VARICANOL INJECTION SOLUTION 0.5%

Active ingredient: Each ampoule (2 mL) contains 10 mg lauromacrogol 400 as the active ingredient.

Excipient(s): Ethanol 96%, potassium dihydrogen phosphate, disodium hydrogen phosphate dihydrate, water for injection.

Before you start using this medicine, read this INSTRUCTIONS FOR USE carefully, because it contains important information for you.

Detailed information for this product is available in the patient information leaflet.

Instructions for proper use and dosage/frequency of administration

In general, the recommended daily dose of 2 mg lauromacrogol 400 per kg body weight should not be exceeded (for a patient with a body weight of 70 kg, this value corresponds to 28 mL VARICANOL). Your doctor will determine the dose of your medicine depending on your disease and administer it to you.

When treating a patient predisposed to hypersensitivity reactions for the first time, more than one injection should not be administered. Depending on the response, more than one injection may be administered in subsequent treatment sessions, provided that the maximum dose is not exceeded.

Depending on the size of the area to be treated, 0.1-0.2 mL VARICANOL is injected intravenously.

Using the closest puncture angle possible, the needle is inserted until the tip is securely located within the blood vessel.

This section describes side effects reported for worldwide use of the active substance. In some cases, these reactions were debilitating, but in most cases they were only temporary. Since these generally involve spontaneous reports, without reference to a defined group of patients or a control group, it is not possible to estimate exact frequencies or always demonstrate a definitive causal relationship to drug exposure. However, based on long-term experience, a solid assessment is possible.

Like all medicines, VARIKANOL may have side effects in people who are sensitive to its ingredients. In the treatment of leg varicose veins, regional side effect reactions (e.g. tissue death) have been observed, especially in the skin and underlying tissue (and in rare cases, nerves), as a result of accidental injection into the surrounding tissue (paravenous injection). The risk increases as VARICANOL concentrations and volumes increase.

Side effects are listed as shown in the following categories:

Allergic reactions (anaphylactic reactions) are rare; but they are potentially life-threatening situations. For such situations, the physician must be prepared and have appropriate emergency equipment available.

If you experience any side effects, whether listed in the Instructions for Use or not, talk to your doctor, pharmacist or nurse. Also, report the side effects you encounter to the Turkish Pharmacovigilance Center (TÜFAM) by clicking on the “Drug Side Effect Reporting” icon on the website www.titck.gov.tr ​​or by calling the side effect reporting line at 0 800 314 00 08. By reporting any side effects that occur, you will contribute to obtaining more information about the safety of the medicine you are using.

⚠️ Disclaimer: The information provided on this website is for informational purposes only and does not substitute professional medical advice. Always consult a healthcare provider before using any medication.