Strepsils Iunior

Package Leaflet: Information for the Patient

Strepsils Junior, 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 your doctor or pharmacist.

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

Table of Contents of the Leaflet

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

1. What is Strepsils Junior and what is it used for

For use in inflammatory conditions of the mouth and throat.
Each Strepsils Junior lozenge contains two active substances with antiviral and antibacterial action.
Strepsils Junior is intended for symptomatic treatment of inflammatory conditions of the mouth and throat.

2. Important information before using Strepsils Junior

When not to use Strepsils Junior:

• if you are 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.

The caloric value of one lozenge is 5.5 kcal/23 kJ.

Warnings and precautions

Before starting to use Strepsils Junior, discuss it with your doctor if you have intolerance to some sugars.

Strepsils Junior and other medicines

No clinically significant interactions of Strepsils Junior with other medicines are known.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice 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 Junior contains:

Maltitol (E 965) and isomalt

If you have previously been diagnosed with intolerance to some sugars, you should consult your doctor before taking the medicine. The medicine may have a mild laxative effect.
The caloric value is 2.3 kcal/g of maltitol/isomalt. One hard lozenge contains 0.458 g of maltitol and 1.83 g of isomalt.

Strawberry flavoring with benzyl alcohol and propylene glycol

The medicine contains a flavoring substance with benzyl alcohol. Benzyl alcohol may cause allergic reactions. This medicine contains 7.3 mg of propylene glycol per hard lozenge.

Sodium [from sodium saccharin and Pink Anto P-WS (anthocyanin) (E 163)]

The medicine contains less than 1 mmol (23 mg) of sodium per hard lozenge, which means that the medicine is considered "sodium-free".

3. How to use Strepsils Junior

This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor or pharmacist. In case of doubt, consult your 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.
Use the smallest effective dose for the shortest duration necessary to relieve symptoms. Do not use more than 8 lozenges per day.
If after 3 days the symptoms do not improve or worsen, consult your doctor.

Using more than the recommended dose of Strepsils Junior

Overdose should not cause other disorders than gastrointestinal disorders. Symptomatic treatment should be applied.

Missing a dose of Strepsils Junior

Do not take a double dose to make up for a missed lozenge.
In case of further doubts about the use of this medicine, consult your 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 (skin and mucous membrane swelling), urticaria, bronchospasm, and hypotension with syncope],
• abdominal pain, nausea, discomfort in the mouth [may manifest as throat irritation, paresthesia in the mouth (abnormal sensations in the mouth such as warmth, burning, tingling, numbness, etc.), mouth swelling, and glossodynia (burning in the mouth)], tongue pain,
• rash.

Reporting side effects
If you experience any side effects, including those not listed in this leaflet, tell your 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Strepsils Junior

Store in a temperature 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 month.
Medicines should not be disposed of via wastewater or household waste. Ask your 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 Junior contains

• The active substances 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 are: strawberry flavoring (contains propylene glycol and benzyl alcohol), Pink Anto P-WS (anthocyanin) (E 163), sodium saccharin (E 954), tartaric acid, liquid maltitol (E 965), isomalt.

What Strepsils Junior looks like and contents of the pack

Pink, round hard lozenge with a strawberry flavor.
The pack contains 12, 16, 24, or 36 hard 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: