L1367F

Patient Information Leaflet

ECOSTATIN PESSARIES

Econazole Nitrate

Your doctor has prescribed Ecostatin Pessaries for you. Please read this leaflet before you take your medicine. It gives a summary of information about your medicine. If you want to know more, or are not sure about anything, ask your doctor or pharmacist.

WHAT IS IN ECOSTATIN PESSARIES?

The active ingredient in Ecostatin Pessaries is econazole nitrate which is an antifungal antibiotic. Each pessary contains 150 mg econazole nitrate in a base consisting of hard vegetable fat. The treatment pack contains three pessaries.

PRODUCT LICENCE HOLDER:

E.R. Squibb & Sons Limited

Hounslow, Middlesex.

PL Number:

0034/0233

Manufacturer:

Cilag Ltd.

Schaffhausen,

Switzerland.

Q. What is this medicine for?

A. Ecostatin Pessaries are for the treatment of vaginal thrush (vulvovaginal candidosis). Vaginal thrush is a common infection and is caused by a yeast (fungus) called Candida infecting the vulva and vagina. This medicine works by killing the fungus that has caused your symptoms such as any itching, soreness, redness, pain or white, non-smelly discharge.

BEFORE TAKING YOUR MEDICINE:

Q. Should I be Using Ecostatin Pessaries?

A. DO NOT use Ecostatin Pessaries if you know you are allergic to any of the ingredients.

Q. What if I am pregnant?

A. DO NOT use Ecostatin Pessaries during the first three months of pregnancy unless your doctor decides it is necessary for you. If Ecostatin Pessaries are prescribed for you later on in pregnancy check with your doctor before using the applicator. It may be better if you use your fingers to insert the pessary.

USING YOUR MEDICINE:

Q. How should I use Ecostatin Pessaries?

A. A pessary should be inserted at bedtime for three nights running. This should be continued for the three nights even if all signs of the thrush disappear beforehand. Wash and dry your hands thoroughly before handling the pessary and applicator and then follow the Instructions For Inserting The Pessary given on the page opposite.

Q. Do I continue the treatment It I have my period?

A. Yes. Do not interrupt the course of treatment. Continue until the prescribed course of pessaries is finished.

Q. Should I continue to have sex?

A. It is not a good idea to have sex while you have a thrush infection as it is easily transmitted to your sexual partner who might in turn give it back to you. Also, Ecostatin can damage the rubber of contraceptive diaphragms and condoms (sheaths) so that they are no longer safe to use.

Q. What it I miss a dose?

A. If you miss the dose insert a pessary as soon as you do remember.

continued

INSTRUCTIONS FOR INSERTING THE PESSARY

LOADING THE APPLICATOR

  1. Pull the plunger out about one inch.
  2. Remove pessary from plastic wrapping.
  3. Place the pessary into the cup end of the applicator.
  4. Insert one pessary high into the vagina.

INSERTING THE APPLICATOR

  1. Lie down on your back with your knees bent.
  2. Insert the open end of the applicator into the vagina as far as it will comfortably go.
  3. Hold the outer part of applicator in position and press plunger slowly with forefinger until the pessary is pushed out from the applicator into the vagina.
  4. Withdraw the applicator from the vagina.

CLEANING THE APPLICATOR

  1. Remove the plunger from the barrel by pulling it right out.
  2. Wash both sections thoroughly under a stream of water allowing water to run through the barrel.
  3. It is not necessary to sterilise the applicator. Do not use extremely hot water because it may soften the plastic
  4. Dry the applicator and store in a clean place.

AVOIDING RE-INFECTION:

  1. After passing water the toilet tissue should be used as a blotter rather than with a forward and backward motion. After bowel movement, the toilet tissue should be wiped in the direction away from the vagina in order to avoid the possibility of spreading infection from the back passage to the vagina.
  2. Towels and underwear should be changed daily.
  3. Your sexual partner should be treated at the same time as you using Ecostatin cream applied twice daily to the external genital area during the treatment period.

UNDESIRABLE EFFECTS:

Q. Are there any unwanted effects from Ecostatin?

A. Occasionally side effects similar to the symptoms of thrush occur (i.e. burning or irritation); this does not usually last long and disappears as the treatment is continued. If your symptoms get worse check with your doctor.

LOOKING AFTER YOUR MEDICINE:

You will see a ‘Use before’ date on the outer packaging of Ecostatin Twin Pack. Do not use after this date. Keep the pessaries and cream in a locked cabinet OUT OF CHILDREN’S REACH. The pessaries and cream should be stored below 25°C. Do not leave near a radiator on a window sill or in the bathroom. If your doctor decides to stop the medicine return any unused pessaries and cream to your pharmacist.

DATE OF PREPARATION: January 1994

E.R. Squibb & Sons Ltd.,

Hounslow Middlesex England