Skilarence 30 mg Dimethyl Fumarate Enteric Tablet
What Skilarence Is And What Skilarence Used For?
What is Skilarence?
Skilarence is a medicine that contains the active substance dimethyl fumarate. Dimethyl fumarate acts on cells in the immune system (the body’s natural defenses). It changes the activity of the immune system and reduces the production of substances that contribute to causing psoriasis.
What Skilarence is used for:
Skilarence tablets are used to treat moderate to severe plaque psoriasis in adults. Psoriasis is a disease that causes thickened, inflamed, red areas of the skin, often covered in silvery scales.
After starting treatment with this medicine, improvement is generally seen as early as week 3 and improves over time. Experience with other medicines containing dimethyl fumarate shows the effect of the treatment for at least up to 24 months.
What You Need To Know Before You Take Skilarence?
Do Not Take Skilarence:
- If you are allergic to dimethyl fumarate or any of the other ingredients of this medicine (listed in section 6)
- If you have severe problems with your stomach or intestines
- If you have severe liver or kidney problems
- If you are pregnant or breastfeeding.
Warnings And Precautions:
Talk to your doctor or pharmacist before taking this medicine.
Investigations
Skilarence may cause problems with the blood, liver, or kidneys. You will have blood and urine samples before treatment and then regularly during treatment to check that you do not develop such complications and can continue to take this medicine. Depending on the results of these blood and urine tests, the doctor may lower the dose of Skilarence or stop the treatment.
Infection you
White blood cells help your body fight infection. Skilarence can cause a reduced number of white blood cells. Talk to your doctor if you think you may have an infection. Symptoms may include:
If you have a serious infection before starting treatment with Skilarence or during treatment, your doctor may advise you not to take this medicine until the infection has cleared.
Diseases of the gastrointestinal tract:
Tell your doctor if you have problems with your stomach or intestines. The doctor will tell you what measures you must take during treatment with Skilarence.
Children And Young People:
Children and adolescents under 18 should not take this medicine as it has not been studied in this age group.
Other Medicines And Skilarence:
Tell your doctor or pharmacist if you have recently taken or might take any other medicines.
In particular, tell your doctor if you are taking any of 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 containing fumarates to prevent taking too much.
- Other medicines for treating psoriasis, eg methotrexate, retinoids, psoralens, and cyclosporine, or other immunosuppressive medicines or cytostatics (medicines that affect the immune system). If you take these medicines with Skilarence, the risk of side effects affecting the immune system may increase.
- Other medicines that can affect kidney function, such as e.g. methotrexate or cyclosporine (used for psoriasis ), aminoglycosides (used for infection ), diuretics (which increase urine output), non-steroidal anti-inflammatory drugs (used for pain) or lithium (used for bipolar disorder and depression). Taking this medicine with Skilarence may increase the risk of side effects in the kidneys.
If you get severe or prolonged diarrhea with Skilarence, it is possible that other medicines will not work as well as they would otherwise. Talk to your doctor if you have severe diarrhea and are concerned that other medicines you take may not work.
Especially if you are taking birth control ( birth control pills ), as the effect may be reduced, and you may need to use an additional barrier method to prevent pregnancy. Read the instructions in the package insert for the contraceptive you are using.
If you need to be vaccinated, talk to your doctor. Certain types of vaccines (live vaccines) can cause infection if used during treatment with Skilarence. The doctor can advise you on what is most suitable.
Ski Clearance 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 affect this medicine. This can cause stomach and intestinal problems.
Pregnancy And Breastfeeding:
Do not take Skilarence if you are pregnant or trying to become pregnant because Skilarence may harm your baby. Use effective contraception to avoid pregnancy during treatment with Skilarence (see also “Other medicines and Skilarence” above). Do not breastfeed during treatment with Skilarence.
Driving Ability And Use Of Machinery:
Skilarence may have a minor effect on the ability to drive and use machines. You may feel dizzy or tired after taking Skilarence. If you are affected, be careful when driving or using machines.
Skilarence Contains Lactose:
Skilarence contains lactose. If you are intolerant to certain sugars, contact your doctor before taking this medicine.
