About budesonide rectal preparations

Colite ulcerativa (CU) is a condition where patches of inflammation develop in your large intestine. The most common symptoms when the disease flares up are diarrhoea mixed with blood, and tummy (abdominal) pain. In between these flare-ups you may have few or no symptoms. If the patches are confined to the lower parts of your bowel (the colon and rectum), it may be helpful during flare-ups for you to be treated with a rectal preparation. This means giving budesonide into your back passage as an enema which you retain for a short time, or administering it as a foam.

Budesonide helps to reduce inflammation. A course of treatment will last a few weeks only - it will be stopped once your flare-up has settled.

Some medicines are not suitable for people with certain conditions, and sometimes a medicine can only be used if extra care is taken. For these reasons, before you start using budesonide it is important that your doctor knows:

• If you are pregnant or breastfeeding (even though budesonide could still be prescribed for you).

• Se você tiver qualquer tipo de infecção, ou se já teve tuberculose (TB).

• Se você teve um ataque cardíaco, ou se você tem uma condição cardíaca.

• Se você tiver algum problema com o funcionamento do seu fígado, ou se tiver algum problema com o funcionamento dos seus rins.

• If you have diabetes (diabetes mellitus), or if you have an eye condition called glaucoma. You should also tell your doctor if a close member of your family has either of these conditions.

• If you currently have any of the following conditions: high blood pressure, 'thinning' of the bones (osteoporosis), diverticulitis, an underactive thyroid gland, epilepsy, cataracts, or a condition causing severe muscle weakness, called myasthenia gravis.

• Se você já teve algum dos seguintes: um coágulo sanguíneo em um vaso sanguíneo, uma úlcera estomacal ou um problema de saúde mental, como depressão ou psicose.

• Se você estiver tomando outros medicamentos. Isso inclui quaisquer medicamentos que estejam disponíveis para compra sem receita médica, bem como medicamentos fitoterápicos e complementares.

• Se você já teve uma reação alérgica a um medicamento, ou se já desenvolveu dor muscular após tomar um medicamento esteroide.

• Before you start the treatment, read the manufacturer's printed information leaflet from inside the pack. It will give you more information about budesonide, and will also provide you with a full list of the side-effects which you could experience from using it. It will also give you a step-by-step guide on how to use it.

• Your doctor will tell you how to use budesonide. If you have been given Budenofalk® Rectal Foam, use one metered application once daily (you can use it in the morning or the evening, whichever suits you best). If you have been given Entocort® Enema, use one enema at bedtime.

• Continue to use budesonide each day until your doctor tells you to stop. A course of treatment with Budenofalk® Rectal Foam may last up to eight weeks, whereas a course of treatment with Entocort® Enema is likely to last four weeks.

How to use Budenofalk® Rectal Foam

1. Attach an applicator to the spray can nozzle and then shake the can well for about 15 seconds.

2. Before you use the foam for the first time, remove the plastic safety lock from under the pump dome, and twist the dome until the small notch on the underneath of it is in line with the nozzle.

3. Turn the spray vertically upside down.

4. Insert the applicator into your back passage as far as is comfortable.

5. Push down the pump dome on the container once, and then release it very slowly.

6. Wait for 10-15 seconds before withdrawing the applicator.

7. Remove the applicator and dispose of it in a plastic bag.

How to use Entocort® Enema

1. Unscrew the cap from one of the plastic bottles containing liquid.

2. Drop one of the tablets from the foil strip into the bottle.

3. Put the cap back on to the bottle and shake the bottle for 15 seconds, or until the tablet has dissolved.

4. Unscrew the cap and replace it with one of the screw-on nozzles (including protective cap) provided in the pack.

5. Lie down, then take off the protective cap and gently insert the nozzle into your back passage as far as is comfortable.

6. Squeeze the bottle to empty it of most of the liquid, then remove the nozzle from your back passage and dispose of the bottle into a plastic bag.

7. Roll over on to your stomach and stay like this for five minutes to keep the liquid in place. After this, get comfortable and allow yourself to go to sleep. The enema is intended to be retained (kept in your bowel) for as long as possible.

• Try to keep your regular appointments with your doctor and clinic. This is so your doctor can check on your progress.

• Budesonide can suppress your immune system, so it is important if you become ill that you make an appointment to see your doctor straightaway. Also, if you come into contact with anyone who has measles, shingles or chickenpox (or anyone who suspects they might have one of these viruses), you should see your doctor as soon as possible.

• Some vaccines may not be suitable for you while you are being treated with budesonide. If you need any immunisations, make sure you mention that you are using a steroid medicine.

• It is recommended that you should not drink grapefruit juice while you are on budesonide. This is because a chemical in grapefruit juice increases the amount of budesonide in your bloodstream and could make side-effects more likely.

• If you are having an operation or any medical treatment, tell the person carrying out the treatment that you are using budesonide.

• Se você comprar qualquer medicamento, verifique com um farmacêutico se é seguro tomá-lo com os medicamentos prescritos.

Along with their useful effects, most medicines can cause unwanted side-effects although not everyone experiences them. The table below contains some of the most common ones associated with budesonide when used rectally. You will find a full list in the manufacturer's information leaflet supplied with your medicine. The unwanted effects often improve as your body adjusts to the new medicine, but speak with your doctor or pharmacist if any of the following continue or become troublesome.

For more information about side-effects which can develop when budesonide is taken by mouth or used long-term, see the separate leaflet called Esteroides orais.

If you experience any other symptoms which you think may be due to budesonide, speak with your doctor or pharmacist for further advice.

• Mantenha todos os medicamentos fora do alcance e da vista das crianças.

• Armazene em local fresco e seco, longe de calor e luz diretos.

• Budenofalk® Rectal Foam should only be used for four weeks once it has been opened. You will need to obtain a fresh supply if you are still using it after this time.