Inovox express active honey-lemon flavour

Package leaflet: Information for the user

Inovox Express Active honey-lemon flavour, 1.2 mg + 0.6 mg, hard lozenges
Alcohol 2,4-dichlorobenzyl + Amylometacresol
Please read all of this leaflet carefully before you start using this medicine, because it contains
important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed by your
doctor, pharmacist or nurse.

• Keep this leaflet. You may need to read it again.
• If you need advice or more information, ask your pharmacist.
• If you get any side effects, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.
• If there is no improvement after 3 days or if your symptoms worsen, consult your doctor.

Contents of the leaflet

1. What Inovox Express Active honey-lemon flavour is and what it is used for
2. What you need to know before you use Inovox Express Active honey-lemon flavour
3. How to use Inovox Express Active honey-lemon flavour
4. Possible side effects
5. How to store Inovox Express Active honey-lemon flavour
6. Contents of the pack and other information

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

Inovox Express Active honey-lemon flavour is intended for symptomatic treatment of inflammatory conditions of the mouth and throat in adults and children aged 6 years and older.
Each Inovox Express Active honey-lemon flavour lozenge contains two active substances: amylometacresol and 2,4-dichlorobenzyl alcohol, both with antiseptic properties.
The active substances in this medicine have local antiviral, antibacterial and antifungal effects.
Sucking the lozenge releases the active substances, thereby helping to relieve sore throat.
If there is no improvement after 3 days or if you feel worse, consult your doctor.

2. What you need to know before you use Inovox Express Active honey-lemon flavour

Do not use Inovox Express Active honey-lemon flavour:

• If you are allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6).
• In children under 6 years of age.

Warnings and precautions
Before using this medicine, consult your doctor or pharmacist if you have intolerance to certain sugars.
Due to the size of the hard lozenges, small children may choke on them.

Children and adolescents
This medicine must not be used in children under 6 years of age.

Inovox Express Active honey-lemon flavour and other medicines
Clinically significant interactions of this medicine with other medicines are currently unknown.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking 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, this medicine is not recommended during pregnancy.

Breast-feeding
It is unknown whether 2,4-dichlorobenzyl alcohol and amylometacresol, and their metabolites, pass into human milk. Risk to newborns and infants cannot be excluded.
Due to the lack of documented safety, this medicine is not recommended during breast-feeding.

Fertility
There are no data on the effect of amylometacresol and 2,4-dichlorobenzyl alcohol on fertility.

Driving and using machines
The effect of this medicine on the ability to drive and use machines is unknown.

Inovox Express Active honey-lemon flavour contains liquid maltitol (E 965) and isomalt (E 953).
If you have been previously diagnosed with intolerance to certain sugars, consult your doctor before taking this medicine.

Inovox Express Active honey-lemon flavour contains the colouring agent sunset yellow (E 110).
This medicine may cause allergic reactions.

Inovox Express Active honey-lemon flavour contains the flavouring agent citral.
Citral may cause allergic reactions.

Inovox Express Active honey-lemon flavour contains sodium.
This medicine contains less than 1 mmol (23 mg) of sodium per lozenge, meaning it is considered "sodium-free".

3. How to take Inovox Express Active honey-lemon flavour

This medicine should always be taken exactly as described in this patient information leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
For oral mucosal use.
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Recommended dosage
Adults: one tablet as needed every 2–3 hours. Do not use more than 8 tablets within 24 hours.
Use in children and adolescents
Children over 6 years of age: one tablet every at least 2 hours, maximum 4 tablets within 24 hours.
Do not use this medicine in children under 6 years of age.
The tablet should be sucked slowly. Do not swallow, chew or crush.
Use the lowest effective dose for the shortest duration necessary to relieve symptoms, no longer than 3 days.
Prolonged use of the medicine is not recommended. If there is no improvement or symptoms recur frequently, consult your doctor.
If symptoms persist for more than 3 days, worsen, or new symptoms appear, such as high fever, headache, nausea or vomiting, or skin rash, consult your doctor.
Do not exceed the recommended dose.
Overdose of Inovox Express Active honey-lemon flavour
Gastrointestinal disturbances may occur in case of overdose. Discontinue use and consult your doctor or pharmacist.
Missed dose of Inovox Express Active honey-lemon flavour
Do not take a double dose to make up for a missed tablet.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
Adverse reactions of unknown frequency (cannot be estimated from the available data):
Hypersensitivity reactions, rash, abdominal pain, nausea, oral discomfort, tongue pain may occur.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in the leaflet, consult a doctor or pharmacist. 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
Tel.: + 48 22 49 21 301, Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Inovox Express Active honey-lemon flavour

Keep this medicine 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 the abbreviation
"EXP". The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Inovox Express Active honey-lemon flavour contains
The active substances are: 2,4-Dichlorobenzyl alcohol and Amylometacresol.
Each hard pastille contains 1.2 mg of 2,4-Dichlorobenzyl alcohol and 0.6 mg of Amylometacresol.
Other ingredients are: Peppermint essential oil, Quinoline Yellow (E 104), Sodium saccharin (E 954), Tartaric acid (E 334), Isomalt (E 953), Liquid maltitol (E 965), Orange Yellow (E 110), Lemon flavour (lemon oil, terpenes, natural citral), Honey flavour (containing 1,2-Propanediol, phenylacetic acid, others).

What Inovox Express Active honey-lemon flavour looks like and contents of the pack
Inovox Express Active honey-lemon flavour are round, yellow pastilles with a honey-lemon flavour, 19 mm in diameter.
The pastilles are packed in PVC/PVDC/Aluminium blisters, placed in a cardboard box with a leaflet.
The pack contains 8, 12, 24 or 48 pastilles.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
US Pharmacia Sp. z o.o.,
ul. Ziębicka 40,
50-507 Wrocław, Poland.

Manufacturer:
LOZY’S PHARMACEUTICALS S.L.,
Campus Empresarial, Lekaroz Navarra,
31795, Spain.

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