Chemische Fabrik Kreussler & Co.
GmbH
Aethoxysklerol 2% (amp.)
Leaflet attached to the packaging: information for the user
Aethoxysklerol 2%, 20 mg/ml solution for injection
Lauromacrogol400
You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.
- You should keep this leaflet, so that you can read it again if you need to.
- In case of any doubts, you should consult a doctor or nurse.
- If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or nurse. See section 4.
Table of contents of the leaflet
- 1. What is Aethoxysklerol 2% and what is it used for
- 2. Important information before using Aethoxysklerol 2%
- 3. How to use Aethoxysklerol 2%
- 4. Possible side effects
- 5. How to store Aethoxysklerol 2%
- 6. Contents of the packaging and other information
1. What is Aethoxysklerol 2% and what is it used for
Aethoxysklerol 2% is a sclerosing agent (sclerotherapy), which involves injecting a thin needle into a vein and injecting lauromacrogol 400, also known as polidocanol or lauryl macrogol ether, which causes the vein wall to become fibrotic, leading to closure and disappearance of the varicose vein. Aethoxysklerol 2% is used for sclerotherapy of varicose veins of the lower limbs.
2. Important information before using Aethoxysklerol 2%
When not to use Aethoxysklerol 2%:
- if the patient is allergic to lauromacrogol 400 or any of the other ingredients of this medicine (listed in section 6)
- if the patient has an acute, severe disease (especially untreated)
- if the patient is immobilized
- if the patient has severe obstructive arterial disease of the lower limbs (stage III and IV on the Fontaine scale)
- if the patient has thromboembolic diseases
- if the patient has a high risk of thrombosis (e.g. proven inherited tendency to thrombosis or multiple risk factors, such as the use of hormonal contraceptives or hormone replacement therapy, obesity, smoking, or prolonged periods of immobilization)
- if sclerotherapy is to be performed with a microfoam: if the patient has symptoms caused by a diagnosed hole in the heart (diagnosed, symptomatic left-to-right shunt).
Special warnings and precautions
Before starting treatment with Aethoxysklerol 2%, the patient should consult a doctor or nurse.
Aethoxysklerol 2% and other medicines
The patient should inform their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before using this medicine.
Driving and using machines
The medicine does not affect the ability to drive or use machines.
3. How to use Aethoxysklerol 2%
This medicine should always be used according to the doctor's recommendations. In case of doubts, the patient should consult their doctor.
Use in children
Aethoxysklerol is not intended for use in children and adolescents.
Overdose of Aethoxysklerol 2%
In case of overdose, local tissue necrosis may occur, especially after para-vascular injection.
4. Possible side effects
Like all medicines, Aethoxysklerol 2% can cause side effects, although not everybody gets them.
Reporting side effects
If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse.
5. How to store Aethoxysklerol 2%
The medicine should be stored out of sight and reach of children.
6. Contents of the packaging and other information
What Aethoxysklerol 2% contains
The active substance of the medicine is lauromacrogol 400.
What Aethoxysklerol 2% looks like and contents of the packaging
The packaging contains 5 ampoules. 1 ampoule of 2 ml contains 40 mg of lauromacrogol 400.
Marketing authorization holder and manufacturer
Chemische Fabrik Kreussler & Co. GmbH, Rheingaustr. 87-93, 65203 Wiesbaden, Germany
Date of last revision of the leaflet
Information intended for healthcare professionals only:
Special warnings
Aethoxysklerol must be administered by a doctor with experience in performing sclerotherapy.
Treatment of poisoning after incorrect administration of the medicinal product
- 1. Leave the cannula in place; if the cannula has already been removed, re-locate the injection site
- 2. Inject 5 to 10 ml of a local anesthetic, without adrenaline
- 3. Inject heparin at a dose of 10,000 IU
- 4. Apply a dressing and lower the affected limb
- 5. As a precaution, hospitalize the patient (vascular surgery)
Emergency procedures and corrective measures
Anaphylactic reactions
Anaphylactic reactions are rare but can be life-threatening. The attending physician should be prepared to take emergency measures and have access to an appropriate emergency kit.