Etoxisclerol 5 mg/ml solution for injection

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Etoxisclerol 5 mg/ml solution for injection

lauromacrogol 400

Read the entire leaflet carefully before starting to use this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only and must 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 these effects are not listed in this leaflet. See section 4.

Package leaflet contents:

1. What Etoxisclerol is and what it is used for
2. What you need to know before using Etoxisclerol
3. How to use Etoxisclerol
4. Possible side effects
5. How to store Etoxisclerol
6. Contents of the pack and other information

1. What Etoxisclerol is and what it is used for

Etoxisclerol is a sclerosing agent whose active ingredient is lauromacrogol 400.

Etoxisclerol is indicated for sclerotherapy or destruction of varicose veins and telangiectasias (spider veins).

2. What you need to know before using Etoxisclerol

Do not use Etoxisclerol in sclerotherapy of varicose veins

• If you are allergic to lauromacrogol 400 or to any of the other components of this medicine (listed in section 6),
• If you have a severe acute systemic disease (affecting the whole body) (especially in untreated patients),
• If you need to remain in bed or are unable to walk,
• If you have severe arterial circulation disorder (occlusive arterial disease, Fontaine stages III and IV),
• If you have a vascular occlusion due to a thrombus or blood clot (thromboembolic diseases),
• If you are at high risk of vascular occlusions (thrombosis), for example, patients with hereditary predisposition to form blood clots or with multiple risk factors such as: use of hormonal contraceptives (e.g. the pill), hormone replacement therapy, overweight, smoking, prolonged periods of immobility, etc.

Warnings and precautions

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

Consult your doctor, pharmacist, or nurse before starting treatment with Etoxisclerol:

• If you have fever,
• If you suffer from respiratory distress attacks (bronchial asthma),
• If you have a strong predisposition to allergies,
• If your general health condition is poor,
• If you are about to undergo sclerotherapy treatment for spider veins: in patients with arterial circulation disorders (arterial occlusive disease, Fontaine stage II),
• If you have swollen legs due to fluid accumulation (edema) that cannot be managed with compression,
• If you have inflammatory skin disease in the area to be treated,
• If you have symptoms of occlusion in the smallest blood vessels, for example due to diabetes (microangiopathy) and impaired sensitivity (neuropathy),
• If you have reduced mobility,
• If you suffer from frequent migraines.

Other medicines and Etoxisclerol

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

The use of Etoxisclerol together with anaesthetics may increase the anaesthetic effect on the cardiovascular system.

Pregnancy, lactation and fertility

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

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

If treatment with Etoxisclerol is necessary during breastfeeding, breastfeeding should be discontinued for 2–3 days, as there are no human data available on the passage of lauromacrogol 400 into breast milk.

Driving and Use of Machines

No negative effects on the ability to drive or operate machinery are known due to the use of Etoxisclerol.

Etoxisclerol contains ethanol, potassium, and sodium

• This medicine contains 84 mg of alcohol (96% ethanol) in each 2 ml ampoule, equivalent to 5% (v/v). The amount in one ampoule of this medicine 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 medicine will have any perceptible effect in adults or adolescents.
• The amount of alcohol contained in this medicine may alter the effect of other medicines. Consult your doctor or pharmacist if you are taking other medicines. If you are pregnant or breastfeeding, consult your doctor or pharmacist before taking this medicine.
• If you have alcohol addiction, consult your doctor or pharmacist before taking this medicine.
• This medicine contains less than 39 mg (1 mmol) of potassium per ampoule and is therefore considered essentially “potassium-free”.

This medicine contains less than 23 mg (1 mmol) of sodium per ampoule, thus being essentially “sodium-free”.

3. How to use Etoxisclerol

Etoxisclerol is a medicine that must be administered by a physician; therefore, it is the physician's responsibility to determine and select the appropriate dosage and technique in each individual case.

Depending on the size of the varicose vein to be treated and the patient's individual condition, your doctor will decide which treatment approach is suitable. 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.

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

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

After treatment with Etoxisclerol, you should follow your doctor's advice. Your doctor may recommend wearing 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 the pediatric population.

If you use more Etoxisclerol than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount ingested.

Overdose may cause local tissue death (necrosis), particularly after injection into tissue adjacent to the varicose vein.

4. Possible adverse effects

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

This section provides information on the adverse reactions reported in association with the long-term use of the active substance. In some cases, these reactions were troublesome, but in most cases, they were only temporary. Since these reports were often spontaneous, without reference to a defined patient population or a control group, it is not possible to calculate exact frequencies or establish a clear causal relationship to the drug in each individual case. However, a reasonable estimation can be made based on long-term experience.

Local adverse effects (e.g. necrosis) have been observed, particularly affecting the skin and tissue adjacent to the varicose vein (and, rarely, nerves), when treating leg varicose veins following accidental injection into surrounding tissue.

The risk increases with higher concentration and volume of Etoxisclerol.

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 hemorrhage (ecchymosis), short-term pain at the injection site, thrombosis at the injection site (local intravaricose blood clots).

• Uncommon (may affect up to 1 in 100 people): venous inflammation (superficial thrombophlebitis, phlebitis), allergic skin inflammation (dermatitis), contact urticaria, skin reaction, redness of the skin (erythema), localized tissue death (necrosis), tissue hardening, swelling, nerve injury.

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

• Very rare (may affect up to 1 in 10,000 people): anaphylactic shock (a severe and sudden allergic reaction, with symptoms such as difficulty breathing, dizziness, and drop in blood pressure), angioedema (symptoms include sudden swelling, especially in the face, such as eyelids, lips, or larynx), generalized urticaria, asthma (asthmatic attack), stroke (cerebrovascular accident), weakness causing loss of mobility in part of the body (hemiparesis), headache, migraine, local sensory disturbances (local paresthesia), reduced sensitivity or sensations in the mouth (oral hypoesthesia), loss of consciousness, confusion, central origin speech disorders (aphasia), difficulty controlling movements (ataxia), dizziness, visual disturbances, heart attack (cardiac arrest), broken heart syndrome (stress-induced cardiomyopathy), rapid or irregular heartbeats (palpitations), abnormal heart rate, blockage of the pulmonary artery (pulmonary embolism), fainting (vasovagal syncope), circulatory collapse, inflammation of blood vessel walls (vasculitis), difficulty breathing (dyspnea), sensation of chest pressure, cough, taste disturbances, nausea, vomiting, excessive hair growth (hypertrichosis) in the treated area, fever, hot flushes, unusual weakness (asthenia), general malaise, 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 not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Etoxisclerol

This medicinal product does not require any special storage temperature.

Keep this medicinal product out of the sight and reach of children.

Do not use this medicinal product after the expiry date stated on the container, after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Return unused containers and medicines to the SIGRE collection point at your pharmacy. If you are unsure, please ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Etoxisclerol 5 mg/ml

• The active substance is lauromacrogol 400.

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

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

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

Appearance of the product and contents of the pack

Etoxisclerol is a clear solution with a slight yellowish-green tint. It is supplied as an injectable solution in a carton containing 5 ampoules of 2 ml each.

Other presentations

• 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.
• Etoxisclerol 30 mg/ml injectable solution. Package containing 5 ampoules of 2 ml each.

Marketing Authorization Holder and Manufacturing Responsibility

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]

Further information on this medicinal product may be requested from the local representative of the marketing authorization holder:

FERRER FARMA, S.A.
Av. Diagonal 549, 5th Floor,
08029 Barcelona (Spain)

Date of latest review of this leaflet: June 2021

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.gob.es/

This information is intended for healthcare professionals only

For further information, see the Summary of Product Characteristics.

Important Precautions for Use

• Etoxisclerol should only be administered by a healthcare professional experienced in venous anatomy and in the diagnosis and treatment of diseases affecting the venous system, and who is familiar with correct injection techniques.
• Prior to treatment, the healthcare professional must assess the patient's risk factors and inform them of the risks associated with this procedure. Sclerotherapy is particularly not recommended in patients with a history of thromboembolic events. However, if sclerotherapy is deemed necessary, preventive anticoagulation may be initiated.
• Severe local adverse effects, such as tissue necrosis, may occur following extravasation; therefore, great care must be taken in placing the intravenous needle, and it is important to use the smallest effective volume at each injection site.
• Sclerosing agents must never be injected intra-arterially, as this may lead to severe necrosis that could require amputation. In the event of accidental intra-arterial injection, immediate vascular surgical treatment must be initiated.
• The use of any type of sclerosing agent in the facial area must be strictly evaluated, as intravascular injections may result in retrograde embolization into the ophthalmic artery, leading to irreversible vision loss.
• In certain body areas, such as the feet or malleolar region, the risk of inadvertent intra-arterial infiltration may be increased. Therefore, only small amounts and low concentrations should be used, with particular caution during such procedures.

Single and Daily Dosage

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, several injections may be given in subsequent treatment sessions, provided that the maximum dose is not exceeded.

Since the volume to be injected per session is limited, repeated sessions (usually 2 to 4 on average) are generally required.

Paediatric population

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

Administration Method

All injections must be administered intravenously; the needle position should be verified (e.g., by blood aspiration).

Regardless of the venous puncture technique (in a standing patient with a single cannula or in a seated patient with a ready-to-use syringe), injections are typically performed with the leg in a horizontal position. Disposable syringes with smooth plunger action are recommended for sclerotherapy, along with needles of different gauges depending on the indication.

For telangiectasias, very fine needles (e.g., insulin needles) should be used. Puncture is performed tangentially, and the injection is administered slowly.

The sclerosing agent must be administered intravenously in small aliquots at multiple points along the vein to be treated. In the treatment of perforating veins, direct injection into the target vein is not recommended. The goal is to achieve optimal vessel wall destruction with the lowest sclerosant concentration necessary to obtain a clinical effect. If the concentration is too high, necrosis or other adverse sequelae may occur.

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

A strictly aseptic technique must be maintained during the handling of Etoxisclerol.

Compression Treatment Following 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 office where the injection was performed.

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

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