Aethoxysklerol 0.5%

Chemische Fabrik Kreussler & Co. Aethoxysklerol 0.5% (amp.)
GmbH

Package leaflet: Information for the user

Aethoxysklerol 0.5%, 5 mg/ml solution for injection
Lauromacrogolum 400
Please read all of this leaflet carefully before the medicine is administered, because it
contains important information for the patient.

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

Contents of the leaflet

1. What Aethoxysklerol 0.5% is and what it is 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 pack and other information

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

Aethoxysklerol 0.5% is a sclerosing agent (sclerotherapy) used for injecting through a fine needle into the interior of a vein, delivering lauromacrogol 400, previously also known as polidocanol or macrogol lauryl ether, which causes fibrosis of the vessel wall, leading to closure and disappearance of the varicose vein. Aethoxysklerol 0.5% is indicated for sclerotherapy of varicose veins of the lower limbs.

2. Information before using Aethoxysklerol 0.5%

When not to use Aethoxysklerol 0.5%:

• if the patient is allergic to lauromacrogol or to any of the other ingredients of this medicine (listed in section 6)
• if the patient has an acute, serious illness (particularly untreated)
• if the patient is immobilized
• if the patient has severe obstructive arterial disease of the lower limbs (stage III and IV according to Fontaine classification)
• if the patient has thromboembolic disorders
• if the patient has a high risk of thrombosis (e.g. confirmed hereditary predisposition to thrombosis or multiple risk factors such as use of hormonal contraceptives or hormone replacement therapy, obesity, smoking, or prolonged periods of immobilization)

Special caution is required when:

• bronchial asthma and a high predisposition to allergies are present
• fever is present
• in patients with very poor general health condition
• in the presence of lower limb edema caused by fluid accumulation that cannot be treated with compression therapy
• in case of spider veins: arterial occlusion (stage II according to Fontaine classification)
• inflammatory skin conditions at the site intended for sclerotherapy
• symptoms of microvascular occlusion, e.g. due to diabetes (microangiopathy), and reduced sensation (neuropathy)
• in patients with limited mobility

Warnings and precautions
Before starting treatment with Aethoxysklerol 0.5%, discuss this with your doctor or
nurse. The medicine must not be administered intra-arterially, as this may cause necrosis,
which could lead to amputation. In such cases, the patient must be treated immediately by a
vascular surgeon. Administration of the product in the facial area may cause reversal of
blood flow in the arteries and consequently lead to permanent visual disturbances (blindness).
In certain locations, e.g. varicose veins around the ankle joint, the risk of accidental intra-arterial administration may be higher; therefore, only small amounts of the medicine should be used, with extreme caution during administration.

Aethoxysklerol 0.5% and other medicines
Inform your doctor about all medicines currently or recently taken, as well as any medicines
you plan to take. The active substance lauromacrogol 400 is also used as a local analgesic (local anesthetic). Therefore, if it is used simultaneously with another anesthetic within 24 hours, there is a risk of enhanced effect, which may lead to bradycardia (slowed heart rate).

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor before using this medicine.
Aethoxysklerol 0.5% should not be used in pregnant women except in cases where it is absolutely necessary. There are no adequate data on the use of Aethoxysklerol 0.5% in pregnant women. Animal studies have not shown clear evidence of developmental abnormalities.
If sclerotherapy is necessary in breastfeeding women, breastfeeding should be interrupted for 2 to 3 days, as there are no human studies on the passage of lauromacrogol 400 into breast milk.

Driving and operating machinery
The medicine has no influence on the ability to drive or operate machinery.
The medicine contains 5% v/v ethanol (alcohol), i.e. up to 84 mg per dose, equivalent to 2 ml of beer or 0.83 ml of wine per dose. Harmful in individuals with alcoholism. This should be taken into account when using the medicine in pregnant or breastfeeding women, children, and individuals in high-risk groups, such as patients with liver disease or epilepsy.
The medicine contains less than 1 mmol (39 mg) of potassium per dose, meaning the medicine is considered "potassium-free". The medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning the medicine is considered "sodium-free".

3. How to use Aethoxysklerol 0.5%

This medicine should always be used as directed by the physician. In case of doubt, consult
your doctor.
Aethoxysklerol 0.5% is indicated for sclerotherapy of telangiectasias
and for sclerotherapy of the central veins of telangiectasias.
Recommended dose
The daily dose should not exceed 2 mg of lauromacrogol 400 per kg of body weight,
which means that in a patient weighing 70 kg, no more than 28 ml of the 0.5% solution
should be administered per day.
In patients with a known history of drug hypersensitivity, during the first obliteration procedure,
no more than 1 injection should be performed. In subsequent sessions,
lauromacrogol 400 may be administered in several injections, provided that the total dose does not exceed
the maximum recommended dose.
Depending on the size of the area to be treated, 0.1 to 0.2 ml of Aethoxysklerol 0.5% solution
is injected intravenously per injection.
Method of administration:
Injections of Aethoxysklerol 0.5% should be performed only with the leg placed
in a horizontal position or elevated approximately 30–45° above horizontal level. All injections must
be administered intravenously, including those into telangiectasias.
Very fine needles (e.g. insulin needles) and syringes with smooth plunger movement should be used.
The puncture should be performed tangentially, and the injection should be administered slowly,
maintaining the needle in an intravenous position.
Depending on the extent of varicosities, several treatment sessions may be required,
spaced one or two weeks apart.
Note:
Thrombi that may form in some cases should be removed by puncturing and expressing them.
Compression after injection of Aethoxysklerol 0.5%
After dressing the puncture site, a compression bandage or elastic compression stocking should be applied.
Following application of the dressing, the patient should walk for 30 minutes, preferably
near the clinic.
Compression should be maintained for 2 to 3 days after sclerotherapy of telangiectasias, and in
other cases for 5 to 7 days. In extensive varicose disease, prolonged compression therapy is recommended,
using short compression bandages.
The success of sclerotherapy depends on careful and conscientious post-procedure
compression treatment.
Use of a higher than recommended dose of Aethoxysklerol 0.5%
If a dose higher than recommended is administered, local tissue necrosis may occur,
particularly after perivascular injection.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
The following adverse reactions have been reported worldwide with the use of lauromacrogol 400. In some cases, symptoms were troublesome but in most cases transient.
Since 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 or establish a causal relationship with the administered medicine for each reported event. However, some estimation of frequency is possible based on long-term experience.
Local adverse reactions (e.g. necrosis), particularly of the skin tissue and deeper tissues (and rarely nerves), have been observed following accidental injection into surrounding tissue (perivascular injection). The occurrence of adverse reactions is dependent on the dose and concentration of the administered medicine. Additionally, the following adverse reactions have been observed:

