoms worsen or persist for more than 1 week, 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.
If a double or triple dose of Strepsils Natur dry cough and hoarseness is accidentally taken, no adverse
effects are usually expected. Continue using this medicine as directed in the dosage instructions or as
advised by your doctor. If a significantly larger dose than the recommended one above has been taken,
contact your doctor.
Missed dose of Strepsils Natur dry cough and hoarseness
Do not take a double dose to make up for a missed dose. Continue treatment as described in the
recommendations in this package leaflet or as advised by your doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everybody will experience them.
If adverse reactions occur, consult a doctor or pharmacist.
No adverse reactions have been reported.

Reporting adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, inform a doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products 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 authorization holder. Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Strepsils Natur dry cough and hoarseness medicine

Keep this medicine 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 pack.
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 in use. This will help protect the environment.

6. Contents of the package and other information

What Strepsils Natur kaszel suchy i chrypka contains
Each pastille contains:
10 mg of dry extract from Sisymbrium officinale (L.) Scop. (herba of hedge mustard) (6-8:1),
extraction solvent: water.
Other ingredients:
maltodextrin, arabic gum (E414), liquid sorbitol, non-crystallizing (E420), liquid maltitol (E965),
sucralose (E955), medium-chain triglycerides, purified water, corn starch, honey-lemon-balm flavour (the flavour contains cinnamaldehyde).
Each pastille contains 100 mg of sorbitol.

What Strepsils Natur kaszel suchy i chrypka looks like and contents of the pack
Strepsils Natur kaszel suchy i chrypka is in the form of soft, brownish, round pastilles, 16 mm in diameter, packed in blisters made of Aluminium/PCV/PE/PVDC foil.
The pack contains 10, 12, 20, 24, 30, 36, 40 or 48 soft pastilles.
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
BOLDER Arzneimittel GmbH & Co. KG
Rheinische Allee 11
50858 Köln
Germany

This medicinal product is authorised in the European Economic Area under the following names: