Strepsils z miodem i citrinom

Package Leaflet: Information for the Patient

Strepsils with Honey and Lemon, 1.2 mg + 0.6 mg, Hard Lozenges
Alcohol 2,4–dichlorobenzylicus + Amylmetacresolum

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist.

• This 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 any possible side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse after 3 days, they should contact their doctor.

Table of Contents of the Leaflet

• 1. What Strepsils with Honey and Lemon is and what it is used for
• 2. Important information before using Strepsils with Honey and Lemon
• 3. How to use 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 effects
• honey as an excipient.

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

2. Important 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 any of the other ingredients of this medicine (listed in section 6);
• in children under 6 years of age.

Warnings and precautions:

Before using Strepsils with Honey and Lemon, the patient should discuss it with their doctor if they have:

• -diabetes (one lozenge contains approximately 2.5 g of sugars),
• intolerance to some sugars.

Strepsils with Honey and Lemon and other medicines

No clinically significant interactions between Strepsils with Honey and Lemon and other medicines are known.

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.

Driving and using machines

The effect of the medicine on the ability to drive and use machines is not known.

Strepsils with Honey and Lemon contains:

Glucose, sucrose, and invert sugar (honey)

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine. The medicine contains 1.44 g of sucrose and 0.98 g of glucose, as well as 100.9 mg of invert sugar (honey) per hard lozenge. This should be taken into account in patients with diabetes.

Wheat starch from glucose syrup

This medicine contains very small amounts of gluten (from wheat starch present in glucose syrup) and is considered "gluten-free". It is therefore very unlikely to cause any problems in patients with coeliac disease. One hard lozenge contains no more than 19.52 micrograms of gluten. Patients with a wheat allergy (other than coeliac disease) should not use this medicine.

Sulfur dioxide (E 220) from glucose syrup

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

Flavoring substances with 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 lozenge, which means it 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 leaflet or as directed by a doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist. For use on the mucous membrane of the mouth. Adults and children over 6 years: suck slowly one lozenge every 2-3 hours. The patient should use the smallest effective dose for the shortest duration necessary to relieve symptoms. The dose should not exceed 8 lozenges per day. If symptoms do not improve or worsen after 3 days, the patient should consult their doctor.

Using more than the recommended dose of Strepsils with Honey and Lemon

Overdose is unlikely to cause any symptoms other than gastrointestinal disorders. Symptomatic treatment should be applied.

Missing a dose of Strepsils with Honey and Lemon

The patient should not take a double dose to make up for a missed lozenge. If the patient has any further questions on the use of this medicine, they 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:

Frequency not known(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, discomfort in the mouth [may manifest as irritation of the throat, paresthesia in the mouth (abnormal sensations in the mouth such as warmth, burning, tingling, numbness, etc.), swelling of the mouth, and glossodynia (burning sensation in the mouth)], soreness of the tongue,
• rash.

Reporting side effects
If the patient experiences any side effects, including any side effects not listed in the leaflet, they should inform their doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309,
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Strepsils with Honey and Lemon

Store in a temperature below 25°C.
The medicine should be stored 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 month stated.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Strepsils with Honey and Lemon contains

• The active substances of the medicine are: 2,4-dichlorobenzyl alcohol and amylmetacresol. One hard lozenge contains 1.2 mg of 2,4-dichlorobenzyl alcohol and 0.6 mg of amylmetacresol.
• The other ingredients of the medicine are: honey, peppermint oil (contains, among others, d-limonene), lemon oil (contains, among others, citral, geraniol, d-limonene, and linalool), tartaric acid, Quinoline Yellow (E 104), glucose syrup (contains, among others, sulfur dioxide (E 220)), sucrose syrup.

What Strepsils with Honey and Lemon looks like and contents of the pack

Yellow, round hard lozenge with a lemon flavor.
The pack contains 8, 12, 24, or 36 hard lozenges. The pack contains 8 lozenges in a cardboard box in the form of a wallet. A polypropylene tube containing 10 lozenges. Not all pack sizes may be marketed.

Marketing authorization holder and importer

Marketing authorization 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,
Netherlands

Date of last revision of the leaflet: