AETHOXYSKLEROL 30 mg /Ml Solution

Contents of the leaflet

1. Chemische Fabrik Kreussler & Co.
2. GmbH
3. Aethoxysklerol 3% (amp.)
4. Package Leaflet: Information for the User
5. Aethoxysklerol 3%, 30 mg/ml Solution for Injection
   1. Read the package leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet
6. What is Aethoxysklerol 3% and what is it used for
7. Important information before using Aethoxysklerol 3%
   1. Special caution is required when using Aethoxysklerol 3% if:
   2. Special caution is required in the case of:
   3. Warnings and precautions
   4. Aethoxysklerol 3% and other medicines
   5. Pregnancy and breastfeeding
   6. Driving and using machines
8. How to use Aethoxysklerol 3%
   1. Methods of administration
   2. Use in children
   3. Use of a higher dose of Aethoxysklerol 3% than recommended
9. Possible side effects
   1. Reporting of side effects
10. How to store Aethoxysklerol 3%
11. Contents of the pack and other information
    1. What Aethoxysklerol 3% contains
    2. What Aethoxysklerol 3% looks like and contents of the pack
    3. Marketing authorization holder and manufacturer
    4. Date of last revision of the leaflet: ---------------------------------------------------------------------------------------------------------------
    5. Special warnings

Chemische Fabrik Kreussler & Co.

GmbH

Aethoxysklerol 3% (amp.)

Package Leaflet: Information for the User

Aethoxysklerol 3%, 30 mg/ml Solution for Injection

Lauromacrogol400

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or nurse.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or nurse. See section 4.

Table of Contents of the Leaflet

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

1. What is Aethoxysklerol 3% and what is it used for

Aethoxysklerol 3% is a sclerosing agent (sclerotherapy), which involves injecting a thin needle into a vein and injecting lauromacrogol 400, formerly also known as polidocanol or lauryl macrogol ether, which causes the vein wall to become fibrotic, leading to closure and disappearance of the varicose vein. Aethoxysklerol 3% is used for sclerotherapy of varicose veins of the lower limbs and sclerotherapy of first- and second-degree hemorrhoids.

2. Important information before using Aethoxysklerol 3%

When not to use Aethoxysklerol 3%:

the use of hormonal contraceptives or hormone replacement therapy, obesity, smoking, or prolonged periods of immobilization)

Special caution is required when using Aethoxysklerol 3% if:

• asthma and a high tendency to allergies occur
• fever occurs
• the patient is in a very poor general state of health

Special caution is required in the case of:

• sclerotherapy of varicose veins of the lower limbs:
• there is swelling of the lower limbs caused by fluid accumulation that cannot be treated with compression therapy
• there is an inflammatory condition of the skin in the area where the sclerotherapy is performed
• there are symptoms of closure of the smallest and thinnest vessels, e.g. due to diabetes (microangiopathy) and impaired sensation (neuropathy) in patients with reduced mobility

Microfoam sclerotherapy:

• sclerotherapy of hemorrhoids:
• there is a chronic inflammatory bowel disease (e.g. Crohn's disease)
• there is a hypercoagulable state

Warnings and precautions

Before starting treatment with Aethoxysklerol 3%, consult a doctor or nurse.
Sclerotherapy of varicose veins
The medicine must not be administered intra-arterially, as this may cause necrosis, which can lead to amputation. In such cases, the patient must be treated by a vascular surgeon. The use of the medicine in the facial area may cause reversal of arterial pressure and consequently lead 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 administration may be higher and therefore special caution should be exercised when administering small amounts of the medicine.
Sclerotherapy of hemorrhoids.
During the procedure, the doctor will pay attention to avoiding damage to the internal anal sphincter, which could lead to fecal incontinence. No more than 0.5 ml of Aethoxysklerol 3% should be administered to men with a hemorrhoid located at the 11 o'clock position, due to the proximity of the urethra and prostate gland.

Aethoxysklerol 3% and other medicines

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 agent). Therefore, if it is used in combination with another anesthetic agent within 24 hours, there is a risk of increased action, which may slow down heart activity.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or plan to have a child, consult your doctor before using this medicine.
In pregnant women, Aethoxysklerol 3% should not be used except in cases where it is absolutely necessary. There are no exact data on the use of Aethoxysklerol 3% in pregnant women. In animal studies, no obvious developmental abnormalities were found.
In the event of a need for sclerotherapy in breastfeeding women, breastfeeding should be interrupted for 2 to 3 days, as no studies have been conducted in humans regarding the possibility of lauromacrogol 400 penetrating into breast milk.

