AETHOXYSKLEROL 10 mg /Ml Solution

Contents of the leaflet

1. Chemische Fabrik Kreussler & Co.
2. GmbH
3. Aethoxysklerol 1% (amp.)
4. Leaflet attached to the packaging: information for the user
5. Aethoxysklerol 1%, 10 mg/ml solution for injection
   1. You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
6. What is Aethoxysklerol 1% and what is it used for
7. Important information before using Aethoxysklerol 1%
   1. Special caution is required in the following cases:
   2. Warnings and precautions
   3. Aethoxysklerol 1% and other medicines
   4. Pregnancy and breastfeeding
   5. Driving and using machines
8. How to use Aethoxysklerol 1%
   1. Use in children
   2. Use of a higher dose of Aethoxysklerol 1% than recommended
9. Possible side effects
   1. Reporting side effects
10. How to store Aethoxysklerol 1%
11. Contents of the packaging and other information
    1. What does Aethoxysklerol 1% contain?
    2. What does Aethoxysklerol 1% look like and what does the packaging contain?
    3. Marketing authorization holder and manufacturer
    4. Date of last revision of the leaflet: ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
    5. Special warnings

Chemische Fabrik Kreussler & Co.

GmbH

Aethoxysklerol 1% (amp.)

Leaflet attached to the packaging: information for the user

Aethoxysklerol 1%, 10 mg/ml solution for injection

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

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

Aethoxysklerol 1% is a sclerosing agent (sclerotherapy), which involves injecting a thin needle into a vein and injecting lauromacrogol 400, also known as polidocanol or lauryl macrocol, which causes the vein wall to become fibrotic, leading to closure and disappearance of the varicose vein. Aethoxysklerol 1% is used for sclerotherapy of varicose veins of the lower limbs.

2. Important information before using Aethoxysklerol 1%

When not to use Aethoxysklerol 1%:

• if the patient is allergic to lauromacrogol 400 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 arterial disease of the lower limbs (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)
• if sclerotherapy is to be performed with a microfoam: if the patient has symptoms caused by a diagnosed hole in the heart (diagnosed, symptomatic left-to-right shunt).

Special caution is required in the following cases:

• in the presence of asthma and a high tendency to allergies
• in the presence of fever
• in patients with very poor general health
• in the presence of swelling of the lower limbs caused by fluid accumulation that cannot be treated with compression therapy
• in the presence of spider veins: arterial closure (stage II on the Fontaine scale)
• in the presence of skin inflammation at the site of sclerotherapy
• in the presence of symptoms of closure of the smallest and thinnest vessels, e.g. due to diabetes (microangiopathy) and impaired sensation (neuropathy)
• in patients with reduced mobility. Sclerotherapy with microfoam:
• if the patient has a diagnosed hole in the heart, even if it does not cause any symptoms (diagnosed, asymptomatic left-to-right shunt)
• if the patient has had: visual disturbances or nerve damage (visual or neurological symptoms) after previous sclerotherapy with microfoam.

Warnings and precautions

Before starting treatment with Aethoxysklerol 1%, you should consult a doctor or nurse. 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 preparation in the facial area may cause a 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 only small amounts should be used with special caution during administration.

Aethoxysklerol 1% 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. You should inform your doctor about all medicines you have taken recently, even those that are available without a prescription. 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 cause slowing of heart activity.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult a doctor before using this medicine. In pregnant women, Aethoxysklerol 1% should not be used unless absolutely necessary. There is no precise data on the use of Aethoxysklerol 1% in pregnant women. In animal studies, no obvious developmental abnormalities were found. In the case of 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. It is harmful to people with alcoholism. It 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 1%

