Inovox junior flavor strawberry sugar-free

Package leaflet: Information for the user

Inovox Junior strawberry flavour sugar-free, 0.6 mg + 1.2 mg, hard pastilles
Amylometacresol + 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 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 reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. See section 4.
• If there is no improvement after 3 days, or if you feel worse, consult your doctor.

Leaflet contents

1. What Inovox Junior strawberry flavour sugar-free is and what it is used for
2. Important information before using Inovox Junior strawberry flavour sugar-free
3. How to use Inovox Junior strawberry flavour sugar-free
4. Possible side effects
5. How to store Inovox Junior strawberry flavour sugar-free
6. Contents of the pack and other information

1. What Inovox Junior strawberry flavour sugar-free is and what it is used for

Inovox Junior strawberry flavour sugar-free contains amylometacresol and 2,4-dichlorobenzyl alcohol, which have antiseptic properties, i.e. they destroy bacteria, viruses and yeasts causing sore throat and inflammatory conditions in the mouth and throat.
Inovox Junior strawberry flavour sugar-free is used for local, short-term treatment of symptoms of inflammatory and infectious conditions of the mouth and throat, and for relief of sore throat.
This medicine is recommended for adults, adolescents and children aged 6 years and older.
If there is no improvement after 3 days, or if you feel worse, consult your doctor.

2. Information before using Inovox Junior strawberry-flavoured sugar-free

When not to use Inovox Junior strawberry-flavoured sugar-free

• if the patient is allergic to amylopectin, 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 6 years of age. The tablet size is not suitable for young children.

Warnings and precautions
Before starting treatment with Inovox Junior strawberry-flavoured sugar-free, consult your doctor or pharmacist.
Inovox Junior strawberry-flavoured sugar-free is intended for short-term treatment only, for a maximum of 3 days (prolonged use may disrupt the balance of normal oral flora, potentially leading to overgrowth of pathogenic microorganisms).
Contact your doctor if symptoms persist for more than 3 days or if fever develops.
Children
Inovox Junior strawberry-flavoured sugar-free must not be given to children under 6 years of age.
Inovox Junior strawberry-flavoured sugar-free and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines planned for future use.
Concomitant use with other local antiseptics or antibiotics may enhance the antimicrobial effect.
Taking Inovox Junior strawberry-flavoured sugar-free with food and drink
Do not take the tablets immediately before or during meals. Avoid eating or drinking for at least 20 minutes after taking this medicine.
Pregnancy, breastfeeding and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
This medicine has not been evaluated for safety during pregnancy and breastfeeding; therefore, its use is not recommended during pregnancy or while breastfeeding.
Driving and operating machinery
Inovox Junior strawberry-flavoured sugar-free has no effect or negligible effect on the ability to drive and operate machinery.
Inovox Junior strawberry-flavoured sugar-free contains maltitol, isomalt, sodium and propylene glycol.
The medicine contains maltitol and isomalt, which may have a mild laxative effect. The energy value is 2.3 kcal/g of maltitol and isomalt. If the patient has previously been diagnosed with intolerance to certain sugars, consult a doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per hard tablet, meaning it is considered "sodium-free".
The medicine contains 7.22 mg of propylene glycol per hard tablet (present in the strawberry flavouring).

3. How to use Inovox Junior smak truskawkowy bez cukru

This medicine should always be used exactly as described in this patient information leaflet, or as
directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Inovox Junior smak truskawkowy bez cukru is intended for adults, adolescents,
and children aged above 6 years.
Recommended dose:
Adults: 1 tablet every 2 or 3 hours, if needed, up to a maximum of 12 tablets within 24 hours.
Adolescents and children above 6 years of age: 1 tablet every 2 or 3 hours, if needed, up to a maximum of 6 tablets within 24 hours.
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Elderly patients: dose adjustment is not required.
The tablets should be slowly dissolved in the mouth. Do not swallow, chew or crush the tablet.
This medicine is intended for short-term treatment only.
If symptoms persist or worsen after 3 days, consult a doctor.
Use of more than the recommended dose of Inovox Junior smak truskawkowy bez cukru
In case of overdose or accidental ingestion by a child, consult a doctor immediately.
Missed dose of Inovox Junior smak truskawkowy bez cukru
Do not take a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If hypersensitivity to the medicine occurs, treatment should be discontinued and medical advice should be sought from a doctor or pharmacist. If any adverse reaction occurs, or if any adverse reactions not listed in this leaflet occur, inform your doctor or pharmacist.
Frequency unknown (frequency cannot be estimated from the available data):

• Allergic (hypersensitivity) reactions such as redness (urticaria), itching or skin rash, itching or swelling of the mouth or throat (angioedema), breathing difficulties (bronchospasm), hypotension with fainting.
• Abdominal pain, nausea or oral discomfort which may manifest as sore throat, oral or pharyngeal swelling, oral tingling sensation (paresthesia), or oral burning sensation (glossodynia).

Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, consult a doctor or pharmacist. 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 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 Junior strawberry flavour sugar-free

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard package and
blister after: EXP. The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
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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 Junior strawberry-flavoured sugar-free contains

• The active substances are: amylometacresol 0.6 mg and 2,4-dichlorobenzyl alcohol 1.2 mg.
• Other components are: sodium saccharin (E 954), isomalt (E 953), liquid maltitol (E 965), strawberry flavour 0523112B (containing propylene glycol (E 1520)), tartaric acid, carmine red (E 124).

What Inovox Junior strawberry-flavoured sugar-free looks like and contents of the pack
Inovox Junior strawberry-flavoured sugar-free are pink, round, flat-faced hard tablets with a strawberry flavour, with a thickness of 6.5 to 7.5 mm and a diameter of 18.0 to 19.0 mm.
PVC/PVDC/Aluminium blister pack in a cardboard box. The pack contains 8, 16, or 24 hard tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Importer
Marketing Authorisation Holder:
US Pharmacia Sp. z o.o.
ul. Ziębicka 40,
50-507 Wrocław
{logo of the Marketing Authorisation Holder}

Importer:
Infarmade S.L.
Calle Torre de los Herberos, 35
Polígono Industrial Carretera de la Isla
Dos Hermanas, 41703 Sevilla,
Spain

For further information about this medicinal product, 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 countries under the following names:
Poland: Inovox Junior smak truskawkowy bez cukru
Romania: Inovox fără zahăr 0,6 mg/1,2 mg pastile
Czech Republic: Grivox
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