Skilarence contains sodium: This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is almost ‘sodium-free’.
How To Take Skilarence?
- Always take this medicine as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.
- Dose
- The doctor will start your treatment with a low dose (30 mg Skilarence tablets). This helps to reduce the risk of stomach upset and other side effects. Dose one will be increased each week according to the table below (change to 120 mg Skilarence tablets from week 4).
| Treatment week | Tablet strength | Number of tablets to be taken during the day | Number of tablets per day | Total daily dose | ||
|---|---|---|---|---|---|---|
| Breakfast | Lunch | Evening meal | ||||
| 1 | 30 mg | – | – | 1 | 1 | 30 mg |
| 2 | 30 mg | 1 | – | 1 | 2 | 60 mg |
| 3 | 30 mg | 1 | 1 | 1 | 3 | 90 mg |
| 4 | 120 mg | – | – | 1 | 1 | 120 mg |
| 5 | 120 mg | 1 | – | 1 | 2 | 240 mg |
| 6 | 120 mg | 1 | 1 | 1 | 3 | 360 mg |
| 7 | 120 mg | 1 | 1 | 2 | 4 | 480 mg |
| 8 | 120 mg | 2 | 1 | 2 | 5 | 600 mg |
| 9+ | 120 mg | 2 | 2 | 2 | 6 | 720 mg |
The doctor will check how your condition improves after taking Skilarence and if you have any side effects. If you experience serious side effects after a dose increase, the doctor may recommend temporarily returning to the last dose.
If the side effects do not bother you, the dose increases until your condition is controlled. You may not need the maximum dose of 720 mg per day. When your condition has improved enough, the doctor will consider how to gradually reduce the daily dose of Skilarence to the dose you need to maintain the improvement.
How To Take The Tablets?
Swallow the Skilarence tablets whole with liquid. Take the tablets during or immediately after a meal. The tablets should not be crushed, split, dissolved, or chewed as they have a special coating to prevent stomach irritation.
If You Have Taken Too Much Skilarence:
If you think you have taken too many tablets, talk to your doctor or pharmacist.
If You Forget To Take Skilarence:
Do not take a double dose to make up for a missed dose. Take the next dose at the usual time and continue to take medicine exactly as described in this leaflet or as your doctor prescribes. Ask your doctor or pharmacist if you are unsure. If you have any further questions about this medicine, ask your doctor or pharmacist.
Possible Skilarence Side Effects:
This medicine can cause side effects like all medicines, although not everybody gets them. Some side effects, such as:
- Reddening of the face or body (erythema)
- Diarrhea
- Upset stomach
- Nausea usually get better as treatment continues.
The most serious side effects of Skilarence are an allergy or hypersensitivity reaction, kidney failure or a kidney disease called Fanconi syndrome, or a serious brain infection called progressive multifocal leukoencephalopathy (PML). These have been reported (occurring in an unknown number of users). For symptoms, see below.
Allergy or hypersensitivity reaction
Allergic or hypersensitivity reactions are rare but can be very serious. Redness of the face or body is a common side effect that may occur in more than 1 in 10 users. But if you show redness and any of the following signs:
- Wheezing (breath sounds), difficulty breathing, or shortness of breath
- Swelling of the face, lips, mouth, or tongue
stop taking Skilarence and call your doctor right 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 DESCRIBED SYMPTOMS, Stop taking Skilarence and talk to your doctor immediately.
- New or worsening weakness in one side of the body
- Clumsiness
- Vision changes
- Impaired thinking or memory
- Confusion
- Personality changes that last several days
Fanconi syndrome:
Fanconi syndrome is a rare but serious kidney disorder that can occur with Skilarence. If you urinate more often or in larger quantities, are thirstier, and drink more than usual, your muscles seem weaker, you break a bone, or you have aches and pains, talk to your doctor as soon as possible, so this can be investigated further.
Talk to your doctor if you get any of the following side effects.
