Aethilum hloratum Filofarm

Package Leaflet: Information for the Patient

Aethylum Chloratum Filofarm

70 g, spray

(Ethylis chloridum)

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Aethylum Chloratum Filofarm and what is it used for
• 2. Important information before using Aethylum Chloratum Filofarm
• 3. How to use Aethylum Chloratum Filofarm
• 4. Possible side effects
• 5. How to store Aethylum Chloratum Filofarm
• 6. Contents of the pack and other information

1. What is Aethylum Chloratum Filofarm and what is it used for

Aethylum Chloratum Filofarm spray evaporates rapidly on the skin, absorbing a lot of heat, resulting in significant cooling, and even local freezing of the sprayed skin area, causing anesthesia of the sensory nerve endings and elimination of pain sensation.

Indications for Use

Aethylum Chloratum Filofarm is used for short-term local anesthesia of the skin during minor surgical procedures.

2. Important information before using Aethylum Chloratum Filofarm

When not to use Aethylum Chloratum Filofarm

• on damaged skin;
• for inhalation anesthesia;
• in children under 12 years of age. Due to the toxic effect of ethyl chloride on the heart and lungs, the medicine is not intended for general anesthesia.

Warnings and Precautions

Before starting to use Aethylum Chloratum Filofarm, discuss it with your doctor.

DANGER

GHS02 – flammable aerosols, category 1A hazard
GHS04 – gases under pressure
GHS08 – carcinogenicity, category 2 hazard
The aerosol container contains a highly flammable gas under pressure. The packaging exposed to fire or high temperature may explode.
Suspected of causing cancer (ingestion; following inhalation).
Do not inhale gas vapors or eat meals while using the medicine.
Inhaling ethyl chloride vapors can be hazardous to health. Central nervous system disorders may occur, as well as cardiac and respiratory arrest. In case of poisoning, immediately call for emergency services and take the patient to the hospital.
Aethylum Chloratum Filofarm spray is for external use only.
When applying the medicine to the facial skin, protect the eyes, nose, and lips.

Children and Adolescents

The medicine is not intended for use in children and adolescents under 12 years of age, and therefore should not be used in this age group.

Aethylum Chloratum Filofarm and other medicines

Tell your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
No interactions of Aethylum Chloratum Filofarm with other medicines are known.

Using Aethylum Chloratum Filofarm with food, drink, and alcohol

See section 3.
Do not drink alcohol while using the medicine.
Do not eat meals while using the medicine.

Pregnancy, Breast-feeding, and Fertility

If the patient is pregnant or breast-feeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before using this medicine.
Aethylum Chloratum Filofarm should not be used during pregnancy and breast-feeding without explicit doctor's recommendation.

Driving and Using Machines

Aethylum Chloratum Filofarm used as recommended does not affect the ability to drive vehicles and operate machines.

3. How to use Aethylum Chloratum Filofarm

This medicine should always be used as recommended by the doctor. In case of doubts, consult a doctor.
Usually, the medicine is used as described below.

Adults and Adolescents over 12 years:

Aethylum Chloratum Filofarm is applied to the skin. The spray should be sprayed from a distance of 8-23 cm for 3-7 seconds. If the effect of local anesthesia is insufficient, the application can be repeated after 10-15 minutes.

Use in Children and Adolescents under 12 years

The safety and efficacy of Aethylum Chloratum Filofarm in children under 12 years of age have not been established, and therefore it should not be used in this age group.
If you feel that the effect of Aethylum Chloratum Filofarm is too strong or too weak, consult a doctor.

Using a higher dose of Aethylum Chloratum Filofarm than recommended

In case of using a higher dose of the medicine than recommended, immediately consult a doctor or pharmacist.
Acute poisoning symptoms
In case of accidental spraying into the eyes, Aethylum Chloratum Filofarm causes conjunctival redness. Eye contamination with liquid ethyl chloride can cause changes in the conjunctiva and cornea.
Skin contamination can cause local irritation or frostbite.
Inhaling ethyl chloride vapors can cause central nervous system disorders. It may cause cardiac and respiratory arrest.
Chronic poisoning symptoms
Aethylum Chloratum Filofarm may cause chronic contact dermatitis due to skin defatting. Prolonged exposure to ethyl chloride can cause liver or kidney damage.
Treatment
In case of eye contamination, lift the eyelids and rinse the eyes with a large amount of lukewarm water or 0.9% sodium chloride solution (physiological saline) for about 15 minutes.
In any case of eye contamination, it is necessary to urgently consult an ophthalmologist.
In case of skin contamination, rinse with a large amount of cold water, apply a sterile dressing to the frostbitten or reddened skin, and protect against heat loss. If skin irritation does not disappear, consult a dermatologist.
In case of inhalation poisoning, ensure access to fresh air.
In case of cardiac arrest, restore heart function by applying external cardiac massage with simultaneous artificial respiration and immediately call for emergency services.
It is especially important to ensure the patient's complete rest, even in cases of seemingly mild poisoning.

Missing a dose of Aethylum Chloratum Filofarm

Do not use a double dose to make up for a missed dose.

Stopping use of Aethylum Chloratum Filofarm

In case of any further doubts related to the use of this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Aethylum Chloratum Filofarm can cause side effects, although not everybody gets them.
Rare side effects(occurring in 1 to 10 out of 10,000 treated patients):
local skin irritation or frostbite caused by the low temperature of the condensed gas,
chronic contact dermatitis due to skin defatting.

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, tell your doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department for Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
tel.: 22 49 21 301
fax: 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Aethylum Chloratum Filofarm

Keep the medicine out of the sight and reach of children.
Do not use the medicine after the expiry date stated on the packaging after: EXP.
The expiry date refers to the last day of the given month.
Store at a temperature below 25°C.
Protect from fire. Do not spray near open flames or other ignition sources.
Do not pierce or burn the aerosol container, even after use.
Protect from sunlight. Do not expose to temperatures above 50°C.
Harmful to aquatic organisms, causing long-term effects.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Aethylum Chloratum Filofarm contains

The active substance of the medicine is ethyl chloride 70.0 g.

What Aethylum Chloratum Filofarm looks like and contents of the pack

Aethylum Chloratum Filofarm is a spray.
Pack sizes
The carton box contains 1 aluminum aerosol container, holding 70 g of ethyl chloride.

Marketing authorization holder and manufacturer

FILOFARM Pharmaceutical Cooperative
ul. Pułaskiego 39
85-619 Bydgoszcz
To obtain more detailed information about this medicine, please contact the representative of the marketing authorization holder.
FILOFARM Pharmaceutical Cooperative
ul. Pułaskiego 39, 85-619 Bydgoszcz
tel.: +48 52 342 67 88
Information for the blind and visually impaired: The content of the Aethylum Chloratum Filofarm leaflet is available in the Ulotka Audio system under the nationwide free phone number 800 706

• 848.

Date of last revision of the leaflet: