Aspigola smak miemtovi bez cukru

Package Leaflet: Information for the User

ASPIGOLA mint flavor sugar-free, 2 mg + 1.2 mg + 0.6 mg, hard tablets
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.

• This package leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including those not listed in this package leaflet, the doctor or pharmacist should be informed. See section 4.
• If there is no improvement or the patient feels worse after 3 to 4 days, a doctor should be consulted.

Table of Contents of the Package Leaflet

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

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

Aspigola mint 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 local anesthetic.
The medicine is indicated for the symptomatic treatment of painful conditions of the mouth and throat, such as sore throat (i.e., pain in the back of the throat), laryngitis (i.e., pain in the larynx often accompanied by hoarseness and difficulty swallowing), sore throat, and after tonsillectomy in adults and adolescents over 12 years of age.
If there is no improvement or the patient feels worse after 3 to 4 days, a doctor should be consulted.

2.

Important information before taking Aspigola mint flavor sugar-free

When not to take Aspigola mint 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 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, a doctor should be consulted.
Before taking Aspigola mint flavor sugar-free, the patient should discuss it with a 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.
A doctor or pharmacist should be consulted if the patient has 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 mint 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 mint flavor sugar-free and other medicines

The patient should inform the doctor or pharmacist about all medicines being taken, including those planned to be taken, especially if the patient is taking medicines containing:

• beta-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, other antiseptic medicines for use in the mouth or throat should not be used during treatment with Aspigola mint flavor sugar-free.

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

This medicine should not be taken immediately before a meal or drink.

Pregnancy and breastfeeding

If the patient is pregnant, breastfeeding, or thinks she may be pregnant, she should consult a 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 mint flavor sugar-free contains isomalt and maltitol

If the patient has previously been diagnosed with intolerance to some sugars, the patient should consult a doctor before taking the medicine.
Aspigola mint flavor sugar-free containsless than 1 mmol sodium(23 mg) per tablet, which means the medicine is considered "sodium-free".

3. How to take Aspigola mint 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 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 for 3 to 4 days.
Slowly dissolve the tablet in the mouth.
The tablet should not be dissolved between the gum and cheek.
This medicine should not be taken immediately before a meal or drink.
If symptoms persist for more than 3-4 days, worsen, or other symptoms occur, a doctor or pharmacist should be consulted.

Use in children

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

Taking a higher dose of Aspigola mint flavor sugar-free than recommended

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

4. Possible side effects

Like all medicines, Aspigola mint flavor sugar-free can cause side effects, although not everybody gets them.
A doctor or the nearest hospital should be informed immediately if the patient experiences any symptoms that may indicate a rare but serious side effect called angioedema, described below.
Frequency not known (frequency cannot be estimated from the available data):

• 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)
• 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, the doctor or pharmacist should be informed.

Reporting side effects

If the patient experiences any side effects, including those not listed in this package leaflet, the doctor or pharmacist should be informed. Side effects can be reported directly to the Department of Drug Safety Monitoring 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 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 "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. A pharmacist should be asked how to dispose of medicines that are no longer used. This will help protect the environment.

6. Package contents and other information

What Aspigola mint flavor 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 amylmetacresol.
• Other ingredients of the medicine are: sodium saccharin (E 954), isomalt (E 953), liquid maltitol (E 965), indigotine (E132), quinoline yellow (E 104), peppermint oil, star anise essential oil, levomenthol, tartaric acid.

What Aspigola mint flavor sugar-free looks like and contents of the package

Aspigolamint flavor sugar-free are blue-green, round, hard tablets with a diameter of 19 mm, mint flavor.
The tablets are packaged in PVC/PVDC/Aluminum blisters. The package contains: 12, 16, 24, 36, or 48 hard tablets.
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-Ангин мента без захар таблетки за смучене
Romania: ASPIGOLA mentă fără zahăr pastile

Date of last revision of the package leaflet: