INOVOX 2 mg + 0.6 Mg + 1.2 Mg Lozenge

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Inovox Express Orange Flavor,
3. 2 mg + 0.6 mg + 1.2 mg, Hard Lozenges
   1. Read the leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet
4. What is Inovox Express Orange Flavor and what is it used for
5. Important information before using Inovox Express Orange Flavor
   1. When not to use Inovox Express Orange Flavor
   2. Warnings and precautions
   3. Children and adolescents
   4. Inovox Express Orange Flavor and other medicines
   5. Using Inovox Express Orange Flavor with food, drink, and alcohol
   6. Pregnancy and breastfeeding
   7. Driving and using machines
   8. Inovox Express Orange Flavor contains glucose and sucrose.
   9. Inovox Express Orange Flavor contains sodium.
   10. Inovox Express Orange Flavor contains the dyes orange yellow and cochineal red
6. How to take Inovox Express Orange Flavor
   1. Use in children and adolescents
   2. Using more than the recommended dose of Inovox Express Orange Flavor
7. Possible side effects
   1. Reporting side effects
8. How to store Inovox Express Orange Flavor
9. Package contents and other information
   1. What Inovox Express Orange Flavor contains
   2. What Inovox Express Orange Flavor looks like and what the package contains
   3. Marketing authorization holder:
   4. Manufacturer:
   5. For more information, please contact:
   6. This medicinal product is authorized 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 Orange 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 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, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• 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 after 2 days or if the patient feels worse, they should contact their doctor.

Table of Contents of the Leaflet

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

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

Inovox Express Orange Flavor contains antiseptics - amylmetacresol and 2,4-dichlorobenzyl alcohol - and a local anesthetic for the throat - lidocaine hydrochloride.
The medicine 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 Orange Flavor is intended for adults and adolescents over 12 years of age.
If there is no improvement after 2 days or if the patient feels worse, they should consult a doctor.

2. Important information before using Inovox Express Orange Flavor

When not to use Inovox Express Orange Flavor

• If the patient is allergic to lidocaine hydrochloride or other amide local anesthetics, amylmetacresol, 2,4-dichlorobenzyl alcohol, or any of the other ingredients of this medicine (listed in section 6).
• This medicine should not be used in children under 12 years of age.

Warnings and precautions

Before using Inovox Express Orange Flavor, the patient should discuss it with their doctor, pharmacist, or nurse.
The patient should inform their doctor if:

• they have asthma,

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• symptoms do not decrease after 2 days or if fever, headache, nausea, vomiting, or skin rash occur.

The medicine may be harmful to teeth.

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

Children and adolescents

This medicine should not be used in children under 12 years of age.

Inovox Express Orange Flavor and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
In particular, the patient should inform their doctor or pharmacist if they are taking any of the following medicines, as their dosage may need to be adjusted:

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

Although there should be no interactions, the patient should not take other antiseptic medicines for use in the mouth or throat while using Inovox Express Orange Flavor.

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

The patient should not use this medicine before a meal or drinking a beverage.

Pregnancy and breastfeeding

Pregnancy:
The use of this medicine is not recommended during pregnancy.
Breastfeeding:
The use of this medicine is not recommended during breastfeeding.

Driving and using machines

This medicine, when taken in the recommended dose, has no effect or a negligible effect on the ability to drive and use machines.

Inovox Express Orange Flavor contains glucose and sucrose.

The medicine contains 1.016 g of glucose and 1.495 g of sucrose per lozenge. This should be taken into account in patients with diabetes. If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.
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Inovox Express Orange Flavor contains sodium.

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

Inovox Express Orange Flavor contains the dyes orange yellow and cochineal red

Cochineal red.The medicine may cause allergic reactions.

3. How to take Inovox Express Orange Flavor

The patient should follow the instructions in this leaflet. This medicine should always be used as directed by a doctor or pharmacist. If the patient is unsure, they should consult their doctor or pharmacist.
Recommended dosage

• Adults and adolescents over 12 years of age: 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 there is no improvement after 2 days or if the patient feels worse, they should contact their doctor.
The medicine should not be used for more than 5 days, as it may change the natural bacterial flora in the throat.

Use in children and adolescents

This medicine should not be used in children under 12 years of age.

Using more than the recommended dose of Inovox Express Orange Flavor

Symptoms that may occur in case of improper use or overdose include:
excessive numbness of the upper gastrointestinal tract and airways, insomnia, restlessness, excitement, respiratory depression. Methemoglobinemia may also occur, with symptoms such as: shortness of breath, headache, fatigue, intolerance to exertion, dizziness, and loss of consciousness. The patient should immediately consult a doctor or contact a poison control center, stating the name of the medicine and the dose taken.
If the patient has any further questions about the use of this medicine, they should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been reported during the use of the active substances contained in this medicine:
The patient should stop using Inovox Express Orange Flavor and immediately consult their doctor if they experience symptoms of angioedema, such as:

• swelling of the face, tongue, or throat,
• difficulty swallowing,

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• 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.

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their 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 to gather more information on the safety of the medicine.

5. How to store Inovox Express Orange Flavor

The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiration date stated on the packaging after the term "EXP". The expiration date refers to the last day of the given month.
The medicine should not be stored at a temperature above 30°C.
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 Orange Flavor contains

The active substances of the medicine 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.
The other ingredients are:
Levomenthol,
Sodium saccharin (E 954),
Sucrose,
Glucose liquid,
Orange yellow (E 110),
Cochineal red (E 124),
Citric acid monohydrate (E 330),
Orange flavor.

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

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Inovox Express Orange Flavor is an orange, biconvex, cylindrical hard lozenge with a diameter of 19 mm, orange flavor.
The lozenges are packaged in PVC/PVDC/Aluminum blisters.
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 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 in the Member States of the European Economic Area under the following names:

Poland:
INOVOX Express Orange Flavor
Bulgaria:
INOVOX Express orange flavor
Lithuania:
Inovox orange 2 mg / 0.6 mg / 1.2 mg hard lozenges

Date of last revision of the leaflet:

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