Patient Information Leaflet

Skilarence 120mg gastro-resistant tablets

dimethyl fumarate

Read this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4

What is Skilarence

Skilarence is a medication that contains the active ingredient dimethylfumarate. Dimethylfumarate acts on the cells of the immune system (the body's natural defenses), reducing the production of certain substances involved in the appearance of psoriasis through its action.

What is Skilarence used for

The Skilarence tablets are used to treat plaque psoriasis of moderate to severe severity in adults. Psoriasis is a disease that causes certain areas of the skin to thicken, inflame, or redden, often covered with white scales.

Generally, the response to Skilarence can be observed as early as week 3 and improves over time. Experience with related medications containing dimethylfumarate has shown that the beneficial effects of treatment last for at least 24 months.

Do not take Skilarence

• if you are allergic to dimethylfumarate or any of the other components of this medication (listed in section6)
• if you have severe stomach or intestinal problems
• if you have severe liver or kidney problems
• if you are pregnant or breastfeeding

Warnings and precautions

Consult your doctor or pharmacist before starting to take Skilarence.

Monitoring

Skilarence may cause blood, liver, or kidney problems. Blood and urine tests will be done before treatment and periodically during treatment. These tests are done to check that you do not have these complications and can continue to take this medication. Depending on the results of these blood and urine tests, your doctor may decide to increase the dose of Skilarence according to the recommended schedule (see section 3), maintain the dose, reduce the dose, or stop treatment completely.

Infections

White blood cells help the body fight infections. Skilarence may reduce the number of white blood cells. Talk to your doctor if you think you have contracted an infection. Symptoms include fever, pain, muscle aches, headache, loss of appetite, and general weakness. If you have a severe infection before starting treatment with Skilarence or during treatment, your doctor may recommend that you stop taking Skilarence until the infection is resolved.

Gastrointestinal disorders

Inform your doctor if you have or have had stomach or intestinal problems. Your doctor will advise you on precautions to take during treatment with Skilarence.

Children and adolescents

Children and adolescents under 18 years of age should not take this medication because it has not been studied in this age group.

Other medications and Skilarence

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Especially, inform your doctor if you are taking the following:

• Dimethylfumarate or other fumarates: the active substance of Skilarence, dimethylfumarate, is also used in other medications, such as tablets, ointments, and baths. Avoid using other products that contain fumarates to avoid taking too much.
• Other medications for treating psoriasis,such as methotrexate, retinoids, psoralens, cyclosporine, or other medicationsthat affect the immune system (such asimmunosuppressants or cytostatics).The simultaneous use of these medications with Skilarence may increase the risk of adverse effects on your immune system.
• Other medications that may affect kidney function,such as methotrexate or cyclosporine (for treating psoriasis), aminoglycosides (for infections), diuretics (for urination), nonsteroidal anti-inflammatory drugs (for pain relief), or lithium (used for bipolar disorder and depression).The simultaneous use of these medications with Skilarence may increase the risk of adverse effects on your kidneys.

If you have severe diarrhea due to the use of Skilarence, other medications may not work as well as they should. If you have severe diarrhea, consult your doctor. If you are taking a contraceptive (the pill), this is especially important because the effect may be reduced and you may need to use other contraceptive methods to prevent pregnancy. Consult the instructions in the contraceptive prospectus you are taking.

If you need to be vaccinated, consult your doctor. Certain types of vaccines (attenuated vaccines) may cause an infection if used during treatment with Skilarence. Your doctor may advise you on what is best.

Skilarence and alcohol

Do not consume strong alcoholic beverages (more than 50ml of spirits containing more than 30% alcohol by volume) during treatment with Skilarence, as alcohol may interact with this medication. This interaction between alcohol and the medication may cause stomach and intestinal problems.

Pregnancy and breastfeeding

Do not take Skilarence if you are pregnant or intend to become pregnant, as Skilarence may cause harm to the baby. Use effective contraceptive methods to avoid becoming pregnant during treatment with Skilarence (see also “Other medications and Skilarence” above).

Consult your doctor if you have stomach or intestinal problems that may reduce the effectiveness of oral contraceptives, who will advise you on other contraceptive methods.

Do not breastfeed during treatment with Skilarence.

Driving and using machines

The influence of Skilarence on the ability to drive and use machines is small. You may feel dizzy or tired after taking Skilarence. If you are affected, be careful when driving or using machines.

Skilarence contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medication.

Skilarence contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per tablet; that is, it is essentially “sodium-free”.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Dose

Your doctor will start treatment with a low dose of Skilarence using 30 mg tablets. This helps your body adapt to the medication and reduces the risk of side effects, such as gastrointestinal problems. The dose will be increased each week by 30 mg as indicated in the table below. Once you reach the Skilarence 120 mg per day dose, usually from week 4, you can switch to 120 mg tablets for convenience. When changing from 30 mg to 120 mg, make sure the tablet and dose you are taking are correct.

