STREPSILS WITH HONEY AND LEMON

Patient Information Leaflet

Strepsils with Honey and Lemon, 1.2 mg + 0.6 mg, hard lozenges
Alcohol 2,4–dichlorobenzylicus + Amylmetacresolum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
This medicine should always be used exactly as described in this patient leaflet or as advised by
your 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 possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 3 days, or if you feel worse, you should contact your doctor.

Contents of the leaflet

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

1. What Strepsils with Honey and Lemon is and what it is used for

Strepsils with Honey and Lemon contains:

• two active substances with antiviral and antibacterial properties,
• honey as an excipient.

Strepsils with Honey and Lemon is intended for symptomatic treatment of inflammatory conditions of the mouth and throat.

2. Information before using Strepsils with honey and lemon

When not to use Strepsils with honey and lemon:

• 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 honey and lemon, consult a doctor if the patient has:

• diabetes (one tablet contains approximately 2.5 g of sugars),
• intolerance to certain sugars.

Strepsils with honey and lemon and other medicines
Clinically significant interactions between Strepsils with honey and lemon 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 the medicine on the ability to drive and operate machinery is unknown.

Strepsils with honey and lemon contains:

Glucose, sucrose and invert sugar (honey)
If a patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine. The product contains 1.44 g of sucrose and 0.98 g of glucose, as well as 100.9 mg of invert sugar (honey) per hard tablet. 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 celiac disease.
Each hard tablet contains no more than 19.52 micrograms of gluten.
Patients with a wheat allergy (other than celiac 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.

Fragrances: citral, geraniol, d-limonene, and linalool
Citral, geraniol, d-limonene, and linalool may cause allergic reactions.

Quinoline yellow (E 104) and sodium
The medicine may cause allergic reactions.
Quinoline yellow contains trace amounts of sodium. The medicine contains less than 1 mmol (23 mg) of sodium per hard tablet, meaning the medicine is considered "sodium-free".

3. How to use Strepsils with honey and lemon

This medicine should always be used exactly as described in this patient information leaflet or as advised by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
For use on the oral mucosa.
Adults and children over 6 years of age: slowly suck one lozenge every 2 to 3 hours.
Use the lowest effective dose for the shortest duration necessary to relieve symptoms. Do not exceed a dose of 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 honey and lemon
Overdose should not cause any disturbances other than gastrointestinal complaints. Symptomatic treatment should be applied.
Missed dose of Strepsils with honey and lemon
Do not take a double dose to make up for a missed lozenge.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

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

• hypersensitivity reactions [may manifest as rash, angioedema (skin and mucosal swelling), 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.), oral swelling, and glossodynia (burning mouth)], tongue pain,
• rash.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform your doctor, pharmacist, or nurse. 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.: 22 49-21-301, fax: 22 49-21-309,
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the Marketing Authorisation Holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Strepsils with Honey and Lemon

Store below 25°C.
Keep the medicine out of 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 should 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 with honey and lemon contains

• The active substances are: 2,4-dichlorobenzyl alcohol and amylometacresol. Each hard tablet contains 1.2 mg of 2,4-dichlorobenzyl alcohol and 0.6 mg of amylometacresol.
• Other ingredients are: honey, peppermint oil (containing, among others, d-limonene), lemon oil (containing, among others, citral, geraniol, d-limonene and linalool), tartaric acid, quinoline yellow (E 104), glucose syrup (containing, among others, sulfur dioxide (E 220)), sucrose syrup.

What Strepsils with honey and lemon looks like and contents of the pack
Yellow, round hard tablet with a lemon flavour.
Pack contains 8, 12, 24 or 36 hard tablets. The pack containing 8 tablets is in a cardboard wallet. Polypropylene tube containing 10 tablets.
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