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Fibro-Vein 3% Ampoule 2mL 5
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EP61827
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General Information
FIBRO-VEIN 3%, 1%, 0.5% AND 0.2%
containing sodium tetradecyl sulphate
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Consumer Medicine Information

Please read this leaflet carefully. It contains important information about your treatment. If you have any doubts or questions, or if you are not sure about anything, ask your doctor or pharmacist.

It is important that you follow the instructions before and after administration of FIBRO-VEIN. Look at the label on the pack and this leaflet for details.

What is in the pack?
The name of your medicine is FIBRO-VEIN. It comes in the form of a glass ampoules or glass vials containing a clear sterile solution. FIBRO-VEIN contains the active ingredient, sodium tetradecyl sulphate at either 3%, 1%, 0.5% or 0.2% strength. The solution also contains the inactive ingredients: benzyl alcohol, di-sodium hydrogen phosphate, potassium di-hydrogen phosphate and water.

FIBRO-VEIN 3%, 1% and 0.5% is packed as 5 x 2ml glass ampoules, with a different colour label for each strength. In addition FIBRO-VEIN 3% also comes in 10 x 5ml rubber packed glass vials. FIBRO-VEIN 0.2% is only packed as 10 x 5ml rubber capped glass vials.

What is FIBRO-VEIN?
FIBRO-VEIN contains sodium tetradecyl sulphate which is one of the group of medicines known as sclerosants.

Who supplies FIBRO-VEIN?
The product licence holder is STD Pharmaceutical Products Limited, Hereford, HR4 0EL, UK and the manufacturer is CP Pharmaceuticals, at Wexham LL13 9UF, UK.

What is FIBRO-VEIN used for?
FIBRO-VEIN is used in a procedure called compression sclerotherapy in the treatment of varicose veins.

Before receiving FIBRO-VEIN
Before you start treatment:

Are you pregnant, trying to become pregnant or breast feeding?
Have you previously experienced a reaction to FIBRO-VEIN or a product containing sodium tetradecyl sulphate?
Do you suffer from asthma or any other allergic disease?
Are you currently taking oral contraceptive tablets?
Are you taking medicines for thrombosis?
If the answer is YES to any of these questions, tell your doctor before you are treated with FIBRO-VEIN.

You should inform medical staff that you expect to be treated with FIBRO-VEIN; for example if you go into hospital or see a dentist or doctor for another matter.

How to take FIBRO-VEIN
Because FIBRO-VEIN is administered by injection into the vein it is always administered by a medically competent person. The normal dose administered is up to 1ml. For the 3% strength, a maximum of 4 sites (total 4ml) should be treated and for 1%, 0.5% and 0.2% strengths a maximum of 10 sites (total 10ml) should be treated. It is not supplied for self administration.

After taking FIBRO-VEIN
To obtain a satisfactory result from your treatment you should follow the following instructions:

You should walk for 30-60 minutes immediately after treatment, as much as you can, but at least 3 miles a day.
The stocking and bandages must not be removed for at least 6 weeks after your last injection and then only when specified by your doctor.
You should not stand still unless strictly necessary, and only then for very short periods of time, when you should change weight from one foot to the other by alternating the raising of each heel.
When you bath or shower you should keep the bandages and stockings dry.
If you are a sportsperson you may continue with your sport providing the bandages and stockings do not get wet.
When your treatment is completely finished, elastic stockings should still be worn if your legs feel tired or if your occupation requires long periods of standing.
It is important to continue to exercise your legs daily.
Tell medical staff that you have taken FIBRO-VEIN; for example, if you go into hospital or see a dentist or doctor.

Side Effects
FIBRO-VEIN can sometimes cause side-effects in some people. The most often reported side effects are:

Allergy (eg rash) and anaphylaxis (hypersensitivity)
Urticaria (severe itching)
Pain at the injection site
If you get any of these, or any other unusual effects, it is very important that you tell your doctor before receiving any further treatment.

How to store FIBRO-VEIN
FIBRO-VEIN is stored at the treatment centre below 25 °C away from direct sunlight, you will not be asked to take it home. As with all medicines it should be kept out of the reach of children.
FIBRO-VEIN should not be used after the expiry date.
REMEMBER: This medicine is for you. Only your doctor can prescribe it for you.

FIBRO-VEIN is a trademark.

Date of leaflet: 21 August 1995

100307/3

Published by MIMS/myDr November 2006

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