BUDENOFALK 3MG GASTRO-RESISTANT CAPSULES
Active substance: BUDESONIDE
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Budenofalk 3mg Gebrauchsinformation (GI) fr Grobritannien-Irland Mat.-Nr.: Mock-up (Losan Pharma) Format: 290 x 195 mm Falk-Datumscode: GB-IE/10.12 Farbigkeit: 2/2 (Schwarz + Pant. 644) Laetuscode-Nr.: 118
PACKAGE LEAFLET: INFORMATION FOR THE USER
2. EFORE YOU TAKE BUDENOFALK 3mg CAPSULES B DO NOT take Budenofalk if you have: n allergy (hypersensitivity) to budesonide or any of the other a ingredients in this medicine (see Section 6 and end of Section 2) a severe liver disease (liver cirrhosis)
Budenofalk 3mg gastro-resistant capsules
Budesonide Read all of this leaflet carefully before you start taking this medicine. eep this leaflet. You may need to read it again. K f you have any further questions, please ask your doctor or your I pharmacist. his medicine has been prescribed for you. Do not pass it on to others. T It may harm them, even if their symptoms are the same as yours. f any of the side effects gets serious, or if you notice any side I effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. hat Budenofalk 3mg capsules are and what they are used for W 2. efore you take Budenofalk 3mg capsules B 3. ow to take Budenofalk 3mg capsules H 4. ossible side effects P 5. ow to store Budenofalk 3mg capsules H 6. urther information F 1. WHAT BUDENOFALK 3mg CAPSULES ARE AND WHAT THEY ARE USED FOR Budenofalk 3mg capsules contain the active substance budesonide, a type of locally acting steroid used to treat chronic inflammatory diseases of the intestine and the liver. Budenofalk is used in the treatment of: rohns disease: mild to moderate acute attacks of chronic inflamC mation of the intestine affecting the lower part of the small bowel (ileum) and/or upper part of the large bowel (the ascending colon). Note: Budenofalk is not suitable for patients with Crohns disease affecting the upper gastrointestinal tract. Sometimes this disease may cause symptoms outside the intestine (e.g. affecting the skin, eyes and joints) which are unlikely to respond to this medicine. ymptomatic relief of chronic diarrhoea due to collagenous S colitis (a disease with chronic inflammation of the large bowel which is characterized by chronic watery diarrhoea). utoimmune hepatitis (a disease with chronic inflammation of A the liver).
If you take cholestyramine (for hypercholestrolemia and also used to treat diarrhoea) or antacids (for indigestion) in addition to Budenofalk, take these medicines at least 2 hours apart. Taking Budenofalk with food and drink You should not drink grapefruit juice whilst you are taking this medicine as this can alter its effects. Pregnancy and breast-feeding Ask your doctor or pharmacist for advice before taking any medicine. It is important that you tell your doctor if you are, or think you may be pregnant as you should only take Budenofalk during pregnancy if your doctor tells you to. Do not breast-feed during treatment with Budenofalk as the drug may pass into breast milk. Driving and using machines Budenofalk is not expected to affect your ability to drive or operate machinery. Important information about some of the ingredients of Budenofalk 3mg capsules Each capsule contains 240 mg sucrose and 12 mg lactose monohydrate if you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. 3. OW TO TAKE BUDENOFALK 3mg CAPSULES H Always take Budenofalk exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Dosage Crohns disease and symptomatic treatment of collagenous colitis Adults (over 18 years) Take one capsule 3 times a day (morning, midday and evening), unless your doctor instructs you otherwise. Autoimmune hepatitis Adults (over 18 years) Treatment of acute inflammation: Take one capsule 3 times a day (morning, midday and evening), unless your doctor instructs you otherwise. Depending on the results of laboratory examinations, your doctor will decide how long you should take 3 capsules per day. Maintenance treatment: Take one capsule 2 times a day (morning and evening), unless your doctor instructs you otherwise. Depending on the results of laboratory examinations, your doctor will decide how long you should take 2 capsules per day.
Take special care with Budenofalk Before you start taking this medicine, tell your doctor if you have: tuberculosis high blood pressure diabetes, or if diabetes has been diagnosed in your family brittle bones (osteoporosis) ulcers in the stomach or first part of the small intestine (peptic ulcer) increased pressure in your eye (glaucoma) or eye problems such as clouding of the lens (cataracts) or if glaucoma has been diagnosed in your family severe liver problems Typical effects of cortisone preparations may occur which may affect all parts of the body, particularly when you take Budenofalk at high doses and for prolonged periods (see section 4. Possible side effects). Further precautions during treatment with Budenofalk: Keep away from people who have chickenpox or herpes zoster (shingles), if you have never had them. They could affect you severely. If you do come into contact with chickenpox or shingles, see your doctor straight away. Tell your doctor if you have not yet had measles. you know that you need to be vaccinated please speak to your If doctor first. you know that you are due to have an operation please tell your If doctor that you are using Budenofalk. you have been treated with a stronger cortisone preparation If before starting treatment with Budenofalk, your symptoms may reappear when the medicine is changed. If this happens, contact your doctor. Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription. In particular: ardiac glycosides such as digoxin (medicines used to treat heart C conditions) Diuretics (to remove excess fluid from the body) Ketoconazole or itraconazole (to treat fungal infections) Antibiotic drugs used to treat infections (such as clarithromycin) Ritonavir (for HIV infections) Carbamazepine (used in the treatment of epilepsy) Rifampicin (for treating tuberculosis) Oestrogens or oral contraceptives Cimetidine (used to inhibit the production of acid in the stomach)
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Please note that in most cases your doctor will prescribe Budenofalk together with azathioprine, a medicine that works by reducing the bodys immune response. Children (all indications) Budenofalk 3mg capsules should NOT be used in children under 12 years of age. There is only limited experience with the use of this medicine in children older than 12 years of age. Method of administration Budenofalk 3mg capsules are for oral use only. The capsules are to be swallowed whole, with a glass of water about hour before meals. Do not chew the capsules. Duration of treatment Your doctor will decide how long you are to continue the medication, depending on your condition. Crohns disease and collagenous colitis Your treatment should last about 8 weeks. Autoimmune hepatitis Depending on the results of examinations of your blood and liver tissue, your doctor will decide how long you should take this medicine and how many capsules per day you should take. If you take more Budenofalk than you should If you have taken too much medicine on one occasion, take your next dose as prescribed. Do not take a smaller amount. Contact a doctor if you are in doubt, so he or she can decide what to do; take the packet and this leaflet with you if possible. If you forget to take Budenofalk If you miss a dose, just continue your treatment at the prescribed dosage. Do not take a double dose to make up for the forgotten one. If you stop taking Budenofalk Speak to your doctor if you want to interrupt or end your treatment early. It is important that you do not stop taking your medicine suddenly as it could make you ill. Keep taking your medicine until your doctor tells you to stop, even if you start to feel better. Your doctor will probably want to reduce your dose gradually, first from three to two capsules for 1 week (one in the morning and one in the evening) and then only one capsule a day in the last week of treatment (taken in the morning). 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 can cause side effects, although not everybody gets them.
If you get any of the following symptoms after taking this medicine, you should contact your doctor immediately: Infection Headache Changes in behaviour or psychiatric effects for example depression, irritability and euphoria The following side effects have also been reported: Very rare (affecting less than 1 in 10,000 patients) Cushings syndrome - roundness of the face, weight gain, reduced glucose tolerance, high blood sugar, fluid retention, increased excretion of potassium (hypokaliemia), reduced growth in children, irregular periods in women, unwanted body hair in women, impotence, abnormal laboratory findings (reduced adrenal function), swelling of the legs (because of fluid retention, oedema) increased pressure in the brain, possibly with increased pressure in the eye (swelling of the optic disk) in adolescents constipation muscle and joint pain and weakness, muscle twitching brittle bones (osteoporosis) tiredness, general feeling of being ill. The following side effects are typical of steroid medication and may occur depending on your dose, period of treatment, whether you have had or are having treatment with other cortisone preparations, and your individual susceptibility. Most of the following side effects were noted after use of stronger steroids and so should be less frequent with Budenofalk 3mg capsules: Cushings Syndrome (for a description of typical symptoms, see above). increased risk of infection. mood changes such as depression, irritability or euphoria. blurred vision (caused by increased pressure in the eye (glaucoma) or clouding of the lens (cataract)). high blood pressure, increased risk of blood clotting, inflammation of the blood vessels (associated with stopping cortisone use after long term therapy). stomach ache and complaints, nausea, vomiting (feeling sick), ulcers in the stomach and/or small intestine, inflammation of the pancreas. rash from hypersensitivity reactions, red stripes on the skin, bleeding in the skin, acne, delayed wound healing, local skin reactions such as contact dermatitis. bone and cartilage loss (aseptic bone necrosis). 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 3mg CAPSULES H Keep out of the reach and sight of children. Do not store the medicine above 25C.
