patient information leaflet entocort enema

PATIENT INFORMATION LEAFLET

Entocort® Enema

budesonide

Please read this leaflet carefully before you use your enema. If you have any questions or are unsure about anything to do with your medicine please ask your doctor or pharmacist (chemist). Remember this medicine is only for you. Only a doctor can prescribe it. Never give it to anyone else even if their symptoms are similar to yours.

Entocort Enema, once prepared, is a whitish yellow liquid. Each bottle will provide a dose of around 2 mg of the active ingredient budesonide at a concentration of 0.02 mg of budesonide per ml of solution. Entocort Enema also contains lactose anhydrous, polyvidone, riboflavine sodium phosphate, lactose monohydrate, magnesium stearate, colloidal anhydrous silica, sodium chloride, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216) and water purified.

Entocort Enema comes in a box containing the following:

7 tablets wrapped in foil, inside a small box
7 plastic bottles containing solution
7 plastic bags to be used when giving the enema.

Budesonide is a type of steroid which reduces inflammation.

What is your medicine used for?

Entocort Enema can be used to treat inflammation and ulceration of the large intestine (colon) and rectum known as ulcerative colitis.

Before using your medicine

Make sure you have told your doctor about any other medicines that you are taking including those you have bought without prescription.

Please read the following questions carefully. The questions below are to check that it is safe for you to use this medicine. If you can answer yes to any of these you should discuss it with your doctor or pharmacist before using this medicine.

Have you had any recent infection in your bowel?
Have you ever had an unpleasant reaction to budesonide or any of the other ingredients in Entocort Enema?
Are you already taking steroids?
Are you taking ketoconazole, itraconazole, oestrogens or oral contraceptives?
Are you pregnant, think you might be pregnant or considering becoming pregnant?
Are you breast-feeding?

Using your medicine

It is important to use each enema at the right time. Usually this will be once a day, just before bedtime. A normal course of treatment lasts 4 weeks but the doctor may need to prescribe this treatment for longer. Entocort Enema is currently not recommended for use by children. To prepare one enema, dissolve one tablet in one bottle of solution.

Preparing the enema for use

	1. Take one of the plastic bottles and unscrew the complete nozzle section and protective cap in one piece.
	2. Take one of the tablets from its foil strip and drop it into the bottle.
	3. Put the nozzle and protective cap back onto the bottle. Then screw up again until tight.
	4. Shake the bottle well for at least 15 seconds, or until the tablet can no longer be seen in the liquid.
	5. The enema is now ready and should be used straight away.

You will find it more comfortable to use the enema if you empty your bowels and bladder before using Entocort Enema. Entocort Enema can stain your bedclothes so it is best to use a plastic sheet to protect them in case any liquid is spilled.

Follow these easy stages

1. Shake the bottle again, then this time take off the protective cap only, to reveal the nozzle.
2. Undress from the waist down, then lie down on your side; whichever is most comfortable.

Note: The liquid will be easier to retain if you lie down so that your bottom is slightly higher than the rest of your body. For example, you can raise the bottom of the bed onto blocks or place one or two pillows under your bottom.

3. If you wish, hold the bottle using one of the plastic bags.
4. Gently ease the nozzle into your back passage (rectum) as far as is comfortable.
5. Squeeze the bottle, this will push most of the liquid into your back passage. However, you will not be able to empty the whole bottle as it has been designed to retain some liquid after being used.
6. When you have completed this stage, remove the nozzle from your back passage.
7. If used, remove the plastic bag from your hand by pulling it forward over the bottle. This will leave the bottle inside the bag, ready to be disposed of.
8. Now, roll over onto your stomach and stay like this for 5 minutes to stop any loss of liquid from your back passage.
9. Then, find a comfortable position to sleep in so as to retain the liquid for as long as possible, the longer, the better.

Note: Entocort Enema is a ‘retention enema’, which means that the liquid is meant to be held in the back passage for as long as possible. The longer it is kept there the more time it has to work and therefore the better the results should be.

What happens if you use too many?

If you use more than the recommended number of enemas, contact your doctor or pharmacist (chemist) straight away.

What to do if you forget to take a dose?

If you forget one dose, use it as soon as you remember then go on as before.

After using your medicine

Like all medicines, Entocort Enema may sometimes cause side effects as well as the effects that are needed.

You may feel sick, have diarrhoea or trapped wind, or get a skin rash. Less common are feelings of nervousness and difficulty sleeping.

If you suffer from any of these side effects, or if you get any other unusual or unexpected symptoms, talk to your doctor or pharmacist (chemist)

Storing your medicine

Do not use your enemas after the expiry date shown on the bottle or foil.
Keep your medicine in a safe place where children cannot reach or see it.
Do not store this medicine above 30°C.
Remember to return any unused medicine to your pharmacist (chemist).

Medicine: entocort enema