Inovox Express Active smak miodovo-citrinovi

Package Leaflet: Information for the Patient

Inovox Express Active Honey-Lemon Flavor, 1.2 mg + 0.6 mg, Hard Lozenges
2,4-Dichlorobenzyl Alcohol and Amylometacresol

Read the package 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 package leaflet for the patient or as advised by a doctor, pharmacist, or nurse.

• This package 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 package leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after 3 days or the patient feels worse, they should contact their doctor.

Table of Contents of the Package Leaflet

• 1. What is Inovox Express Active Honey-Lemon Flavor and what is it used for
• 2. Important information before using Inovox Express Active Honey-Lemon Flavor
• 3. How to take Inovox Express Active Honey-Lemon Flavor
• 4. Possible side effects
• 5. How to store Inovox Express Active Honey-Lemon Flavor
• 6. Package contents and other information

1. What is Inovox Express Active Honey-Lemon Flavor and what is it used for

Inovox Express Active Honey-Lemon Flavor is used for the symptomatic treatment of inflammatory conditions of the mouth and throat in adults and children over 6 years of age.
Each Inovox Express Active Honey-Lemon 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 alleviate throat pain.
If there is no improvement after 3 days or the patient feels worse, they should consult their doctor.

2. Important information before using Inovox Express Active Honey-Lemon Flavor

Honey-Lemon Flavor

When not to use Inovox Express Active Honey-Lemon 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 of age.

Warnings and precautions

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

Children and adolescents

This medicine should not be used in children under 6 years of age.

Inovox Express Active Honey-Lemon Flavor and other medicines

No clinically significant interactions with other medicines have been reported.
The patient should inform 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 using 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 breast 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 effects 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 Honey-Lemon Flavor contains liquid maltitol (E 965) and isomalt (E

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

Inovox Express Active Honey-Lemon Flavor contains the colorant Orange Yellow S (E

• 110).The medicine may cause allergic reactions.

The medicine contains the fragrance substance citral.

Citral may cause allergic reactions.

Inovox Express Active Honey-Lemon 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 Honey-Lemon Flavor

This medicine should always be used exactly as described in this package leaflet for the patient or as advised 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.
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Recommended dosage

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

Use in children and adolescents

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

Using more than the recommended dose of Inovox Express Active Honey-Lemon Flavor

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

Missing a dose of Inovox Express Active Honey-Lemon Flavor

Do 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):
May cause hypersensitivity reactions, rash, abdominal pain, nausea, discomfort in the mouth, tongue pain.

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in the package leaflet, they should inform 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, Tel.: +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. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Inovox Express Active Honey-Lemon Flavor

The medicine should be stored out of sight and reach of children.
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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 month stated.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Inovox Express Active Honey-Lemon Flavor contains

The active substances 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, Quinoline Yellow (E 104), Sodium Saccharin (E 954), Tartaric Acid (E 334), Isomalt (E 953), Liquid Maltitol (E 965), Orange Yellow S (E 110), Lemon Flavor (lemon oil, terpenes, natural citral), Honey Flavor (including 1,2-Propanediol, benzoic acid, other).

What Inovox Express Active Honey-Lemon Flavor looks like and contents of the package

Inovox Express Active Honey-Lemon Flavor is a round, yellow lozenge with a honey-lemon flavor, 19 mm in diameter.
The lozenges are packaged in PVC/PVDC/Aluminum blisters in a cardboard box with a package 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 information, please contact:

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

Date of last revision of the package leaflet:

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