Do not use Budenofalk after the expiry date which is stated on the carton and blister pack. The expiry date refers to the last day of that month. 6. URTHER INFORMATION F What Budenofalk 3mg capsules contain The active substance is budesonide. Each capsule with gastro-resistant pellets contains 3 mg of budesonide. The other ingredients are ammonio methacrylate copolymer (type A) (Eudragit RL), ammonio methacrylate copolymer (type B) (Eudragit RS), lactose monohydrate, maize starch, methacrylic acid-methyl methacrylate copolymer (1:1) (Eudragit L 100), methacrylic acidmethyl methacrylate copolymer (1:2) (Eudragit S 100), povidone K25, purified water, sucrose, talc, triethyl citrate, gelatin, erythrosine (E127), titanium dioxide (E171), red and black iron oxide (E172), sodium laurilsulphate (see also end of Section 2 for further, important information on lactose and sucrose). What Budenofalk 3mg capsules look like and contents of the pack Budenofalk 3mg capsules are pink coloured gastro-resistant hard capsules contained in blister strips. Budenofalk 3mg capsules are available in pack sizes of 10, 50, 90, 100 or 120 not all may be marketed. Marketing Authorisation Holder and Manufacturer Leinenweberstr. 5 79108 Freiburg Germany
E-mail: zentrale@drfalkpharma.de www.drfalkpharma.de This medicinal product is authorised in the Member States of the EEA under the following names: Belgium, Bulgaria, Czech Republic, Denmark, Finland, Germany, Great Britain, Greece, Hungary, Ireland, Latvia, Lithuania, Luxembourg, The Netherlands, Poland, Romania, Slovakia, Slovenia, Sweden: Budenofalk Austria: Budo-San Portugal: Budo San Spain: Intestifalk France: Mikicort Italy: Rafton This leaflet was last approved in 12/2012. Mock-upGB-IE/10.12
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PACKAGE LEAFLET: INFORMATION FOR THE USER
2. EFORE YOU TAKE BUDENOFALK 3mg CAPSULES B DO NOT take Budenofalk if you have: n allergy (hypersensitivity) to budesonide or any of the other a ingredients in this medicine (see Section 6 and end of Section 2) a severe liver disease (liver cirrhosis)
Budenofalk 3mg gastro-resistant capsules
Budesonide Read all of this leaflet carefully before you start taking this medicine. eep this leaflet. You may need to read it again. K f you have any further questions, please ask your doctor or your I pharmacist. his medicine has been prescribed for you. Do not pass it on to others. T It may harm them, even if their symptoms are the same as yours. f any of the side effects gets serious, or if you notice any side I effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. hat Budenofalk 3mg capsules are and what they are used for W 2. efore you take Budenofalk 3mg capsules B 3. ow to take Budenofalk 3mg capsules H 4. ossible side effects P 5. ow to store Budenofalk 3mg capsules H 6. urther information F 1. WHAT BUDENOFALK 3mg CAPSULES ARE AND WHAT THEY ARE USED FOR Budenofalk 3mg capsules contain the active substance budesonide, a type of locally acting steroid used to treat chronic inflammatory diseases of the intestine and the liver. Budenofalk is used in the treatment of: rohns disease: mild to moderate acute attacks of chronic inflamC mation of the intestine affecting the lower part of the small bowel (ileum) and/or upper part of the large bowel (the ascending colon). Note: Budenofalk is not suitable for patients with Crohns disease affecting the upper gastrointestinal tract. Sometimes this disease may cause symptoms outside the intestine (e.g. affecting the skin, eyes and joints) which are unlikely to respond to this medicine. ymptomatic relief of chronic diarrhoea due to collagenous S colitis (a disease with chronic inflammation of the large bowel which is characterized by chronic watery diarrhoea). utoimmune hepatitis (a disease with chronic inflammation of A the liver).
If you take cholestyramine (for hypercholestrolemia and also used to treat diarrhoea) or antacids (for indigestion) in addition to Budenofalk, take these medicines at least 2 hours apart. Taking Budenofalk with food and drink You should not drink grapefruit juice whilst you are taking this medicine as this can alter its effects. Pregnancy and breast-feeding Ask your doctor or pharmacist for advice before taking any medicine. It is important that you tell your doctor if you are, or think you may be pregnant as you should only take Budenofalk during pregnancy if your doctor tells you to. Do not breast-feed during treatment with Budenofalk as the drug may pass into breast milk. Driving and using machines Budenofalk is not expected to affect your ability to drive or operate machinery. Important information about some of the ingredients of Budenofalk 3mg capsules Each capsule contains 240 mg sucrose and 12 mg lactose monohydrate if you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. 3. OW TO TAKE BUDENOFALK 3mg CAPSULES H Always take Budenofalk exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Dosage Crohns disease and symptomatic treatment of collagenous colitis Adults (over 18 years) Take one capsule 3 times a day (morning, midday and evening), unless your doctor instructs you otherwise. Autoimmune hepatitis Adults (over 18 years) Treatment of acute inflammation: Take one capsule 3 times a day (morning, midday and evening), unless your doctor instructs you otherwise. Depending on the results of laboratory examinations, your doctor will decide how long you should take 3 capsules per day. Maintenance treatment: Take one capsule 2 times a day (morning and evening), unless your doctor instructs you otherwise. Depending on the results of laboratory examinations, your doctor will decide how long you should take 2 capsules per day.
Take special care with Budenofalk Before you start taking this medicine, tell your doctor if you have: tuberculosis high blood pressure diabetes, or if diabetes has been diagnosed in your family brittle bones (osteoporosis) ulcers in the stomach or first part of the small intestine (peptic ulcer) increased pressure in your eye (glaucoma) or eye problems such as clouding of the lens (cataracts) or if glaucoma has been diagnosed in your family severe liver problems Typical effects of cortisone preparations may occur which may affect all parts of the body, particularly when you take Budenofalk at high doses and for prolonged periods (see section 4. Possible side effects). Further precautions during treatment with Budenofalk: Keep away from people who have chickenpox or herpes zoster (shingles), if you have never had them. They could affect you severely. If you do come into contact with chickenpox or shingles, see your doctor straight away. Tell your doctor if you have not yet had measles. you know that you need to be vaccinated please speak to your If doctor first. you know that you are due to have an operation please tell your If doctor that you are using Budenofalk. you have been treated with a stronger cortisone preparation If before starting treatment with Budenofalk, your symptoms may reappear when the medicine is changed. If this happens, contact your doctor. Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription. In particular: ardiac glycosides such as digoxin (medicines used to treat heart C conditions) Diuretics (to remove excess fluid from the body) Ketoconazole or itraconazole (to treat fungal infections) Antibiotic drugs used to treat infections (such as clarithromycin) Ritonavir (for HIV infections) Carbamazepine (used in the treatment of epilepsy) Rifampicin (for treating tuberculosis) Oestrogens or oral contraceptives Cimetidine (used to inhibit the production of acid in the stomach)
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Please note that in most cases your doctor will prescribe Budenofalk together with azathioprine, a medicine that works by reducing the bodys immune response. Children (all indications) Budenofalk 3mg capsules should NOT be used in children under 12 years of age. There is only limited experience with the use of this medicine in children older than 12 years of age. Method of administration Budenofalk 3mg capsules are for oral use only. The capsules are to be swallowed whole, with a glass of water about hour before meals. Do not chew the capsules. Duration of treatment Your doctor will decide how long you are to continue the medication, depending on your condition. Crohns disease and collagenous colitis Your treatment should last about 8 weeks. Autoimmune hepatitis Depending on the results of examinations of your blood and liver tissue, your doctor will decide how long you should take this medicine and how many capsules per day you should take. If you take more Budenofalk than you should If you have taken too much medicine on one occasion, take your next dose as prescribed. Do not take a smaller amount. Contact a doctor if you are in doubt, so he or she can decide what to do; take the packet and this leaflet with you if possible. If you forget to take Budenofalk If you miss a dose, just continue your treatment at the prescribed dosage. Do not take a double dose to make up for the forgotten one. If you stop taking Budenofalk Speak to your doctor if you want to interrupt or end your treatment early. It is important that you do not stop taking your medicine suddenly as it could make you ill. Keep taking your medicine until your doctor tells you to stop, even if you start to feel better. Your doctor will probably want to reduce your dose gradually, first from three to two capsules for 1 week (one in the morning and one in the evening) and then only one capsule a day in the last week of treatment (taken in the morning). 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 can cause side effects, although not everybody gets them.
