Aspigola smak miodovo‐citrinovi bez cukru

Package Leaflet: Information for the User

ASPIGOLA honey and lemon flavor, sugar-free, 2 mg + 1.2 mg + 0.6 mg, hard lozenges
Lidocaine hydrochloride monohydrate + 2,4-Dichlorobenzyl alcohol + Amylmetacresol

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist.

• Keep this package leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including those not listed in this package leaflet, they should inform their doctor or pharmacist. See section 4.
• If after 3 to 4 days there is no improvement or the patient feels worse, they should contact their doctor.

Package Leaflet Contents

• 1. What is Aspigola honey and lemon flavor, sugar-free, and what is it used for
• 2. Important information before taking Aspigola honey and lemon flavor, sugar-free
• 3. How to take Aspigola honey and lemon flavor, sugar-free
• 4. Possible side effects
• 5. How to store Aspigola honey and lemon flavor, sugar-free
• 6. Package contents and other information

1. What is Aspigola honey and lemon flavor, sugar-free, and what is it used for

Aspigola honey and lemon flavor, sugar-free, contains the active substances: amylmetacresol and 2,4-dichlorobenzyl alcohol (both with antiseptic properties) and lidocaine (in the form of monohydrate hydrochloride) - a locally anesthetizing medicine.
The medicine is indicated for local, short-term, symptomatic treatment of painful conditions of the mouth and throat, such as sore throat (i.e., pain in the back of the throat and difficulty swallowing), throat pain, and after tonsillectomy, in adults and adolescents over 12 years of age.
If after 3 to 4 days there is no improvement or the patient feels worse, they should consult their doctor.

2. Important information before taking Aspigola honey and lemon flavor, sugar-free

When not to take Aspigola honey and lemon flavor, sugar-free:

• if the patient is allergic to:
• lidocaine or other local anesthetics of the amide group,
• amylmetacresol,
• 2,4-dichlorobenzyl alcohol,
• any of the other ingredients of this medicine (listed in section 6).
• if the patient has a tendency to methemoglobinemia, has had methemoglobinemia in the past, or suspects methemoglobinemia.

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

Warnings and precautions

If symptoms persist for more than 3-4 days, worsen, or other symptoms occur, such as high fever, headache, nausea, or vomiting, the patient should consult a doctor.
Before taking Aspigola honey and lemon flavor, sugar-free, the patient should discuss it with their doctor or pharmacist if:

• the patient has large, unhealed wounds in the mouth and throat. The medicine should not be used in this case.
• the patient is elderly or weakened. The patient may be more susceptible to potential side effects.

This medicine may cause numbness of the tongue and increase the risk of injury from biting. Additionally, it may cause choking (coughing during meals or a feeling of choking) due to anesthesia of the throat. The patient should not drink or eat immediately after taking this medicine.
The patient should consult their doctor or pharmacist if they have taken this medicine in large quantities, at short intervals, or on damaged mucous membranes (additional information can be found in the section "Taking a higher dose of Aspigola honey and lemon flavor, sugar-free than recommended").

Children and adolescents

This medicine should not be used in children under 12 years of age due to the presence of lidocaine.

Aspigola honey and lemon flavor, sugar-free and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, especially if they are taking medicines containing:

• beta-adrenergic receptor blockers (used to treat heart failure or vascular diseases),
• cimetidine (used to treat stomach ulcers),
• mexiletine or procainamide (used to treat 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, the patient should not use other antiseptic products for oral or throat use while taking Aspigola honey and lemon flavor, sugar-free.

Taking Aspigola honey and lemon flavor, sugar-free with food, drink, and alcohol

The patient should not take this medicine immediately before a meal or drink.

Pregnancy and breastfeeding

If the patient is pregnant, breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
This medicine is not recommended during pregnancy and breastfeeding.

Driving and using machines

This medicine has no or negligible influence on the ability to drive and use machines.

Aspigola honey and lemon flavor, sugar-free contains isomalt and maltitol

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking this medicine.
Aspigola honey and lemon flavor, sugar-free contains less than 1 mmol of sodium (23 mg) per lozenge, which means the medicine is considered "sodium-free".
Aspigola honey and lemon flavor, sugar-free contains orange yellow.
The medicine may cause allergic reactions.

3. How to take Aspigola honey and lemon flavor, sugar-free

This medicine should always be taken exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.
Recommended dose for adults and adolescents over 12 years of age:
1 lozenge every 2-3 hours, maximum 8 lozenges per day.
Slowly dissolve the lozenge in the mouth.
The lozenge should not be dissolved between the gum and cheek.
If symptoms persist for more than 3 to 4 days, worsen, or other symptoms occur, the patient should consult their doctor (see section 2. Warnings and precautions).

Use in children

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

Taking a higher dose of Aspigola honey and lemon flavor, sugar-free than recommended

In case of suspected overdose, the patient should immediately contact their doctor.
Symptoms that may occur in case of improper use or overdose include:
excessive numbness of the upper gastrointestinal tract and airways, insomnia, restlessness, excitement, respiratory depression, and respiratory arrest, apnea (cessation of breathing), seizures, severe hypotension, bradycardia, asystole, cardiac arrest, coma, and death.
Methemoglobinemia may also occur.
If the patient has any further doubts about the use of this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The patient should immediately inform their doctor or go to the nearest hospital if they experience any symptoms that may indicate a rare but very serious side effect called angioedema, which is described below.
Frequency not known:

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

If the patient experiences any side effects, including those not listed in this package leaflet, they should inform their doctor or pharmacist.

Reporting side effects

If the patient experiences any side effects, including those not listed in this package leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, 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
Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Aspigola honey and lemon flavor, sugar-free

The medicine should be stored out of sight and reach of children.
This medicine should not be used after the expiry date stated on the carton and blister after the term "EXP". The expiry date refers to the last day of the month.
There are no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Aspigola honey and lemon flavor, sugar-free contains

• Each lozenge contains as active substances:
• 2.0 mg lidocaine hydrochloride monohydrate
• 1.2 mg 2,4-dichlorobenzyl alcohol
• 0.6 mg amylmetacresol.
• Other ingredients of the medicine are: sodium saccharin (E 954), isomalt (E 953), liquid maltitol (E 965), quinoline yellow (E 104), orange yellow (E 110), peppermint oil, lemon flavor, honey flavor (propylene glycol, flavoring substances), tartaric acid.

What Aspigola honey and lemon flavor, sugar-free looks like and what the package contains

Yellow, round, hard lozenge with a diameter of 19 mm, with a honey and lemon flavor.
Lozenges are packaged in PVC/PVDC/Aluminum blisters. The package contains: 12, 16, 24, 36, or 48 hard lozenges.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Bayer Sp. z o. o.
Al. Jerozolimskie 158
02-326 Warsaw
Phone: +48 22 572 35 00

Manufacturer:

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

This medicine is authorized in the Member States of the European Economic Area under the following names:

Bulgaria: Аспи-Aнгин мед и лимон без захар таблетки за смучене
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

Date of last revision of the package leaflet: