Inovox express honey-lemon flavour

Package leaflet: Information for the user

Inovox Express honey-lemon flavour, 2 mg + 0.6 mg + 1.2 mg, hard pastilles
Hydrochloride lidocaine + Amylometacresol + 2,4-Dichlorobenzyl alcohol
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
Always use this medicine 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 contact your pharmacist.
• If you experience any adverse reactions, including any possible side effects not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after 2 days or if you feel worse, contact your doctor.

Leaflet contents

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

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

Inovox Express honey-lemon flavour contains antiseptics – amylometacresol 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 relieve sore throat symptoms.
Inovox Express honey-lemon 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, consult your doctor.

2. Information before using Inovox Express honey-lemon flavour

When not to use Inovox Express honey-lemon 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 should not be used in children under 12 years of age.

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

• the patient has asthma,

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• symptoms do not improve after 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 biting the tongue or inside of the mouth. Therefore, caution should be exercised when eating and drinking hot food or 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 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 should not be used in children under 12 years of age.
Inovox Express honey-lemon 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 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 gastric 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 simultaneously with Inovox Express honey-lemon flavour.
Using Inovox Express honey-lemon 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 or operate machinery.
Inovox Express honey-lemon 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.
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If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
Inovox Express honey-lemon flavour contains sodium.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".
Inovox Express honey-lemon flavour contains the colouring agent sunset yellow FCF.
This medicine may cause allergic reactions.

3. How to take Inovox Express honey-lemon 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 symptoms worsen, consult a
doctor.
Prolonged use of this medicine for more than 5 days is not recommended, as it may alter the natural bacterial flora of 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 honey-lemon 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. Immediate medical attention should be sought, or contact should be made with a poison information centre, specifying the name of the medicine and the dose taken.
If you have any further questions regarding the use of this medicine, consult your
doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this product may 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 honey-lemon flavour should be discontinued and immediate
medical advice sought if the patient experiences 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 not 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 any adverse reactions occur in the patient, including any possible adverse reactions 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 at 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 may also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Inovox Express honey-lemon 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 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 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 honey-lemon flavour contains
The active substances are lidocaine hydrochloride, amylmetacresol and 2,4-dichlorobenzyl alcohol.
Each hard pastille 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,
Liquid glucose,
Orange yellow (E 110),
Lemon flavour,
Honey flavour.
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What Inovox Express honey-lemon flavour looks like and contents of the pack
Inovox Express honey-lemon flavour are yellow, cylindrical, biconvex hard pastilles, 19 mm in diameter, with a honey-lemon flavour.
The pastilles are packed in PVC/PVDC/Aluminium blisters.
Pack sizes contain 12, 24 or 36 pastilles.
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 European Economic Area under the following names:
Poland: INOVOX Express honey-lemon flavour
Bulgaria: INOVOX Express honey-lemon flavour
Lithuania: Inovox honey lemon 2 mg/ 0.6 mg/ 1.2 mg pastilles
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