Aspigola honey lemon flavour sugar-free

Package leaflet: Information for the user

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

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, 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 to 4 days, or if you feel worse, consult your doctor.

Contents of the leaflet

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

1. What Aspigola honey-lemon flavour sugar-free is and what it is used for
Aspigola honey-lemon flavour sugar-free contains the active substances: amylometacresol
and 2,4-dichlorobenzyl alcohol (both with antiseptic properties), and lidocaine (as monohydrate hydrochloride) – a local anaesthetic.
The medicine is indicated for local, short-term, symptomatic relief of oral and throat pain, e.g. pharyngitis (i.e. pain in the back of the throat and difficulty swallowing), sore throat, and after tonsillectomy, in adults and adolescents aged 12 years and over.
If there is no improvement after 3 to 4 days, or if you feel worse, consult your doctor.

2. Important information before taking Aspigola honey-lemon flavour sugar-free

When not to take Aspigola honey-lemon 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 methaemoglobinaemia, have previously experienced methaemoglobinaemia, or have suspected methaemoglobinaemia.

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

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

This medicine may cause numbness of the tongue and increase the risk of injury due to biting. It may also cause choking (coughing during meals or a sensation of suffocation) due to anaesthetisation 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 large quantities, at too short intervals between doses, or on damaged mucous membranes (further information is provided in the section “If you take more Aspigola honey-lemon flavour sugar-free than you should”).
Children and adolescents
This medicine must not be used in children under 12 years of age due to its lidocaine content.
Aspigola honey-lemon 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, particularly if you are using medicines containing:

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

Although no interactions are expected, do not use other antiseptic products intended for use in the mouth or throat while using Aspigola honey-lemon flavour sugar-free.
Taking Aspigola honey-lemon 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, 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 use machines.
Aspigola honey-lemon flavour sugar-free contains isomalt and maltitol
If you have been previously diagnosed with intolerance to certain sugars, consult your doctor before taking this medicine.
Aspigola honey-lemon flavour sugar-free contains less than 1 mmol of sodium (23 mg) per pastille, meaning the medicine is considered "sodium-free".
Aspigola honey-lemon flavour sugar-free contains sunset yellow.
The medicine may cause allergic reactions.

3. How to use ASPIGOLA honey‐lemon 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 over 12 years of age:
1 tablet every 2–3 hours, maximum 8 tablets per day.
Allow the tablet to dissolve slowly in the mouth.
Do not place the tablet between the gum and cheek.
If symptoms persist for more than 3 to 4 days, worsen, or new symptoms occur, consult a doctor (see section 2. Warnings and precautions).

Use in children
This medicine must not be used in children under 12 years of age.

Overdose of ASPIGOLA honey‐lemon 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 and respiratory tract, insomnia, restlessness, stimulation, respiratory depression and breathing difficulties, apnoea (cessation of breathing), seizures, severe hypotension, bradycardia, asystole, circulatory arrest, coma, and death.
Methemoglobinemia may also occur.

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.
You should immediately inform a doctor or go to the nearest hospital if the patient experiences any symptoms which may indicate a rare but very serious adverse reaction called angioedema, described below.
Frequency unknown:

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

If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist.
Reporting of adverse reactions
If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department for 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 this medicine.

5. How to store ASPIGOLA smak miodowo-cytrynowy bez cukru

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box and blister pack following the abbreviation "EXP". The expiry date refers to the last day of the specified 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 required. Such measures will help protect the environment.

6. Contents of the packaging and other information

What Aspigola honey-lemon sugar-free contains

• Each hard tablet contains as active substances:
  • 2.0 mg lidocaine hydrochloride monohydrate
  • 1.2 mg 2,4-dichlorobenzyl alcohol
  • 0.6 mg amylometacresol.
• Other ingredients are: sodium saccharin (E 954), isomalt (E 953), maltitol liquid (E 965), quinoline yellow (E 104), sunset yellow (E 110), peppermint oil, lemon flavour, honey flavour (propylene glycol, flavouring substances), tartaric acid.

What Aspigola honey-lemon sugar-free looks like and contents of the pack
Yellow, round hard tablet with a diameter of 19 mm, with a honey-lemon flavour.
The tablets are packed in PVC/PVDC/Aluminium blisters. The pack contains: 12, 16, 24, 36 or 48 hard tablets.
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 medicinal product is authorised in the European Economic Area member states under the following names:
Bulgaria: Аспи Ангин мед и лимон 2,0 mg/1,2 mg/0,6 mg таблетки за смучене без захар
Czech Republic: Aspegola
Hungary: ASPEGOLA méz-citrom ízű cukormentes szopogató tabletta
Slovakia: ASPEGOLA s príchuťou medu a citrónu
Romania: ASPIGOLA miere și lămâie fără zahăr pastile