Aethoxisklerol 0,5%

Chemische Fabrik Kreussler & Co.

GmbH

Aethoxysklerol 0.5% (amp.)

Leaflet attached to the packaging: information for the user

Aethoxysklerol 0.5%, 5 mg/ml solution for injections

Lauromacrogol400

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

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or nurse.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Aethoxysklerol 0.5% and what is it used for
• 2. Important information before using Aethoxysklerol 0.5%
• 3. How to use Aethoxysklerol 0.5%
• 4. Possible side effects
• 5. How to store Aethoxysklerol 0.5%
• 6. Contents of the packaging and other information

1. What is Aethoxysklerol 0.5% and what is it used for

Aethoxysklerol 0.5% is a sclerosing agent (sclerotherapy), which means it is used to inject a thin needle into a vein and inject lauromacrogol 400 through it, which is also known as polidocanol or lauryl ether of macrogol, causing the vein wall to become fibrotic, leading to its closure and disappearance. Aethoxysklerol 0.5% is used for sclerotherapy of varicose veins of the lower limbs.

2. Important information before using Aethoxysklerol 0.5%

When not to use Aethoxysklerol 0.5%:

• if the patient is allergic to lauromacrogol or any of the other ingredients of this medicine (listed in section 6)
• if the patient has an acute, severe disease (especially untreated)
• if the patient is immobilized
• if the patient has severe obstructive disease of the lower limb arteries (stage III and IV on the Fontaine scale)
• if the patient has thromboembolic diseases
• if the patient has a high risk of thrombosis (e.g. proven inherited tendency to thrombosis or multiple risk factors, such as the use of hormonal contraceptives or hormone replacement therapy, obesity, smoking, or prolonged periods of immobilization).

Special caution is required when:

• asthma and a high tendency to allergies occur
• there is a fever
• the patient is in very poor general health
• there is swelling of the lower limbs caused by fluid accumulation that cannot be treated with compression therapy
• there are spider veins: arterial closure (stage II on the Fontaine scale)
• there is skin inflammation at the site of sclerotherapy
• there are symptoms of closure of the smallest and thinnest vessels, e.g. due to diabetes (microangiopathy) and impaired sensation (neuropathy)
• the patient has reduced mobility

Warnings and precautions

Before starting treatment with Aethoxysklerol 0.5%, you should discuss it with your doctor or nurse. The medicine must not be administered intra-arterially, as this may cause tissue necrosis, which can lead to amputation. In such cases, the patient must be treated by a vascular surgeon. The use of the preparation in the face area may cause a reversal of blood pressure in the arteries, leading to permanent vision disturbances (blindness). In some areas, e.g. in the case of varicose veins in the ankle area, the risk of accidental intra-arterial injection may be higher, so only small amounts of the medicine should be used, with special caution during administration.

Aethoxysklerol 0.5% and other medicines

You should tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. The active substance lauromacrogol 400 is also used as a local anesthetic (local anesthetic). Therefore, if it is used simultaneously with another anesthetic within 24 hours, there is a risk of increased action, which can cause cardiac arrest.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor before using this medicine. In pregnant women, Aethoxysklerol 0.5% should not be used unless absolutely necessary. There are no exact data on the use of Aethoxysklerol 0.5% in pregnant women. In animal studies, no obvious developmental abnormalities were found. In the case of necessary sclerotherapy in breastfeeding women, breastfeeding should be interrupted for 2 to 3 days, as no human studies have been conducted on the penetration of lauromacrogol 400 into breast milk.

Driving and using machines

The medicine does not affect the ability to drive or use machines. The medicine contains 5% v/v ethanol (alcohol), i.e. up to 84 mg per dose, which is equivalent to 2 ml of beer, 0.83 ml of wine per dose. Harmful to people with alcoholism. Should be taken into account when used in pregnant or breastfeeding women, children, and people at high risk, such as patients with liver disease or epilepsy. The medicine contains less than 1 mmol (39 mg) of potassium per dose, i.e. the medicine is considered "potassium-free". The medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. the medicine is considered "sodium-free".

3. How to use Aethoxysklerol 0.5%

This medicine should always be used as directed by your doctor. If you are unsure, you should consult your doctor. Aethoxysklerol 0.5% is used in sclerotherapy of spider veins and in sclerotherapy of central veins of spider veins. Recommended dose Do not use a daily dose greater than 2 mg of lauromacrogol 400 per kg of body weight, which means that in a patient with a body weight of 70 kg, no more than 28 ml of 0.5% solution can be administered per day. In patients with known hypersensitivity to medicines from the medical history, during the first obliteration procedure, no more than one injection should be performed. During subsequent sessions, lauromacrogol 400 can be administered in several injections in a dose not greater than the maximum. Depending on the size of the area to be treated, 0.1 to 0.2 ml of Aethoxysklerol 0.5% is injected into the vein per injection (intravenously). Methods of administration: Injections of Aethoxysklerol 0.5% should only be performed in the leg placed in a horizontal position or elevated about 30-45° above the horizontal. All injections must be performed intravenously, including injections into spider veins. Very thin needles (e.g. insulin needles) and syringes with a smooth plunger movement are used for injections. The puncture is performed tangentially, and the injection is administered slowly, keeping the needle in the intravenous position. Depending on the extent of the varicose veins, it may be necessary to perform several treatment sessions at one- or two-week intervals. Note:Thrombi that form in some cases are removed by puncturing and pushing them out. Compression after injection of Aethoxysklerol 0.5%After dressing the puncture site, a compression bandage or elastic stocking should be applied. After applying the dressing, the patient should walk for 30 minutes, preferably near the clinic. Compression should be applied for 2 to 3 days after sclerotherapy of spider veins, and in other cases for 5 to 7 days. In the case of extensive varicose veins, longer compression treatment with the use of short compressive bandages is recommended. The success of sclerotherapy depends on careful and careful post-treatment compression.

Using a higher dose of Aethoxysklerol 0.5% than recommended

In the event of administration of a higher dose of the medicine than recommended, local tissue necrosis may occur, especially after peri-vascular injection.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although they do not occur in everyone. The following side effects have been reported in connection with the use of lauromacrogol 400 worldwide. In some cases, the symptoms were troublesome, but in most cases, they were transient. As the reports usually came from spontaneous reports, without reference to a defined patient group and without a control group, it is not possible to determine the exact frequency and establish a connection with the administered medicine for each reported event. However, it is possible to estimate the frequency based on long-term experience. Local side effects (e.g. necrosis) of the skin and deeper tissues (and rarely nerves) have been found after accidental injection into the surrounding tissue (peri-vascular injection). There is a risk of side effects depending on the amount and concentration of the administered medicine. Additionally, the following side effects have been observed: Very rare (may occur in no more than 1 in 10,000 patients): anaphylactic shock, angioedema, urticaria (generalized), asthma (asthma attacks), cerebral circulation disorders, hemiplegia, headaches, migraines, local sensory disturbances (paresthesia), numbness in the mouth, loss of consciousness, dizziness, speech disorders, coordination disorders, disorientation, visual impairment (vision disorders), cardiac arrest, broken heart syndrome (stress-induced cardiomyopathy), palpitations, irregular heart rhythm (tachycardia, bradycardia), pulmonary embolism, fainting, vascular or cardiac collapse, vasculitis, shortness of breath, feeling of discomfort in the chest (feeling of pressure in the chest), cough, taste disorders, nausea, vomiting, excessive hair growth at the site of sclerotherapy, fever, sudden flushing, malaise, weakness, blood pressure disorders. Rare (may occur in no more than 1 in 1,000 patients): deep vein thrombosis (possible connection with underlying diseases), limb pain. Uncommon (may occur in no more than 1 in 100 patients): superficial thrombophlebitis, phlebitis, allergic skin inflammation, contact urticaria, erythema, skin allergic reactions, necrosis, hardening, swelling, nerve damage. Common (may occur in no more than 1 in 10 patients): neovascularization (formation of blood vessels based on existing vessels), hematomas, skin discoloration, bruising, pain (short-term at the site of sclerotherapy), thrombosis at the injection site (local blood clots within varicose veins).

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, you should inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of 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. By reporting side effects, you can help provide more information on the safety of the medicine.

5. How to store Aethoxysklerol 0.5%

The medicine should be stored out of sight and reach of children. Store in a temperature below 25°C. Do not use this medicine after the expiry date stated on the packaging. The immediate packaging is designed for single use.

6. Contents of the packaging and other information

What Aethoxysklerol 0.5% contains

The active substance of the medicine is lauromacrogol 400. The other excipients are: ethanol 96%, disodium phosphate dihydrate, potassium dihydrogen phosphate, water for injections.

What Aethoxysklerol 0.5% looks like and what the packaging contains

The packaging contains 5 ampoules. 1 ampoule of 2 ml contains 10 mg of lauromacrogol 400.

Marketing authorization holder and manufacturer

Chemische Fabrik Kreussler & Co. GmbH, Rheingaustr. 87-93, 65203 Wiesbaden, Germany. For more detailed information, please contact: Alfasigma Polska Sp. z o.o., Al. Jerozolimskie 96, 00-807 Warsaw, Tel/: 22 824 03 64, email: [email protected]

Date of last revision of the leaflet: ---------------------------------------------------------------------------------------------------------------

Information intended only for healthcare professionals:

Special warnings

Sclerotherapy of varicose veins Medicines for varicose vein obliteration must not be injected into arteries under any circumstances, as this may cause severe tissue necrosis, which can lead to amputation. In the event of such an incident, you should immediately contact a vascular surgeon. Indications for use in the face area must be carefully evaluated due to all possible means of varicose vein obliteration, as intra-arterial injection may lead to a reversal of blood pressure in the arteries, resulting in irreversible vision disturbances (blindness). In some areas of the body, such as the feet and ankles, the risk of accidental intra-arterial injection may be increased. Therefore, only small amounts of the medicinal product should be used, with special caution during administration. Treatment of poisoning after incorrect administration of the medicinal producta) Intra-arterial injection

• 1. Leave the cannula in place; if the cannula has already been removed, re-locate the puncture site
• 2. Inject 5 to 10 ml of a local anesthetic, without adrenaline
• 3. Inject heparin at a dose of 10,000 IU
• 4. Apply a cotton swab and lower the ischemic leg
• 5. As a precaution, hospitalize the patient (vascular surgery) b) Peri-vascular injection Depending on the amount and concentration of the Aethoxysklerol medicinal product injected peri-vascularly, 5 to 10 ml of physiological saline should be injected at the injection site, possibly mixed with hyaluronidase. If the patient experiences severe pain, a local anesthetic (without adrenaline) can be injected.

Emergency measures and remediesAnaphylactic reactionsAnaphylactic reactions are rare but can be life-threatening. The attending physician should be prepared to take emergency measures and have access to an appropriate emergency kit. Treatment with beta-adrenolytics or ACE inhibitors may affect the course of emergency measures in the event of anaphylactic shock due to their effect on the circulatory system.