BUDENOFALK 2MG/DOSE RECTAL FOAM
Active substance: BUDESONIDE
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If you forget to use Budenofalk Rectal Foam Do not take a larger than normal dose of Budenofalk Rectal Foam next time, but continue treatment at the prescribed dosage If you stop using Budenofalk Rectal Foam Do not stop taking this product until you have talked to your doctor. If you have any further questions on the use of this product, ask your doctor or pharmacist. 4. POSSIBLE SIDE EFFECTS Like all medicines, Budenofalk Rectal Foam can cause side effects, although not everybody gets them. The following effects have been reported: If you get any of the following symptoms after taking this medicine, you should contact your doctor immediately: Infection eadache H The following side effects have been reported: Common side effects (that affect less than 1 in 10 patients): Burning or pain in the rectum
Uncommon side effects (that affect less than 1 in 100 patients): Anaemia or other changes to the blood Headache, giddiness, disturbance of smell Urinary tract infections High blood pressure Sleeplessness Nausea, abdominal pain, dyspepsia, wind, tingling in the abdomen, anal fissure, mouth rash, urgent need to empty the bowels , haemorrhoids, rectal bleeding Changes in liver function Changes in pancreatic function, changes in adrenal hormones Acne, increased sweating Tiredness, increase in body weight. increase in appetite An When Budenofalk Rectal Foam is used, side effects may occur which are typical of the more active cortisone preparations (Cushing-like properties). The side effects listed below depend on the dose, the period of treatment, whether there has been prior or accompanying treatment with other cortisone preparations and on the individual sensitivity. Increased risk of infection Cushing Syndrome: Roundness of the face, weight gain, increased risk of high blood sugar, fluid retention, reduced growth in children Irregular periods in women, male hair growth patterns in women, impotence
Mood changes such as depression, irritation or euphoria Blurred vision (e.g. glaucoma and cataract) Increased risk of blood clotting, disease of the blood vessels (associated with stopping steroid use after long term therapy) Stomach complaints such as ulcers, pancreatitis and constipation Muscle pain and bone weakness (osteoporosis), loss of bone and cartilage (aseptic bone necrosis) Rash from hypersensitivity reactions (allergic exanthema), formation of red stripes (striations) and bleeding in the skin, delayed wound healing. Local skin reactions such as contact dermatitis may develop. Isolated cases: increased brain pressure with possible additional swelling of the optic disk in adolescents Most of these unwanted effects were noted after long-term use of oral steroids and so these effects will be less with Budenofalk Rectal Foam. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. OW TO STORE BUDENOFALK H RECTAL FOAM Keep out of the reach and sight of children. Do not use Budenofalk Rectal Foam after the expiry date which is stated on the carton and on the pressurised container. The contents of the container must be used within 4 weeks after first opening. Do not store above 30 C. Do not refrigerate or freeze! The container is pressurised and contains flammable propellant. Do not expose to temperature higher than 50C, protect from direct sunlight. Do not pierce or burn, even when empty. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION What Budenofalk Rectal Foam contains The active substance is budesonide. Each dose of foam contains 2 mg budesonide. The other ingredients are cetyl alcohol, emulsifying wax, purified water, disodium edetate, macrogol stearyl ether, propylene glycol, citric acid monohydrate and n-butane, isobutane and propane as propellants. What Budenofalk Rectal Foam looks like and contents of the pack Budenofalk Rectal Foam is a white to pale white, creamy, firm foam and is presented in a pressurised container. Budenofalk Rectal Foam is available in packs containing 1 pressurised container, 14 applicators and 14 plastic bags or in packs containing 2 pressurised containers, 28 applicators and 28 plastic bags, for the hygienic disposal of the applicators. Each pressurised container contains at least 14 doses of 1.2 g rectal foam. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
PACKAGE LEAFLET: INFORMATION FOR THE USER
Budenofalk 2mg/dose Rectal Foam
Budesonide Read all of this leaflet carefully before you start using this medicine. This medicinal product is authorised in the Member States of the EEA und the following names: Denmark, Finland, Great Britain, Greece, Ireland, Luxembourg, Romania and Sweden: Budenofalk Austria: Budo-San Italy: Rafton Spain: Intestifalk eep this leaflet. You may need to K read it again. f you have any further questions, I ask your doctor or pharmacist. his medicine has been prescribed T for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. f any of the side effects gets serious, I or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1.What Budenofalk Rectal Foam is and what it is used for 2. efore you use Budenofalk B Rectal Foam 3. ow to use Budenofalk H Rectal Foam 4. ossible side effects P 5. ow to store Budenofalk H Rectal Foam 6.Further information
This leaflet was last approved in May 2012 PL 08637/0011 PA573/2/2
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1.WHAT BUDENOFALK RECTAL FOAM 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. 2. EFORE YOU USE B BUDENOFALK RECTAL FOAM Do not use Budenofalk Rectal Foam you are or have been told you are If allergic (hypersensitive) to budesonide or any of the other ingredients of Budenofalk Rectal Foam (these are listed in section 6, Further information) you have a serious liver disease If (e.g. liver cirrhosis). Take special care with Budenofalk Rectal Foam. Before you start using this medicine you should tell your doctor: you know or have been told that If you have tuberculosis, high blood pressure, fragile bones (osteoporosis)
you or any of your family suffers If with diabetes (diabetes mellitus), or glaucoma (increase in the pressure within the eye) you suffer with ulcers in the stomIf ach or duodenum (peptic ulcer) you suffer with eye problems such If as cataracts. you suffer with problems of your If liver Further precautions: ell your doctor if you have not yet T had chickenpox or measles, or if you have come into contact with anybody who has chickenpox, shingles or measles. you know that you need to be If vaccinated please speak to your doctor first. you know that you are due to If have an operation please tell your doctor that you are using Budenofalk Rectal Foam. you have been treated with a If stronger cortisone preparation before starting treatment with Budenofalk Rectal Foam, your symptoms may reappear when the medicine is changed. If this happens, contact your doctor! Using other medicines Please tell your doctor if you take or use any of the medicines mentioned below as the effects of these medicines may change (interactions): edicines used to treat heart M conditions (cardiac glycosides such as digoxin)
Diuretics (medicines used to treat excess fluid in your body) etoconazole and itraconazole K (substances used to treat fungal infections) ntibiotic drugs used to treat A infections (such as clarithromycin) itonavir (a substance used for R treating HIV infections) arbamazepine (substance used C for treating epilepsy) ifampicin (substance used against R tuberculosis) ontraceptive pill C Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. It may still be all right for you to use Budenofalk Rectal Foam and your doctor will be able to decide what is suitable for you. Using Budenofalk Rectal Foam with food and drink You should not drink grapefruit juice during your treatment with Budenofalk Rectal Foam, as this can change the effects of Budenofalk Rectal Foam. Pregnancy and breast-feeding Ask your doctor or pharmacist for advice before taking any medicine. It is important that you tell you doctor if you are, or think you may be pregnant, as you should only use Budenofalk Rectal Foam during pregnancy if your doctor tells you to.
You should only use Budenofalk Rectal Foam during breast-feeding if your doctor tells you to, as it is not known if budesonide passes into breast milk. Driving and using machines There are no effects on the ability to drive and use machines. Important information about some of the ingredients of Budenofalk Rectal Foam This medicine contains cetyl alcohol and propylene glycol which can cause local skin reactions (e.g. contact dermatitis). 3. OW TO USE BUDENOFALK H RECTAL FOAM Always use Budenofalk Rectal Foam exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. 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. Dosage: Dose for adults over 18 years of age: The usual dose is 1 spray actuation per day, either in the morning or to be taken at bedtime.
Emptying your bowels before using Budenofalk Rectal Foam produces the best results. 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. Picture of the spray can:
pump dome spout applicator spray can
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 semi-circular gap faces the opposite direction to the nozzle. Please wash your hands and try not to empty your bowels until the next morning. you go to hospital or see another If 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 Contact a doctor if you are in doubt, so he or she can decide what to do. If you use too much Budenofalk Rectal Foam on one occasion, just take your next dose as prescribed. Do not use a smaller amount.
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
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Uncommon side effects (that affect less than 1 in 100 patients): Anaemia or other changes to the blood Headache, giddiness, disturbance of smell Urinary tract infections High blood pressure Sleeplessness Nausea, abdominal pain, dyspepsia, wind, tingling in the abdomen, anal fissure, mouth rash, urgent need to empty the bowels , haemorrhoids, rectal bleeding Changes in liver function Changes in pancreatic function, changes in adrenal hormones Acne, increased sweating Tiredness, increase in body weight. increase in appetite An When Budenofalk Rectal Foam is used, side effects may occur which are typical of the more active cortisone preparations (Cushing-like properties). The side effects listed below depend on the dose, the period of treatment, whether there has been prior or accompanying treatment with other cortisone preparations and on the individual sensitivity. Increased risk of infection Cushing Syndrome: Roundness of the face, weight gain, increased risk of high blood sugar, fluid retention, reduced growth in children Irregular periods in women, male hair growth patterns in women, impotence
Mood changes such as depression, irritation or euphoria Blurred vision (e.g. glaucoma and cataract) Increased risk of blood clotting, disease of the blood vessels (associated with stopping steroid use after long term therapy) Stomach complaints such as ulcers, pancreatitis and constipation Muscle pain and bone weakness (osteoporosis), loss of bone and cartilage (aseptic bone necrosis) Rash from hypersensitivity reactions (allergic exanthema), formation of red stripes (striations) and bleeding in the skin, delayed wound healing. Local skin reactions such as contact dermatitis may develop. Isolated cases: increased brain pressure with possible additional swelling of the optic disk in adolescents Most of these unwanted effects were noted after long-term use of oral steroids and so these effects will be less with Budenofalk Rectal Foam. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. OW TO STORE BUDENOFALK H RECTAL FOAM Keep out of the reach and sight of children. Do not use Budenofalk Rectal Foam after the expiry date which is stated on the carton and on the pressurised container. The contents of the container must be used within 4 weeks after first opening. Do not store above 30 C. Do not refrigerate or freeze! The container is pressurised and contains flammable propellant. Do not expose to temperature higher than 50C, protect from direct sunlight. Do not pierce or burn, even when empty. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION What Budenofalk Rectal Foam contains The active substance is budesonide. Each dose of foam contains 2 mg budesonide. The other ingredients are cetyl alcohol, emulsifying wax, purified water, disodium edetate, macrogol stearyl ether, propylene glycol, citric acid monohydrate and n-butane, isobutane and propane as propellants. What Budenofalk Rectal Foam looks like and contents of the pack Budenofalk Rectal Foam is a white to pale white, creamy, firm foam and is presented in a pressurised container. Budenofalk Rectal Foam is available in packs containing 1 pressurised container, 14 applicators and 14 plastic bags or in packs containing 2 pressurised containers, 28 applicators and 28 plastic bags, for the hygienic disposal of the applicators. Each pressurised container contains at least 14 doses of 1.2 g rectal foam. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
PACKAGE LEAFLET: INFORMATION FOR THE USER
Budenofalk 2mg/dose Rectal Foam
Budesonide Read all of this leaflet carefully before you start using this medicine. This medicinal product is authorised in the Member States of the EEA und the following names: Denmark, Finland, Great Britain, Greece, Ireland, Luxembourg, Romania and Sweden: Budenofalk Austria: Budo-San Italy: Rafton Spain: Intestifalk eep this leaflet. You may need to K read it again. f you have any further questions, I ask your doctor or pharmacist. his medicine has been prescribed T for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. f any of the side effects gets serious, I or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1.What Budenofalk Rectal Foam is and what it is used for 2. efore you use Budenofalk B Rectal Foam 3. ow to use Budenofalk H Rectal Foam 4. ossible side effects P 5. ow to store Budenofalk H Rectal Foam 6.Further information
