SALOFALK 1.5G GASTRO-RESISTANT PROLONGED RELEASE GRANULES
Active substance: MESALAZINE
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PACKAGE LEAFLET: INFORMATION FOR THE USER
Salofalk 1.5g
Mesalazine
Salofalk 1.5g granules are used for: t he treatment of acute episodes and prevention of further episodes (recurrence) of an inflammatory disease of the large intestine (colon), known by doctors as ulcerative colitis. 2. EFORE YOU TAKE SALOFALK 1.5g GRANULES B Do not take Salofalk granules f you are or have been told you are allergic (hypersensitive) I to salicylic acid, to salicylates such as Aspirin or to any of the other ingredients of Salofalk 1.5g granules (these are listed in section 6, Further information) If you have a serious liver or kidney disease Take special care with Salofalk granules. Before you start taking this medicine you should tell your doctor f you have a history of problems with your lungs, I particularly if you suffer from bronchial asthma f you have a history of allergy to sulphasalazine, I a substance related to mesalazine If you suffer with problems of your liver If you suffer with problems of your kidney Further precautions During treatment your doctor may want to keep you under close medical supervision and you may need to have regular blood and urine tests. 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): C ertain agents that inhibit blood clotting (medicines for thrombosis or to thin your blood e.g., warfarin)
A zathioprine, 6-mercaptopurine or thioguanine (medicines used to treat immune disorders) actulose (medicine used to treat constipation) or other L preparations that can change the acidity of your stools 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 Salofalk granules and your doctor will be able to decide what is suitable for you. Pregnancy and breast-feeding Ask your doctor or pharmacist for advice before taking any medicine. You should only use Salofalk granules during pregnancy if your doctor tells you to. You should also only use Salofalk granules during breastfeeding if your doctor tells you to, as this medicine may pass 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 Salofalk 1.5g granules This medicine contains the sweetening agent aspartame. Aspartame is a source of phenylalanine and may be harmful if you suffer from phenylketonuria. One sachet of Salofalk 1.5g granules contains the equivalent of 1.68mg phenylalanine. 3. OW TO TAKE SALOFALK 1.5g GRANULES H Always take Salofalk granules exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
gastro-resistant prolonged-release granules
Read all of this leaflet carefully before you start taking this medicine. Keep this leaflet. You may need to read it again. f you have any further questions, ask your doctor or I pharmacist. his medicine has been prescribed for you. Do not pass it T on to others. 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 I side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1.What Salofalk 1.5g granules are and what they are used for 2.Before you take Salofalk 1.5g granules 3.How to take Salofalk 1.5g granules 4.Possible side effects 5.How to store Salofalk 1.5g granules 6.Further information 1. HAT SALOFALK 1.5g GRANULES ARE W AND WHAT THEY ARE USED FOR Salofalk granules contain the active substance mesalazine, an anti-inflammatory agent used to treat inflammatory bowel disease.
Method of administration Salofalk granules are for oral use only. Salofalk granules should not be chewed. You should take the Salofalk granules by placing the granules directly on the tongue and then swallowing them with plenty of liquid without chewing. Dosage Age and body weight Single dose Total daily dose
2 sachets of Salofalk 1.5g granules once daily preferably in the morning (equivalent to 3g mesalazine per day). Children There is only limited documentation for an effect in children (age 6-18 years). Children 6 years of age and older Please ask your doctor about the precise dosage of Salofalk granules for your child. In acute episodes: to be determined individually, starting with 30-50mg mesalazine per kg body weight per day that should be given once daily preferably in the morning or in divided doses. The maximum dose is 75mg mesalazine per kg body weight per day. The total dose should not exceed the maximum adult dose. It is generally recommended that half the adult dose should be given to children up to a body weight of 40kg and the normal adult dose to those above 40kg. Due to their high content in active substance, Salofalk 1.5g granules are not suitable for children weighing less than 40kg. Please use Salofalk 500mg granules or 1000mg instead. Duration of treatment Your doctor will decide how long you need to continue treatment with this medicine. This will depend on your condition. To obtain the maximum benefit from this medicine you should use Salofalk granules regularly and consistently both during the acute episode of inflammation and also as long-term treatment, as directed. If you think that your Salofalk granules are too strong or too weak, talk to your doctor.
KLEBEFLCHE
Adults, elderly and children weighing more than 40kg Treatment of acute episodes Prevention of further episodes (for patients at increased risk for recurrence) Up to 2 sachets Salofalk 1.5g granules 2 sachets Salofalk 1.5g granules 1 x 1-2 sachets
1 x 2 sachets
PACKAGE LEAFLET: INFORMATION FOR THE USER
Adults and the elderly Unless otherwise prescribed by your doctor, the normal dosage for the treatment of acute episodes of ulcerative colitis is: 1-2 sachets of Salofalk 1.5g granules once daily preferably in the morning (equivalent to 1.5-3g mesalazine per day) depending on the clinical requirements in the individual case. To prevent a relapse of ulcerative colitis The normal dosage to prevent further episodes of ulcerative colitis is: 1 sachet of Salofalk 500mg granules three times daily (equivalent to 1.5g mesalazine per day). If upon the decision of your doctor you are at increased risk for recurrence, the dosage for prevention of further episodes of ulcerative colitis is:
Salofalk 1.5g
gastro-resistant prolonged-release granules
If you take more Salofalk granules 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 Salofalk granules on one occasion, just take your next dose as prescribed. Do not use a smaller amount. If you forget to take Salofalk granules Do not take a larger than normal dose of Salofalk granules next time, but continue treatment at the prescribed dosage. If you stop taking Salofalk granules 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.
agranulocytosis) which may make you more prone to developing a serious infection. A blood test can confirm whether your symptoms are due to an effect of this medicine on your blood. The following side effects have also been reported by patients using mesalazine: Rare side effects (that affect less than 1 in 1,000 patients): A bdominal pain, diarrhoea, wind (flatulence), nausea and vomiting Headache, dizziness hest pain, breathlessness or swollen limbs because of an C effect on your heart Very rare side effects (that affect less than 1 in 10,000 patients): C hanges in kidney function, sometimes with swollen limbs or flank pain S evere abdominal pain because of acute inflammation of the pancreas hortness of breath, cough, wheezing, lung shadow on S x-ray due to allergic and/or inflammatory lung conditions S evere diarrhoea and abdominal pain because of allergic reaction to this medicine within the bowel Skin rash or inflammation Muscle and joint pain ever, sore throat or malaise because of blood count F changes aundice or abdominal pain because of liver and bile flow J disorders Hair loss and the development of baldness umbness and tingling in the hands and feet (peripheral N neuropathy) Reversible decrease in semen production 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. HOW TO STORE SALOFALK 1.5g GRANULES Keep out of the reach and sight of children. Do not use Salofalk granules after the expiry date which is stated on the carton and the sachet. The expiry date refers to the last day of that month. This medicinal product does not require any special storage conditions. 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 Salofalk 1.5g granules contain The active substance is mesalazine and one sachet of Salofalk 1.5g granules contains 1.5g mesalazine. The other ingredients are aspartame (E 951); carmellose sodium; cellulose, microcrystalline; citric acid, anhydrous; silica, colloidal anhydrous; hypromellose; magnesium stearate; methacrylic acid-methyl methacrylate copolymer (1:1) (Eudragit L 100); methylcellulose; polyacrylate dispersion 40% (Eudragit NE 40 D containing 2% nonoxynol 100); povidone K 25; simeticone; sorbic acid; talc; titanium dioxide (E 171); triethyl citrate; vanilla custard flavour (containing propylene glycol). What Salofalk 1.5g granules look like and contents of the pack Salofalk 1.5g gastro-resistant prolonged-release granules are rod-shaped or round, grey-white granules.
Each sachet contains 2.79g granules Salofalk 1.5g granules are available in packs of 20, 30, 35, 45, 50, 60, 70, 90, 100 and 150 sachets. Not all package sizes may be marketed. Marketing Authorisation Holder and Manufacturer
KLEBEFLCHE
4. POSSIBLE SIDE EFFECTS Like all medicines, Salofalk granules can cause side effects, although not everybody gets them. All medicines can cause allergic reactions although serious allergic reactions are very rare. If you get any of the following symptoms after taking this medicine, you should contact your doctor immediately: Allergic skin rash Fever Breathing difficulties If you experience a marked reduction of your general health, especially if accompanied by fever and/or a sore throat and mouth, stop using these granules and contact your doctor immediately. These symptoms can, very rarely, be due to a fall in the number of white cells in your blood (a condition called
This medicinal product is authorised in the Member States of the EEA under the following names: Denmark, Finland, Germany, Great Britain, Greece, The Netherlands, Norway, Portugal, Slovenia, Sweden and Spain: Salofalk. Belgium, Luxembourg: Colitofalk. Austria: Mesagran. This leaflet was last approved in 03/2012 PL08637/0016
Salofalk 1.5g
Mesalazine
Salofalk 1.5g granules are used for: t he treatment of acute episodes and prevention of further episodes (recurrence) of an inflammatory disease of the large intestine (colon), known by doctors as ulcerative colitis. 2. EFORE YOU TAKE SALOFALK 1.5g GRANULES B Do not take Salofalk granules f you are or have been told you are allergic (hypersensitive) I to salicylic acid, to salicylates such as Aspirin or to any of the other ingredients of Salofalk 1.5g granules (these are listed in section 6, Further information) If you have a serious liver or kidney disease Take special care with Salofalk granules. Before you start taking this medicine you should tell your doctor f you have a history of problems with your lungs, I particularly if you suffer from bronchial asthma f you have a history of allergy to sulphasalazine, I a substance related to mesalazine If you suffer with problems of your liver If you suffer with problems of your kidney Further precautions During treatment your doctor may want to keep you under close medical supervision and you may need to have regular blood and urine tests. 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): C ertain agents that inhibit blood clotting (medicines for thrombosis or to thin your blood e.g., warfarin)
A zathioprine, 6-mercaptopurine or thioguanine (medicines used to treat immune disorders) actulose (medicine used to treat constipation) or other L preparations that can change the acidity of your stools 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 Salofalk granules and your doctor will be able to decide what is suitable for you. Pregnancy and breast-feeding Ask your doctor or pharmacist for advice before taking any medicine. You should only use Salofalk granules during pregnancy if your doctor tells you to. You should also only use Salofalk granules during breastfeeding if your doctor tells you to, as this medicine may pass 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 Salofalk 1.5g granules This medicine contains the sweetening agent aspartame. Aspartame is a source of phenylalanine and may be harmful if you suffer from phenylketonuria. One sachet of Salofalk 1.5g granules contains the equivalent of 1.68mg phenylalanine. 3. OW TO TAKE SALOFALK 1.5g GRANULES H Always take Salofalk granules exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
gastro-resistant prolonged-release granules
Read all of this leaflet carefully before you start taking this medicine. Keep this leaflet. You may need to read it again. f you have any further questions, ask your doctor or I pharmacist. his medicine has been prescribed for you. Do not pass it T on to others. 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 I side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1.What Salofalk 1.5g granules are and what they are used for 2.Before you take Salofalk 1.5g granules 3.How to take Salofalk 1.5g granules 4.Possible side effects 5.How to store Salofalk 1.5g granules 6.Further information 1. HAT SALOFALK 1.5g GRANULES ARE W AND WHAT THEY ARE USED FOR Salofalk granules contain the active substance mesalazine, an anti-inflammatory agent used to treat inflammatory bowel disease.
Method of administration Salofalk granules are for oral use only. Salofalk granules should not be chewed. You should take the Salofalk granules by placing the granules directly on the tongue and then swallowing them with plenty of liquid without chewing. Dosage Age and body weight Single dose Total daily dose
2 sachets of Salofalk 1.5g granules once daily preferably in the morning (equivalent to 3g mesalazine per day). Children There is only limited documentation for an effect in children (age 6-18 years). Children 6 years of age and older Please ask your doctor about the precise dosage of Salofalk granules for your child. In acute episodes: to be determined individually, starting with 30-50mg mesalazine per kg body weight per day that should be given once daily preferably in the morning or in divided doses. The maximum dose is 75mg mesalazine per kg body weight per day. The total dose should not exceed the maximum adult dose. It is generally recommended that half the adult dose should be given to children up to a body weight of 40kg and the normal adult dose to those above 40kg. Due to their high content in active substance, Salofalk 1.5g granules are not suitable for children weighing less than 40kg. Please use Salofalk 500mg granules or 1000mg instead. Duration of treatment Your doctor will decide how long you need to continue treatment with this medicine. This will depend on your condition. To obtain the maximum benefit from this medicine you should use Salofalk granules regularly and consistently both during the acute episode of inflammation and also as long-term treatment, as directed. If you think that your Salofalk granules are too strong or too weak, talk to your doctor.
KLEBEFLCHE
Adults, elderly and children weighing more than 40kg Treatment of acute episodes Prevention of further episodes (for patients at increased risk for recurrence) Up to 2 sachets Salofalk 1.5g granules 2 sachets Salofalk 1.5g granules 1 x 1-2 sachets
1 x 2 sachets
PACKAGE LEAFLET: INFORMATION FOR THE USER
Adults and the elderly Unless otherwise prescribed by your doctor, the normal dosage for the treatment of acute episodes of ulcerative colitis is: 1-2 sachets of Salofalk 1.5g granules once daily preferably in the morning (equivalent to 1.5-3g mesalazine per day) depending on the clinical requirements in the individual case. To prevent a relapse of ulcerative colitis The normal dosage to prevent further episodes of ulcerative colitis is: 1 sachet of Salofalk 500mg granules three times daily (equivalent to 1.5g mesalazine per day). If upon the decision of your doctor you are at increased risk for recurrence, the dosage for prevention of further episodes of ulcerative colitis is:
Salofalk 1.5g
gastro-resistant prolonged-release granules
If you take more Salofalk granules 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 Salofalk granules on one occasion, just take your next dose as prescribed. Do not use a smaller amount. If you forget to take Salofalk granules Do not take a larger than normal dose of Salofalk granules next time, but continue treatment at the prescribed dosage. If you stop taking Salofalk granules 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.
agranulocytosis) which may make you more prone to developing a serious infection. A blood test can confirm whether your symptoms are due to an effect of this medicine on your blood. The following side effects have also been reported by patients using mesalazine: Rare side effects (that affect less than 1 in 1,000 patients): A bdominal pain, diarrhoea, wind (flatulence), nausea and vomiting Headache, dizziness hest pain, breathlessness or swollen limbs because of an C effect on your heart Very rare side effects (that affect less than 1 in 10,000 patients): C hanges in kidney function, sometimes with swollen limbs or flank pain S evere abdominal pain because of acute inflammation of the pancreas hortness of breath, cough, wheezing, lung shadow on S x-ray due to allergic and/or inflammatory lung conditions S evere diarrhoea and abdominal pain because of allergic reaction to this medicine within the bowel Skin rash or inflammation Muscle and joint pain ever, sore throat or malaise because of blood count F changes aundice or abdominal pain because of liver and bile flow J disorders Hair loss and the development of baldness umbness and tingling in the hands and feet (peripheral N neuropathy) Reversible decrease in semen production 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. HOW TO STORE SALOFALK 1.5g GRANULES Keep out of the reach and sight of children. Do not use Salofalk granules after the expiry date which is stated on the carton and the sachet. The expiry date refers to the last day of that month. This medicinal product does not require any special storage conditions. 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 Salofalk 1.5g granules contain The active substance is mesalazine and one sachet of Salofalk 1.5g granules contains 1.5g mesalazine. The other ingredients are aspartame (E 951); carmellose sodium; cellulose, microcrystalline; citric acid, anhydrous; silica, colloidal anhydrous; hypromellose; magnesium stearate; methacrylic acid-methyl methacrylate copolymer (1:1) (Eudragit L 100); methylcellulose; polyacrylate dispersion 40% (Eudragit NE 40 D containing 2% nonoxynol 100); povidone K 25; simeticone; sorbic acid; talc; titanium dioxide (E 171); triethyl citrate; vanilla custard flavour (containing propylene glycol). What Salofalk 1.5g granules look like and contents of the pack Salofalk 1.5g gastro-resistant prolonged-release granules are rod-shaped or round, grey-white granules.
Each sachet contains 2.79g granules Salofalk 1.5g granules are available in packs of 20, 30, 35, 45, 50, 60, 70, 90, 100 and 150 sachets. Not all package sizes may be marketed. Marketing Authorisation Holder and Manufacturer
KLEBEFLCHE
4. POSSIBLE SIDE EFFECTS Like all medicines, Salofalk granules can cause side effects, although not everybody gets them. All medicines can cause allergic reactions although serious allergic reactions are very rare. If you get any of the following symptoms after taking this medicine, you should contact your doctor immediately: Allergic skin rash Fever Breathing difficulties If you experience a marked reduction of your general health, especially if accompanied by fever and/or a sore throat and mouth, stop using these granules and contact your doctor immediately. These symptoms can, very rarely, be due to a fall in the number of white cells in your blood (a condition called
This medicinal product is authorised in the Member States of the EEA under the following names: Denmark, Finland, Germany, Great Britain, Greece, The Netherlands, Norway, Portugal, Slovenia, Sweden and Spain: Salofalk. Belgium, Luxembourg: Colitofalk. Austria: Mesagran. This leaflet was last approved in 03/2012 PL08637/0016
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.
