Package leaflet: Information for the user

Strepsils with menthol and eucalyptus, 1.2 mg + 0.6 mg, hard pastilles
Alcohol 2,4–dichlorobenzylicus + Amylmetacresolum
Please read this leaflet carefully before using this medicine, as it contains important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor or pharmacist.

Keep this leaflet, as you may need to read it again.
If you need advice or further information, consult your pharmacist.
If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor or pharmacist. See section 4.
If there is no improvement after 3 days, or if you feel worse, consult your doctor.

Contents of the leaflet

What Strepsils with menthol and eucalyptus is and what it is used for
Important information before using Strepsils with menthol and eucalyptus
How to use Strepsils with menthol and eucalyptus
Possible side effects
How to store Strepsils with menthol and eucalyptus
Contents of the pack and other information

1. What Strepsils with menthol and eucalyptus is and what it is used for

Strepsils with menthol and eucalyptus contains:

two active substances with antiviral and antibacterial activity
menthol, an excipient, which helps reduce the sensation of nasal congestion.

Strepsils with menthol and eucalyptus is intended for symptomatic treatment of inflammatory conditions of the mouth and throat.

2. Important information before using Strepsils with menthol and eucalyptus

When not to use Strepsils with menthol and eucalyptus:

if the patient is allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6);
in children under 6 years of age.

Warnings and precautions
Before starting to use Strepsils with menthol and eucalyptus, consult a doctor if the patient has:

diabetes,
intolerance to certain sugars.

Strepsils with menthol and eucalyptus and other medicines
Clinically significant interactions between Strepsils with menthol and eucalyptus and other medicines are currently unknown.

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.

Driving and operating machinery
The effect of this medicine on the ability to drive and operate machinery is unknown.

Strepsils with menthol and eucalyptus contains:

Glucose and sucrose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine. The medicine contains 1.496 g of sucrose and 1.013 g of glucose per lozenge. This should be taken into account in patients with diabetes.

Wheat starch from glucose syrup
This medicine contains very small amounts of gluten (derived from wheat starch present in glucose syrup) and is classified as "gluten-free". Therefore, it is very unlikely to cause any problems in patients with coeliac disease.
One lozenge contains no more than 20.26 micrograms of gluten.
Patients with a wheat allergy (other than coeliac disease) should not use this medicine.

Sulfur dioxide (E 220) derived from glucose syrup
Due to trace amounts of sulfur dioxide (E 220) derived from glucose syrup, this medicine may rarely cause severe hypersensitivity reactions and bronchospasm.

Sodium derived from indigo carmine (E 132)
Indigo carmine contains trace amounts of sodium. The medicine contains less than 1 mmol (23 mg) of sodium per lozenge, meaning the medicine is considered "sodium-free".

Eucalyptus oil with d-limonene
The medicine contains a fragrance ingredient with d-limonene. D-limonene may cause allergic reactions.

3. How to use Strepsils with menthol and eucalyptus

This medicine should always be used exactly as described in this patient information leaflet or as directed by a doctor or pharmacist.
If in doubt, consult a doctor or pharmacist.
For application to the oral mucosa.
Adults and children over 6 years of age: slowly suck one lozenge every 2–3 hours.
Use the lowest effective dose for the shortest duration necessary to relieve symptoms. Do not exceed 8 lozenges per day. If symptoms persist or worsen after 3 days, consult a doctor.
Use of a higher than recommended dose of Strepsils with menthol and eucalyptus
Overdose should not cause any disturbances other than gastrointestinal discomfort. Symptomatic treatment should be administered.
Missed dose of Strepsils with menthol and eucalyptus
Do not take a double dose to make up for a missed lozenge.
If you have any further doubts concerning the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Adverse reactions that may occur:
Frequency unknown (frequency cannot be estimated from the available data)

hypersensitivity reactions [may manifest as rash, angioedema (swelling of the skin and mucous membranes), urticaria, bronchospasm, and hypotension with fainting],
abdominal pain, nausea, oral discomfort [may manifest as sore throat, oral paresthesia (abnormal sensations in the mouth such as warmth, burning, tingling, numbness, etc.), swelling of the mouth, and glossodynia (burning sensation in the mouth)], tongue pain,
rash.

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

5. How to store Strepsils with menthol and eucalyptus

Store below 25°C.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging 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 you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Strepsils with menthol and eucalyptus contains

The active substances are: 2,4-dichlorobenzyl alcohol and amylometacresol. Each hard pastille contains 1.2 mg of 2,4-dichlorobenzyl alcohol and 0.6 mg of amylometacresol.
Other components are: menthol, eucalyptus oil (contains, among others, d-limonene), tartaric acid, indigotine (E 132), glucose syrup (contains, among others, sulphur dioxide (E 220)) and sucrose syrup.

What Strepsils with menthol and eucalyptus looks like and contents of the pack
Blue, round hard pastilles.
The pack contains 8, 12, 24, 32 or 36 hard pastilles.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Importer
Marketing Authorisation Holder:
Reckitt Benckiser (Poland) S.A.
ul. Okunin 1
05 – 100 Nowy Dwór Mazowiecki
tel. 801 88 88 07
Importer:
RB NL Brands B.V.
WTC Schiphol Airport,
Schiphol Boulevard 207,
1118 BH Schiphol,
The Netherlands