Aspigola sprai smak miemtovi

Leaflet attached to the packaging: information for the user

ASPIGOLA mint-flavored spray

(7.39 mg + 4.46 mg + 2.23 mg)/mL, a spray for oral use, solution
Lidocaine hydrochloride monohydrate + 2,4-Dichlorobenzyl alcohol + Amylmetacresol

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If the patient experiences any side effects, including those not listed in this 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.

Table of contents of the leaflet

• 1. What is Aspigola mint-flavored spray and what is it used for
• 2. Important information before using Aspigola mint-flavored spray
• 3. How to use Aspigola mint-flavored spray
• 4. Possible side effects
• 5. How to store Aspigola mint-flavored spray
• 6. Contents of the packaging and other information

1. What is Aspigola mint-flavored spray and what is it used for

Aspigola mint-flavored spray 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.
This medicine is indicated for local, short-term antiseptic treatment of painful and inflammatory conditions of the throat and mouth (redness, swelling) and other symptoms of throat pain 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 a doctor.

2. Important information before using Aspigola mint-flavored spray

When not to use Aspigola mint-flavored spray:

• 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 is suspected of having 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 starting to use Aspigola mint-flavored spray, the patient should discuss it with their doctor or pharmacist if:

• the patient has or has had asthma or bronchospasm
• the patient has larger, unhealed wounds in the mouth and throat area. In this case, the medicine should not be used.
• 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 the anesthesia of the throat. The patient should not drink or eat immediately after using this medicine.

The patient should consult a doctor or pharmacist if they have taken this medicine in large quantities, at short intervals between doses, or on damaged mucous membranes (additional information can be found in the section "Taking a higher dose of Aspigola mint-flavored spray than recommended").

Children and adolescents

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

Aspigola mint-flavored spray 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 in the case of using 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 medicines for oral or throat use while using Aspigola mint-flavored spray.

Using Aspigola mint-flavored spray with food, drink, and alcohol

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

Pregnancy and breastfeeding

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

Driving and using machines

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

Aspigola mint-flavored spray contains ethanol

This medicine contains 84.03 mg of alcohol (ethanol) in each dose (2 sprays). The amount of alcohol in a dose of the medicine is equivalent to less than 2.1 mL of beer or 0.84 mL of wine. The small amount of alcohol in this medicine will not cause noticeable effects.

Aspigola mint-flavored spray contains sorbitol

This medicine contains 33.8 mg of sorbitol in each dose (2 sprays).

Aspigola mint-flavored spray contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose (2 sprays), which means the medicine is considered "sodium-free".

3. How to use Aspigola mint-flavored spray

This medicine should always be taken exactly as described in this patient leaflet or as directed by the doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.
Recommended doses are:
Adults and adolescents over 15 years of age:
2 sprays in the mouth and/or throat 1 to 6 times a day.
Adolescents between 12 and 15 years of age:
2 sprays in the mouth and/or throat 1 to 4 times a day.
If symptoms persist for more than 3 to 4 days, worsen, or other symptoms occur, the patient should consult a doctor (see section 2 "Warnings and precautions").

Use in children

This medicine should not be used in children under 12 years of age.
For use only on the mucous membrane of the mouth.
Do not inhale while spraying the aerosol.
Instructions for use:

• 1. Lift the spray nozzle.
• 2. Insert the spray nozzle into the mouth and direct it at the treated area. Press the pump with your index finger.

Before the first use of Aspigola mint-flavored spray, direct the nozzle away from yourself and spray the aerosol several times until a uniform mist is obtained.
Avoid direct contact of the spray with the eyes.

Taking a higher dose of Aspigola mint-flavored spray 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 anesthesia of the upper gastrointestinal tract and respiratory tract, insomnia, restlessness, excitement, depression of respiration 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 (itching swelling of the skin and/or mucous membranes, causing difficulty swallowing, urticaria, bronchospasm, and hypotension with loss of consciousness)
• methemoglobinemia
• 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 leaflet, they should inform their doctor or pharmacist.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Pharmacovigilance 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
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 mint-flavored spray

The medicine should be stored 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 month.
Shelf life after first use: 1 month
Store in a temperature below 30°C. Store the bottle in the outer packaging to protect it from light.
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. Contents of the packaging and other information

What Aspigola mint-flavored spray contains

• 1 mL of the spray for oral use, solution contains as active substances:
• 7.39 mg of lidocaine hydrochloride monohydrate (equivalent to 6.0 mg of lidocaine)
• 4.46 mg of 2,4-dichlorobenzyl alcohol
• 2.23 mg of amylmetacresol.
• One spray (0.13 mL) contains as active substances:
• 0.96 mg of lidocaine hydrochloride monohydrate
• 0.58 mg of 2,4-dichlorobenzyl alcohol
• 0.29 mg of amylmetacresol.
• The other ingredients of the medicine are: ethanol 96%, glycerol (E 422), sodium hydroxide (to adjust pH), purified water, sorbitol liquid (non-crystallizing) (E420), sodium saccharin, citric acid monohydrate, erythrosine (E 127), levomenthol, peppermint flavor (L-menthone, isomenthone, menthyl acetate, isopulegol, propylene glycol (E 1520), neomenthol, L-menthol, pulegone, piperytone), aniseed flavor (propylene glycol (E 1520), ethyl alcohol, anethole, and natural flavoring substances)

What Aspigola mint-flavored spray looks like and what the packaging contains

A clear, reddish solution with an aniseed and mint flavor and aroma.
The medicine is packaged in type III glass bottles with a metering pump. The pump consists of polypropylene and polyethylene.
Each bottle contains 20 mL of solution, which provides 153 sprays.

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:

Laboratories CHEMINEAU
93, route de la Monnaie
37210 Vouvray
France

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

Bulgaria: Аспи-Ангин мента оромукозен спрей, разтвор
Czech Republic: Aspegola
Hungary: ASPEGOLA szájnyálkahártyán alkalmazott oldatos spray
Slovakia: ASPEGOLA 6,0 mg/ml + 4,46 mg/ml + 2,23 mg/ml orálny roztokový sprej
Romania: ASPIGOLA mentă spray bucofaringian, soluție

Date of last revision of the leaflet: