Aethoxysklerol Solution for injection

Aethoxysklerol Solution for injection is a brand of medicine containing the active ingredients laureth-9.

Find out more about active ingredients.

Consumer medicine information (CMI) leaflet

Developed by the pharmaceutical company responsible for this medicine in Australia, according to TGA regulations.

Aethoxysklerol®

Generic name Laureth-9


Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about Aethoxysklerol.

It does not contain all the available information.

It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you having Aethoxysklerol against the benefits they expect it will have for you.

If you have any concerns about this medicine, ask your doctor, nurse or pharmacist.

Keep this leaflet. You may need to read it again.

Back to top

What Aethoxysklerol is used for

Aethoxysklerol is a sterile solution that is injected into varicose veins to cause closure of the affected vein and shrink the vessel(s).

How it works

Upon injection, Aethoxysklerol works by causing the lining of the blood vessel to break up and also stops the flow of blood through that vein. The affected area is then squeezed by application of a compression bandage which helps to complete closure of the varicose vein.

Back to top

Before you are given Aethoxysklerol

When you must not be given it

Do not have Aethoxysklerol injected if you have an allergy to:

  • Laureth-9 or any of the ingredients listed at the end of this leaflet.

Symptoms of an allergic reaction may include:

  • shortness of breath, wheezing or difficulty breathing
  • swelling of the face, lips, tongue or other parts of the body
  • skin rash, itching or hives

Do not have Aethoxysklerol injected if you have any of the following medical conditions:

  • you are confined to bed or have difficulty in walking
  • you have severe arterial disease
  • blockage of blood vessels by blood clots or at least three of the following: you take oral contraceptive pills or hormone replacement medication, you are overweight, smoke or remain immobile for long periods
  • swelling and redness along a vein which is extremely tender when touched
  • acute infection of the skin (hot, tender and red skin, sometimes with fever and chills)
  • any allergic disease
  • acute infections
  • uncontrolled systemic disease such as diabetes, overactive thyroid gland with increased sweating, tremors and rapid heart rate, tuberculosis, asthma, tumours, severe venous abnormalities, blood poisoning (symptoms may include high fever, chills, headache, confusion, rapid breathing), a disease of the blood with a reduced number of red or white blood cells or platelets (symptoms may include tiredness, headaches, dizziness, being short of breath when exercising and looking pale; frequent infections such as fever, severe chills, sore throat or mouth ulcers; bleeding or bruising more easily than normal, nosebleeds), any lung or skin disease

If you are not sure whether you should have injections of Aethoxysklerol, talk to your doctor.

Before you are given it

Tell your doctor if have, or have had, any medical conditions, especially the following:

  • a blood clotting disorder
  • arterial disease with severe pain on walking (only if treatment of spider veins is intended)
  • numbness or weakness of the arms and legs
  • excessive accumulation of fluid in the leg
  • blood vessels affected by diabetes
  • pain, swelling, redness and heat on skin in the area that is to be injected
  • you have severe heart disease
  • recent feverish temperature
  • you are over 75 years old and in poor health

Tell your doctor if you have allergies to:

  • any other medicines
  • any other substances, such as foods, preservatives or dyes

Tell your doctor if you are pregnant or intend to become pregnant. Aethoxysklerol is not recommended for use during pregnancy. If there is a need to consider injections during your pregnancy, your doctor will discuss the benefits and risks with you.

Tell your doctor if you are breast-feeding. It is not known whether Aethoxysklerol passes into breast milk. If there is a need to consider injections whilst you are breast-feeding, your doctor will discuss the benefits and risks with you.

Tell your doctor if you have suffered from alcoholism. Aethoxysklerol contains ethanol.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop. Some medicines and Aethoxysklerol may interfere with each other. These include:

  • anaesthetics (medicines causing loss of feeling, especially pain)

These medicines may be affected by Aethoxysklerol or may affect how well it works. (You may need different amounts of these medicines, or you may need to take different medicines.) Your doctor or pharmacist will advise you and decide whether or not to give the medicine.

Back to top

How and when Aethoxysklerol is given

Aethoxysklerol is given by injection into the varicose vein. It should always be injected by a doctor who has been trained in the proper techniques for injecting varicose veins. The actual dose and selection of the Aethoxysklerol concentration to be used will depend on the size of the varicose vein to be treated. Before injection, the leg must be lifted to a horizontal position or preferably lifted 30-45° above the horizontal.

Once the injection site has been covered, a firm compression bandage or elastic stocking will be applied. Immediately after fitting of the bandage, you will be asked to walk for 30 minutes in the surgery. The bandage or stocking should be worn for several days or weeks, depending on the size of the varicose veins treated. For very small vessels a period of 2-7 days is usually sufficient.

For larger varicose veins, longer compression-treatment with bandages is recommended. The bandage may need to be worn for 4-6 weeks.

Several repeat treatments at intervals of 1-2 weeks may be necessary, depending on the severity and extent of the varicose veins.

