Prospect: information for the user

Etoxisclerol 30 mg/ml injectable solution

Lauromacrogol 400

Read this prospect carefully before starting to use this medicine, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed only for you and should not be given to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they do not appear in this prospect. See section 4.

Content of the prospect

1.What Etoxisclerol is and for what it is used

2.What you need to know before starting to use Etoxisclerol

3.How to use Etoxisclerol

4.Possible adverse effects

5.Storage of Etoxisclerol

6.Contents of the package and additional information

Etoxisclerol is a sclerosant whose active principle is lauromacrogol 400.

Etoxisclerol 30 mg/ml is indicated for sclerosing or destruction treatment of:

• Varicose veins,
• Telangiectasias (vascular spiders),
• Hemorrhoids.

No use Etoxisclerol in sclerosing treatment of varices

• If you are allergic to lauromacrogol 400 or any of the other components of this medication (listed in section 6),
• If you have a severe acute systemic disease (affecting the entire body) (especially in untreated patients),
• If you must remain in bed or cannot walk,
• If you have severe arterial circulation disorder (arterial occlusive disease, Fontaine stages III and IV),
• If you have a vascular occlusion due to a blood clot or thrombus (thromboembolic diseases),
• If you have a high risk of vascular occlusions (thrombosis), for example, patients with hereditary predisposition to produce blood clots or with multiple risk factors such as: use of hormonal contraceptives (e.g. the pill), hormone replacement therapy, obesity, smoking, prolonged periods of immobility, etc.

Do not use Etoxisclerol in sclerosing treatment of varices with microfoam

• If you have symptoms due to a known perforation in the interauricular septum of the heart (symptomatic patent foramen ovale).

Do not use Etoxisclerol in sclerosing treatment of hemorrhoids

• If you are allergic to lauromacrogol 400 or any of the other components of this medication (listed in section 6),
• If you have a severe acute systemic disease (affecting the entire body) (especially in untreated patients),
• If you have acute inflammation in the anal region (acute proctitis).

Warnings and precautions in sclerosing treatment of varices

Etoxisclerol should be administered by a healthcare professional experienced in sclerotherapy techniques.

Consult your doctor, pharmacist, or nurse before starting to use Etoxisclerol:

• If you have a fever,
• If you have a severe respiratory difficulty crisis (asthma bronchial),
• If you have a strong predisposition to allergies,
• If your general state of health is poor,
• If you are to undergo sclerosing treatment of spider veins: in patients with arterial circulation disorders (arterial occlusive diseases, Fontaine stage II),
• If you have swollen legs due to fluid accumulation (edema) and cannot be modified by compression,
• If you have skin inflammation disease in the treatment area,
• If you have symptoms of occlusion of small blood vessels, for example due to diabetes (microangiopathy) and nerve damage (neuropathy),
• If you have reduced mobility,
• If you have frequent migraines.

Consult your doctor, pharmacist, or nurse before starting a sclerosing treatment with microfoam:

• If you have a known perforation in the interauricular septum of the heart, even if it does not cause symptoms (known as asymptomatic patent foramen ovale),
• If you have a history of visual defects (visual symptoms or neurological symptoms) after a previous sclerosing treatment with microfoam.

Warnings and precautions in sclerosing treatment of hemorrhoids

Consult your doctor, pharmacist, or nurse before starting to use Etoxisclerol

• If you have a fever,
• If you have a severe respiratory difficulty crisis (asthma bronchial),
• If you have a strong predisposition to allergies,
• If your general state of health is poor,
• If you have a chronic inflammatory intestinal disease (e.g. Crohn's disease),
• If you have an excessive blood clotting tendency (hypercoagulability).

Other medications and Etoxisclerol

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

The use of Etoxisclerol with anesthetics may increase the anesthetic effect on the cardiovascular system.

Pregnancy, lactation, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

If you are pregnant, your doctor should not administer Etoxisclerol 30 mg/ml, unless it is strictly necessary, as there is not enough information available on the use of Etoxisclerol 30 mg/ml in pregnant women. Animal studies did not show any evidence of malformations.

If treatment with Etoxisclerol 30 mg/ml is necessary during breastfeeding, it is recommended to suspend it for 2-3 days, as there is no data available in humans on the passage of lauromacrogol 400 to breast milk.

Driving and operating machines

No adverse effects on the ability to drive and operate machines have been reported due to the use of Etoxisclerol.

Etoxisclerol contains ethanol, potassium, and sodium

This medication contains 84.00 mg of alcohol (ethanol at 96%) in each 2 ml ampoule, equivalent to 5% (v/v). The amount in a 2 ml ampoule of this medication is equivalent to less than 3 ml of beer or 1 ml of wine.

It is unlikely that the amount of alcohol contained in this medication will have any perceptible effect in adults or adolescents.

The amount of alcohol contained in this medication may alter the effect of other medications.

Consult your doctor or pharmacist if you are taking other medications. If you are pregnant or breastfeeding, consult your doctor or pharmacist before taking this medication.

If you have an alcohol addiction, consult your doctor or pharmacist before taking this medication.

• This medication contains less than 39 mg (1 mmol) of potassium per ampoule, making it essentially "potassium-free".
• This medication contains less than 23 mg (1 mmol) of sodium per ampoule, making it "sodium-free".

Etoxisclerol is a medication that should be administered by a doctor, so it is the doctor's responsibility to know and choose the most suitable dosage and technique for each case.

-Varicose veins sclerosing treatment

Etoxisclerol can be used in both liquid and microfoam form (viscous microfoam, standardized, homogeneous, and fine bubble).

Depending on the size of the varicose vein to be treated and the individual situation of each patient, the doctor will decide which treatment to apply.In case of doubt, the lowest possible dose should be chosen.Generally, the dose of 2 mg/kg/day of lauromacrogol 400 should not be exceeded.

In routine cases, a maximum volume of 10 ml of microfoam (the volume of microfoam corresponds to the sum of the liquid and the gas) per session is recommended, regardless of the patient's body weight and the concentration of lauromacrogol 400.

To avoid a possible allergic reaction, especially in a patient with a high predisposition to hypersensitivity reactions, it is recommended that for the first treatment, only a small test dose of Etoxisclerol be administered. Depending on the response, several injections can be administered in subsequent treatment sessions, as long as the maximum dose is not exceeded.

Since the volume to be injected per session is limited, multiple sessions (usually 2 to 4 on average) are often needed.

After being treated with Etoxisclerol, you should follow your doctor's advice. You may be advised to wear a bandage or compression stockings to help reduce inflammation and skin pigmentation.

-Haemorrhoid sclerosing treatment

Dose

The dose of 2 ml of Etoxisclerol per session should not be exceeded.Depending on the type of haemorrhoids, 1 to 4 sessions are usually necessary.

Administration method

For haemorrhoid sclerotherapy, Etoxisclerol should be used in liquid form.

The injection should be strictly submucosal (under the mucous membrane) and applied directly to the haemorrhoid or above it.

Use in children and adolescents

There is no relevant use of Etoxisclerol in pediatric populations.

If you use more Etoxisclerol than you should

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

-Varicose veins sclerosing treatment

Overdose can cause local tissue death (necrosis), especially after injection into tissue near the varicose vein.

-Haemorrhoid sclerosing treatment

Overdose can cause local tissue death (necrosis), which may extend to tissue near the haemorrhoid.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

In this section, we inform about adverse reactions that have been reported associated with the extended use of the active substance.In some cases, these reactions were annoying but, in most cases, only temporary. As they were often spontaneous reports, without any reference to a defined group of patients and without any reference group, it is not possible to calculate exactly the frequencies or establish a clear causal relationship with the contact with the drug in each case. However, a reasonable estimate can be made from long-term experience.

-Treatment of sclerosing varices

Local side effects (e.g. necrosis) have been observed, especially in the skin and tissue near the varix (and, in rare cases, in the nerves), when varices of the legs are treated after accidental injections in the tissue near the same. The risk increases when the concentration and volume of Etoxisclerol 30 increase.

The following side effects have been observed with the frequencies described below:

• Frequent (may affect up to 1 in 10 people):appearance of blood vessels in the treated area not visible before treatment (neovascularization), bruising (hematoma), skin discoloration (hyperpigmentation), skin bleeding (ecchymosis), pain at the injection site (short-term), thrombosis at the injection site (local intravaricosus blood clots).

• Poorly frequent (may affect up to 1 in 100 people):inflammation of the vein (superficial thrombophlebitis, phlebitis), allergic skin inflammation (dermatitis), contact urticaria, skin reaction, skin redness (erythema), local tissue death (necrosis), tissue hardening, swelling, nerve damage.

• Rare (may affect up to 1 in 1,000 people):deep vein thrombosis (possibly due to another underlying condition), pain in the limbs.

• Very rare (may affect up to 1 in 10,000 people):anaphylactic shock (severe and sudden allergic reaction, symptoms include difficulty breathing, dizziness, drop in blood pressure), angioedema (symptoms include sudden swelling, especially on the face, for example, eyelids, lips, or larynx), generalized urticaria, asthma (asthmatic crisis), stroke (cerebrovascular accident), weakness causing loss of mobility in a part of the body (hemiparesis), headache, migraine (rare when using sclerosing treatment with microfoam), local sensory disturbances (paresthesia), decreased sensitivity or sensations in the mouth (hypoaesthesia oral), loss of consciousness, confusion, central speech disorder (aphasia), difficulty controlling movements (ataxia), dizziness, visual disturbances (rare when using sclerosing treatment with microfoam), heart attack (cardiac arrest), broken heart syndrome (stress cardiomyopathy), rapid or irregular heartbeats (palpitations), abnormal heart rate, pulmonary embolism (obstruction of the pulmonary artery), fainting (vasovagal syncope), circulatory collapse, inflammation of the blood vessel wall (vasculitis), difficulty breathing (dyspnea), sensation of pressure in the chest, cough, taste disorders, nausea, vomiting, excessive hair growth (hypertrichosis) in the treated area, fever, hot flashes, unusual weakness (asthenia), general discomfort, abnormal blood pressure.

-Treatment of sclerosing hemorrhoids

Local side effects such as burning, pain, discomfort, and sensation of pressure have been observed when treating hemorrhoids during and after injection, especially when they are located in the upper left (prostatic region) of the anus.These reactions are temporary and may last for 2-3 days in rare cases.

The sclerosing treatment of hemorrhoids is painless if the appropriate technique is used, as there are no sensitive nerve fibers in the injection area.

The following side effects have been observed with the frequencies described below:

• Frequent (may affect up to 1 in 10 people):burning sensation of the mucosa at the injection site, pain at the injection site, discomfort at the injection site, sensation of pressure.

• Poorly frequent (may affect up to 1 in 100 people):inflammation of the anus and/or rectum (proctitis), itching around the anus (pruritus ani), allergic skin inflammation (allergic dermatitis), contact urticaria, skin reactions, tissue hardening.

• Rare (may affect up to 1 in 1,000 people):local tissue death (necrosis), rarely extending to the tissue near the hemorrhoid, bleeding at the injection site, thrombosis at the injection site (intrahemorrhoidal).

• Very rare(may affect up to 1 in 10,000 people):anaphylactic shock (severe and sudden allergic reaction, symptoms include difficulty breathing, dizziness, drop in blood pressure), angioedema (symptoms include sudden swelling, especially on the face, for example, eyelids, lips, or larynx), generalized urticaria, asthma (asthmatic crisis), loss of consciousness, confusion, dizziness, rapid or irregular heartbeats, fainting (vasovagal syncope), circulatory collapse, nausea, erectile dysfunction, fever, abnormal blood pressure.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

This medication does not require any special temperature for conservation.

Keepthis medicationout of sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging, after CAD. The expiration date is the last day of the month indicated.

Medicines should not be thrown down the drains or in the trash.Dispose of the packaging and medicines that you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines that you no longer need. In this way, you will help protect the environment.

