Package leaflet: Information for the user

Inovox Express Active mint flavour, 1.2 mg + 0.6 mg, hard pastilles
Benzalkonium chloride 2,4-dichlorobenzyl alcohol + Amylmetacresol
Read the following information carefully before using this 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, pharmacist, or nurse.

Keep this leaflet, as you may need to read it again.
If you need advice or further information, consult your pharmacist.
If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
If there is no improvement within 3 days or if your condition worsens, consult a doctor.

Leaflet contents

What Inovox Express Active mint flavour is and what it is used for
Important information before using Inovox Express Active mint flavour
How to take Inovox Express Active mint flavour
Possible side effects
How to store Inovox Express Active mint flavour
Contents of the pack and other information

1. What Inovox Express Active mint flavour is and what it is used for

Inovox Express Active mint flavour is intended for symptomatic treatment of inflammatory conditions of the mouth and throat in adults and children over 6 years of age.
Each Inovox Express Active mint flavour pastille contains two active substances: amylmetacresol and 2,4-dichlorobenzyl alcohol, both with antiseptic properties.
The active substances in this medicine have local antiviral, antibacterial, and antifungal effects.
Sucking the pastille releases the active substances, thereby helping to relieve sore throat pain.
If there is no improvement within 3 days or if your condition worsens, consult a doctor.

2. Important information before using Inovox Express Active mint flavour

When not to use Inovox Express Active mint flavour

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 treatment, discuss with a doctor or pharmacist if the patient
has intolerance to certain sugars.
Due to the size of the hard pastilles, young children may choke on the medicine.
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Children and adolescents
This medicine should not be used in children under 6 years of age.
Inovox Express Active mint flavour and other medicines
Clinically significant interactions of this medicine with other medicines are currently unknown.
You should inform your doctor or pharmacist about all medicines the patient is currently taking or
has recently taken, as well as any medicines the patient plans to take.
Pregnancy, breastfeeding and fertility
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.
Pregnancy
There are insufficient data on the use of amylometacresol and 2,4-dichlorobenzyl alcohol during
pregnancy. Due to lack of documented safety, the medicine is not recommended during pregnancy.
Breastfeeding
It is unknown whether 2,4-dichlorobenzyl alcohol and amylometacresol, and their metabolites, pass into
human milk. Risk to newborns and infants cannot be excluded.
Due to lack of documented safety, the medicine is not recommended during breastfeeding.
Fertility
There are no data on the effect of amylometacresol and 2,4-dichlorobenzyl alcohol on fertility.
Driving and operating machinery
The effect of the medicine on the ability to drive and operate machinery is unknown.
Inovox Express Active mint flavour contains liquid maltitol and isomalt
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should
consult a doctor before taking this medicine.
Inovox Express Active mint flavour contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per pastille, meaning the medicine is considered "sodium-free".

3. How to take Inovox Express Active mint flavour

This medicine should always be taken exactly as described in this patient information leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
For use on the oral mucosa.
Recommended dosage
Adults: one tablet as needed, every 2–3 hours. Do not use more than 8 tablets in 24 hours.
Use in children and adolescents
Children over 6 years of age: one tablet every at least 2 hours, maximum 4 tablets in 24 hours.
Do not use this medicine in children under 6 years of age.
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Allow the tablet to dissolve slowly in the mouth. Do not swallow, chew or crush.
Use the lowest effective dose for the shortest duration necessary to relieve symptoms, not longer than 3 days.
Prolonged use of this medicine is not recommended. If there is no improvement or symptoms recur frequently, consult a doctor.
If symptoms persist for more than 3 days, worsen, or new symptoms appear such as high fever, headache, nausea or vomiting, or skin rash, consult a doctor.
Do not exceed the recommended dose.
Taking more Inovox Express Active mint flavour than recommended
Gastrointestinal disturbances may occur in case of overdose. Discontinue use and consult a doctor or pharmacist.
Missing a dose of Inovox Express Active mint flavour
Do not take a double dose to make up for a missed tablet.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Adverse reactions with unknown frequency (cannot be estimated based on available data):
Hypersensitivity reactions, rash, abdominal pain, nausea, oral discomfort, and tongue pain may occur.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, patients should contact a doctor or pharmacist. 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 Inovox Express Active mint flavour

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging following the term
"EXP". The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. Such measures help protect
the environment.

6. Contents of the packaging and other information

What Inovox Express Active mint flavour contains
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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 are: Peppermint essential oil, Star anise essential oil,
Levomenthol, Sodium saccharin (E 954), Tartaric acid (E 334), Isomalt, Liquid maltitol, Indigotine
(E 132), Quinoline yellow (E 104).

What Inovox Express Active mint flavour looks like and contents of the pack
Inovox Express Active mint flavour is a round, green pastille with a mint flavour, 19 mm in diameter.
The pastilles are packed in PVC/PVDC/Aluminium blisters, placed in a cardboard box with a leaflet.
Pack sizes contain 8, 12, 24 or 48 pastilles.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
US Pharmacia Sp. z o.o.,
Ziębicka 40 Street,
50-507 Wrocław, Poland

Manufacturer:
LOZY’S PHARMACEUTICALS S.L.,
Campus Empresarial, Lekaroz Navarra
31795, Spain

For further information, please contact:
USP Zdrowie Sp. z o.o., Poleczki 35 Street, 02-822 Warsaw, Poland, tel. +48 (22) 543 60 00.
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