The success of treatment depends heavily on the thorough and careful follow-up compression treatment. Please follow the advice of your doctor.

How much is given

Your doctor will decide on the dose depending on the size and type of vein to be treated.

If you are given too much

It is unlikely that you will be given too much medicine. Extensive varicose veins will always be treated in several sessions. If there is any likelihood of a hypersensitivity (allergic-type) reaction, only one injection will be given. Depending on the outcome and size of the area to be treated, several injections may be given at subsequent treatment sessions.

Back to top

After Aethoxysklerol injection

Things you must do

Keep a record of your injections.

Keep follow-up appointments with your doctor or clinic. It is important to have your follow-up injections of Aethoxysklerol at the appropriate times to help make sure the treatment is successful.

Things to be careful of

Make sure that the bandage does not slip down, if you suspect that the compression bandage is not doing its job see your doctor.

Back to top

Side effects

Tell your doctor as soon as possible if you do not feel well after having an injection of Aethoxysklerol. Aethoxysklerol may have unwanted side effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

Tell your doctor if you notice any of the following and they worry you:

  • pinkish, itchy swellings on the skin, also called hives or nettle rash
  • asthma
  • headache or migraine
  • tingling or numbness of the hands or feet
  • feeling of confusion or dizziness
  • visual disturbances
  • fast or irregular heart beats, also called palpitations
  • development of new tiny blood vessels
  • swelling and redness along a vein which is extremely tender when touched
  • fainting
  • narrowing or blockage of blood vessels
  • difficulty in breathing or sensation of pressure in the chest
  • coughing
  • taste disturbance or loss of taste
  • nausea
  • darker areas of skin or bruising
  • skin rash, hives, redness of the skin or any other skin reaction
  • excessive growth of normal hair at the injection site
  • pain in the limb
  • pain or blood clot formation at the injection site
  • local tissue death
  • appearance of lumps or swelling at the injection site.
  • fever, sensation of heat
  • unusual weakness or generally feeling unwell
  • change of blood pressure
  • nerve injury

Some of the side effects listed above are more common but most of them are rare or very rare. They are usually mild and short-lived.

Tell your doctor immediately if you notice any of the following:

  • sudden signs of allergy such as rash, itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body, difficulty in swallowing, shortness of breath, wheezing or trouble breathing.
  • stroke
  • loss of consciousness
  • heart attack
  • blood clot, usually in a leg, which causes pain, swelling or redness
  • blockage of lung artery which causes chest pain and breathlessness
  • collapse due to very low blood pressure

These may be serious side effects. Tell your doctor immediately or go to Accident and Emergency at your nearest hospital. You may need urgent medical attention.

Most of the serious side effects are very rare.

Other side effects not listed above may occur in some patients. Tell your doctor if you notice anything that is making you feel unwell.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

Back to top

Storing Aethoxysklerol

Aethoxysklerol is usually stored in the doctor’s surgery or clinic, or at the pharmacy. However, if you need to store Aethoxysklerol:

  • Keep it where children cannot reach it.
  • Keep Aethoxysklerol in the original pack until it is time for it to be given.
  • Keep it at room temperature (below 25° C), do not expose to excessive heat.

Back to top

Product description

What it looks like

A clear, colourless to faintly yellowish-green solution, free of particles

Ingredients

Active ingredient: laureth-9

Other ingredients: ethanol, sodium phosphate, potassium phosphate, water

Aethoxysklerol does not contain lactose, sucrose, gluten, tartrazine or any other azo dyes.

Manufacturer/ Distributor

Aethoxysklerol is made in Germany by:
Chemische Fabrik
Kreussler & Co. GmbH

Rheingaustrasse 87-93
65203 Wiesbaden

and distributed in Australia by:
BASE Pharma Pty Ltd
Suite 1A, Level 2
802 Pacific Highway
Gordon NSW 2072
Phone: 1800 607 302

Aethoxysklerol 0.5% (10 mg / 2 mL laureth-9) AUST R 79118
Aethoxysklerol 1% (20 mg / 2 mL laureth-9) AUST R 79119
Aethoxysklerol 2% (40 mg / 2 mL laureth-9) AUST R 79120
Aethoxysklerol 3% (60 mg / 2 mL laureth-9) AUST R 79121

This leaflet was prepared in January 2012

Back to top

CMI provided by MIMS Australia, December 2014  

Related information - Aethoxysklerol Solution for injection

Audience:
       

(Medicine)
30 Oct 2012 Information on medicines available in Australia containing laureth-9, including our latest evidence-based information and resources for health professionals and consumers. Laureth-9 is also known as polidocanol. The active ingredient is the chemical in a medicine that makes it work. Medicines that contain the same active ingredient can be available under more than one brand name. Brands include both active ingredients and inactive ingredients. You'll find information about brands of medicines that contain laureth-9 below, including their consumer medicine information (CMI) leaflets.