This medicine should always be used as directed by a doctor. In case of doubts, you should consult a doctor. Aethoxysklerol 1% is used in sclerotherapy of telangiectasias (spider veins), sclerotherapy of reticular varicose veins, and sclerotherapy of small varicose veins. This medicine can 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, as well as the individual situation of each patient, the doctor will decide what treatment to use. In case of doubts, the smallest possible dose should be chosen. The daily dose should not exceed 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 14 ml of 1% solution can 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-to-risk ratio. In patients with known hypersensitivity to medicines, during the first obliteration procedure, no more than 1 injection should be performed. During subsequent sessions, lauromacrogol 400 can be administered in several injections in a dose not exceeding the maximum. In the case of using the medicine in sclerotherapy of central spider veins, depending on the size of the area to be treated, 0.1 to 0.2 ml of Aethoxysklerol 1% is injected into the vein per injection (intravenously). In the case of using the medicine in sclerotherapy of reticular varicose veins and small varicose veins, depending on the size of the varicose vein to be treated, 0.1 to 0.3 ml of Aethoxysklerol 1% in liquid form is injected into the vein per injection (intravenously). When using the medicine in the form of microfoam, e.g. in the treatment of varicose veins of the perforating veins, during one puncture, up to 4-6 ml of the medicine is injected. In the treatment of varicose veins of the communicating veins (perforators), during one puncture, up to 2-4 ml of the medicine is injected. Methods of administration: All injections must be given intravenously; the position of the needle (e.g. by aspirating blood) should be checked. Sclerotherapy of central spider veins and reticular varicose veinsInjections of Aethoxysklerol 1% are usually performed in the leg placed in a horizontal position. Single-use syringes with a smooth plunger movement are used. In the case of telangiectasias, very thin needles (e.g. insulin needles) are used for injections. The puncture is performed tangentially, and the injection is performed slowly, keeping the needle in the intravenous position. Sclerotherapy of small varicose veinsRegardless of the method of puncturing the vein (in a patient standing with a cannula for infusion or in a patient sitting with a syringe prepared for injection), the injection is usually performed in the leg 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 the form of microfoam, 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 size of the varicose veins, it may be necessary to perform several treatment sessions at intervals of one or two weeks. Note:Local thrombi that may form in some cases are removed by puncturing and pushing them out. Compression after injection of Aethoxysklerol 1%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 the liquid product Aethoxysklerol, compression is applied immediately after the injection. After sclerotherapy with microfoam, the patient's leg is initially immobilized for about 2-5 minutes. The Valsalva maneuver and muscle activation should be avoided 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.

Use in children

Aethoxysklerol is not intended for use in children and adolescents.

Use of a higher dose of Aethoxysklerol 1% than recommended

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

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 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 (periarterial injection). There is a dose-dependent and concentration-dependent occurrence of side effects. Additionally, the following side effects have been observed: Very rare (may occur in fewer than 1 in 10,000 patients): anaphylactic shock, angioedema, urticaria (generalized), asthma (asthma attacks), cerebral circulation disorders, hemiparesis, headaches, migraines (rarely in the case of microfoam sclerotherapy), local sensory disturbances (paresthesia), oral sensory impairment, loss of consciousness, dizziness, speech disorders, coordination disorders, disorientation, visual impairment (visual disturbances) (rarely in the case of microfoam sclerotherapy), 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 fewer than 1 in 1,000 patients): deep vein thrombosis (possible connection with underlying diseases), limb pain. Uncommon (may occur in fewer than 1 in 100 patients): superficial thrombophlebitis, phlebitis, allergic skin inflammation, contact urticaria, erythema, skin allergic reactions, necrosis, induration, swelling, nerve damage. Common (may occur in fewer than 1 in 10 patients): neovascularization (formation of new 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 this 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 this medicine.

5. How to store Aethoxysklerol 1%

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 intended for single use.

6. Contents of the packaging and other information

What does Aethoxysklerol 1% contain?

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 does Aethoxysklerol 1% look like and what does the packaging contain?

The packaging contains 5 ampoules. 1 ampoule of 2 ml contains 20 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 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 varicose vein sclerotherapy, 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, a vascular surgeon should be contacted immediately. Indications for use in the facial area must be carefully evaluated due to all possible means of varicose vein obliteration, as intra-arterial injection may lead to reversal of arterial pressure and consequently to 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 swab and lower the affected limb 5. As a precaution, hospitalize the patient (vascular surgery) b) Periarterial injection Depending on the amount and concentration of the medicinal product Aethoxysklerol injected subcutaneously, 5 to 10 ml of physiological saline, possibly mixed with hyaluronidase, should be injected at the injection site. 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-adrenergic agents or ACE inhibitors may affect the course of emergency measures in the event of anaphylactic shock due to their effect on the circulatory system.