Very common side effects (may affect more than 1 in 10 users):
- Reduced number of a type of white blood cell called lymphocytes (lymphopenia)
- Decreased number of all types of white blood cells ( leukopenia )
- Redness of the face or body (erythema)
- Diarrhea
- Bloated stomach, stomach ache, or stomach cramps
- Nausea
Common side effects (may affect up to 1 in 10 people):
- Increased number of all types of white blood cells ( leukocytosis )
- Increased number of eosinophils, a special type of white blood cell
- Increased levels of certain enzymes in the blood (used to check liver function)
- Vomiting
- Constipation
- Flatulence
- Upset stomach
- Indigestion
- Decreased appetite
- Headache
- Fatigue
- Weakness
- Feeling of warmth
- Abnormal sensation in the skin, such as:
- Itching
- Burning
- Tingling
- Tickling
- A stinging sensation
- Pink or red spots on the skin ( erythema )
Uncommon side effects (may affect up to 1 in 100 people):
- Dizziness
- The increased amount of protein in the urine ( proteinuria )
- Elevated serum creatinine (a substance in the blood used to measure how well your kidneys are working)
Rare side effects (may affect up to 1 in 1,000 people):
- Allergic skin reactions
Very rare side effects (may affect up to 1 in 10,000 people):
- Acute lymphoblastic leukemia (a type of blood cancer)
- Lack of all types of blood cells (pancytopenia)
Frequency not known (cannot be estimated from available data):
- Herpes zoster ( shingles )
How To Store Skilarence?
- Keep this medicine out of sight and reach of children.
- Use before the expiry date on the carton and the blister after EXP. The expiration date is the last day of the specified month.
- No special storage instructions.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents Of The Packaging And Other Information:
Contents Declaration
- The active substance is dimethyl fumarate. One tablet contains 30 mg of dimethyl fumarate.
- Other ingredients are lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate, methacrylic acid ethyl acrylate copolymer (1:1), talc, triethyl citrate, titanium dioxide (E171) and simethicone.
Appearance And Package Sizes Of The Medicine:
- Skilarence 30 mg is a white, round tablet with a diameter of approximately 6.8 mm.
- Skilarence 30 mg is available in packs of 42, 70, or 210 gastro-resistant tablets.
- Not all pack sizes may be marketed. The tablets are packed in PVC/PVCD aluminum blister packs.
Marketing Authorisation Holder
Admiral, SA
Ronda General Miter, 151
E-08022 Barcelona
Spain
Tel. +34 93 291 30 00
Manufacturer
Industrias Farmacéuticas Almirall, SA
Ctr. de Martorell 41-61
E-08740 Sant Andreu de la Barca, Barcelona
Spain
Contact the representative of the marketing authorization holder if you want to know more about this medicine:
België/Belgique/Belgien/ Luxembourg/Luxemburg
Almirall NV, Tél/Tel: +32 (0)2 771 86 37
Bulgaria/ Czech Republic/ Eesti/ España/ Hrvatska/ Cyprus/ Latvija/ Lietuva/ Magyarország/ Malta/ România/ Slovenija/ Slovenská republika
Almirall, SA, Tel./ Tel/ Τηλ: +34 93 291 30 00 Tel (Česká republika / Slovenská republika): +420 220 990 139
Denmark/ Norway / Finland/ Finland/ Sweden
Almirall ApS, Tel/ Puh/Tel: +45 70 25 75 75
Deutschland
Almirall Hermal GmbH, Tel.: +49 (0)40 72704-0
Greece
Galenica AE, Tel: +30 210 52 81 700
France
Almirall SAS, Tel.: +33(0)1 46 46 19 20
Ireland/ United Kingdom (Northern Ireland)
Almirall, SA, Tel: +353 (0) 1431 9836
Iceland
Visitor hf., Phone: +354 535 70 00
Italy
Almirall SpA, Tel.: +39 02 346181
The Netherlands
Almirall BV, Tel: +31 (0)307991155
Austria
Almirall GmbH, Tel.: +43 (0)1/595 39 60
Polish
Almirall Sp.z oo, Tel.: +48 22 330 02 57
Portugal
Almirall – Produtos Farmacêuticos, Lda., Tel.: +351 21 415 57 50