Strepsils pomaranihovi z vitaminom C

Leaflet attached to the packaging: patient information

Strepsils orange with vitamin C, 1.2 mg + 0.6 mg, hard lozenges
Alcohol 2,4–dichlorobenzylicus + Amylmetacresolum

You should carefully read the contents of the leaflet 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.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If you experience any side effects, including any possible side effects not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.
• If after 3 days there is no improvement or you feel worse, you should contact your doctor.

Table of contents of the leaflet

• 1. What is Strepsils orange with vitamin C and what is it used for
• 2. Important information before using Strepsils orange with vitamin C
• 3. How to use Strepsils orange with vitamin C
• 4. Possible side effects
• 5. How to store Strepsils orange with vitamin C
• 6. Package contents and other information

1. What is Strepsils orange with vitamin C and what is it used for

Strepsils orange with vitamin C contains:

• two active substances with antibacterial and antiviral effects
• vitamin C.

Strepsils orange with vitamin C is intended for symptomatic treatment of inflammatory conditions of the mouth and throat.

2. Important information before using Strepsils orange with vitamin C

When not to use Strepsils orange with vitamin C:

• 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.

Warnings and precautions:

Before using Strepsils orange with vitamin C, you should consult a doctor if you have:

• diabetes (one lozenge contains about 2.4 g of sugars),
• intolerance to some sugars.

Strepsils orange with vitamin C and other medicines

So far, no clinically significant interactions between Strepsils orange with vitamin C and other medicines have been reported.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your 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 orange with vitamin C contains:

• Glucose and sucroseIf you have previously been diagnosed with intolerance to some sugars, you should consult your doctor before taking the medicine. The medicine contains 1.44 g of sucrose and 0.97 g of glucose per hard lozenge. This should be taken into account in patients with diabetes.
• This medicine contains very small amounts of gluten (from wheat starch present in liquid glucose) and is considered "gluten-free". It is therefore very unlikely to cause any problems in patients with celiac disease. One hard lozenge contains no more than 19.36 micrograms of gluten. Patients with a wheat allergy (other than celiac disease) should not use this medicine.
• Sulfur dioxide (E220) present in liquid glucoseThe medicine may rarely cause severe hypersensitivity reactions and bronchospasm due to the trace amounts of sulfur dioxide (E220) present in liquid glucose.
• Propylene glycolThis medicine contains 3 mg of propylene glycol in each hard lozenge.
• SodiumThe medicine contains less than 1 mmol (23 mg) of sodium per hard lozenge, which means the medicine is considered "sodium-free".

Orange essence (including citral, citronellol, d-limonene, geraniol, linalol, and ethanol)
Citral, citronellol, d-limonene, geraniol, and linalol may cause allergic reactions.
This medicine contains 0.156 micrograms of alcohol (ethanol) in each hard lozenge. The amount of alcohol in one hard lozenge of this medicine is equivalent to less than 1 ml of beer or 1 ml of wine. The small amount of alcohol in this medicine will not have noticeable effects. Ethanol comes from orange essence.

• Orange yellow (E110) and cochineal red (E124)The medicine may cause allergic reactions.

3. How to use Strepsils orange with vitamin C

This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist.
For use on the mucous membrane of the mouth.
Adults and children over 6 years of age: slowly suck one lozenge every 2-3 hours.
You should not use more than 8 lozenges per day. If after 3 days the symptoms do not improve or worsen, you should consult a doctor.

Using a higher dose of Strepsils orange with vitamin C than recommended

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

Missing a dose of Strepsils orange with vitamin C

You should not use a double dose to make up for a missed lozenge.
If you have any further doubts about using this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Possible side effects with unknown frequency (frequency cannot be estimated from the available data) include:

• hypersensitivity reactions that may manifest as rash, angioedema (skin and mucous membrane swelling), urticaria, bronchospasm, and hypotension with fainting,
• rash,
• abdominal pain,
• nausea,
• discomfort in the mouth that 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.

Reporting side effects
If you experience any side effects, including any possible side effects not listed in this leaflet, you should 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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Strepsils orange with vitamin C

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 carton after: EXP. The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste containers. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Strepsils orange with vitamin C 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 are: ascorbic acid, sodium ascorbate, levomenthol, orange essence (also containing citral, citronellol, d-limonene, geraniol, linalol, and ethanol), tartaric acid, propylene glycol, orange yellow (E110), cochineal red (E124), liquid glucose (containing sulfur dioxide (E220)), and sucrose.

What Strepsils orange with vitamin C looks like and what the package contains

Orange, round hard lozenge with an orange flavor.
The package contains 8, 12, 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: