Voxsill honey-lemon flavour

Package leaflet: Information for the patient

Voxsill honey-lemon flavour, 0.6 mg + 1.2 mg, hard pastilles
Amylmetacresolum + Alcohol 2,4–dichlorobenzylicus
Please read carefully the entire leaflet before using this 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 for future reference.
• If advice or further information is needed, consult a pharmacist.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform a doctor or pharmacist. See section 4.
• If there is no improvement after 3 days, or if the patient feels worse, consult a doctor.

Table of contents

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

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

Voxsill honey-lemon flavour 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 honey-lemon flavour 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 intended for adults, adolescents and children aged 6 years and older.
If there is no improvement after 3 days, or if the patient feels worse, consult a doctor.

2. Important information before using Voxsill honey-lemon flavoured medicine

When not to use Voxsill honey-lemon flavoured medicine

• 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 size of the tablet is not suitable for small children.

Warnings and precautions
Voxsill honey-lemon flavoured medicine is intended for short-term treatment only,
for a maximum of 3 days (prolonged use may disrupt the balance of normal oral microflora,
which may lead to overgrowth of pathogenic microorganisms).
Contact a doctor if symptoms persist for more than 3 days or if fever occurs.

Children
Voxsill honey-lemon flavoured medicine must not be given to children under 6 years of age.

Voxsill honey-lemon flavoured medicine 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 antimicrobial activity.

Use of Voxsill honey-lemon flavoured medicine 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, breastfeeding, suspects she may be pregnant, or is planning to become pregnant, 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 honey-lemon flavoured medicine has no effect or has a negligible effect on the ability to drive and operate machinery.

Voxsill honey-lemon flavoured medicine contains glucose, sucrose, propylene glycol, citronellol,
citral and linalool
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine. This medicine contains approximately 1068.96 mg of glucose and 1306.74 mg of sucrose per tablet. This should be taken into account in patients with diabetes.
This medicine contains 8.9 mg of propylene glycol in each tablet (present in the honey flavour).
Voxsill honey-lemon flavoured medicine contains fragrance substances with citronellol, citral and linalool, which may cause allergic reactions.

3. How to take Voxsill honey-lemon flavour

This medicine should always be taken 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 honey-lemon flavour is intended for adults, adolescents and children aged over 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 over 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.
Taking more Voxsill honey-lemon flavour than recommended
In case of overdose or accidental ingestion by a child, consult a doctor immediately.
Missing a dose of Voxsill honey-lemon flavour
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 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 consulted.

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, oral tingling sensation (paresthesia), or burning mouth (glossodynia).

Reporting of adverse reactions
If any adverse reactions 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
Phone: +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 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 carton and blister pack following EXP.
The expiry date refers to the last day of the stated month.
No special storage conditions apply.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the packaging and other information

What Voxsill honey-lemon flavour contains

• The active substances are: amylometacresol 0.6 mg and 2,4-dichlorobenzyl alcohol 1.2 mg.
• The other ingredients are: levomenthol, sucrose (E473), glucose, liquid (E418), honey flavour (containing citronellol and propylene glycol), lemon flavour (containing citral and linalool), caramel colour (E150) (contains sucrose (E473)).

What Voxsill honey-lemon flavour looks like and contents of the pack
Voxsill honey-lemon flavour is brown-yellow, round, flat-faced hard pastilles with a honey-lemon flavour, with a thickness of 6.5 to 7.5 mm and a diameter of 18.0 to 19.0 mm.
Packaged in PVC-PVDC/Aluminium blisters, in a cardboard box. Each pack contains 8, 24 or 36 hard pastilles.
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 Member States of the European Economic Area under the following names:
Slovakia: Voxsill s príchuťou medu a citrónu tvrdé pastilky
Poland: Voxsill smak miodowo-cytrynowy
Hungary: Voxsill citrom-méz ízű szapogató tabletta
Czech Republic: Voxsill med a citron
Romania: Voxsill miere și lămâie 0,6 mg/1,2 mg pastile