Aspigola mint flavor sugar-free

Package leaflet: information for the user

ASPIGOLA mint flavour sugar-free, 2 mg + 1.2 mg + 0.6 mg, hard pastilles
Hydrochloride monohydrate lidocaine + 2,4-dichlorobenzyl alcohol + Amylometacresol
Please read this leaflet carefully before taking this medicine, as it contains important information
for you.
This medicine should always be taken exactly as described in this patient leaflet or as directed by your
doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, please contact your pharmacist.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If there is no improvement after 3 to 4 days, or if you feel worse, consult your doctor.

Contents of the leaflet

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

1. What Aspigola mint flavour sugar-free is and what it is used for

Aspigola mint flavour sugar-free contains the active substances: amylometacresol and 2,4-dichlorobenzyl alcohol – both with antiseptic properties, and lidocaine (in the form of monohydrate hydrochloride) – a local anaesthetic.
This medicine is indicated for symptomatic treatment of pain in the mouth and throat, e.g. pharyngitis (i.e. pain in the back of the throat), laryngitis (i.e. pain in the larynx often associated with hoarseness and difficulty swallowing), sore throat, and after tonsillectomy in adults and adolescents over 12 years of age.
If there is no improvement after 3 to 4 days, or if you feel worse, you should consult your doctor.

2. Important information before taking Aspigola mint flavour sugar-free

When not to take Aspigola mint flavour sugar-free:

• if you are allergic to:
  • lidocaine or other local anaesthetics of the amide group,
  • amylometacresol,
  • 2,4-dichlorobenzyl alcohol,
  • any of the other ingredients of this medicine (listed in section 6).
• if you have a predisposition to methemoglobinemia, have previously experienced methemoglobinemia, or have suspected methemoglobinemia.

Do not use this medicine in children under 12 years of age.
Warnings and precautions
If symptoms persist for longer than 3–4 days, worsen, or if other symptoms such as high fever, headache, nausea or vomiting occur, consult your doctor.
Before starting treatment with Aspigola mint flavour sugar-free, discuss with your doctor or pharmacist if:

• you have larger unhealed wounds in the area of the mouth or throat. In such cases, do not use this medicine.
• you are elderly or debilitated. You may be more susceptible to possible side effects.

This medicine may cause numbness of the tongue and increase the risk of injury due to biting. In addition, it may cause choking (coughing during meals or a choking sensation) due to anaesthesia of the throat. Do not drink or eat immediately after using this medicine.
Consult your doctor or pharmacist if you have taken this medicine in excessive amounts, at too short intervals between doses, or on damaged mucous membranes (further information is provided in the section “Taking more Aspigola mint flavour sugar-free than you should”).

Children and adolescents
Do not use this medicine in children under 12 years of age due to the presence of lidocaine.

Aspigola mint flavour sugar-free and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take, especially if you are using medicines containing:

• beta-blocking agents (used in the treatment of heart failure or arterial diseases),
• cimetidine (used to treat stomach ulcers),
• mexiletine or procainamide (used in the treatment of heart diseases),
• fluvoxamine (used to treat depression),
• antibiotics or antifungal medicines (used to treat bacterial or fungal infections), such as erythromycin or itraconazole.

Although no interactions are expected, do not use other antiseptic medicines intended for use in the mouth or throat during treatment with Aspigola mint flavour sugar-free.

Taking Aspigola mint flavour sugar-free with food, drink and alcohol
Do not take this medicine immediately before eating or drinking.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should consult your doctor or pharmacist before using this medicine.
Use of this medicine is not recommended during pregnancy and breastfeeding.

Driving and operating machinery
This medicine has no effect or negligible effect on the ability to drive and operate machinery.

Aspigola mint flavour sugar-free contains isomalt and maltitol
If you have previously been diagnosed with intolerance to certain sugars, you should consult your doctor before taking this medicine.

Aspigola mint flavour sugar-free contains less than 1 mmol of sodium (23 mg) per pastille, meaning the medicine is considered "sodium-free".

3. How to use ASPIGOLA mint flavour sugar-free

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.
Recommended dose for adults and adolescents aged 12 years and older:
1 pastille every 2–3 hours, up to a maximum of 8 pastilles per day for 3 to 4 days.
Allow the pastille to dissolve slowly in the mouth.
Do not place the pastille between the gum and cheek.
Do not take this medicine immediately before eating or drinking.
If symptoms persist for more than 3–4 days, worsen, or new symptoms appear, consult a doctor or pharmacist.
Use in children
This medicine must not be used in children under 12 years of age.
Overdose of ASPIGOLA mint flavour sugar-free
In case of suspected overdose, seek immediate medical advice.
Symptoms that may occur in case of improper use or overdose include:
excessive anaesthesia of the upper gastrointestinal tract and respiratory tract, insomnia, restlessness, agitation, respiratory depression and breathing difficulty, apnoea (cessation of breathing), seizures, severe hypotension, bradycardia, asystole, circulatory arrest, coma, and death.
Methemoglobinemia may also occur.
If you have any further doubts 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.
You should immediately inform a doctor or go to the nearest hospital if the patient experiences any symptoms that may indicate a rare but very serious adverse reaction called angioedema, which is described below.
Frequency unknown (frequency cannot be estimated from the available data):

• hypersensitivity: hypersensitivity to lidocaine may manifest as angioedema (itchy swelling of the skin and/or mucous membranes, causing difficulty in swallowing, urticaria, breathing difficulties), urticaria, bronchospasm, and hypotension with loss of consciousness
• swelling of the tongue or throat
• abdominal pain, nausea, oral discomfort (may present as a burning or prickling sensation in the mouth or throat), unpleasant taste sensation
• skin rash

If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, this should be reported to a doctor or pharmacist.
Reporting of adverse reactions
If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, this should be reported to a doctor or pharmacist. 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 enhance the safety information available for the medicine.

5. How to store ASPIGOLA smak miętowy bez cukru

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box and blister pack
following "EXP". The expiry date refers to the last day of the specified month.
No special storage instructions apply for this medicine.
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 Aspigola sugar-free mint-flavoured medicine contains

• Each hard pastille contains as active substances:
  • 2.0 mg lidocaine hydrochloride monohydrate
  • 1.2 mg 2,4-dichlorobenzyl alcohol
  • 0.6 mg amylmetacresol.
• Other ingredients are: sodium saccharin (E 954), isomalt (E 953), maltitol liquid (E 965), indigo carmine (E132), quinoline yellow (E 104), peppermint oil, star anise essential oil, levomenthol, tartaric acid.

What Aspigola sugar-free mint-flavoured medicine looks like and contents of the pack
Aspigola sugar-free mint-flavoured are blue-green, round hard pastilles with a diameter of 19 mm,
with a mint flavour.
The pastilles are packed in PVC/PVDC/Aluminium blisters. The pack contains: 12, 16, 24, 36 or 48
hard pastilles.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Bayer Sp. z o.o.
Al. Jerozolimskie 158
02-326 Warsaw
Tel.: +48 22 572 35 00

Manufacturer:
LOZY´S PHARMACEUTICALS S.L.
Campus Empresarial 1
31795 Lekaroz, Navarra, Spain

This medicine is authorised in the European Economic Area member states under the following names:
Bulgaria: Аспи-Aнгин мента без захар таблетки за смучене
Romania: ASPIGOLA mentă fără zahăr pastile