Patient Information Leaflet: Ethanolamine Oleate (monoethanolamine oleate) Solution for Injection    Ethanolamine Oleate 5% w/v

Read all of this leaflet carefully before you start

taking this medicine.

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

•    If you have further questions, please ask your doctor or pharmacist

•    This medicine has been prescribed for you.

Do not pass it on to others. It may harm them, even if their symptoms are the same as yours

•    In this leaflet, Ethanolamine Oleate Injection will be called Ethanolamine Oleate.

In this leaflet:

1    What Ethanolamine Oleate is for

2    Before you take Ethanolamine Oleate

3    How to take Ethanolamine Oleate

4    Possible side effects

5    How to store Ethanolamine Oleate

6    Further information.

1.    What Ethanolamine Oleate is for

Ethanolamine Oleate belongs to a group of medicines called ‘sclerosing agents’.

When this medicine is injected inside a varicose vein, it irritates the vein and stops blood flowing through it. Scar tissue grows inside the varicose vein and stops it from reforming. Ethanolamine Oleate is used to treat small, simple varicose veins in the legs.

2.    Before you use Ethanolamine Oleate

Do not use Ethanolamine Oleate if:

•    You are allergic to oleic acid, ethanol amine or benzyl alcohol

•    You are unable to walk

•    You suffer from inflammation of the veins (acute phlebitis)

•    You take oral contraceptives (the ‘pill’)

•    You have very fat (obese) legs

•    You have inflamed veins near to your varicose veins

•    You have blood clots in veins near your

varicose veins

•    You have any problems with your circulation

•    You suffer from heart disease

•    You suffer from kidney disease

•    If you have diabetes

•    You have a local infection such as an infected cut

•    You have an infection such as a virus or a cold

•    You are a child.

If any of the above applies to you talk to your doctor or pharmacist.

Taking other medicines

Tell your doctor or pharmacist if you are taking

or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding

Do not use Ethanolamine Oleate if you are pregnant or are trying to become pregnant. Ifyou are breast-feeding, ask your doctor or pharmacist for advice before taking any medicine.

3. How to use Ethanolamine Oleate

A doctor will give you your Ethanolamine Oleate injection.

Adults and the elderly

•    Your doctor will slowly inject 2 to 5 ml of this medicine into your varicose vein

•    The dose may be divided into 3 or 4 injections given at different sites

•    Your doctor will ensure that the injection does not leak into the surrounding area as this could be harmful

•    This inj ection should only be given to you by trained medical staff.

Ethanolamine Oleate is not suitable for children.

If you are given more Ethanolamine Oleate than you should

If you think you have been given too much Ethanolamine Oleate tell your doctor. This may damage your kidneys (acute nephrotoxicity).

4.    Possible side effects

Like all medicines, Ethanolamine Oleate can cause side effects, although not everybody gets them.

•    Allergic reactions (rash, itching, sometimes shortness of breath) which may occasionally be very serious

•    Burning sensation

•    Cramping sensation

•    Itchy rash (urticaria).

If any of the side effects gets serious or if you notice any side effect not mentioned in this

leaflet, please tell your doctor.

5.    How to store Ethanolamine Oleate

Keep out of the reach and sight of children.

Do not use after the expiry date shown on the pack. The expiry date refers to the last day of that month.

Store below 25° C. Keep the ampoule in the outer carton to protect it from light.

Medicines should not be disposed of via wastewater or household waste. Return any medicine you no longer need to your pharmacist.

Your doctor or nurse will make sure your medicine is stored and disposed of correctly.

6. Further information

What Ethanolamine Oleate contains

The active ingredient is Ethanolamine as Ethanolamine Oleate (50 mg/ml).

The other ingredients are oleic acid, benzyl alcohol (20.8 mg/ml) and Water for Injections.

What Ethanolamine Oleate looks like

Ethanolamine Oleate solution for injection is a clear liquid in a clear glass ampoule. There are 10 ampoules in a pack.

Marketing Authorisation Holder

Phoenix Labs,

Suite 12, Bunkilla Plaza, Bracetown Business Park Clonee, Co. Meath, Ireland

Manufacturer

Recipharm Limited, Vale of Bardsley, Ashton-under-Lyne, OL7 9RR, UK

This leaflet was last updated January 2015.

If this leaflet is difficult to see or read, or you would like it in a different format, please contact

Phoenix Labs, Suite 12, Bunkilla Plaza,

Bracetown Business Park, Clonee, Co. Meath, Ireland.