Strepsils orange with vitamin c

Patient Information Leaflet

Strepsils Orange with Vitamin C, 1.2 mg + 0.6 mg, hard pastilles
Dichlorobenzyl alcohol + Amylmetacresol
Please read the entire 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.

• Keep this leaflet for future reference.
• 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, consult a doctor.

Table of Contents

1. What Strepsils Orange with Vitamin C is and what it is 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. Contents of the pack and other information

1. What Strepsils Orange with Vitamin C is and what it is used for

Strepsils Orange with Vitamin C contains:

• two active substances with antiviral and antibacterial properties,
• vitamin C.

Strepsils Orange with Vitamin C is intended for symptomatic relief 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 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 Orange with Vitamin C, consult a doctor if the patient has:

• diabetes (one tablet contains approximately 2.4 g of sugars),
• intolerance to certain sugars.

Strepsils Orange with Vitamin C and other medicines
Clinically significant interactions between Strepsils Orange with Vitamin C 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 child, 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 Orange with Vitamin C contains:

• Glucose and sucrose If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact a doctor before taking this medicine. The medicine contains 1.44 g of sucrose and 0.97 g of glucose per hard tablet. This should be taken into account in patients with diabetes.
• Wheat starch (containing gluten) present in liquid glucose This medicine contains a very small amount of gluten (derived from wheat starch present in liquid glucose) and is classified as "gluten-free". Therefore, it is very unlikely to cause any problems in patients with celiac disease. One hard tablet contains no more than 19.36 micrograms of gluten. Patients with wheat allergy (other than celiac disease) should not use this medicine.
• Sulfur dioxide (E 220) present in liquid glucose This medicine may rarely cause severe hypersensitivity reactions and bronchospasm due to trace amounts of sulfur dioxide (E 220) present in liquid glucose.
• Propylene glycol This medicine contains 3 mg of propylene glycol in each hard tablet.
• Sodium The medicine contains less than 1 mmol (23 mg) of sodium per hard tablet, meaning the medicine is considered "sodium-free".

Orange flavouring (including citral, citronellol, d-limonene, geraniol, linalool, and ethanol)
Citral, citronellol, d-limonene, geraniol, and linalool may cause allergic reactions.
This medicine contains 0.156 micrograms of alcohol (ethanol) in each hard tablet. The amount of alcohol in one hard tablet 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 cause noticeable effects. Ethanol is derived from orange flavouring.

• Orange yellow (E 110) and carmine red (E 124) 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 information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
For oral mucosal use.
Adults and children over 6 years of age: slowly suck one lozenge every 2–3 hours.
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 Orange with Vitamin C
Overdose should not cause any adverse effects other than gastrointestinal discomfort. Symptomatic treatment should be administered.
Missed use of Strepsils Orange with Vitamin C
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 everyone experiences them.
Possible adverse reactions with unknown frequency (frequency cannot be estimated from available data) include:

• hypersensitivity reactions which may manifest as rash, angioedema (skin and mucosal swelling), urticaria, bronchospasm, and hypotension with fainting,
• rash,
• abdominal pain,
• nausea,
• oral discomfort which may present as throat irritation, 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.

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, phone: +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 Authorisation Holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Strepsils orange with vitamin C

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 carton after EXP. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Strepsils Orange with Vitamin C contains

• The active substances are: 2,4-dichlorobenzyl alcohol and amylometacresol. Each pastille contains 1.2 mg of 2,4-dichlorobenzyl alcohol and 0.6 mg of amylometacresol.
• Other components are: ascorbic acid, sodium ascorbate, levomenthol, orange flavour (containing also citral, citronellol, d-limonene, geraniol, linalool and ethanol), tartaric acid, propylene glycol, sunset yellow (E 110), cochineal red (E 124), liquid glucose (containing sulphur dioxide (E 220)) and liquid sucrose.

What Strepsils Orange with Vitamin C looks like and contents of the pack
Orange, round pastilles with an orange flavour.
Pack contents: 8, 12, 24 or 36 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. (22) 211 26 92
Importer:
RB NL Brands B.V.
WTC Schiphol Airport,
Schiphol Boulevard 207,
1118 BH Schiphol,
The Netherlands