Very rare (may occur in not more than 1 in 10,000 patients): anaphylactic shock, angioedema, generalized urticaria, asthma (asthma attacks), cerebral circulation disorders, hemiplegia, headache, migraine, local sensory disturbances (paraesthesia), reduced sensation in the oral cavity, loss of consciousness, dizziness, speech disorders, coordination disorders, disorientation, impaired vision (visual disturbances), cardiac arrest, broken heart syndrome (stress-induced cardiomyopathy), palpitations, irregular heartbeat (tachycardia, bradycardia), pulmonary embolism, fainting, vascular or cardiac collapse, vasculitis, dyspnoea, chest discomfort (feeling of pressure in the chest), cough, taste disturbances, nausea, vomiting, excessive hair growth at the site of sclerotherapy, fever, sudden redness, malaise, fatigue, blood pressure disturbances.

Rare (may occur in not more than 1 in 1,000 patients): deep vein thrombosis (possible association with underlying diseases), limb pain.

Uncommon (may occur in not more than 1 in 100 patients): thrombophlebitis, phlebitis, allergic dermatitis, contact urticaria, erythema, skin allergic reactions, necrosis, sclerosis, swelling, nerve damage.

Common (may occur in not more than 1 in 10 patients): neovascularization (formation of blood vessels based on already existing vessels), haematomas, skin discoloration, bruising, pain (short-term at the site of sclerotherapy), thrombosis at the injection site (local blood clots within varicose veins).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at 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 reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions allows the collection of further information on the safety of the medicine.

5. How to store Aethoxysklerol 0.5%

Keep this medicine out of the sight and reach of children.
Store below 25°C.
Do not use this medicine after the expiry date stated on the packaging.
The immediate packaging is for single use only.

6. Contents of the pack and other information

What Aethoxysklerol 0.5% contains
The active substance is lauromacrogol 400.
The other ingredients are: ethanol 96%, disodium phosphate dihydrate, potassium dihydrogen phosphate, water for injections.

What Aethoxysklerol 0.5% looks like and contents of the pack
The pack contains 5 ampoules. 1 ampoule of 2 ml contains 10 mg of lauromacrogol 400.

Marketing Authorisation Holder and Manufacturer
Chemische Fabrik Kreussler & Co. GmbH
Rheingaustr. 87-93
65203 Wiesbaden
Germany

For further information, please contact:
Alfasigma Polska Sp. z o.o.
Al. Jerozolimskie 96, 00-807 Warsaw
Tel.: 22 824 03 64
email: [email protected]

Information intended exclusively for medical professionals:

Special warnings
Sclerotherapy of varicose veins
Sclerosing medicinal products must never be injected into arteries, as this may cause severe tissue necrosis, potentially leading to the necessity of amputation. In the event of such occurrence, immediate contact with a vascular surgeon is required.
Indications for use in the facial area must be carefully evaluated for all possible sclerosing agents, since intravenous injection may lead to reversal of pressure in the arteries and consequently to irreversible visual disturbances (blindness).
In certain body regions, such as the feet and ankles, the risk of inadvertent intra-arterial injection may be increased. Therefore, only small amounts of the medicinal product at low concentration should be used, and particular caution must be exercised during treatment.

Management of poisoning following 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 local anesthetic without adrenaline
3. Administer heparin at a dose of 10,000 IU
4. Apply cotton wool and keep the ischemic limb dependent
5. As a precaution, hospitalize the patient (vascular surgical intervention)

b) Perivenous injection
Depending on the amount and concentration of the percutaneously injected medicinal product Aethoxysklerol, inject 5 to 10 ml of physiological saline at the injection site, preferably mixed with hyaluronidase if possible. If the patient experiences severe pain, a local anesthetic (without adrenaline) may be administered.

Emergency management and corrective measures
Anaphylactic reactions
Anaphylactic reactions are rare but may be life-threatening. The physician providing medical care should be prepared to initiate emergency measures and have access to an appropriate emergency kit.
Treatment with β-blockers or angiotensin-converting enzyme (ACE) inhibitors may affect the management of emergency procedures in anaphylactic shock due to their influence on the circulatory system.