Health Boards
Mon-07-08-2017, 14:35 PM
(This post was last modified: Wed-09-08-2017, 12:32 PM by jiml. Edited 3 times in total.)
What Skilarence is and what it is used for
What Skilarence is
Skilarence is a medicine that contains the active substance dimethyl fumarate. Dimethyl fumarate works on cells of the immune system (the body's natural defences). It changes the activity of the immune system and reduces the production of substances involved in causing psoriasis.
What Skilarence is used for
Skilarence tablets are used to treat moderate to severe plaque psoriasis in adults.
Response to Skilarence can be generally seen as early as week 3 and improves over time. Experience with related products containing dimethyl fumarate shows treatment benefit for at least up to
24 months.
Do not take Skilarence
- if you are allergic to dimethyl fumarate or any of the other ingredients of this medicine
- if you have severe problems with your stomach or intestines
- if you have severe liver or kidney problems
- if you are pregnant or breast-feeding
Monitoring
Skilarence may cause problems with your blood, liver or kidneys. You will have blood and urine tests before treatment and then regularly during your treatment to make sure that you are not getting these complications and can continue to take this medicine. Depending on the results of these blood and urine tests, your doctor may reduce your dose of Skilarence or stop treatment.
Infections
White blood cells help your body to fight infections. Skilarence may reduce the number of your white blood cells. Talk to your doctor, if you think you may have an infection. Symptoms include fever, pain, aching muscles, headache, loss of appetite and a general feeling of weakness. If you have a serious infection, either before starting treatment with Skilarence or during treatment, your doctor may advise you not to take Skilarence until the infection has resolved.
Gastrointestinal disorders
Tell your doctor if you have or have had problems with your stomach or intestines. Your doctor will advise you on what care you need to take during Skilarence treatment.
Children and adolescents
Children and adolescents below the age of 18 years should not take this medicine because it has not been studied in this age group.
Other medicines and Skilarence
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
In particular, tell your doctor if you are taking the following:
- Dimethyl fumarate or other fumarates. The active ingredient in Skilarence, dimethyl fumarate, is also used in other medicines such as tablets, ointments and baths. You must avoid using other products that contain fumarates to prevent taking too much.
- Other medicines used to treat psoriasis, such as methotrexate, retinoids, psoralens, ciclosporin, or other immunosuppressants or cytostatics (medicines that affect the immune system). Taking these medicines with Skilarence could increase the risk of side effects on your immune system.
- Other medicines that can affect your kidney function, such as methotrexate or ciclosporin (used to treat psoriasis), aminoglycosides (used to treat infections), diuretics (which increase urine), nonsteroidal anti-inflammatory drugs (used to treat pain) or lithium (used for bipolar disease and depression). These medicines taken together with Skilarence could increase the risk of side effects on your kidneys.
If you get severe or prolonged diarrhoea with Skilarence, other medicines may not work as well as they should. Talk to your doctor if you have bad diarrhoea and are concerned that other medicines you are taking might not work. In particular, if you are taking a contraceptive medicine (the pill), the effect may be reduced and you may need to use other barrier methods to prevent pregnancy. See the instructions in the patient leaflet of the contraceptive you are taking.
Skilarence with alcohol
Avoid strong alcoholic drinks (more than 50 ml of spirits containing more than 30% alcohol by volume) during treatment with Skilarence, as alcohol can interact with this medicine. This could cause stomach and intestinal problems.
Pregnancy and breast-feeding
Do not take Skilarence if you are pregnant or trying to become pregnant, as Skilarence may harm your baby. Use effective methods of contraception to avoid becoming pregnant during treatment with..
Do not breastfeed while taking Skilarence
Dose
Your doctor will start your treatment with a low dose (using 30 mg Skilarence tablets). This helps to reduce stomach problems and other side effects. Your dose will be increased every week (switching to 120 mg Skilarence tablets from week 4 onwards).up to a maximum of 720mg a day at week 9
Your doctor will check how well your condition is improving after you start taking Skilarence and will check for side effects. If you have severe side effects after an increase in dose, your doctor may recommend that you temporarily go back to the last dose. If the side effects are not troublesome, your dose will be increased until your condition is well controlled. You may not need the maximum dose of 720 mg per day. After your condition has improved sufficiently, your doctor will consider how to gradually reduce the daily dose of Skilarence to what you need to maintain your improvement.
Method of administration
Swallow Skilarence tablets whole with liquid. Take your tablets during or immediately after a meal. Do not crush, break, dissolve or chew your tablets, as they have a special coating to help prevent irritation of your stomach
Possible side effects]
Like all medicines, this medicine can cause side effects, although not everybody gets them. Some of these side effects, such as reddening of the face or body (flushing), diarrhoea, stomach problems and nausea usually improve as you continue treatment.
The most serious side effects that may occur with Skilarence are allergic or hypersensitivity reactions; kidney failure or a kidney disease called Fanconi syndrome; or a severe brain infection called progressive multifocal leukoencephalopathy (PML). It is not known how commonly they occur. For symptoms see below.
Allergic or hypersensitivity reactions
Allergic or hypersensitivity reactions are rare but may be very serious. Reddening of the face or body (flushing) is a very common side effect which may affect more than 1 in 10 people. However, if you become flushed and get any of the following signs:
- wheezing, difficulty breathing or shortness of breath,
- swelling of the face, lips, mouth or tongue
stop taking Skilarence and call a doctor straight away.
Brain infection called PML
Progressive multifocal leukoencephalopathy (PML) is a rare but serious brain infection that can lead to severe disability or death. If you notice new or worsening weakness on one side of the body; clumsiness; changes in vision, thinking or memory; confusion; or personality changes lasting several days, stop taking Skilarence and talk to your doctor straight away.
Fanconi syndrome
Fanconi syndrome is a rare but serious kidney disorder which may occur with Skilarence. If you notice you are passing more urine, are more thirsty and drinking more than normal, your muscles seem weaker, you break a bone, or just have aches and pains, talk to your doctor as soon as possible so that this can be investigated further.
Very common side effects (may affect more than 1 in 10 people):
- decrease in white blood cells called lymphocytes (lymphopenia)
- decrease in all white blood cells (leukopenia) - reddening of the face or body (flushing)
- diarrhoea
- bloating, stomach pain or stomach cramps
- feeling sick (nausea)
Common side effects (may affect up to 1 in 10 people):
- increase in all white blood cells (leukocytosis)
- increase in specific white blood cells called eosinophils
- increase in certain enzymes in the blood (used for checking the health of your liver) - being sick
- constipation
- gas (flatulence), stomach discomfort, indigestion
- decreased appetite
- headache
- feeling tired
- weakness
- feeling hot
- abnormal sensations of the skin, such as itching, burning, stinging, tickling or tingling - pink or red blotches on the skin (erythema)
Uncommon side effects (may affect up to 1 in 100 people):
- dizziness
- excess protein in the urine (proteinuria)
- increase in serum creatinine (a substance in the blood used for measuring how well your kidneys are working)
Rare side effects (may affect up to 1 in 1,000 people): - allergic skin reaction
Very rare side effects (may affect up to 1 in 10,000 people): - acute lymphatic leukaemia (a type of blood cancer)
- decrease in all types of blood cells (pancytopenia)
What Skilarence 120 mg contains
- the active substance is dimethyl fumarate. One tablet contains 120 mg dimethyl fumarate. - the other ingredients are: lactose monohydrate, cellulose microcrystalline, croscarmellose
sodium, colloidal anhydrous silica, magnesium stearate, methacrylic acid-ethyl acrylate copolymer (1:1), talc, triethyl citrate, titanium dioxide (E171), simethicone, indigo carmine (E132) and sodium hydroxide.
This post was edited to show very common side effects from modified leaflet
Posts from this thread have been split to: [split] Skilarence
What Skilarence is
Skilarence is a medicine that contains the active substance dimethyl fumarate. Dimethyl fumarate works on cells of the immune system (the body's natural defences). It changes the activity of the immune system and reduces the production of substances involved in causing psoriasis.
What Skilarence is used for
Skilarence tablets are used to treat moderate to severe plaque psoriasis in adults.
Response to Skilarence can be generally seen as early as week 3 and improves over time. Experience with related products containing dimethyl fumarate shows treatment benefit for at least up to
24 months.
Do not take Skilarence
- if you are allergic to dimethyl fumarate or any of the other ingredients of this medicine
- if you have severe problems with your stomach or intestines
- if you have severe liver or kidney problems
- if you are pregnant or breast-feeding
Monitoring
Skilarence may cause problems with your blood, liver or kidneys. You will have blood and urine tests before treatment and then regularly during your treatment to make sure that you are not getting these complications and can continue to take this medicine. Depending on the results of these blood and urine tests, your doctor may reduce your dose of Skilarence or stop treatment.
Infections
White blood cells help your body to fight infections. Skilarence may reduce the number of your white blood cells. Talk to your doctor, if you think you may have an infection. Symptoms include fever, pain, aching muscles, headache, loss of appetite and a general feeling of weakness. If you have a serious infection, either before starting treatment with Skilarence or during treatment, your doctor may advise you not to take Skilarence until the infection has resolved.
Gastrointestinal disorders
Tell your doctor if you have or have had problems with your stomach or intestines. Your doctor will advise you on what care you need to take during Skilarence treatment.
Children and adolescents
Children and adolescents below the age of 18 years should not take this medicine because it has not been studied in this age group.
Other medicines and Skilarence
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
In particular, tell your doctor if you are taking the following:
- Dimethyl fumarate or other fumarates. The active ingredient in Skilarence, dimethyl fumarate, is also used in other medicines such as tablets, ointments and baths. You must avoid using other products that contain fumarates to prevent taking too much.
- Other medicines used to treat psoriasis, such as methotrexate, retinoids, psoralens, ciclosporin, or other immunosuppressants or cytostatics (medicines that affect the immune system). Taking these medicines with Skilarence could increase the risk of side effects on your immune system.
- Other medicines that can affect your kidney function, such as methotrexate or ciclosporin (used to treat psoriasis), aminoglycosides (used to treat infections), diuretics (which increase urine), nonsteroidal anti-inflammatory drugs (used to treat pain) or lithium (used for bipolar disease and depression). These medicines taken together with Skilarence could increase the risk of side effects on your kidneys.
If you get severe or prolonged diarrhoea with Skilarence, other medicines may not work as well as they should. Talk to your doctor if you have bad diarrhoea and are concerned that other medicines you are taking might not work. In particular, if you are taking a contraceptive medicine (the pill), the effect may be reduced and you may need to use other barrier methods to prevent pregnancy. See the instructions in the patient leaflet of the contraceptive you are taking.
Skilarence with alcohol
Avoid strong alcoholic drinks (more than 50 ml of spirits containing more than 30% alcohol by volume) during treatment with Skilarence, as alcohol can interact with this medicine. This could cause stomach and intestinal problems.
Pregnancy and breast-feeding
Do not take Skilarence if you are pregnant or trying to become pregnant, as Skilarence may harm your baby. Use effective methods of contraception to avoid becoming pregnant during treatment with..
Do not breastfeed while taking Skilarence
Dose
Your doctor will start your treatment with a low dose (using 30 mg Skilarence tablets). This helps to reduce stomach problems and other side effects. Your dose will be increased every week (switching to 120 mg Skilarence tablets from week 4 onwards).up to a maximum of 720mg a day at week 9
Your doctor will check how well your condition is improving after you start taking Skilarence and will check for side effects. If you have severe side effects after an increase in dose, your doctor may recommend that you temporarily go back to the last dose. If the side effects are not troublesome, your dose will be increased until your condition is well controlled. You may not need the maximum dose of 720 mg per day. After your condition has improved sufficiently, your doctor will consider how to gradually reduce the daily dose of Skilarence to what you need to maintain your improvement.
Method of administration
Swallow Skilarence tablets whole with liquid. Take your tablets during or immediately after a meal. Do not crush, break, dissolve or chew your tablets, as they have a special coating to help prevent irritation of your stomach
Possible side effects]
Like all medicines, this medicine can cause side effects, although not everybody gets them. Some of these side effects, such as reddening of the face or body (flushing), diarrhoea, stomach problems and nausea usually improve as you continue treatment.
The most serious side effects that may occur with Skilarence are allergic or hypersensitivity reactions; kidney failure or a kidney disease called Fanconi syndrome; or a severe brain infection called progressive multifocal leukoencephalopathy (PML). It is not known how commonly they occur. For symptoms see below.
Allergic or hypersensitivity reactions
Allergic or hypersensitivity reactions are rare but may be very serious. Reddening of the face or body (flushing) is a very common side effect which may affect more than 1 in 10 people. However, if you become flushed and get any of the following signs:
- wheezing, difficulty breathing or shortness of breath,
- swelling of the face, lips, mouth or tongue
stop taking Skilarence and call a doctor straight away.
Brain infection called PML
Progressive multifocal leukoencephalopathy (PML) is a rare but serious brain infection that can lead to severe disability or death. If you notice new or worsening weakness on one side of the body; clumsiness; changes in vision, thinking or memory; confusion; or personality changes lasting several days, stop taking Skilarence and talk to your doctor straight away.
Fanconi syndrome
Fanconi syndrome is a rare but serious kidney disorder which may occur with Skilarence. If you notice you are passing more urine, are more thirsty and drinking more than normal, your muscles seem weaker, you break a bone, or just have aches and pains, talk to your doctor as soon as possible so that this can be investigated further.
Very common side effects (may affect more than 1 in 10 people):
- decrease in white blood cells called lymphocytes (lymphopenia)
- decrease in all white blood cells (leukopenia) - reddening of the face or body (flushing)
- diarrhoea
- bloating, stomach pain or stomach cramps
- feeling sick (nausea)
Common side effects (may affect up to 1 in 10 people):
- increase in all white blood cells (leukocytosis)
- increase in specific white blood cells called eosinophils
- increase in certain enzymes in the blood (used for checking the health of your liver) - being sick
- constipation
- gas (flatulence), stomach discomfort, indigestion
- decreased appetite
- headache
- feeling tired
- weakness
- feeling hot
- abnormal sensations of the skin, such as itching, burning, stinging, tickling or tingling - pink or red blotches on the skin (erythema)
Uncommon side effects (may affect up to 1 in 100 people):
- dizziness
- excess protein in the urine (proteinuria)
- increase in serum creatinine (a substance in the blood used for measuring how well your kidneys are working)
Rare side effects (may affect up to 1 in 1,000 people): - allergic skin reaction
Very rare side effects (may affect up to 1 in 10,000 people): - acute lymphatic leukaemia (a type of blood cancer)
- decrease in all types of blood cells (pancytopenia)
What Skilarence 120 mg contains
- the active substance is dimethyl fumarate. One tablet contains 120 mg dimethyl fumarate. - the other ingredients are: lactose monohydrate, cellulose microcrystalline, croscarmellose
sodium, colloidal anhydrous silica, magnesium stearate, methacrylic acid-ethyl acrylate copolymer (1:1), talc, triethyl citrate, titanium dioxide (E171), simethicone, indigo carmine (E132) and sodium hydroxide.
This post was edited to show very common side effects from modified leaflet
Posts from this thread have been split to: [split] Skilarence