Composition of Etoxisclerol 30 mg/ml

• The active principle is lauromacrogol 400.

Each ml of injectable solution contains 30 mg of lauromacrogol 400.

Each ampoule of 2 ml of injectable solution contains 60 mg of lauromacrogol 400.

• The other components (excipients) are: ethanol 96%, dihydrogen phosphate of potassium, dihydrate of hydrogen phosphate of sodium, water for injectable preparations.

Appearance of the product and contents of the package

Etoxisclerol is a transparent solution, with a slight yellowish green color. It is presented as an injectable solution in a package containing 5 ampoules of 2 ml each.

Other presentations

• Etoxisclerol 5 mg/ml injectable solution. Package containing 5 ampoules of 2 ml each.
• Etoxisclerol 10 mg/ml injectable solution. Package containing 5 ampoules of 2 ml each.
• Etoxisclerol 20 mg/ml injectable solution. Package containing 5 ampoules of 2 ml each.

Holder of the marketing authorization and responsible for manufacturing

Chemische Fabrik Kreussler & Co. GmbH

Rheingaustrasse 87-93

65203 Wiesbaden, Germany

tel.: +49 611 9271-0

fax: +49 611 9271-111

e-mail: [email protected]

You can request more information about this medication by contacting the local representative of the holder of the marketing authorization:

FERRER FARMA, S.A.

Av. Diagonal 549 5th Floor,

08029 Barcelona (Spain

Date of the last review of this leaflet:June 2023

The detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

-Treatment of varicose veins

• Etoxisclerolshould be administered only by an experienced healthcare professional invenous anatomyand in the diagnosis and treatment of diseases affecting the venous system and familiar with a correct injection technique.
• Before treatment, the healthcare professional must investigate the patient's risk factors and inform them about the risks of this technique. Sclerotherapy is particularly not recommended in patients with a history of thromboembolic events. However, if sclerotherapy is deemed necessary, preventive anticoagulation can be initiated.
• Due to the risk of product circulation, bubbles, or particles in the right heart, the presence of aright-left communication (e.g., a patent foramen ovale)may increase the occurrence of severe arterial adverse events. In patients with a history of migraine with aura, severe cerebrovascular events, or pulmonary hypertension, it is recommended to seek aright-left communication (e.g., a patent foramen ovale)before sclerotherapy.
• In asymptomatic patients, but with aright-left communication (e.g., a patent foramen ovale)known, it is recommended to use smaller volumes and avoid the Valsalva maneuver in the minutes following injection.
• Use smaller volumes in patients with a history of migraine.
• Severe local adverse effects, such as tissue necrosis, can occur after extravasation, so great care must be taken in the placement of the intravenous needle and it is essential to use the minimum effective volume at each injection site.
• Scatterers should never be injected intraarterially, as this can cause severe necrosis that may require amputation.In the event of an accident, immediate vascular surgical treatment should be sought.
• The use of any type of sclerosant in the facial area should be strictly evaluated, as intravascular injections can cause irreversible loss of vision.
• In some parts of the body, such as the feet or the malleolar region, the risk of inadvertently infiltrating into the interior of the artery may be increased.Therefore, only small amounts and low concentrations should be used with special care during this type of treatment.
• When treating major saphenous veins, the injection of microfoam should be administered at a distance of at least8 to 10 cmfrom the saphenofemoral junction. If ultrasound monitoring reveals a foam bolus in the deep venous system, the patient should perform muscle activation, such as dorsal flexion of the ankle joint.
• When using Etoxisclerol in the form of microfoam, it is recommended to use disposable syringes with low silicone content, as this ensures better foam quality.

-Treatment of hemorrhoids

• Care should be taken not to damage the internal anal sphincter muscle to prevent incontinence problems.
• For the treatment of hemorrhoids in men at position 11,the amount injected should not exceed 0.5 ml of Etoxisclerol 30 mg/ml.

Dosage

-Treatment of varicose veins

Single and daily dose posology

Adults and elderly

Generally, the dose of 2 mg/kg/day of lauromacrogol 400 should not be exceeded.

