STREPSILS JUNIOR

Patient Information Leaflet

Strepsils Junior, 1.2 mg + 0.6 mg, hard pastilles
Alcohol 2,4–dichlorobenzylicus + Amylmetacresolum
Please read all of this leaflet carefully before you start 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 directed 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 contact your pharmacist.
• If you experience any adverse effects, 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 of treatment, or if you feel worse, consult your doctor.

Table of Contents

1. What Strepsils Junior is and what it is used for
2. Important information before taking 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 Strepsils Junior is and what it is used for

For use in inflammatory conditions of the mouth and throat.
Each Strepsils Junior pastille contains two active substances with antiviral and antibacterial properties.
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 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.

The energy value of one tablet is 5.5 kcal/23 kJ.
Warnings and precautions
Before starting to use Strepsils Junior, consult a doctor if the patient
has intolerance to certain sugars.
Strepsils Junior with other medicines
Clinically significant interactions of Strepsils Junior with other medicines are currently unknown.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant,
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 Junior contains:
Maltitol (E 965) and isomalt
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should
consult a doctor before taking the medicine. The medicine may have a mild laxative effect.
Energy value: 2.3 kcal/g of maltitol/isomalt. One hard tablet contains 0.458 g of maltitol
and 1.83 g of isomalt.
Strawberry flavour with benzyl alcohol and propylene glycol
The medicine contains a flavouring substance with benzyl alcohol. Benzyl alcohol may cause
allergic reactions. This medicine contains 7.3 mg of propylene glycol per hard tablet.
Sodium [from sodium saccharin and colouring Pink Anto P-WS (anthocyanin) (E 163)]
The medicine contains less than 1 mmol (23 mg) of sodium per hard tablet, meaning 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 information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
For use on 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 Junior
Overdose should not cause any disturbances other than gastrointestinal discomfort. Symptomatic treatment should be applied.
Missed dose of Strepsils Junior
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 a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody 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.), oral swelling, and glossodynia (burning sensation in the mouth)], tongue pain,
• rash.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a 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.: +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 Junior

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 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 amylometacresol. Each hard pastille contains 1.2 mg of 2,4-dichlorobenzyl alcohol and 0.6 mg of amylometacresol.
• Other ingredients: strawberry flavour (containing, among others, 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 pastilles with a strawberry flavour.
Packs contain 12, 16, 24 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