Aethylum chloratum filofarm

Package leaflet: Information for the patient

Aethylum Chloratum Filofarm
70 g, aerosol
(Ethylis chloridum)
Please read carefully this leaflet before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the 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 adverse reactions
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 sprayed onto the skin evaporates rapidly, absorbing a large amount of heat, resulting in significant cooling or even local freezing of the sprayed area of skin, leading to anaesthesia of sensory nerve endings and loss of pain sensation.
Indications for use
Aethylum Chloratum Filofarm is used for short-term local anaesthesia of the skin during minor surgical procedures.

2. Important information before using Aethylum Chloratum Filofarm

When not to use Aethylum Chloratum Filofarm

• if the patient is allergic to ethyl chloride;
• on damaged skin;
• for inhalational anaesthesia;
• in children under 12 years of age. Due to the toxic effects of ethyl chloride on the heart and lungs, the medicine is not intended for general anaesthesia.

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

DANGER
GHS02 – Flammable aerosols, hazard category 1A
GHS04 – Gases under pressure
GHS08 – Carcinogenicity, hazard category 2
The aerosol container contains extremely flammable gas under pressure. Exposure of the container to
fire or high temperatures may cause an explosion.
Suspected of causing cancer (oral route, after swallowing; as a result of inhalation).
Do not inhale vapours or consume food during use of the medicine.
Inhaling ethyl chloride vapours may be hazardous to health. Central nervous system disturbances may occur, as well as cardiac and respiratory arrest. In case of poisoning, call emergency services immediately and transport the patient to hospital.
Aethylum Chloratum Filofarm aerosol is a medicine intended 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
Inform your doctor about all medicines currently used or recently used, as well as any medicines the patient intends to use.
No interactions of Aethylum Chloratum Filofarm with other medicines are known.
Use of Aethylum Chloratum Filofarm with food, drink and alcohol
See section 3.
Do not drink alcohol during treatment with this medicine.
Do not consume food during use of the medicine.
Pregnancy, breastfeeding and effects on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Aethylum Chloratum Filofarm should not be used during pregnancy or breastfeeding unless clearly recommended by a doctor.
Driving and operating machinery
Aethylum Chloratum Filofarm, when used as directed, does not impair the ability to drive or operate machinery.

3. How to use Aethylum Chloratum Filofarm

This medicine should always be used as directed by the physician. In case of doubt, consult your
doctor.
Usually, the medicine is used as described below.
Adults and adolescents over 12 years of age:
Aethylum Chloratum Filofarm is applied to the skin. The spray should be administered from a distance of 8–23 cm for 3–7 seconds. If local anaesthetic effect is insufficient, the application may be repeated after 10–15 minutes.
Use in children and adolescents under 12 years of age
The safety and efficacy of Aethylum Chloratum Filofarm in children under 12 years of age have not been established; 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 your doctor.
Use of more than the recommended dose of Aethylum Chloratum Filofarm
In case of administration of a higher than recommended dose, seek immediate medical advice from a doctor or pharmacist.
Symptoms of acute poisoning
In case of accidental spraying into the eyes, Aethylum Chloratum Filofarm causes redness of the conjunctiva. Contamination of the eyes with liquid ethyl chloride may cause lesions of the conjunctiva and cornea.
Skin contamination may cause local irritation or frostbite.
Inhalation of ethyl chloride vapours causes disturbances in the function of the central nervous system. It may lead to cardiac and respiratory arrest.
Symptoms of chronic poisoning
Aethylum Chloratum Filofarm may cause chronic contact dermatitis due to skin defatting. Prolonged exposure to ethyl chloride may cause liver or kidney damage.
Treatment
In case of eye contamination, evert eyelids and rinse eyes for about 15 minutes with large amounts of lukewarm water or 0.9% sodium chloride solution (physiological saline).
In every case of eye contamination, urgent consultation with an ophthalmologist is necessary.
In case of skin contamination, rinse thoroughly with large amounts of cold water, apply a sterile dressing to the frostbitten or reddened skin, and protect against heat loss. If skin irritation persists, consult a dermatologist.
In case of inhalation poisoning, ensure access to fresh air.
In case of cardiac arrest, restore heart function by performing external cardiac massage combined with artificial respiration and call emergency services immediately.
It is particularly important to ensure complete rest for the patient, even in cases of apparently mild poisoning.
Missed dose of Aethylum Chloratum Filofarm
Do not use a double dose to make up for a missed dose.
Discontinuation of Aethylum Chloratum Filofarm
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although they do not occur in every person.
Rare adverse effects (occur 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 of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist, or nurse.
Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Aethylum Chloratum Filofarm

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging following: EXP.
The expiry date refers to the last day of the specified month.
Store below 25°C.
Protect from fire. Do not spray near open flame or other sources of ignition.
Do not pierce the aerosol container, and do not throw it into the fire.
Do not puncture or burn, even when empty.
Protect from sunlight. Do not expose to temperatures exceeding 50°C.
Harmful to aquatic organisms with long-lasting effects.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the package and other information

What Aethylum Chloratum Filofarm contains
The active substance is ethyl chloride 70.0 g.
What Aethylum Chloratum Filofarm looks like and contents of the pack
Aethylum Chloratum Filofarm is an aerosol.
Available pack
One aluminium aerosol container containing 70 g of ethyl chloride in a cardboard box.
Marketing Authorisation Holder and Manufacturer
Farmaceutyczna Spółdzielnia Pracy FILOFARM
ul. Pułaskiego 39
85-619 Bydgoszcz
For further information on this medicinal product, please contact the representative of the Marketing Authorisation Holder.
Farmaceutyczna Spółdzielnia Pracy FILOFARM
ul. Pułaskiego 39, 85-619 Bydgoszcz
tel.: +48 52 342 67 88
Information for blind and partially sighted people: The package leaflet of Aethylum Chloratum Filofarm is available in the Audio Leaflet system via the nationwide freephone number 800 706 848.
Date of the latest revision of the leaflet: