Aspigola spray with mint flavor

Package leaflet: Information for the user

ASPIGOLA spray mint flavour
(7.39 mg + 4.46 mg + 2.23 mg)/mL, oral aerosol, solution
Lidocaine hydrochloride monohydrate + 2,4-Dichlorobenzyl alcohol + Amylometacresol
Please read all of this leaflet carefully before using this medicine, because it contains important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, please consult 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 spray mint flavour is and what it is used for
2. Important information before using Aspigola spray mint flavour
3. How to use Aspigola spray mint flavour
4. Possible side effects
5. How to store Aspigola spray mint flavour
6. Contents of the pack and other information

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

Aspigola spray mint flavour contains the active substances: amylometacresol and 2,4-dichlorobenzyl alcohol (both with antiseptic properties), and lidocaine (as lidocaine hydrochloride monohydrate), a local anaesthetic.
This medicine is indicated for local, short-term antiseptic treatment of painful and inflammatory conditions of the throat and oral cavity (redness, swelling), and other symptoms of sore throat in adults and adolescents over 12 years of age.
If there is no improvement after 3 to 4 days, or if you feel worse, consult your doctor.

2. Important information before using ASPIGOLA spray smak miętowy

When not to take ASPIGOLA spray smak miętowy:

• if the patient is allergic to:
  • lidocaine or other local anaesthetics 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 predisposition to methaemoglobinaemia, has previously experienced methaemoglobinaemia, or has suspected methaemoglobinaemia.

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 if other symptoms occur such as high fever, headache, nausea or vomiting, consult a doctor.
Before starting to use ASPIGOLA spray smak miętowy, discuss with a doctor or pharmacist if:

• the patient has or has ever had asthma or bronchospasm,
• the patient has large, unhealed wounds in the area of the mouth or throat. This medicine should not be used in such cases.
• the patient is elderly or debilitated. The patient 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 anaesthesia of the throat. Do not eat or drink immediately after using this medicine.

Consult a doctor or pharmacist if the patient has taken this medicine in large amounts, at too short intervals between doses, or applied it to damaged mucous membranes (additional information is provided in section "If more ASPIGOLA spray smak miętowy has been used than recommended").
Children and adolescents
This medicine should not be used in children under 12 years of age due to its lidocaine content.
ASPIGOLA spray smak miętowy and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, especially when using medicines containing:

• beta-blocking agents (used in the treatment of heart failure or arterial diseases),
• cimetidine (used in the treatment of stomach 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, other antiseptic medicines intended for use in the mouth or throat should not be used concurrently with ASPIGOLA spray smak miętowy.
Use of ASPIGOLA spray smak miętowy with food, drink and alcohol
Do not take this medicine immediately before eating or drinking.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Use of this medicine during pregnancy and breastfeeding is not recommended.
Driving and operating machinery
This medicine has no effect or has negligible effect on the ability to drive and operate machinery.
ASPIGOLA spray smak miętowy contains ethanol
This medicine contains 84.03 mg of alcohol (ethanol) per 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 spray smak miętowy contains sorbitol
This medicine contains 33.8 mg of sorbitol per dose (2 sprays).
ASPIGOLA spray smak miętowy contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose (2 sprays), meaning the medicine is considered "sodium-free".

3. How to use ASPIGOLA spray mint flavour

This medicine should always be used exactly as described in this patient information leaflet or as advised by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Recommended doses are:
Adults and adolescents aged 15 years and above:
2 sprays into the mouth and/or throat 1 to 6 times daily.
Adolescents aged 12 to 15 years:
2 sprays into the mouth and/or throat 1 to 4 times daily.
If symptoms persist for more than 3 to 4 days, worsen, or new symptoms appear, 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.
For topical use on the oral mucosa only.
Do not inhale the aerosol during spraying.

Instructions for use:

1. Lift the spray nozzle.
2. Place the spray nozzle into the mouth and direct it towards the affected area. Press the pump with the index finger.

Before first use of ASPIGOLA spray mint flavour, point the nozzle away from yourself and spray several times until a uniform mist is obtained.
Avoid direct contact of the spray with the eyes.

Accidental overdose of ASPIGOLA spray mint flavour
In case of suspected overdose, contact a doctor immediately.
Symptoms which may occur following improper use or overdose include:
excessive anaesthesia of the upper gastrointestinal tract and respiratory tract, insomnia, restlessness, agitation, 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 questions 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 experiences them.
Immediately inform a doctor or go to the nearest hospital if the patient develops any symptoms that may indicate a rare but very serious adverse reaction called angioedema, described below.
Frequency unknown:

• hypersensitivity: hypersensitivity to lidocaine may manifest as angioedema (itchy swelling of the skin and/or mucous membranes, causing difficulty in swallowing), urticaria, bronchospasm, and hypotension with loss of consciousness
• methemoglobinemia
• 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 of Monitoring of 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 allows the collection of additional information on the safety of medicine use.

5. How to store ASPIGOLA spray smak miętowy

Keep the 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 "EXP". The expiry date refers to the last day of the specified month.
Duration of use after first opening: 1 month
Store below 30°C. Keep the bottle in the outer packaging to protect it from light.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Aspigola spray mint flavour contains

• 1 mL of oral aerosol 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 amylometacresol.
• 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 amylometacresol.

Other ingredients: ethanol 96%, glycerol (E 422), sodium hydroxide (for pH adjustment), purified water, liquid non-crystallizing sorbitol (E420), sodium saccharin, monohydrate citric acid, erythrosine (E 127), levomenthol, mint flavour (L-menthone, isomenthone, menthyl acetate, isopulegol, propylene glycol (E 1520), neomenthol, L-menthol, pulegone, piperytone), aniseed flavour (propylene glycol (E 1520), ethyl alcohol, anethole, and natural flavouring substances).

What Aspigola spray mint flavour looks like and contents of the pack
A clear, reddish solution with aniseed and mint flavour and odour.
The medicine is packed in glass bottles (Type III) with a metering pump. The pump is made of polypropylene and polyethylene.
Each bottle contains 20 mL of solution, providing 153 sprays.

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:
Laboratories CHEMINEAU
93, route de la Monnaie
37210 Vouvray
France

PHARMEX ADVANCED LABORATORIES S.L.
Ctra. A-431 Km. 19
14720 Almodóvar del Río, Córdoba
Spain

This medicine is authorised in the following names in the European Economic Area countries:
Bulgaria: Аспи-Aнгин 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