If you get any of the following symptoms after taking this medicine, you should contact your doctor immediately: Infection Headache Changes in behaviour or psychiatric effects for example depression, irritability and euphoria The following side effects have also been reported: Very rare (affecting less than 1 in 10,000 patients) Cushings syndrome - roundness of the face, weight gain, reduced glucose tolerance, high blood sugar, fluid retention, increased excretion of potassium (hypokaliemia), reduced growth in children, irregular periods in women, unwanted body hair in women, impotence, abnormal laboratory findings (reduced adrenal function), swelling of the legs (because of fluid retention, oedema) increased pressure in the brain, possibly with increased pressure in the eye (swelling of the optic disk) in adolescents constipation muscle and joint pain and weakness, muscle twitching brittle bones (osteoporosis) tiredness, general feeling of being ill. The following side effects are typical of steroid medication and may occur depending on your dose, period of treatment, whether you have had or are having treatment with other cortisone preparations, and your individual susceptibility. Most of the following side effects were noted after use of stronger steroids and so should be less frequent with Budenofalk 3mg capsules: Cushings Syndrome (for a description of typical symptoms, see above). increased risk of infection. mood changes such as depression, irritability or euphoria. blurred vision (caused by increased pressure in the eye (glaucoma) or clouding of the lens (cataract)). high blood pressure, increased risk of blood clotting, inflammation of the blood vessels (associated with stopping cortisone use after long term therapy). stomach ache and complaints, nausea, vomiting (feeling sick), ulcers in the stomach and/or small intestine, inflammation of the pancreas. rash from hypersensitivity reactions, red stripes on the skin, bleeding in the skin, acne, delayed wound healing, local skin reactions such as contact dermatitis. bone and cartilage loss (aseptic bone necrosis). 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 3mg CAPSULES H Keep out of the reach and sight of children. Do not store the medicine above 25C.
Do not use Budenofalk after the expiry date which is stated on the carton and blister pack. The expiry date refers to the last day of that month. 6. URTHER INFORMATION F What Budenofalk 3mg capsules contain The active substance is budesonide. Each capsule with gastro-resistant pellets contains 3 mg of budesonide. The other ingredients are ammonio methacrylate copolymer (type A) (Eudragit RL), ammonio methacrylate copolymer (type B) (Eudragit RS), lactose monohydrate, maize starch, methacrylic acid-methyl methacrylate copolymer (1:1) (Eudragit L 100), methacrylic acidmethyl methacrylate copolymer (1:2) (Eudragit S 100), povidone K25, purified water, sucrose, talc, triethyl citrate, gelatin, erythrosine (E127), titanium dioxide (E171), red and black iron oxide (E172), sodium laurilsulphate (see also end of Section 2 for further, important information on lactose and sucrose). What Budenofalk 3mg capsules look like and contents of the pack Budenofalk 3mg capsules are pink coloured gastro-resistant hard capsules contained in blister strips. Budenofalk 3mg capsules are available in pack sizes of 10, 50, 90, 100 or 120 not all may be marketed. Marketing Authorisation Holder and Manufacturer Leinenweberstr. 5 79108 Freiburg Germany
E-mail: zentrale@drfalkpharma.de www.drfalkpharma.de This medicinal product is authorised in the Member States of the EEA under the following names: Belgium, Bulgaria, Czech Republic, Denmark, Finland, Germany, Great Britain, Greece, Hungary, Ireland, Latvia, Lithuania, Luxembourg, The Netherlands, Poland, Romania, Slovakia, Slovenia, Sweden: Budenofalk Austria: Budo-San Portugal: Budo San Spain: Intestifalk France: Mikicort Italy: Rafton This leaflet was last approved in 12/2012. Mock-upGB-IE/10.12
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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.
