INOVOX 2 mg + 0.6 Mg + 1.2 Mg Lozenge

Contents of the leaflet

1. Package Leaflet: Information for the Patient
   1. Read the Leaflet Carefully Before Using the Medication, as it Contains Important Information for the Patient.
   2. Table of Contents of the Leaflet
2. What is Inovox Express Mint Flavor and what is it used for
3. Important information before using Inovox Express Mint Flavor
   1. When not to use Inovox Express Mint Flavor
   2. Warnings and precautions
   3. Children and adolescents
   4. Inovox Express Mint Flavor and other medications
   5. Using Inovox Express Mint Flavor with food, drink, and alcohol
   6. Pregnancy and breastfeeding
   7. Driving and operating machinery
   8. Inovox Express Mint Flavor contains glucose and sucrose.
   9. Inovox Express Mint Flavor contains sodium.
4. How to take Inovox Express Mint Flavor
   1. Use in children and adolescents
   2. Using more than the recommended dose of Inovox Express Mint Flavor
5. Possible side effects
   1. Reporting side effects
6. How to store Inovox Express Mint Flavor
7. Package contents and other information
   1. What Inovox Express Mint Flavor contains
   2. What Inovox Express Mint Flavor looks like and what the package contains
   3. Marketing authorization holder:
   4. Manufacturer:
   5. For more detailed information, please contact:
   6. This medicinal product is authorized for sale in the Member States of the European Economic Area under the following names:
   8. Date of last revision of the leaflet:

Package Leaflet: Information for the Patient

Inovox Express Mint Flavor, 2 mg + 0.6 mg + 1.2 mg, Hard Lozenges
Lidocaine Hydrochloride + Amylmetacresol + 2,4-Dichlorobenzyl Alcohol

Read the Leaflet Carefully Before Using the Medication, as it Contains Important Information for the Patient.

This medication should always be used exactly as described in this patient leaflet or as advised by your doctor, pharmacist, or nurse.

• Keep this leaflet, you may need to read it again.
• If you need advice or further information, consult a pharmacist.
• If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.
• If after 2 days there is no improvement or you feel worse, contact your doctor.

Table of Contents of the Leaflet

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

1. What is Inovox Express Mint Flavor and what is it used for

Inovox Express Mint Flavor contains antiseptics - amylmetacresol and 2,4-dichlorobenzyl alcohol - and a local anesthetic for the throat - lidocaine hydrochloride.
The medication is indicated for local antiseptic treatment of inflammatory conditions (redness, swelling) of the throat and mouth, as well as for relieving pain in these conditions.
It soothes throat pain symptoms.
Inovox Express Mint Flavor is intended for adults and adolescents over 12 years old.
If after 2 days there is no improvement or you feel worse, consult your doctor.

2. Important information before using Inovox Express Mint Flavor

When not to use Inovox Express Mint Flavor

• If you are allergic to lidocaine hydrochloride or other amide local anesthetics, amylmetacresol, 2,4-dichlorobenzyl alcohol, or any of the other ingredients of this medication (listed in section 6).
• Do not use this medication in children under 12 years old.

Warnings and precautions

Before using Inovox Express Mint Flavor, discuss it with your doctor, pharmacist, or nurse.
Tell your doctor if:

• you have asthma,
• symptoms do not decrease after 2 days or if you develop a fever, headache, nausea, vomiting, or skin rash.

The medication may be harmful to teeth.

• The anesthetics in this medication may cause choking (coughing during meals or feeling of choking) while eating. Do not eat a meal immediately after using the medication.
• The medication may cause numbness of the tongue and increase the risk of biting. Be careful while eating and drinking hot foods and beverages.
• Do not use this medication for more than 5 days, as it may change the natural bacterial flora in the throat.
• Follow the recommended dosage: using the medication in high doses or for a long time may affect the heart or nervous system and may cause seizures.
• Elderly or weakened individuals are more susceptible to possible side effects and should consult a doctor before taking this medication.
• Do not use this medication if there are large, unhealed wounds in the mouth and throat.

Children and adolescents

Do not use this medication in children under 12 years old.

Inovox Express Mint Flavor and other medications

Tell your doctor or pharmacist about all medications you are currently taking or plan to take.
In particular, tell your doctor or pharmacist if you are taking any of the following medications, as their dosage may need to be adjusted:

• beta blockers (used to treat heart failure or vascular disease) or medications containing cimetidine (used to treat stomach ulcers),
• other local anesthetics (amides),
• medications used to treat heart conditions, such as mexiletine or procainamide,
• medications such as fluvoxamine (used to treat depression),
• antibiotics such as erythromycin or itraconazole.

