Inovox express mint flavor

Package leaflet: Information for the patient

Inovox Express mint flavour, 2 mg + 0.6 mg + 1.2 mg, hard pastilles
Lidocaine hydrochloride + Amylmetacresol + 2,4-Dichlorobenzyl alcohol
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
This medicine should always be taken exactly as described in this patient leaflet or as directed by
your doctor, pharmacist or nurse.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse effects, including any possible side effects not listed in this leaflet, inform your doctor, pharmacist or nurse. See section 4.
• If there is no improvement within 2 days or if your condition worsens, consult your doctor.

Table of contents

1. What Inovox Express mint flavour is and what it is used for
2. Important information before taking Inovox Express mint flavour
3. How to take Inovox Express mint flavour
4. Possible side effects
5. How to store Inovox Express mint flavour
6. Contents of the pack and other information

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

Inovox Express mint flavour contains antiseptics – amylmetacresol and 2,4-dichlorobenzyl alcohol – and lidocaine hydrochloride, a local anaesthetic for the throat.
The medicine is indicated for local antiseptic treatment of inflammatory conditions (redness, swelling) of the throat and oral cavity, and for relief of pain associated with these conditions.
It helps to relieve sore throat symptoms.
Inovox Express mint flavour is intended for adults and adolescents aged 12 years and above.
If there is no improvement within 2 days or if you feel worse, consult your doctor.

2. Important information before using Inovox Express mint flavour

When not to use Inovox Express mint flavour

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

Warnings and precautions
Before using Inovox Express mint flavour, discuss this with your doctor, pharmacist, or nurse.
You should inform your doctor if:

• the patient has asthma,
• symptoms do not improve within 2 days or if fever, headache, nausea, vomiting, or skin rash occur. page 1 of 5

This medicine may be harmful to teeth.

• The anaesthetic agents contained in this medicine may cause choking (coughing during meals or a sensation of choking) while eating. Do not eat immediately after using this medicine.
• This medicine may cause numbness of the tongue and increase the risk of biting the tongue. Therefore, caution should be exercised when eating and drinking hot food and beverages.
• Prolonged use of this medicine (longer than 5 days) is not recommended, as it may alter the natural bacterial flora in the throat.
• Recommended dosage must be observed: using this medicine in high doses or for prolonged periods may affect the heart or nervous system and may cause seizures.
• Elderly or debilitated patients are more susceptible to potential adverse effects and should consult a doctor before taking this medicine.
• This medicine should not be used if there are large, unhealed wounds in the mouth or throat.

Children and adolescents
This medicine must not be used in children under 12 years of age.
Inovox Express mint flavour and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
In particular, inform your doctor or pharmacist if the patient is taking any of the following medicines, as dose adjustment may be necessary:

• beta-blocking agents (used in the treatment of heart failure or vascular disease) or medicines containing cimetidine (used in the treatment of stomach ulcers),
• other local anaesthetics (amide-type),
• medicines used in the treatment of heart diseases, such as mexiletine or procainamide,
• medicines such as fluvoxamine (used in the treatment of depression),
• antibiotics such as erythromycin, or itraconazole.

Although no interactions are expected, other antiseptic products for use in the mouth or throat should not be used during treatment with Inovox Express mint flavour.
Taking Inovox Express mint flavour with food, drink, and alcohol
Do not use this medicine before eating or drinking.
Pregnancy and breastfeeding
Pregnancy:
Use of this medicine during pregnancy is not recommended.
Breastfeeding:
Use of this medicine during breastfeeding is not recommended.
Driving and operating machinery
This medicine, when taken at the recommended dose, has no effect or has a negligible effect on the ability to drive and operate machinery.
Inovox Express mint flavour contains glucose and sucrose.
This medicine contains 1.016 g of glucose and 1.495 g of sucrose per tablet. This should be taken into account in patients with diabetes. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
Inovox Express mint flavour contains sodium.
page 2 of 5
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".
Inovox Express mint flavour contains terpenes present in levomenthol. Excessive doses of terpenes may lead to neurological complications, such as seizures in children.

3. How to take Inovox Express mint flavour

Follow the instructions provided in this leaflet. This medicine should always be used as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.

Recommended dosage:

• Adults and adolescents over 12 years of age: slowly dissolve one tablet in the mouth every 2 to 3 hours; maximum of 8 tablets within 24 hours for adults (maximum 4 tablets for adolescents).

Do not place between the gum and cheek.
If there is no improvement after 2 days, or if the patient feels worse, consult a doctor.
Prolonged use of this medicine beyond 5 days is not recommended, as it may alter 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.

Taking more than the recommended dose of Inovox Express mint flavour
Symptoms that may occur in case of improper use or overdose include: excessive anaesthesia of the upper gastrointestinal and respiratory tracts, insomnia, restlessness, agitation, and respiratory depression. Methemoglobinemia may also occur, with symptoms such as: shortness of breath, headache, fatigue, exercise intolerance, dizziness, and loss of consciousness. Immediate medical attention should be sought, or contact should be made with a poison information centre, stating the name of the medicine and the dose taken.

If in any doubt about the use of this medicine, consult a doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The following adverse reactions have been reported during use of the combination of active substances contained in this medicine:
Treatment with Inovox Express mint flavour should be discontinued immediately and medical advice should be sought without delay if the patient develops symptoms of angioedema such as:

• swelling of the face, tongue or throat,
• difficulty swallowing,
• urticaria and breathing difficulties.

Rare (occurring in not more than 1 in 1,000 people): hypersensitivity reactions (burning, itching), angioedema, sore throat and unpleasant taste.
page 3 of 5

Reporting of adverse reactions
If the patient experiences any adverse effects, including any possible adverse effects not listed in this leaflet, inform a doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse reactions can also be reported directly to the marketing authorisation holder.
Reporting adverse reactions enables better assessment of the safety profile of the medicine.

5. How to store Inovox Express mint flavour

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging following the abbreviation
"EXP". The expiry date refers to the last day of the stated month.
Do not store above 30°C.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist
how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Inovox Express mint flavour contains
The active substances are: lidocaine hydrochloride, amylopectin, 2,4-dichlorobenzyl alcohol.
Each hard tablet contains:
Lidocaine hydrochloride monohydrate 2 mg,
Amylometacresol 0.6 mg,
2,4-Dichlorobenzyl alcohol 1.2 mg.

The other ingredients are:
Peppermint oil with reduced menthol content,
Star anise oil,
Levomenthol,
Indigocarmine (E 132),
Quinoline yellow (E 104),
Sodium saccharin (E 954),
Tartaric acid (E 334),
Sucrose,
Liquid glucose.

What Inovox Express mint flavour looks like and contents of the pack
Inovox Express mint flavour is green, cylindrical, biconvex hard tablets with a mint flavour, 19 mm in diameter.
The tablets are packed in PVC/PVDC/Aluminium blisters.
Page 4 of 5
Pack contains 12, 24 or 36 tablets.

Marketing Authorisation 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 further information, please contact:
USP Zdrowie Sp. z o.o., ul. Poleczki 35, 02-822 Warsaw, tel. +48 (22) 543 60 00.

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Poland: INOVOX Express mint flavour
Bulgaria: INOVOX Express mint flavour
Lithuania: Inovox menthol 2 mg/ 0.6 mg / 1.2 mg kietosios pastilės
Page 5 of 5