VEINFIBRO 0.5% INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the User

Veinfibro 0.5% Solution for Injection

Sodium Tetradecyl Sulfate

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What is Veinfibro and what is it used for
2. What you need to know before you use Veinfibro
3. How to use Veinfibro
4. Possible side effects
5. Storage of Veinfibro

Contents of the pack and further information

1. What is Veinfibro and what is it used for

Veinfibro is a medicine that contains sodium tetradecyl sulfate.

Veinfibro is used to treat varicose veins, large, medium, or small venules, and spider veins.

Veinfibro belongs to a group of medicines called sclerosing agents. Sclerosing agents are chemical agents that, when injected into the affected vein, cause the vein wall to become inflamed and the walls to stick together. This stops the flow of blood and the vein becomes scar tissue. Within a few weeks, the vein should disappear.

Veinfibro is for use in adults only

2. What you need to know before you use Veinfibro

Do not use Veinfibro if you:

• are allergic to sodium tetradecyl sulfate or any of the other ingredients of this medicine (listed in section 6) or have an allergic disease.
• are unable to walk for any reason or are bedridden.

• are at risk of developing blood clots in the veins due to:

• inherited blood disorders such as thrombophilia
• hormonal contraceptive or hormone replacement therapy.
• significant overweight
• being a smoker
• prolonged immobilization

• have recently had blood clots in the superficial or deep veins or in the lungs
• have recently undergone surgery
• have varicose veins (varices) caused by pelvic or abdominal tumors, unless the tumor has been removed
• have uncontrolled diseases such as diabetes, hyperthyroidism, asthma, blood abnormalities, blood infection, or recent respiratory or skin problems
• have swelling or a red area of the skin that is hot or sensitive (cellulitis)
• have any type of infection
• have progressing cancer
• if you have been told you have problems with the closure of the valves in your deep veins (valvular incompetence)
• have any blocked artery
• Have severe inflammation of the veins in the legs (acute phlebitis)
• have symptoms of a congenital heart disease (only if the sclerosant is used as foam)

Warnings and precautions

Talk to your doctor or nurse before starting Veinfibro if:

• you are allergic to any food or medicine or if you have other allergies. You should inform your doctor, as it is necessary to administer a test dose 24 hours before administering a larger dose later.
• you have a history of blood clots in superficial or deep veins or in the lungs
• you have an asymptomatic hole in the heart (if the sclerosant is used as foam)
• you have a symptomatic or asymptomatic hole in the heart (if the sclerosant is used as a liquid)
• you suffer from migraines
• you have problems with the veins in your legs associated with a prolonged disease that causes inflammation of the body tissues (lymphedema). Veinfibro may worsen local pain and inflammation for a few days or several weeks.
• you have a history of pulmonary hypertension
• you have a history of a transient ischemic attack (TIA), stroke, or severe cerebrovascular accident
• you have been told you have any disease in the arteries or veins (arteriosclerosis)
• you have severe inflammation and blood clots in the arteries and veins that affect your hands and feet (Buerger's disease)
• you have any breathing difficulties under control (asthma)

Veinfibro should be administered by a doctor when national guidelines allow it. Veinfibro may be administered by properly qualified healthcare professionals with experience in vein anatomy and familiar with the appropriate injection technique under the supervision of a doctor. Before using this injection, you may need to undergo tests to check if you have any problems with the closure of the valves in your veins.

Your doctor will ask you questions about your health and inform you about the possible side effects of this procedure.

During treatment

Your doctor will monitor you during and after sclerotherapy in case signs of hypersensitivity (redness, itching, cough) or neurological symptoms (visual disturbances, migraine, tingling, numbness) appear.

They will ask you to return for a follow-up visit.

Children and adolescents

The safety and efficacy of Veinfibro in children and adolescents have not been established.

Other medicines and Veinfibro

If you are taking hormonal contraceptives (the pill) or hormone replacement therapy, you may be at risk of developing blood clots in the veins (see "Do not use Veinfibro if you"). You should inform your doctor or nurse.

Tell your doctor or nurse if you are taking or have recently taken any other medicines, including those obtained without a prescription.

Pregnancy and breastfeeding

You should inform your doctor if:

• you are pregnant or think you may be pregnant
• you are planning to become pregnant
• you are breastfeeding

There is not enough information on the use of Veinfibro in pregnant women. Veinfibro should not be used during pregnancy unless clearly necessary. Your doctor will decide whether this treatment is suitable for you or not.

It is not known whether Veinfibro is excreted in breast milk. If you are breastfeeding, your doctor will decide whether you can use Veinfibro.

Driving and using machines

After treatment with this injection, you may be advised to wear a bandage and/or compression stockings to help reduce inflammation and skin pigmentation, which could affect your ability to drive.

Veinfibro contains sodium, potassium, and benzyl alcohol

This medicine contains:

• less than 1 mmol of sodium (23 mg) per vial or ampoule, i.e., essentially "sodium-free".
• less than 1 mmol of potassium (39 mg) per vial or ampoule, i.e., essentially "potassium-free".
• 40 mg of benzyl alcohol in each 2 ml ampoule or 100 mg of benzyl alcohol in each 5 ml vial, which is equivalent to 20 mg/ml. Benzyl alcohol may cause allergic reactions. Talk to your doctor or pharmacist if you are pregnant, breastfeeding, or have liver or kidney disease. This is because large amounts of benzyl alcohol can accumulate in your body and cause side effects (metabolic acidosis).

3. How to use Veinfibro

Do not attemptto inject Veinfibro yourself. You should always be treated by an experienced doctor familiar with the injection technique.

The therapy involves injecting the medicine into the affected vein using the smallest possible needles and should be injected slowly and with extreme care so that the contents of these veins are expelled. The medicine can be manually mixed with air using two syringes and a connector to create foam that helps expel blood from larger veins. In this case, it should be administered by a doctor trained in the correct generation and administration of the foam.

Your doctor should be guided by ultrasound technique in the treatment of non-visible varicose veins to administer the sclerosant in foam.

Your doctor will decide on the areas to be treated and the correct dose for you. The recommended doses are as follows:

Adults and elderly

The dose varies between 0.1 and 2 ml for each injection. A maximum of 10 ml of the three injections of lower concentration can be used; however, no more than 4 ml is used when the higher concentration injection is used.

Due to the limited volume of sclerosant authorized, repeated sessions of sclerotherapy may be necessary.

After being treated with Veinfibro, 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.

If you have any doubts about the use of this medicine, talk to your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

You may experience serious side effects. Stop treatment with Veinfibro and contact your doctor or go to a hospital emergency department immediately if you have:

Uncommon (may affect up to 1 in 100 patients):

• Blood clots in deep veins (deep vein thrombosis possibly due to an underlying disease). Symptoms can include pain, swelling, sensitivity in one of the legs (usually the calf), intense pain in the affected area, hot skin in the area of the clot, or red skin, especially on the back of the leg below the knee.

Rare (may affect up to 1 in 1,000 patients):

• Local tissue death of the skin and, less commonly, nerves. Symptoms include pain, skin discoloration (redness), inflammation, or fluid accumulation, blisters (which can be filled with clear fluid or blood), the skin turns dark red, purple, or black, abnormal sensation (tingling, stabbing, burning), numbness, or loss of sensation.

Very rare (may affect up to 1 in 10,000 patients):

• A very severe allergic reaction (anaphylactic shock), which can cause difficulty breathing or a sudden drop in blood pressure, making you feel dizzy or faint. It is very rare but must be treated immediately as it can be fatal.
• Blockage of an artery due to a clot that can cause:
• • a stroke or interruption of blood supply to the brain or eye (transient ischemic attack). Symptoms can include weakness, numbness, paralysis in the face, arm, or leg, usually on one side of the body, slurred or unintelligible speech, or difficulty understanding others, blindness in one or both eyes, or double vision.
  • a clot in the lungs. Symptoms can include sudden difficulty breathing, sharp and sudden chest pain that worsens with deep breathing or coughing, rapid heart rate, or rapid breathing.

To avoid this serious and very rare event, this medicine should not be administered to patients at high risk of forming clots in veins and arteries (risk of thrombosis).

• Circulatory failure. Symptoms can include fatigue, loss of consciousness, fainting, chest pain, difficulty breathing, weakness, dizziness, vomiting, and palpitations.
• Tissue death after intra-arterial injection. Symptoms can vary depending on the amount of medicine injected and how quickly medical attention is received. Symptoms can range from pain without long-term damage to loss of large areas of tissue, including the foot, resulting in amputation.

Other side effects that you may experience are:

Very common (may affect more than 1 in 10 patients):

• Superficial inflammation of the vein

Common (may affect up to 1 in 10 patients):

• Pain or burning (short-term at the injection site),
• Skin discoloration

• Growth of very fine vascular spiders in the treated area (capillarization)

Uncommon (may affect up to 1 in 100 patients):

• Local allergic and non-allergic skin reactions such as redness, itching, rash, skin inflammation.
• Visual disturbances
• Migraine

Rare (may affect up to 1 in 1,000 patients):

• Cough, difficulty breathing, feeling of pressure, chest tightness
• Burning, tingling, numbness, or itching of the skin
• Headache and feeling of fainting
• Confusion, dizziness, and loss of consciousness

Very rare (may affect up to 1 in 10,000 patients):

• Fever, hot flashes, itching, and redness of the skin (urticaria)
• Nausea, vomiting, diarrhea, sensation of inflammation in the tongue, dry mouth

• Inflammation of blood vessels

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Veinfibro

Keep this medicine out of the sight and reach of children.

• This medicine does not require any special storage temperature
• Do not freeze.
• Keep the container in the outer packaging to protect it from light
• Do not use this medicine after the expiry date stated on the label or carton. The expiry date is the last day of the month stated.

For single use. Once the container is opened, the contents must be used immediately. Discard any unused portion of the product.

Medicines should not be disposed of via wastewater or household waste. Deposit the containers and medicines you no longer need at the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the containers of medicines you no longer need. This will help protect the environment.

6. Container Contents and Additional Information

Composition of Veinfibro

The active ingredient is sodium tetradecyl sulfate.

Each ml of injectable solution contains 5 mg of sodium tetradecyl sulfate.

Each 2 ml ampoule contains 10 mg of sodium tetradecyl sulfate.

The other components are: benzyl alcohol (20 mg/ml), disodium phosphate dodecahydrate, potassium dihydrogen phosphate, water for injectable preparations, sodium hydroxide (for pH adjustment). See section 2, "Veinfibro contains sodium and potassium".

Appearance of Veinfibro and Container Contents

This medicine is presented as an injectable solution in transparent glass vials or ampoules.

The solution is transparent, colorless, sterile, and free of visible particles.

Packaging of 5 ampoules of 2 ml

Only some package sizes may be marketed.

Marketing Authorization Holder:

STD Pharmaceutical (Ireland) Limited,

Block 1, Blanchardstown Corporate Park,

Ballycoolen Road, Blanchardstown,

Dublin 15, D15 AKK1, Ireland

Manufacturer:

Medipha Sante

Les Fjords-Immeuble Oslo

19 Avenue de Norvege

91953 Courtaboeuf CEDEX

France

Or

Chemische Fabrik Kreussler & Co. GmbH

Rheingaustrasse 87-93

65203 Wiesbaden,

Germany

For further information on this medicinal product, please contact the local representative of the marketing authorization holder:

Local Representative:

Logsa Endomedical, S.L.

Calle Escritora Carmen Martín Gaite no.2,

Local 2, 29196 Málaga, Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Germany, Bulgaria, France, Ireland, Netherlands, Poland, Czech Republic, Romania Fibrovein

Austria, Spain Veinfibro

Date of the last revision of this leaflet: 05/2024

The following information is intended for healthcare professionals only

Veinfibro 0.5% injectable solution

For more information, see the Summary of Product Characteristics

Posology and Method of Administration

Posology

Veinfibro should be administered only by the intravenous route. The necessary concentration will depend on the size and degree of varicosity. Vascular spiders should be treated with the 0.2% solution and reticular veins with the 0.5% solution. The 1% solution is more useful for small or medium varices and the 3% solution for large varices. The size of non-visible varices should be measured by ultrasound.

The sclerosing agent should be administered intravenously in small aliquots at multiple points along the vein to be treated. Veinfibro 0.2% and 0.5% should be administered in liquid form. Veinfibro 1% and 3% solutions can be administered either as a liquid or as a sclerosant/air mixture (foam) as detailed in the table below. The goal is to achieve optimal destruction of the vessel wall with the lowest concentration of sclerosant necessary for a clinical result. If the concentration is too high, necrosis or other adverse sequelae may occur.

Adults

When special caution is required, it is recommended to administer a test dose of 0.25 to 0.5 ml of Veinfibro and observe the patient for several hours before administering a second dose or a larger dose.

Since the volume to be injected is limited per session, repeated sessions (2 to 4 on average) are often necessary. To prevent a possible allergic reaction, it is recommended to give a small test dose of Veinfibro at the beginning of each session.

Elderly Population

No specific dosage recommendation is applicable.

Pediatric Population

The safety and efficacy of Veinfibro in children and adolescents have not been established. No data are available.

Method of Administration

A strictly aseptic technique should be maintained during handling of Veinfibro. Veinfibro is a single-use parenteral medicinal product. Once the container is opened, it should be used immediately and any unused portion discarded.

Visually inspect before use to ensure that there are no visible particles. Solutions containing visible particles should not be used.

When the sclerosing agent is administered as foam, it should be administered ideally under ultrasound guidance. It should be administered by a physician trained in the correct generation and administration of foam.

Incompatibilities

This medicinal product is incompatible with heparin.

In the absence of compatibility studies, this medicinal product should not be mixed with other medicinal products.

Special Warnings and Precautions

Veinfibro should be administered only by a physician when national guidelines permit it. Veinfibro may be administered by qualified healthcare professionals with experience in venous anatomy and in the diagnosis and treatment of diseases affecting the venous system and who are familiar with the correct injection technique under the supervision of a physician.

Allergic reactions, including anaphylaxis, have been reported, and the physician should be prepared to treat them appropriately. An emergency resuscitation team should be available. As a precaution, the patient should be treated in the hospital.

Severe local adverse effects, including tissue necrosis, may occur after extravasation; therefore, extreme care should be taken in the intravenous placement of the needle, and the effective minimum volume should be used at each injection site. The solution should be injected slowly.

It is necessary to exercise caution not to inject the solution into an artery, as this could cause tissue death (necrosis) and could lead to the death of the limb.

Caution should be exercised when injecting into the foot and the area above and below the ankle (malleolar area) due to the risk to one of the arteries. Compression should be applied when treating small veins, as pigmentation may occur if blood is expelled into the injection site.

Excipients

This medicinal product contains:

• Less than 1 mmol of sodium (23 mg) per vial/ampoule, i.e., essentially "sodium-free".
• Less than 1 mmol of potassium (39 mg) per vial/ampoule, i.e., essentially "potassium-free".
• 40 mg of benzyl alcohol in each 2 ml ampoule or 100 mg of benzyl alcohol in each 5 ml vial, which is equivalent to 20 mg/ml. Benzyl alcohol may cause allergic reactions. It may cause metabolic acidosis in pregnant women, during lactation, or in patients with hepatic or renal disease.