In routine cases, a maximum volume of 10 ml of microfoam (the volume of microfoam corresponds to the sum of the liquid and the gas) per session, regardless of the patient's body weight and the concentration of lauromacrogol 400, is recommended. Larger volumes of microfoam are applicable on an individual benefit-risk assessment. The volumes of microfoam injected per session are generally kept below the maximum values, i.e., between 2 and 8 ml.

* The volume is the sum of the liquid and the gas.

** In routine cases.

When using Etoxisclerol 30 mg/ml in liquid form for sclerotherapy of medium and large varicose veins, and depending on the length of the segment to be treated, several injections with a maximum of 2 ml of liquid per injection can be administered.

When using Etoxisclerol 30 mg/ml in microfoam form, up to 4 ml can be injected per puncture for the treatment of the saphenous vein, and up to 6 ml for the treatment of the major saphenous vein.

To avoid a possible allergic reaction, especially in a patient with a high predisposition to hypersensitivity reactions, it is recommended that for the first treatment, only a small test dose of Etoxisclerol be administered. Depending on the response, several injections can be administered in subsequent treatment sessions, provided that the maximum dose is not exceeded.

Since the volume to be injected per session is limited, multiple sessions (on average2 to 4) are usually required.

Paediatric population

There is no relevant use of Etoxisclerol in the paediatric population.

Administration route

All injections must be administered intravenously; the position of the needle must be checked (e.g., by aspirating blood).

Regardless of the venous puncture method (in a patient standing with only one cannula or in a patient sitting with a syringe ready for injection), the injections will be performed normally in one leg in a horizontal position. Disposable syringes with smooth movement are recommended for sclerotherapy, as well as needles of different diameters, depending on the indication.

When using microfoam, the leg can be placed horizontally or elevated approximately 30-45° above the horizontal for injection.The ideal microfoam injection should be administered under the guidance of ultrasound.Direct puncture and injection in non-visible veins should be guided by duplex ultrasound. The needle should not be less than 25G.

The sclerosant must be administered intravenously in small aliquots in multiple points of the vein to be treated, either in liquid or microfoam form.In the treatment of perforating veins, it is recommended not to inject directly into the target vein.The goal is to achieve optimal destruction of the vessel wall with the minimum concentration of sclerosant necessary for a clinical result. If the concentration is too high, necrosis or other adverse sequelae may occur.

Microfoam must be prepared just before use and administered by a healthcare professional adequately trained in the correct generation and administration of microfoam. The preparation of microfoam is described in the Technical Dossier section 6.6. Most techniques involve mixing sclerosant and gas (e.g., sterile air) by repeatedly transferring it through 2 connected syringes.

Depending on the degree and extent of varicose veins, multiple treatment sessions may be required.

Strict aseptic technique should be maintained during the handling ofEtoxisclerol.

Treatment of compression after Etoxisclerol injection

After sclerotherapy with Etoxisclerol liquid, a compressive bandage or elastic stocking should be applied.

After sclerotherapy with microfoam, the patient's leg is initially immobilized for 2-5 minutes. The Valsalva maneuver and muscle activation should be avoided during this time, and compression should not be applied immediately, but 5-10 minutes after injection.

After this, the patient should walk for 30 minutes, preferably within the clinic or consultation area where the injection was performed.

Compression should be applied from several days to several weeks, depending on the extent and severity of varicose veins.

Occasionally, thrombi may appear, which can be removed by incision and evacuation of the thrombus.

-Treatment of hemorrhoids

• For sclerotherapy of hemorrhoids, Etoxisclerol 30 mg/mlin liquid formshould be used.
• During a treatment session, a total of no more than 2 ml of Etoxisclerol 30 mg/ml should be administered. Depending on the results, a maximum of 1 ml per hemorrhoid can be administered.For the treatment of hemorrhoids in men at position 11,the amount injected should not exceed 0.5 ml. Depending on the type of hemorrhoids, 1 to 4 sessions may be required. The injection should be strictly submucosal and applied directly to the hemorrhoid or above (cranial to) it in the tissue surrounding the blood vessels of the hemorrhoid.