SALOFALK ENEMA 2G
Active substance: MESALAZINE
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PACKAGE LEAFLET: INFORMATION FOR THE USER
Salofalk Enema 2g
Mesalazine
Read all of this leaflet carefully before you start taking this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. his medicine has been prescribed for you. Do not pass it on to T 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 enemas are and what they are used for 2.Before you use Salofalk enemas 3.How to use Salofalk enemas 4.Possible side effects 5.How to store Salofalk enemas 6.Further information 1. HAT SALOFALK ENEMAS 2G ARE AND WHAT THEY W ARE USED FOR Salofalk enemas contain the active substance mesalazine, an antiinflammatory agent used to treat inflammatory bowel disease. Salofalk enemas are used for: t he treatment of mild episodes of an inflammatory disease in parts of the colon and the rectum (back passage) known by doctors as ulcerative colitis or ulcerative proctitis. 2. EFORE YOU USE SALOFALK ENEMAS 2G B
Take special care with Salofalk enemas Before you start using this medicine you should tell your doctor:
3. OW TO USE SALOFALK ENEMAS 2G H Always take Salofalk enemas exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
f you have a history of problems with your lungs, particularly if I you suffer from bronchial asthma. f you have a history of allergy to sulphasalazine, a substance I 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.
Method of administration:
This medicine may only be used rectally, so it has to be inserted through the anus. Do NOT take by mouth. Dosage: Adults and elderly The usual dose is one enema once a day, at bedtime. Children There is little experience and only limited documentation for an effect in children. Duration of treatment Your doctor will decide how long you need to continue the treatment with this medicine. This will depend on your condition. To obtain the maximum benefit from this medicine, you should use Salofalk enemas regularly and consistently, as directed. If you think your Salofalk enemas are too strong or too weak, talk to 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): ertain agents that inhibit blood clotting (medicines for C thrombosis or to thin your blood, e.g., warfarin) zathioprine, 6-mercaptopurine or thioguanine (medicines A used to treat immune disorders). 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 alright for you to use Salofalk enemas and your doctor will be able to decide what is suitable for you.
If you use more Salofalk enemas than you should
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine. You should only use Salofalk enemas during pregnancy if your doctor tells you to. You should also only use Salofalk enemas during breast-feeding if your doctor tells you to, as this medicine may pass into breast milk.
Contact a doctor if you are in doubt, so he or she can decide what to do. If you use too many enemas on one occasion, just take your next dose as prescribed. Do not use a smaller amount.
If you forget to use Salofalk enemas
Do not take a larger than normal dose of Salofalk enemas next time, but continue treatment at the prescribed dosage.
Driving and using machines
If you stop using Salofalk enemas
There are no effects on the ability to drive and use machines.
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.
Do not use Salofalk enemas
you are or have been told you are allergic (hypersensitive) If to salicylic acid, to salicylates such as Aspirin or to the other ingredient of the enemas (listed in section 6, Further information). If you have a serious liver or kidney disease.
Important information about some of the ingredients of Salofalk Enemas 2g
This medicine contains sodium benzoate, which may be mildly irritant to the skin, eyes and mucous membranes.
The other ingredients in Salofalk enemas are not likely to cause side effects (see 6. Further information).
4. POSSIBLE SIDE EFFECTS Like all medicines, Salofalk enemas 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 the enemas 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 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, constipation Headache, dizziness Chest pain, breathlessness or swollen limbs because of an effect on your heart Very Rare side effects (that affect less than 1 in 10,000 patients): hanges in kidney function, sometimes with swollen limbs or C flank pain Severe abdominal pain because of acute inflammation of the pancreas Fever, sore throat or malaise because of blood count changes Shortness of breath, cough, wheezing, lung shadow on x-ray due to allergic and/or inflammatory lung conditions Severe diarrhoea and abdominal pain because of an allergic reaction to this medicine within the bowel Skin rash or inflammation Muscle and joint pain Jaundice or abdominal pain because of liver and bile flow disorders Hair loss and the development of baldness Numbness and tingling in the hands and feet (peripheral 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 ENEMAS 2G Keep out of the reach and sight of children. Do not use Salofalk enemas after the expiry date which is stated on the bottle and on the carton. The expiry date refers to the last day of that month. Do not store above 25C. Store in the original container in order to protect contents from light. 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
Manufacturer
Leinenweberstr. 5 79108 Freiburg Germany
This leaflet was last approved in 02/2012 PL 10341/0008
What Salofalk enemas contain
The active substance in Salofalk enemas 2g is mesalazine and one enema contains 2g mesalazine. The other ingredients are Carbomer, disodium edetate, potassium acetate (E261), potassium metabisulphite (E224), purified water, sodium benzoate (E211), xanthan gum (E415).
What Salofalk enemas look like and contents of the pack
Salofalk enemas are in a low-density, concertina shaped, polythene bottle with a low-density polythene application nozzle. Salofalk enemas are available in packs of 7 Marketing Authorisation Holder Dr. Falk Pharma UK Ltd Bourne End Business Park, Cores End Road Bourne End, Buckinghamshire, SL8 5AS
Salofalk Enema 2g
Mesalazine
Read all of this leaflet carefully before you start taking this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. his medicine has been prescribed for you. Do not pass it on to T 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 enemas are and what they are used for 2.Before you use Salofalk enemas 3.How to use Salofalk enemas 4.Possible side effects 5.How to store Salofalk enemas 6.Further information 1. HAT SALOFALK ENEMAS 2G ARE AND WHAT THEY W ARE USED FOR Salofalk enemas contain the active substance mesalazine, an antiinflammatory agent used to treat inflammatory bowel disease. Salofalk enemas are used for: t he treatment of mild episodes of an inflammatory disease in parts of the colon and the rectum (back passage) known by doctors as ulcerative colitis or ulcerative proctitis. 2. EFORE YOU USE SALOFALK ENEMAS 2G B
Take special care with Salofalk enemas Before you start using this medicine you should tell your doctor:
3. OW TO USE SALOFALK ENEMAS 2G H Always take Salofalk enemas exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
f you have a history of problems with your lungs, particularly if I you suffer from bronchial asthma. f you have a history of allergy to sulphasalazine, a substance I 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.
Method of administration:
This medicine may only be used rectally, so it has to be inserted through the anus. Do NOT take by mouth. Dosage: Adults and elderly The usual dose is one enema once a day, at bedtime. Children There is little experience and only limited documentation for an effect in children. Duration of treatment Your doctor will decide how long you need to continue the treatment with this medicine. This will depend on your condition. To obtain the maximum benefit from this medicine, you should use Salofalk enemas regularly and consistently, as directed. If you think your Salofalk enemas are too strong or too weak, talk to 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): ertain agents that inhibit blood clotting (medicines for C thrombosis or to thin your blood, e.g., warfarin) zathioprine, 6-mercaptopurine or thioguanine (medicines A used to treat immune disorders). 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 alright for you to use Salofalk enemas and your doctor will be able to decide what is suitable for you.
If you use more Salofalk enemas than you should
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine. You should only use Salofalk enemas during pregnancy if your doctor tells you to. You should also only use Salofalk enemas during breast-feeding if your doctor tells you to, as this medicine may pass into breast milk.
Contact a doctor if you are in doubt, so he or she can decide what to do. If you use too many enemas on one occasion, just take your next dose as prescribed. Do not use a smaller amount.
If you forget to use Salofalk enemas
Do not take a larger than normal dose of Salofalk enemas next time, but continue treatment at the prescribed dosage.
Driving and using machines
If you stop using Salofalk enemas
There are no effects on the ability to drive and use machines.
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.
Do not use Salofalk enemas
you are or have been told you are allergic (hypersensitive) If to salicylic acid, to salicylates such as Aspirin or to the other ingredient of the enemas (listed in section 6, Further information). If you have a serious liver or kidney disease.
Important information about some of the ingredients of Salofalk Enemas 2g
This medicine contains sodium benzoate, which may be mildly irritant to the skin, eyes and mucous membranes.
The other ingredients in Salofalk enemas are not likely to cause side effects (see 6. Further information).
4. POSSIBLE SIDE EFFECTS Like all medicines, Salofalk enemas 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 the enemas 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 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, constipation Headache, dizziness Chest pain, breathlessness or swollen limbs because of an effect on your heart Very Rare side effects (that affect less than 1 in 10,000 patients): hanges in kidney function, sometimes with swollen limbs or C flank pain Severe abdominal pain because of acute inflammation of the pancreas Fever, sore throat or malaise because of blood count changes Shortness of breath, cough, wheezing, lung shadow on x-ray due to allergic and/or inflammatory lung conditions Severe diarrhoea and abdominal pain because of an allergic reaction to this medicine within the bowel Skin rash or inflammation Muscle and joint pain Jaundice or abdominal pain because of liver and bile flow disorders Hair loss and the development of baldness Numbness and tingling in the hands and feet (peripheral 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 ENEMAS 2G Keep out of the reach and sight of children. Do not use Salofalk enemas after the expiry date which is stated on the bottle and on the carton. The expiry date refers to the last day of that month. Do not store above 25C. Store in the original container in order to protect contents from light. 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
Manufacturer
Leinenweberstr. 5 79108 Freiburg Germany
This leaflet was last approved in 02/2012 PL 10341/0008
What Salofalk enemas contain
The active substance in Salofalk enemas 2g is mesalazine and one enema contains 2g mesalazine. The other ingredients are Carbomer, disodium edetate, potassium acetate (E261), potassium metabisulphite (E224), purified water, sodium benzoate (E211), xanthan gum (E415).
What Salofalk enemas look like and contents of the pack
Salofalk enemas are in a low-density, concertina shaped, polythene bottle with a low-density polythene application nozzle. Salofalk enemas are available in packs of 7 Marketing Authorisation Holder Dr. Falk Pharma UK Ltd Bourne End Business Park, Cores End Road Bourne End, Buckinghamshire, SL8 5AS
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.
