INOVOX 2 mg + 0.6 Mg + 1.2 Mg Lozenge

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
   1. You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
2. What is Inovox Express honey-lemon flavor and what is it used for
3. Important information before using Inovox Express honey-lemon flavor
   1. When not to use Inovox Express honey-lemon flavor
   2. Warnings and precautions
   3. Children and adolescents
   4. Inovox Express honey-lemon flavor and other medicines
   5. Using Inovox Express honey-lemon flavor with food, drink, and alcohol
   6. Pregnancy and breastfeeding
   7. Driving and using machines
   8. Inovox Express honey-lemon flavor contains glucose and sucrose.
   9. Inovox Express honey-lemon flavor contains sodium.
   10. Inovox Express honey-lemon flavor contains the dye Orange Yellow S.
4. How to take Inovox Express honey-lemon flavor
   1. Use in children and adolescents
   2. Using a higher dose of Inovox Express honey-lemon flavor than recommended
5. Possible side effects
   1. You should stop using Inovox Express honey-lemon flavor and immediately consult a doctor if you experience symptoms of angioedema, such as:
   2. Reporting side effects
6. How to store Inovox Express honey-lemon flavor
7. Package contents and other information
   1. What Inovox Express honey-lemon flavor contains
   2. What Inovox Express honey-lemon 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 for sale in the Member States of the European Economic Area under the following names:
   7. Date of last revision of the leaflet:

Leaflet attached to the packaging: patient information

Inovox Express honey-lemon flavor, 2 mg + 0,6 mg + 1,2 mg, hard lozenges
Lidocaine hydrochloride + Amylmetacresol + 2,4-Dichlorobenzyl alcohol

You should carefully read the contents of the leaflet 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 your doctor, pharmacist, or nurse.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should tell 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 honey-lemon flavor and what is it used for
• 2. Important information before using Inovox Express honey-lemon flavor
• 3. How to take Inovox Express honey-lemon flavor
• 4. Possible side effects
• 5. How to store Inovox Express honey-lemon flavor
• 6. Package contents and other information

1. What is Inovox Express honey-lemon flavor and what is it used for

Inovox Express honey-lemon 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 honey-lemon 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 honey-lemon flavor

When not to use Inovox Express honey-lemon 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 honey-lemon flavor, you should discuss it with your doctor, pharmacist, or nurse.
You should inform your doctor if:

• the patient has 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. You 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, you should be careful when 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.
• You should follow the recommended dosage: the medicine taken 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 a 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 honey-lemon flavor and other medicines

You should tell your doctor or pharmacist about all medicines the patient is taking or has recently taken, as well as any medicines the patient plans to take.
In particular, you should tell your doctor or pharmacist if the patient is 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 local anesthetics (amides),
• 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, you should not take other antiseptic medicines for use in the mouth or throat while using Inovox Express honey-lemon flavor.

Using Inovox Express honey-lemon flavor with food, drink, and alcohol

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

Pregnancy and breastfeeding

Pregnancy:
This medicine is not recommended during pregnancy.
Breastfeeding:
This medicine is not recommended during breastfeeding.

Driving and using machines

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

Inovox Express honey-lemon flavor contains glucose and sucrose.

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

Inovox Express 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".

Inovox Express honey-lemon flavor contains the dye Orange Yellow S.

The medicine may cause allergic reactions.

3. How to take Inovox Express honey-lemon flavor

You should follow the instructions in this leaflet. This medicine should always be used in accordance with the doctor's or pharmacist's recommendations. If you have any doubts, you should consult a 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.
Prolonged use of the medicine (longer than 5 days) is not recommended, 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 a higher dose of Inovox Express honey-lemon flavor than recommended

Symptoms that may occur in case of improper use or overdose include: excessive numbness of the upper digestive 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. You should immediately consult a doctor or contact a poison control center, stating the name of the medicine and the dose taken.
If you have any further doubts about using this medicine, you should consult a 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 substance combination in this medicine:

You should stop using Inovox Express honey-lemon flavor and immediately consult a doctor if you 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 people): hypersensitivity reactions (burning, itching), angioedema, burning sensation in the throat, and unpleasant taste.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in the leaflet, you should 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 the medicine.

5. How to store Inovox Express honey-lemon flavor

The medicine should be stored out of sight and reach of children.
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.
Do not store above 30°C.
Medicines should not be disposed of via wastewater or household waste. You should ask your 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 honey-lemon flavor contains

The active substances of the medicine are lidocaine hydrochloride, amylmetacresol, and 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,
Quinoline Yellow (E 104),
Sodium saccharin (E 954),
Tartaric acid (E 334),
Sucrose,
Glucose syrup,
Orange Yellow S (E 110),
Lemon flavor,
Honey flavor.
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What Inovox Express honey-lemon flavor looks like and what the package contains

Inovox Express honey-lemon flavor is a yellow, biconvex, cylindrical hard lozenge with a diameter of 19 mm, with a honey-lemon 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 for sale in the Member States of the European Economic Area under the following names:

Poland:
INOVOX Express honey-lemon flavor
Bulgaria:
INOVOX Express honey-lemon flavor
Lithuania:
Inovox honey lemon 2 mg/ 0,6 mg/ 1,2 mg hard lozenges

Date of last revision of the leaflet:

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