Driving and using machines

The medicine does not affect the ability to drive and 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 alcohol disease. 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 3%

This medicine should always be used as directed by your doctor. In case of doubt, consult your doctor.
Aethoxysklerol 3% is used in sclerotherapy of varicose veins of the lower limbs of medium and large size and in sclerotherapy of first- and second-degree hemorrhoids.
This medicine may be administered in liquid form or as a standardized, homogeneous, fine-bubble, viscous microfoam.
Recommended dose
Depending on the size of the varicose veins to be treated and the individual situation of each patient, the doctor will decide which treatment to use. In case of doubt, the smallest possible dose should be chosen.
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 4.6 ml of 3% solution should be administered per day.
In routine cases, regardless of the patient's body weight and the concentration of lauromacrogol 400 used, the maximum recommended volume of microfoam used per session and per day is 10 ml. Higher volumes of microfoam are used after individual assessment of the benefit-risk ratio.
In patients with a known history of hypersensitivity to drugs, during the first obliteration procedure, no more than one injection should be performed. During subsequent sessions, lauromacrogol 400 may be administered in several injections in a dose not greater than the maximum dose.
Sclerotherapy of varicose veins of the lower limbs of medium size
Depending on the diameter of the varicose veins to be treated, Aethoxysklerol 2% or 3% is used. During the first procedure, only one injection of Aethoxysklerol 2% or 3% in liquid form should be performed, in a volume of 0.5 to 1 ml. Depending on the treatment outcome and the size of the area to be treated, during subsequent sessions, several injections may be performed in a volume not greater than 2 ml of liquid per injection, provided that the maximum dose is not exceeded.
In the case of administration of Aethoxysklerol 2% in microfoam form, e.g. in the treatment of perforating veins or tributary veins, during one puncture, up to 2 ml of microfoam is injected. In the case of administration of Aethoxysklerol 2% or 3% in microfoam form, e.g. in the treatment of saphenous veins, during one puncture, up to 4 ml of microfoam is injected for small saphenous veins and up to 6 ml of microfoam for large saphenous veins.
Sclerotherapy of varicose veins of the lower limbs of large size
During the first procedure, only one injection of 1 ml of Aethoxysklerol 3% in liquid form may be performed. Depending on the efficacy and size of the area to be treated, during subsequent sessions, several injections (2 to 3) may be performed in a volume not greater than 2 ml per injection, not exceeding the maximum dose.
In the case of administration of Aethoxysklerol 3% in microfoam form, e.g. in the treatment of saphenous veins, during one puncture, up to 4 ml of microfoam is injected for small saphenous veins and up to 6 ml of microfoam for large saphenous veins.
Sclerotherapy of first- and second-degree hemorrhoids
During one procedure, no more than 3 ml of Aethoxysklerol 3% should be administered. Depending on the treatment outcome, a maximum of 1 ml of Aethoxysklerol 3% should be administered per hemorrhoid, exclusively in the form of a submucosal injection. In men, in the case of hemorrhoids located near the prostate gland and urethra, no more than 0.5 ml of the medicine should be administered.

Methods of administration

Sclerotherapy of varicose veins of the lower limbs
All injections must be administered intravenously; the position of the needle (e.g. by aspirating blood) must be checked.
Regardless of the method of vein puncture (in a patient standing with a cannula for infusion or in a patient sitting with a syringe prepared for injection), the injection should only be performed in the lower limb placed in a horizontal position.
For sclerotherapy, single-use syringes with a smooth plunger movement and needles of various diameters are recommended, depending on the indication.
During the injection of the product in microfoam form, the lower limb may be placed in a horizontal position or elevated by about 30-45° above the level. Direct puncture and injection into invisible veins should be performed using duplex ultrasound. The needle should not be smaller than 25G.
Depending on the degree and extent of the varicose veins, it may be necessary to perform several treatment sessions at intervals of one or two weeks.
Warning:
Local thrombi that may form in some cases are removed by puncturing and pushing them out.
Compression after injection of Aethoxysklerol 3%
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.
After sclerotherapy with liquid Aethoxysklerol, compression is applied immediately after injection.
After microfoam sclerotherapy, the patient's leg is initially immobilized for about 2-5 minutes. One should avoid Valsalva maneuver and muscle activation during this time. Compression on the limb should not be applied immediately, but 5-10 minutes after injection.
Compression should be applied for several days, up to several weeks after injection, depending on the extent and degree of varicose veins.
To prevent the bandage from slipping, especially from the thigh or conical limb, it is recommended to use an additional foam dressing under the compression dressing.
The success of sclerotherapy depends on careful and careful post-procedure compression treatment.
Sclerotherapy of first- and second-degree hemorrhoids
Injections must be administered exclusively submucosally and directly into the hemorrhoid above the dentate line (Z-line) in the direction of the vascular pedicle.
Special caution should be exercised in the area of the internal anal sphincter due to the risk of muscle damage and resulting fecal incontinence. In the treatment of hemorrhoids in the 11 o'clock position in men, the injected amount of Aethoxysklerol 3% should not exceed 0.5 ml, due to the proximity of the urethra and prostate gland.
Depending on the degree of hemorrhoids, it may be necessary to perform several treatment sessions at intervals of one or two weeks.

Use in children

Aethoxysklerol is not intended for use in children and adolescents.

