Inovox express orange flavor

Package leaflet: Information for the user

Inovox Express orange 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 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 further information, please consult your pharmacist.
• If you experience any side 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 after 2 days, or if you feel worse, consult your doctor.

Leaflet contents

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

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

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

2. Information before using Inovox Express orange flavour

When not to use Inovox Express orange 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 orange flavour, discuss it with your doctor,
pharmacist, or nurse.
Inform your doctor if:

• the patient suffers from asthma,

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

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 self-biting. Therefore, caution is advised when eating or 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 of the throat.
• Recommended dosage must be observed: taking this medicine in high doses or for prolonged periods may affect the heart or nervous system and may cause seizures.
• Elderly patients or weakened individuals are more susceptible to possible 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 orange flavour and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking,
has recently taken, or plans to take.
In particular, inform your doctor or pharmacist if the patient is taking any of
the following medicines, as dosage adjustment may be necessary:

• beta-blocking agents (used in the treatment of heart failure or arterial disease) or medicines containing cimetidine (used in the treatment of stomach ulcers),
• other local anaesthetics (amides),
• 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, do not use other antiseptic agents intended for use in the mouth or throat while using Inovox Express orange flavour.
Use of Inovox Express orange 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 using machines
This medicine, when taken at the recommended dose, has no effect or negligible effect on the ability
to drive or operate machinery.
Inovox Express orange flavour contains glucose and sucrose.
The 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.
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Inovox Express orange flavour contains sodium.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".
Inovox Express orange flavour contains terpenes present in levomenthol. Excessive doses of terpenes may lead to neurological complications, such as seizures in children.
Inovox Express orange flavour contains the colouring agents orange yellow and carmine red. The medicine may cause allergic reactions.

3. How to take the medicine Inovox Express orange flavour

You must 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 lozenge in the mouth every 2 to 3 hours; maximum of 8 lozenges within 24 hours for adults (maximum of 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, 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 must not be used in children under 12 years of age.

Taking more than the recommended dose of Inovox Express orange flavour
Symptoms that may occur in case of improper use or overdose include: excessive anaesthesia of the upper gastrointestinal and respiratory tract, insomnia, restlessness, agitation, respiratory depression. Methemoglobinemia may also occur, with symptoms such as: shortness of breath, headache, fatigue, exercise intolerance, dizziness, and loss of consciousness. In such cases, seek immediate medical attention or contact 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 experiences them.
The following adverse reactions have been reported during use of the combination of active substances contained in this medicine:
Treatment with Inovox Express orange flavour should be discontinued and immediate medical advice sought if the patient develops symptoms of angioedema such as:

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

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• urticaria and breathing difficulties.

Rare (occurring in no more than 1 in 1,000 people): hypersensitivity reactions (burning sensation, itching), angioedema, burning sensation in the throat and unpleasant taste.

Reporting of adverse reactions
If the patient experiences any adverse effects, including any possible adverse effects not listed in this leaflet, advise 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
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 to provide more information on the safety of this medicine.

5. How to store Inovox Express orange flavour

Keep this medicine out of the sight and reach of children.
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 specified month.
Do not store above 30°C.
Medicines must not be disposed of via wastewater 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 orange flavour contains
The active substances in this medicine are: lidocaine hydrochloride, amylometacresol, 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:
Levomenthol,
Sodium saccharin (E 954),
Sucrose,
Liquid glucose,
Orange yellow (E 110),
Carmine red (E 124),
Citric acid monohydrate (E 330),
Orange flavour.

What Inovox Express orange flavour looks like and contents of the pack
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Inovox Express orange flavour is orange-coloured, double convex, cylindrical hard tablets with a diameter of 19 mm and an orange taste.
The tablets are packed in PVC/PVDC/Aluminium blisters.
Pack sizes contain 12, 24 or 36 tablets.

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

Manufacturer:
LOZY’S PHARMACEUTICALS S.L.,
Campus Empresarial s/n,
31795 - Lekaroz Navarra, Spain
US Pharmacia Sp. z o.o.,
Ziębicka Street 40,
50-507 Wrocław, Poland

For further information, please contact:
USP Zdrowie Sp. z o.o., Poleczki Street 35, 02-822 Warsaw, Poland, 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 orange flavour
Bulgaria: INOVOX Express orange flavor
Lithuania: Inovox orange 2 mg / 0.6 mg / 1.2 mg kietosios pastilės
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