FIBROVEIN 3%, 1%, 0.5% and 0.2%

Sodium tetradecyl sulfate injection BP


Consumer Medicine Information

WHAT IS IN THIS LEAFLET

This leaflet answers some common questions about FIBROVEIN. 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 using FIBROVEIN against the benefits they expect it will have for you. It is important that you follow the instructions before and after treatment with FIBROVEIN.

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

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

Keep this leaflet with the medicine. You may need to read it again.

WHAT FIBROVEIN IS USED FOR

FIBROVEIN contains sodium tetradecyl sulfate, which is one of the group of medicines known as sclerosants.

FIBROVEIN is only for use in adults (including the elderly) in a procedure called compression sclerotherapy; for the treatment of varicose veins.

BEFORE USING FIBROVEIN

FIBROVEIN should not be used if you have any of the following medical conditions. Before starting treatment, you must tell your doctor if you:

  • are pregnant, trying to become pregnant or breast feeding
  • have previously experienced a reaction to FIBROVEIN or any other product containing sodium tetradecyl sulfate
  • are allergic (hypersensitive) to other medicines or to a variety of foods
  • suffer from any of the following medical conditions:
    – asthma, lung disease, breathing problems or any allergic disease
    – tumours or any blood disorders
    – diabetes
    – difficulty walking
    – any skin problems
    – recent surgery
    – recent blood clots in superficial or deep veins or in the lungs
    – twisted veins (varicose veins) caused by pelvic or abdominal tumours, unless the tumour has been removed
    – any kind of infection
    – severe heart disease
    – excessive fluid accumulation in the lungs causing shortness of breath
    – blockage in an artery
    – problems with closing of valves in deep veins (valvular incompetence)
  • are taking any of these medicines:
    – the oral contraceptive pill
    – medicines for the treatment of blood clots (thrombosis)
  • have severe inflammation of veins in the legs (acute phlebitis)
  • have blood clots in your veins (thrombosis)
  • have risk of developing blood clots in your veins due to:
    – inherited blood disorders such as thrombophilia
    – being significantly overweight
    – immobility for long duration
    – having hormonal contraception or hormone replacement therapy.
    – smoking

FIBROVEIN should be administered only by experienced healthcare professionals experienced in venous anatomy and familiar with proper injection technique. Before using this injection you may be tested to see if you have any problems with the closing of the valves in your veins.

During one treatment session, up to 10 sites of each limb may be injected with the lower strength solutions.

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

Your doctor will monitor you during and after the sclerotherapy for signs of hypersensitivity (redness, itching, cough) or neurological symptoms (visual disorders, migraine, tingling or numbness).

He will ask you to come back for a follow up visit.

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

Driving and using machinery
After the treatment with this injection