This leaflet was last approved in May 2012 PL 08637/0011 PA573/2/2
p. 9
p. 10
p. 11
p. 12
p. 13
p. 14 = last page
p. 1
1.WHAT BUDENOFALK RECTAL FOAM 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. 2. EFORE YOU USE B BUDENOFALK RECTAL FOAM Do not use Budenofalk Rectal Foam you are or have been told you are If allergic (hypersensitive) to budesonide or any of the other ingredients of Budenofalk Rectal Foam (these are listed in section 6, Further information) you have a serious liver disease If (e.g. liver cirrhosis). Take special care with Budenofalk Rectal Foam. Before you start using this medicine you should tell your doctor: you know or have been told that If you have tuberculosis, high blood pressure, fragile bones (osteoporosis)
you or any of your family suffers If with diabetes (diabetes mellitus), or glaucoma (increase in the pressure within the eye) you suffer with ulcers in the stomIf ach or duodenum (peptic ulcer) you suffer with eye problems such If as cataracts. you suffer with problems of your If liver Further precautions: ell your doctor if you have not yet T had chickenpox or measles, or if you have come into contact with anybody who has chickenpox, shingles or measles. you know that you need to be If vaccinated please speak to your doctor first. you know that you are due to If have an operation please tell your doctor that you are using Budenofalk Rectal Foam. you have been treated with a If stronger cortisone preparation before starting treatment with Budenofalk Rectal Foam, your symptoms may reappear when the medicine is changed. If this happens, contact your doctor! Using other medicines Please tell your doctor if you take or use any of the medicines mentioned below as the effects of these medicines may change (interactions): edicines used to treat heart M conditions (cardiac glycosides such as digoxin)
Diuretics (medicines used to treat excess fluid in your body) etoconazole and itraconazole K (substances used to treat fungal infections) ntibiotic drugs used to treat A infections (such as clarithromycin) itonavir (a substance used for R treating HIV infections) arbamazepine (substance used C for treating epilepsy) ifampicin (substance used against R tuberculosis) ontraceptive pill C Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. It may still be all right for you to use Budenofalk Rectal Foam and your doctor will be able to decide what is suitable for you. Using Budenofalk Rectal Foam with food and drink You should not drink grapefruit juice during your treatment with Budenofalk Rectal Foam, as this can change the effects of Budenofalk Rectal Foam. Pregnancy and breast-feeding Ask your doctor or pharmacist for advice before taking any medicine. It is important that you tell you doctor if you are, or think you may be pregnant, as you should only use Budenofalk Rectal Foam during pregnancy if your doctor tells you to.
You should only use Budenofalk Rectal Foam during breast-feeding if your doctor tells you to, as it is not known if budesonide passes into breast milk. Driving and using machines There are no effects on the ability to drive and use machines. Important information about some of the ingredients of Budenofalk Rectal Foam This medicine contains cetyl alcohol and propylene glycol which can cause local skin reactions (e.g. contact dermatitis). 3. OW TO USE BUDENOFALK H RECTAL FOAM Always use Budenofalk Rectal Foam exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. 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. Dosage: Dose for adults over 18 years of age: The usual dose is 1 spray actuation per day, either in the morning or to be taken at bedtime.
Emptying your bowels before using Budenofalk Rectal Foam produces the best results. 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. Picture of the spray can:
pump dome spout applicator spray can
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 semi-circular gap faces the opposite direction to the nozzle. Please wash your hands and try not to empty your bowels until the next morning. you go to hospital or see another If 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 Contact a doctor if you are in doubt, so he or she can decide what to do. If you use too much Budenofalk Rectal Foam on one occasion, just take your next dose as prescribed. Do not use a smaller amount.
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
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Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
