Prospect: information for the user

Etoxisclerol 5 mg/ml injectable solution

Lauromacrogol 400

Read this prospect carefully before starting to use this medicine, as 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 are not listed 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 is indicated for sclerosing or destruction of varicose veins and telangiectasias (vascular spiders).

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 mustremain in bedor 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 a 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.

Warnings and precautions

Etoxisclerol should be administered by a healthcare professional with experience 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 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 relieved by compression,
• If you have skin inflammatory 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 frequently have migraines.

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, breastfeeding, and fertility

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

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

If Etoxisclerol treatment 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 machinery

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

Etoxisclerol contains ethanol, potassium, and sodium

• This medication contains 84 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 on adults or adolescents.
• The amount of alcohol contained in this medication may affect 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 essentially “sodium-free”.

Etoxisclerol is a medication whose administration must be practiced by a doctor, so it is up to the doctor to know and choose the most suitable dosage and technique in each case.

In accordance with the size of the varicose vein to be treated and the individual situation of each patient, the doctor will decide what treatment to apply. In case of doubt, the lowest possible dose should be chosen. .

The dose of 2 mg/kg/day of lauromacrogol 400 should not be exceeded in general.

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 may 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, generally, repeated sessions (2 to 4 on average) are needed.

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

Use in children and adolescents

There is no relevant use of Etoxisclerol in pediatric population.

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.

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

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

In this section, we inform you about the 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 drug in each case. However, a reasonable estimate can be made from long-term experience.

Local adverse effects (e.g. necrosis) have been observed, especially in the skin and tissue near the varicose vein (and in rare cases, in the nerves) when treating leg varicose veins after accidental injections in the tissue near the same.

The risk increases when the concentration and volume of Etoxisclerol increase.

The following adverse 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).

• Infrequent (may affect up to 1 in 100 people):venous inflammation (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), limb pain.

• Very rare (may affect up to 1 in 10,000 people):anaphylactic shock (severe and sudden allergic reaction, symptoms include difficulty breathing, dizziness, fall 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, local sensory disturbances (paresthesia), decreased sensitivity or sensations in the mouth (hypoaesthesia oral), loss of consciousness, confusion, central speech disorders (aphasia), difficulty controlling movements (ataxia), dizziness, visual disturbances, 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), chest pressure, cough, taste disorders, nausea, vomiting, excessive hair growth (hypertrichosis) in the treated area, fever, hot flashes, unusual weakness (asthenia), general discomfort, abnormal blood pressure.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es.By reporting adverse 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 into the drains or trash. Dispose of the packaging and medicines you no longer need at the SIGRE point of the pharmacy.In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition of Etoxisclerol 5 mg/ml

• The active principle is lauromacrogol 400.

Each ml of injectable solution contains 5 mg of lauromacrogol 400.

Each ampoule of 2 ml of injectable solution contains 10 mg of lauromacrogol 400.

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

Appearance of the product and contents of the package

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

Other presentations

• Etoxisclerol 10 mg/ml injectable solution. Box containing 5 ampoules of 2 ml each.
• Etoxisclerol 20 mg/ml injectable solution. Box containing 5 ampoules of 2 ml each.
• Etoxisclerol 30 mg/ml injectable solution. Box 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)

Last review date of this leaflet:June 2021

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/

• Etoxisclerolshould only be administered by an experienced healthcare professional in venous anatomy and 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.
• 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.
• Scalerosants should never be injected intraarterially as this can cause severe necrosis that may require amputation. In the event of an accident, immediate surgical vascular 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 ankle region, the risk of inadvertently infiltrating 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.

Dosageof single and daily doses

Adults and elderly

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

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, multiple 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 (usually 2 to 4) are generally required.

Pediatric population

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

Administration form

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

Regardless of the mode of venous puncture (in a patient standing with only one cannula or in a seated patient with a syringe ready for injection), the injections will be performed normally in a horizontal leg. Smooth-bore disposable syringes are recommended for sclerotherapy, as well as needles of different diameters, depending on the indication.

For telangiectasias, very fine needles (e.g., insulin needles) are used.The puncture is performed tangentially and the injection is administered slowly.

The sclerosant must be administered intravenously in small aliquots in multiple points of the vein to be treated.In the treatment of perforating veins, it is recommended not to inject directly into the main 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.

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

Strict asepsis must be maintained during the handling ofEtoxisclerol.

Treatment with compression after Etoxisclerol injection

Once the injection site has been covered, a compression bandage or elastic stocking should be applied. 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 for several days to several weeks, depending on the extent and severity of the varicose veins.

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