Your doctor will check how your condition is improving after starting to take Skilarence and also if you experience any side effects. If you experience severe side effects after increasing the dose, your doctor may recommend that you temporarily return to the previous dose. If the side effects are not very bothersome, the dose will be increased until your condition is well controlled.It is possible that you will not need the maximum dose of 720 mg per day as indicated in the table above. Once your condition has improved enough, your doctor will study how to gradually reduce the daily dose of Skilarence to the amount needed to maintain the improvement.

Administration form

Skilarence tablets should be swallowed whole with a liquid. Take the tablet(s) during a meal or immediately after it. Do not crush, break, dissolve, or chew the tablets, as they have a special coating that helps prevent stomach irritation.

If you take more Skilarence than you should

If you think you have taken too many Skilarence tablets, contact your doctor or pharmacist.

If you forgot to take Skilarence

Do not take a double dose to compensate for the missed doses. Take the next dose at the usual time and continue taking the medication exactly as described in this leaflet or exactly as agreed with your doctor. In case of doubt, consult your doctor or pharmacist.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them. Some of these side effects, such as facial or body redness, diarrhea, stomach problems, and nausea, usually improve as treatment continues.

The most serious side effects that can occur with Skilarence are allergic reactions or hypersensitivity, kidney insufficiency or a kidney disease called Fanconi syndrome, or a severe brain infection called progressive multifocal leukoencephalopathy (PML). The frequency of these is unknown. For more information on symptoms, see the information included below.

Allergic reactions or hypersensitivity

Allergic reactions or hypersensitivity are rare but can be very serious. Facial or body redness (erythema) is a very common side effect that can affect more than 1 in 10 people. However, if you experience redness and any of the following symptoms:

• Shortness of breath or difficulty breathing;
• Swelling of the face, lips, mouth, or tongue,

Stop taking Skilarence and call your doctor immediately.

Brain infection called PML

Progressive multifocal leukoencephalopathy (PML) is a rare but serious brain infection that can lead to significant disability or death. If you notice the onset or worsening of weakness on one side of the body; clumsiness; visual, thought, or memory disturbances; confusion; or changes in personality that last for several days, stop taking Skilarence and speak with your doctor immediately.

Fanconi syndrome

Fanconi syndrome is a rare but serious kidney disorder that can occur when taking Skilarence. If you are urinating more (or more frequently), feeling more thirsty and drinking more than usual, your muscles seem weaker, you break a bone, or simply feel pain and discomfort, speak with your doctor as soon as possible so they can perform additional tests.

Consult your doctor if you experience any of the following side effects.

Very common(can affect more than 1 in 10 people):

• Decreased white blood cell count called lymphocytes (lymphopenia)
• Decreased white blood cell count (leucopenia)
• Facial or body redness
• Diarrhea
• Swelling, pain, or stomach cramps
• Nausea

Common(can affect up to 1 in 10 people):

• Increased white blood cell count (leucocytosis)
• Increased eosinophils (a type of white blood cell)
• Increased certain enzymes in the blood (used to check liver health)
• Vomiting
• Constipation
• Gas (flatulence), stomach discomfort, indigestion
• Loss of appetite
• Headache
• Feeling tired
• Weakness
• Sensation of heat
• Abnormal skin sensations, such as itching, burning, stinging, tingling, or prickling
• Rosacea or red spots on the skin (erythema)

Uncommon(can affect up to 1 in 100 people):

• Dizziness
• Excess protein in the urine (proteinuria)
• Increased serum creatinine (a substance present in the blood used to measure kidney function)

Rare(can affect up to 1 in 1,000 people):

• Allergic reaction on the skin

Very rare(can affect up to 1 in 10,000 people):

• Acute lymphocytic leukemia (a type of blood cancer)
• Pancytopenia (decreased white blood cell, red blood cell, and platelet count)

Unknown(cannot be estimated from available data):

• Herpes zoster (shingles)

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist,even if it is a possible side effect that does not appear in this prospectus.

You can also reportthem directly through the national notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box and blister after "EXP". The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. By doing so, you will help protect the environment.

Skilarence 120 Composition mg

• The active ingredient is dimethylfumarate. One tablet contains 120 mg of dimethylfumarate.
• The other components are: lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, anhydrous colloidal silica, magnesium stearate, copolymer of methacrylic acid and ethyl acrylate (1:1), talc, triethyl citrate, titanium dioxide (E171), simethicone, indigotin (E132), and sodium hydroxide.

Appearance of the product and contents of the package

Skilarence 120 mg is a blue and round tablet, with an approximate diameter of 11.6 mm.

Pack sizes: 40, 70, 90, 100, 120, 180, 200, 240, 300, 360, and 400 gastro-resistant tablets. Only some pack sizes may be marketed. The tablets are packaged in aluminum and PVC/PVDC blisters.

Marketing Authorization Holder

Almirall, S.A.

Ronda General Mitre, 151

08022 Barcelona

Spain

Phone +34 93 291 30 00

Responsible for manufacturing

Industrias Farmacéuticas Almirall, S.A.

Ctra. de Martorell 41-61

08740 Sant Andreu de la Barca, Barcelona

Spain

To obtain more information about this medicine, please contact the local representative of the marketing authorization holder:

Last review date of this leaflet

Other sources of information

The detailed information on this medicine is available on the website of the European Medicines Agency: https://www.ema.europa.eu .