What Entocort EC is and what it is used for
Budenofalk Rectal Foam contains the active substance budesonide, a type of locally acting steroid used to treat inflammatory bowel disease. Budenofalk Rectal Foam is used for the treatment of:
• Inflammation of the rectum (back passage) and the lower part of the colon (sigmoid colon), known by doctors as ulcerative colitis.
How to take Entocort EC
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. The recommended dose is Dose for adults over 18 years of age The usual dose is 1 spray actuation per day, either in the morning or to be used at bedtime. Emptying your bowels before using Budenofalk Rectal Foam produces the best results. Use in children and adolescents Budenofalk Rectal Foam should not be used in children under 18 years of age, because there is very limited experience with Budenofalk Rectal Foam in this age group. Method of administration This medicine may only be used rectally, so it has to be inserted through the anus. It is not intended to be taken by mouth. Do not swallow. Picture of the spray can The applicators are in a special rail. Please hold the rail firmly and pull the applicator out sharply. Preparing to use the foam Push applicator firmly onto the spout of the spray can. Shake the spray can for about 15 seconds to mix the contents. Before the first use, remove the safety lock (plastic flap) from under the pump dome. Twist the dome on the top of the spray can until the semi-circular gap underneath is in line with the nozzle. The spray can is now ready for use. Using the foam Place your index finger on the top of pump dome and turn the can upside down. Please note that the spray can will only work properly when held with the pump dome pointing down as vertically as possible. Insert the applicator into your rectum as far as possible. The best way to do this is to place one foot on a chair or stool. To administer a dose of Budenofalk Rectal Foam, push down fully the pump dome once and release it very slowly. Wait 10
•15 seconds before withdrawing the applicator as the foam still expands a little and would otherwise drop out of the applicator. After administering the foam, remove the applicator and dispose of it as household waste in the plastic bag provided. Use a new applicator for another administration. In order to prevent the inadvertent loss of foam from the spray can between applications turn the pump dome around so that the semicircular gap faces the opposite direction to the nozzle.
• Please wash your hands and try not to empty your bowels until the next morning.
• If you go to hospital or see another doctor or dentist tell them you are using this medicine. Duration of treatment How long you will use the medicine depends upon your condition. Your doctor will decide how long you are to continue the medication. Acute episodes of inflammatory bowel disease (ulcerative colitis) generally subside after 6
•8 weeks. If you think that the effect of Budenofalk Rectal Foam is too strong or too weak, talk to your doctor. If you use more Budenofalk Rectal Foam than you should If you have used too much medicine on one occasion, use your next dose as prescribed. Do not use a smaller amount. Contact a doctor if you are in doubt, so he or she can decide what to do; take the carton and this leaflet with you if possible. If you forget to use Budenofalk Rectal Foam If you miss a dose, just continue your treatment at the prescribed dosage. Do not use a double dose to make up for a forgotten dose. If you stop using Budenofalk Rectal Foam Speak to your doctor if you want to interrupt or end your treatment early. It is important that you do not stop using your medicine suddenly as it could make you ill. Keep using your medicine until your doctor tells you to stop, even if you start to feel better. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. If you get any of the following symptoms after using this medicine, you should contact your doctor immediately:
•changes in behaviour such as depression, irritability, euphoria, restlessness, anxiety or aggression
The following side effects have also been reported:
Common: may affect up to 1 in 10 people
•burning or pain in the rectum
•Cushing’s syndrome – e.g. with roundness of the face, weight gain, reduced glucose tolerance, high blood sugar, high blood pressure, fluid retention in the tissues (e.g. swollen legs), increased excretion of potassium (hypokalaemia), irregular periods in women, unwanted body hair in women, impotence, abnormal laboratory findings (reduced adrenal function), red stripes on the skin (stretch marks), acne.
•indigestion, irritable stomach (dyspepsia)
•increased risk of infection
•muscle and joint pain, muscle weakness, muscle twitching
•brittle bones (osteoporosis)
•mood changes, such as depression, irritability or euphoria
•rash from hypersensitivity reactions, red spots from bleeding in the skin, delayed wound healing, local skin reactions such as contact dermatitis
Uncommon: may affect up to 1 in 100 people
•an increase in appetite
•changes to the blood (increase in erythrocyte sedimentation rate, increase in the number of white blood cells)
•nausea, abdominal pain, wind, tingling or numbness in the abdomen, anal fissure, mouth ulcers, frequent need to empty the bowels, rectal bleeding
•ulcers in the stomach or small intestine
•changes in liver function parameters
•changes in pancreatic function, changes in adrenal hormones
•urinary tract infections
•giddiness, disturbance of smell
•sleeplessness, restlessness with increased physical activity, anxiety
•increased sweating, weakness
Rare: may affect up to 1 in 1,000 people
•inflammation of the pancreas
•bone loss due to poor circulation of blood (osteonecrosis)
Very rare: may affect up to 1 in 10,000 people
•slowed growth in children
•increased pressure in the brain, possibly with increased pressure in the eye (swelling of the optic disk) in adolescents
•increased risk of blood clotting, inflammation of the blood vessels (associated with stopping cortisone use after long-term therapy)
•tiredness, general feeling of being ill These side effects are typical of steroid medication and most of them can also be expected for treatments with other steroids. They may occur depending on your dose, duration of treatment, whether you have had or are having treatment with other cortisone preparations, and your individual susceptibility. Some of these unwanted effects were only reported after long-term use of oral budesonide. In general, the risk of side effects with Budenofalk Rectal Foam is lower than with systemically acting (affecting the whole body) cortisone preparations due to its local action. If you have been treated with a stronger cortisone preparation before starting treatment with Budenofalk Rectal Foam, your symptoms may reappear when the medicine is changed.
Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system: Republic of Ireland: HPRA Pharmacovigilance Earlsfort Terrace IRL
•Dublin 2 Tel: +353 1 6764971 Fax: +353 1 6762517 Website: www.hpra.ie E-mail: [email protected] United Kingdom Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard By reporting side effects, you can help provide more information on the safety of this medicine.
How to Store Entocort EC
Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton and on the pressurised container. The expiry date refers to the last day of that month. The contents of the container must be used within 4 weeks after first opening. Do not store above 25°C. Do not refrigerate or freeze The container is pressurised and contains flammable propellant. Do not expose to temperature higher than 50°C, protect from direct sunlight. Do not pierce or burn, even when empty. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
2 to 3 weeks on average
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