Use of a higher dose of Aethoxysklerol 3% than recommended

Sclerotherapy of medium and large varicose veins of the lower limbs
In the event of administration of a higher dose of the medicine than recommended, local tissue necrosis may occur, especially after perivenous injection.
Sclerotherapy of first- and second-degree hemorrhoids
Administration of a higher dose of the medicine than recommended may lead to local tissue necrosis with possible extension to the surrounding tissue.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
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 causal relationship with the administered medicine for each reported event. However, it is possible to make some estimate of the frequency based on long-term experience.
Sclerotherapy of varicose veins of the lower limbs
Local side effects (e.g. necrosis) of the skin and deeper tissues (and rarely nerves) have been observed after accidental injection into the surrounding tissue (perivenous 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 less than 1 in 10,000 patients): anaphylactic shock, angioedema, urticaria (generalized), asthma (asthma attacks), cerebral circulatory disorders, hemiplegia, headaches, migraines (rarely in the case of microfoam sclerotherapy), local sensory disturbances (paresthesia), numbness in the mouth, loss of consciousness, dizziness, speech disorders, coordination disorders, disorientation, visual impairment (vision disorders) (rarely in the case of microfoam sclerotherapy), cardiac arrest, stress-induced cardiomyopathy, palpitations, irregular heart rhythm (tachycardia, bradycardia), pulmonary embolism, fainting, vascular or cardiac collapse, vasculitis, dyspnea, feeling of discomfort in the chest (feeling of pressure in the chest), cough, taste disorders, nausea, vomiting, excessive hair growth at the injection site, fever, sudden flushing, malaise, weakness, blood pressure disorders.
Rare (may occur in less than 1 in 1,000 patients): deep vein thrombosis (possible association with underlying diseases), limb pain
Uncommon (may occur in less than 1 in 100 patients): superficial thrombophlebitis, phlebitis, allergic contact dermatitis, urticaria, skin allergic reactions, necrosis, induration, swelling, nerve damage
Common (may occur in less than 1 in 10 patients): neovascularization (formation of new blood vessels based on existing vessels), hematomas, skin discoloration, bruising, pain (short-term at the injection site), thrombosis at the injection site (local blood clots within varicose veins).
Sclerotherapy of first- and second-degree hemorrhoids:
During the obliteration of hemorrhoids, the following side effects have been observed:
Burning, pain, discomfort, unpleasant sensation, especially in men during the procedure in the 11 o'clock position. These reactions are transient, although they may rarely persist for 2 to 3 days. Sclerotherapy of hemorrhoids is painless, provided that the proper technique is used, as there are no sensitive nerve fibers in the area of the injection site. The following additional reactions have been observed:
Very rare (may occur in less than 1 in 10,000 patients): anaphylactic shock, angioedema, urticaria (generalized), asthma (asthma attacks), loss of consciousness, disorientation, dizziness, palpitations, fainting, vascular or cardiac collapse, nausea, erectile dysfunction, fever, blood pressure disorders.
Rare (may occur in less than 1 in 1,000 patients): bleeding at the injection site, thrombosis at the injection site (within the hemorrhoid), necrosis (local, rarely with possible extension to the surrounding tissue).
Uncommon (may occur in less than 1 in 100 patients): proctitis, allergic contact dermatitis, urticaria, skin reactions, itching in the anal canal, induration.
Common (may occur in less than 1 in 10 patients): sensation of burning of the mucous membrane, pain at the injection site, feeling of discomfort, sensation of pressure.

Reporting of side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist or nurse. 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:
Jerozolimskie Avenue 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 this medicine.

5. How to store Aethoxysklerol 3%

Keep the medicine out of the 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 pack and other information

What Aethoxysklerol 3% 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 3% looks like and contents of the pack

The pack contains 5 ampoules. 1 ampoule of 2 ml contains 60 mg of lauromacrogol 400.

Marketing authorization holder and manufacturer

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

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

Information intended exclusively for healthcare professionals:

Special warnings

Aethoxysklerol must be administered by a doctor with appropriate experience in performing sclerotherapy. To prepare a standardized microfoam for sclerotherapy of varicose veins, the instructions for the appropriate methods should be taken into account.
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, immediate contact with a vascular surgeon is necessary.
Indications for use in the facial area must be carefully evaluated due to all possible measures for varicose vein obliteration, as intra-arterial injection may lead to reversal of arterial pressure and consequently to permanent 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 and special caution should be exercised during treatment.
Treatment of poisoning after incorrect administration of the medicinal product
a)
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 compress and lower the ischemic leg
• 5. As a precaution, hospitalize the patient (vascular surgery)

b)
Perivenous injection
Depending on the amount and concentration of the medicinal product Aethoxysklerol administered subcutaneously, inject 5 to 10 ml of physiological saline, if possible mixed with hyaluronidase, at the injection site. If the patient experiences severe pain, a local anesthetic (without adrenaline) may be injected.
Sclerotherapy of hemorrhoids
During the treatment of hemorrhoids, caution should be exercised to avoid damage to the internal anal sphincter, resulting in fecal incontinence.
In the treatment of hemorrhoids in the 11 o'clock position in men, the injected amount of Aethoxysklerol 3% should not exceed 0.5 ml, due to the proximity of other organs (urethra and prostate gland).
Emergency measures and remedies
Anaphylactic reactions
Anaphylactic reactions are rare, but they 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-adrenergic agents or angiotensin-converting enzyme (ACE) inhibitors may affect the course of emergency procedures in the event of anaphylactic shock due to their effect on the circulatory system.