Voxsill lemon flavour sugar-free

Package leaflet: Information for the patient

Voxsill lemon flavour sugar-free, 0.6 mg + 1.2 mg, hard pastilles
Amymetacresol + 2,4-dichlorobenzyl alcohol
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by a
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 effects, 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 you feel worse, consult your doctor.

Contents of the leaflet

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

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

Voxsill lemon 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 lemon flavour sugar-free is used locally and short-term for symptomatic treatment 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 you feel worse, consult your doctor.

2. Important information before using Voxsill lemon flavour sugar-free

When not to use Voxsill lemon flavour sugar-free

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

Warnings and precautions
Voxsill lemon flavour 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, which could lead to overgrowth of pathogenic microorganisms).
Consult a doctor if symptoms persist for more than 3 days, or if fever occurs.
Children
Voxsill lemon flavour sugar-free must not be given to children under 6 years of age.
Voxsill lemon flavour sugar-free and other medicines
Inform 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.
Concurrent use with other local antiseptic agents or antibiotics may enhance the antimicrobial effect.
Taking Voxsill lemon flavour 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 and breastfeeding has not been established; therefore, use during pregnancy and breastfeeding is not recommended.
Driving and operating machinery
Voxsill lemon flavour sugar-free has no effect or negligible effect on the ability to drive and operate machinery.
Voxsill lemon flavour sugar-free contains maltitol, isomalt and sodium
Voxsill lemon flavour sugar-free contains maltitol and isomalt, which may have a mild laxative effect. The caloric value is 2.3 kcal/g of maltitol and isomalt. Patients with rare hereditary fructose intolerance should not take this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per hard tablet, meaning the medicine is considered "sodium-free".

3. How to use Voxsill smak cytrynowy bez cukru

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 smak cytrynowy bez cukru is intended for adults, adolescents, and children over the age of 6.
Recommended dose:
Adults: 1 tablet every 2 or 3 hours, as needed, up to a maximum of 12 tablets within 24 hours.
Adolescents and children over 6 years of age: 1 tablet every 2 or 3 hours, as 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 only.
If symptoms persist or worsen after 3 days, consult a doctor.
Use of a higher than recommended dose of Voxsill smak cytrynowy bez cukru
In case of overdose or accidental ingestion by a child, consult a doctor immediately.
Missed dose of Voxsill smak cytrynowy bez cukru
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 everybody 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.
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 discomfort in the mouth, which may manifest as sore throat, swelling of the mouth or throat, tingling sensation in the mouth (paraesthesia) or burning mouth (glossodynia).

Reporting of adverse reactions
If any adverse effects occur, including any adverse effects 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 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 the medicine.

5. How to store Voxsill smak cytrynowy bez cukru

Keep this medicine out of 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 conditions are required for this medicine.
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 packaging and other information

What Voxsill lemon flavour sugar-free contains

• The active substances are: amylometacresol 0.6 mg and 2,4-dichlorobenzyl alcohol 1.2 mg.
• Other ingredients: sodium saccharin (E 954), isomalt (E953), maltitol liquid (E 965), lemon flavour, tartaric acid.

What Voxsill lemon flavour sugar-free looks like and contents of the pack
Voxsill lemon flavour sugar-free are white to pale yellow, round, flat-faced hard tablets with a lemon 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 citrónu bez cukru tvrdé pastilky
Poland: Voxsill smak cytrynowy bez cukru
Hungary: Voxsill citromízű cukormentes szapogató tabletta
Czech Republic: Voxsill citron bez cukru
Romania: Voxsill lămâie fără zahăr 0,6 mg/1,2 mg pastile