Although there should be no interactions, do not use other antiseptic medications for oral or throat use while using Inovox Express Mint Flavor.

Using Inovox Express Mint Flavor with food, drink, and alcohol

Do not use this medication before a meal or drink.

Pregnancy and breastfeeding

Pregnancy:
Do not use this medication during pregnancy.
Breastfeeding:
Do not use this medication during breastfeeding.

Driving and operating machinery

This medication, when used as recommended, has no effect or a negligible effect on the ability to drive or operate machinery.

Inovox Express Mint Flavor contains glucose and sucrose.

The medication contains 1.016 g of glucose and 1.495 g of sucrose per lozenge. This should be taken into account for patients with diabetes. If you have previously been diagnosed with intolerance to some sugars, consult your doctor before taking this medication.

Inovox Express Mint Flavor contains sodium.

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The medication contains less than 1 mmol (23 mg) of sodium per lozenge, which means the medication is considered "sodium-free".
Inovox Express Mint Flavor contains terpenes found in levomenthol.Excessive doses of terpenes may lead to neurological complications, such as seizures in children.

3. How to take Inovox Express Mint Flavor

Follow the instructions in this leaflet. This medication should always be used as advised by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
Recommended dosage:

• Adults and adolescents over 12 years old: slowly dissolve one lozenge in the mouth every 2 to 3 hours; use a maximum of 8 lozenges in 24 hours for adults (maximum 4 lozenges for adolescents).

Do not place between the gum and cheek.
If after 2 days there is no improvement or you feel worse, contact your doctor.
Do not use this medication for more than 5 days, as it may change the natural bacterial flora in the throat.

Use in children and adolescents

Do not use this medication in children under 12 years old.

Using more than the recommended dose of Inovox Express Mint Flavor

Symptoms that may occur in case of incorrect use or overdose include:
excessive numbing of the upper digestive tract and airways, insomnia, restlessness, excitement, depression, respiratory depression. Methemoglobinemia may also occur, with symptoms such as: shortness of breath, headache, fatigue, intolerance to exertion, dizziness, and loss of consciousness. Seek medical attention immediately or contact a poison control center, stating the name of the medication and the dose taken.
If you have any further questions about using this medication, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medications, Inovox Express Mint Flavor can cause side effects, although not everybody gets them.
The following side effects have been reported during the use of the active substances in this medication:

• angioedema (swelling of the face, tongue, or throat),
• difficulty swallowing,
• hives and difficulty breathing.

Rarely (occurring in less than 1 in 1000 patients): hypersensitivity reactions (burning, itching), angioedema, burning sensation in the throat, and unpleasant taste.
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Reporting side effects

If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring 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 gather more information on the safety of this medication.

5. How to store Inovox Express Mint Flavor

Store the medication out of sight and reach of children.
Do not use this medication after the expiration date stated on the packaging after "EXP". The expiration date is the last day of the specified month.
Do not store above 30°C.
Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of unused medications. This will help protect the environment.

6. Package contents and other information

What Inovox Express Mint Flavor contains

The active substances of the medication are: lidocaine hydrochloride, amylmetacresol, 2,4-dichlorobenzyl alcohol.
Each hard lozenge contains:
Lidocaine hydrochloride monohydrate 2 mg,
Amylmetacresol 0.6 mg,
2,4-Dichlorobenzyl alcohol 1.2 mg.
Other ingredients are:
Peppermint oil with reduced menthol content,
Star anise oil,
Levomenthol,
Indigo carmine (E 132),
Quinoline yellow (E 104),
Sodium saccharin (E 954),
Tartaric acid (E 334),
Sucrose,
Glucose syrup.

What Inovox Express Mint Flavor looks like and what the package contains

Inovox Express Mint Flavor is a green, biconvex, cylindrical hard lozenge with a diameter of 19 mm, mint flavor.
The lozenges are packaged in PVC/PVDC/Aluminum blisters.
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The package contains 12, 24, or 36 lozenges.

Marketing authorization holder:

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

Manufacturer:

LOZY’S PHARMACEUTICALS S.L.,
Campus Empresarial s/n,

• 31795- Lekaroz Navarra, Spain

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

For more detailed information, please contact:

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

This medicinal product is authorized for sale in the Member States of the European Economic Area under the following names:

Poland:
INOVOX Express Mint Flavor
Bulgaria:
INOVOX Express mint flavor
Lithuania:
Inovox menthol 2 mg/ 0.6 mg / 1.2 mg hard lozenges

Date of last revision of the leaflet:

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