Voxsill flavor strawberry sugar-free

Package leaflet: Information for the user

Voxsill strawberry flavour sugar-free, 0.6 mg + 1.2 mg, hard pastilles
Amylmetacresolum + Alcohol 2,4–dichlorobenzylicus
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 or pharmacist.

• 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 not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 3 days or if your condition worsens, contact your doctor.

Contents of the leaflet

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

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

Voxsill strawberry flavour sugar-free contains amylmetacresol 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.
Voxsill strawberry flavour sugar-free is used for local, short-term treatment of symptoms of
inflammatory and infectious diseases of the mouth and throat, and for relief of sore throat.
This medicine is intended for adults, adolescents and children aged 6 years and older.
If there is no improvement after 3 days or if your condition worsens, consult your doctor.

2. Information before using Voxsill strawberry-flavoured sugar-free

When not to use Voxsill strawberry-flavoured sugar-free

• if the patient is allergic to amylometacresol, 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
Voxsill strawberry-flavoured sugar-free is intended for short-term treatment for a maximum of 3 days (prolonged use may disrupt the balance of normal oral flora, potentially leading to overgrowth of pathogenic microorganisms).
Contact a doctor if symptoms persist for more than 3 days or if fever occurs.

Children
Voxsill strawberry-flavoured sugar-free must not be given to children under 6 years of age.

Voxsill strawberry-flavoured sugar-free 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.
Concomitant use with other local antiseptics or antibiotics may enhance antimicrobial effects.

Taking Voxsill strawberry-flavoured sugar-free with food and drink
Do not take the tablets immediately before or during a meal. Do not eat or drink for at least 20 minutes after using this medicine.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.
The safety of using this medicine during pregnancy or breastfeeding has not been established; therefore, use of the medicine is not recommended during pregnancy or breastfeeding.

Driving and operating machinery
Voxsill strawberry-flavoured sugar-free has no effect or negligible effect on the ability to drive and operate machinery.

Voxsill strawberry-flavoured sugar-free contains maltitol, isomalt, sodium and propylene glycol
The medicine contains maltitol and isomalt, which may have a mild laxative effect. Calorific value: 2.3 kcal/g for maltitol and isomalt. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per hard tablet, meaning the medicine is considered "sodium-free".
The medicine contains 7.22 mg of propylene glycol per tablet (present in the strawberry flavour).

3. How to use Voxsill strawberry flavour sugar-free

This medicine should always be used exactly as described in this patient information leaflet, or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Voxsill strawberry flavour sugar-free is intended for adults, adolescents, and children above 6 years of age.
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.
Elderly patients: dose adjustment is not required.
Allow the tablet to dissolve slowly in the mouth. Do not swallow, chew, or crush the tablet.
This medicine is intended for short-term treatment.
If symptoms persist or worsen after 3 days, consult a doctor.
Use of a higher than recommended dose of Voxsill strawberry flavour sugar-free
In case of overdose or accidental ingestion by a child, consult a doctor immediately.
Missed dose of Voxsill strawberry flavour sugar-free
Do not take a double dose to make up for a missed dose.
If you have any further doubts regarding 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 with this medicine should be discontinued
and medical advice should be sought from a doctor or pharmacist. If any adverse reactions become
severe or if any adverse reactions not listed in this leaflet occur, a doctor or pharmacist should be
informed immediately.

Frequency unknown (frequency cannot be estimated from the available data)

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

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 4921 301
Fax: +48 22 4921 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 the medicine.

5. How to store Voxsill 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 carton and blister after: EXP.
The expiry date refers to the last day of the stated month.
No special storage instructions are required for this medicine.
Medicines should 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 Voxsill sugar-free strawberry flavoured tablets contain

• The active substances are: amylometacresol 0.6 mg and 2,4-dichlorobenzyl alcohol 1.2 mg.
• The other ingredients are: sodium saccharin (E 954), isomalt (E953), liquid maltitol (E 965), strawberry flavour (containing propylene glycol (E1520)), tartaric acid, carmine red (E124).

What Voxsill sugar-free strawberry flavoured tablets look like and contents of the pack
Voxsill sugar-free strawberry flavoured tablets are pink, round, flat-faced 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 blisters in a cardboard box. Each pack contains 8, 16 or 24 hard tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Importer
Marketing Authorisation Holder
Mapaex Consumer Healthcare (Ireland) Private Limited
IDA Business Park, Green Road, Newbridge
KILDARE
W12 X902
Ireland
Tel.: +353858050403
e-mail: [email protected]

Importer
Infarmade S.L.
Calle De La Torre De Los Herberos 35
Polígono Industrial Carretera De La Isla
Dos Hermanas 41703 Sevilla
Spain

This medicinal product is authorised in the European Economic Area countries under the following names:
Slovakia: Voxsill s príchuťou jahody bez cukru tvrdé pastilky
Poland: Voxsill smak truskawkowy bez cukru.
Hungary: Voxsill eperízű cukormentes szapogató tabletta
Czech Republic: Voxsill jahoda bez cukru
Romania: Voxsill căpșuni fără zahăr 0,6 mg/1,2 mg pastile