INOVOX 1.2 mg/0.6 mg Lozenge

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
2. What is Inovox Express Active mint flavor and what is it used for
3. Important information before taking Inovox Express Active mint flavor
   1. When not to take Inovox Express Active mint flavor
   2. Warnings and precautions
   3. Children and adolescents
   4. Inovox Express Active mint flavor and other medicines
   5. Pregnancy, breastfeeding, and fertility
   6. Driving and using machines
   7. Inovox Express Active mint flavor contains maltitol liquid and isomalt
   8. Inovox Express Active mint flavor contains sodium
4. How to take Inovox Express Active mint flavor
   1. Recommended dosage
   2. Use in children and adolescents
   3. Overdose of Inovox Express Active mint flavor
   4. Missed dose of Inovox Express Active mint flavor
5. Possible side effects
   1. Reporting side effects
6. How to store Inovox Express Active mint flavor
7. Package contents and other information
   1. What Inovox Express Active mint flavor contains
   2. What Inovox Express Active mint flavor looks like and what the package contains
   3. Marketing authorization holder and manufacturer
   4. Marketing authorization holder:
   5. Manufacturer:
   6. For more detailed information, please contact:
   7. Date of last update of the leaflet:

Leaflet attached to the packaging: patient information

Inovox Express Active mint flavor, 1.2 mg + 0.6 mg, hard lozenges
2,4-Dichlorobenzyl alcohol + Amylometacresol

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor, pharmacist, or nurse.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.
• If there is no improvement or the patient feels worse after 3 days, they should contact their doctor.

Table of contents of the leaflet

• 1. What is Inovox Express Active mint flavor and what is it used for
• 2. Important information before taking Inovox Express Active mint flavor
• 3. How to take Inovox Express Active mint flavor
• 4. Possible side effects
• 5. How to store Inovox Express Active mint flavor
• 6. Package contents and other information

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

Inovox Express Active mint flavor is intended for symptomatic treatment of inflammatory conditions of the mouth and throat in adults and children over 6 years old.
Each Inovox Express Active mint flavor lozenge contains two active substances: amylometacresol and 2,4-dichlorobenzyl alcohol with antiseptic action.
The active substances in the medicine have local antiviral, antibacterial, and antifungal effects.
Sucking the lozenge releases the active substances, which helps to relieve throat pain.
If there is no improvement or the patient feels worse after 3 days, they should consult their doctor.

2. Important information before taking Inovox Express Active mint flavor

When not to take Inovox Express Active mint flavor

• If the patient is allergic to the active substances or any of the other ingredients of this medicine (listed in section 6)
• In children under 6 years old.

Warnings and precautions

Before starting to take the medicine, the patient should discuss it with their doctor or pharmacist if they have an intolerance to some sugars.
Due to the size of the hard lozenges, small children may choke on the medicine.
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Children and adolescents

This medicine should not be taken by children under 6 years old.

Inovox Express Active mint flavor and other medicines

No clinically significant interactions of this medicine with other medicines are known.
The patient should tell their doctor or pharmacist about all medicines they are taking or have recently taken, as well as any medicines they plan to take.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
There are insufficient data on the use of amylometacresol and 2,4-dichlorobenzyl alcohol during pregnancy. Due to the lack of documented safety, the medicine is not recommended during pregnancy.
Breastfeeding
It is not known whether 2,4-dichlorobenzyl alcohol and amylometacresol and their metabolites pass into human milk. The risk to newborns and infants cannot be excluded.
Due to the 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 using machines

The effect of the medicine on the ability to drive and use machines is not known.

Inovox Express Active mint flavor contains maltitol liquid and isomalt

If the patient has previously been diagnosed with an intolerance to some sugars, they should consult their doctor before taking the medicine.

Inovox Express Active mint flavor contains sodium

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

3. How to take Inovox Express Active mint flavor

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.
For use on the mucous membrane of the mouth.

Recommended dosage

Adults: one lozenge as needed, every 2-3 hours. Do not take more than 8 lozenges in 24 hours.

Use in children and adolescents

Children over 6 years old: one lozenge every minimum 2 hours, maximum 4 lozenges in 24 hours.
This medicine should not be taken by children under 6 years old.
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The lozenge should be sucked slowly. Do not swallow, chew, or crush.
The patient should use the smallest effective dose for the shortest duration necessary to relieve symptoms, not longer than 3 days.
Long-term use of the medicine is not recommended. If there is no improvement or symptoms recur frequently, the patient should consult their doctor.
If symptoms persist for more than 3 days, worsen, or other symptoms appear, such as high fever, headache, nausea, or vomiting and skin rash, the patient should contact their doctor.
Do not exceed the recommended dose.

Overdose of Inovox Express Active mint flavor

In case of overdose, gastrointestinal disorders may occur. The patient should stop taking the medicine and consult their doctor or pharmacist.

Missed dose of Inovox Express Active mint flavor

The patient should not take a double dose to make up for a missed lozenge.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects of unknown frequency (cannot be estimated from the available data):
Allergic reactions, rash, abdominal pain, nausea, discomfort in the mouth, tongue pain.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should consult their doctor or pharmacist. 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
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301, Fax: +48 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 Inovox Express Active mint flavor

The medicine should be stored out of sight and reach of children.
Do not take 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. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Package contents and other information

What Inovox Express Active mint flavor contains

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The active substances of the medicine are:2,4-Dichlorobenzyl alcohol and Amylometacresol.
Each hard lozenge contains 1.2 mg of 2,4-Dichlorobenzyl alcohol and 0.6 mg of Amylometacresol.
Other ingredients are:Peppermint oil, Star anise oil, Levomenthol, Sodium saccharin (E 954), Tartaric acid (E 334), Isomalt, Liquid maltitol, Indigo carmine (E 132), Quinoline yellow (E 104).

What Inovox Express Active mint flavor looks like and what the package contains

Inovox Express Active mint flavor is a round, green lozenge with a mint flavor, 19 mm in diameter.
The lozenges are packaged in PVC/PVDC/Aluminum blisters in a cardboard box with a leaflet.
The package contains 8, 12, 24, or 48 lozenges.

Marketing authorization holder and manufacturer

Marketing authorization holder:

US Pharmacia Sp. z o.o.,
ul. Ziębicka 40,
50-507 Wrocław

Manufacturer:

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

For more detailed information, please contact:

USP Zdrowie Sp. z o.o., ul. Poleczki 35, 02-822 Warsaw, phone +48 (22) 543 60 00.

Date of last update of the leaflet:

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