SKILARENCE 120 mg GASTRO-RESISTANT TABLETS

2. What you need to know before you take Skilarence

Do not take Skilarence

• if you are allergic to dimethylfumarate or any of the other ingredients of this medicine (listed in section 6)
• 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 Skilarence.

Monitoring

Skilarence may cause blood, liver, or kidney problems. You will have blood and urine tests before treatment and periodically during treatment. These tests are done to check that you do not have these complications and that you can continue taking this medicine. 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 altogether.

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 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 advise you to stop taking Skilarence until the infection is resolved.

Gastrointestinal disorders

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

Children and adolescents

Children and adolescents under 18 years of age 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:

• Dimethylfumarate or other fumarates: the active substance of Skilarence, dimethylfumarate, is also used in other medicines, such as tablets, ointments, and baths. You should avoid using other products that contain fumarates to avoid taking too much.
• Other medicines for treating psoriasis, such as methotrexate, retinoids, psoralens, cyclosporine, or other medicines that affect the immune system (such as immunosuppressants or cytostatics). Taking these medicines with Skilarence may increase the risk of side effects on your immune system.
• Other medicines that may affect kidney function, such as methotrexate or cyclosporine (for treating psoriasis), aminoglycosides (for treating infections), diuretics (for urinating more), non-steroidal anti-inflammatory drugs (for pain relief), or lithium (used for bipolar disorder and depression). Taking these medicines with Skilarence may increase the risk of side effects on your kidneys.

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

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

Taking Skilarence with alcohol

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

Pregnancy and breastfeeding

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

Consult your doctor if you experience stomach or intestinal problems that could 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

Skilarence has a minor influence 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

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Skilarence contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially "sodium-free".

3. How to take Skilarence

Follow exactly the administration instructions of this medicine given 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 get used to the medicine and reduces the risk of side effects, such as stomach and intestinal problems. The dose will be increased by 30 mg each week as indicated in the table below. Once you reach the dose of Skilarence 120 mg per day, usually from week 4, you can switch to 120 mg tablets for convenience. When changing the dose 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 Skilarence and also if you experience side effects. If you experience intense side effects after increasing the dose, your doctor may advise you to temporarily go back to the previous dose. If the side effects are not very bothersome, the dose will be increased until your disease is well controlled. You may 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 dose you need to maintain the improvement.

Method of administration

Skilarence tablets should be swallowed whole with liquid. Take the tablet(s) during a meal or immediately after. 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 forget to take Skilarence

Do not take a double dose to make up for forgotten doses. Take the next dose at the usual time and continue taking the medicine exactly as described in this leaflet or exactly as agreed with your doctor. If you have any further questions, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Some of these side effects, such as flushing of the face or body, 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 failure, or a kidney disease called Fanconi syndrome, or a severe brain infection called progressive multifocal leukoencephalopathy (PML). The frequency of these side effects is unknown. For more information on symptoms, see the information below.

Allergic reactions or hypersensitivity

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

• shortness of breath, difficulty breathing, or lack of breath;
• swelling of the face, lips, mouth, or tongue,

stop taking Skilarence and call your doctor immediately.

Progressive multifocal leukoencephalopathy (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, thinking, or memory disturbances; confusion; or personality changes that last for several days, stop taking Skilarence and talk to 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), are thirstier and drink more than usual, your muscles seem weaker, you break a bone, or simply have aches and pains, talk to your doctor as soon as possible so that they can do additional tests.

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

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

• Decrease in a type of white blood cell called lymphocytes (lymphopenia)
• Decrease in all white blood cells (leukopenia)
• Flushing of the face or body
• Diarrhea
• Swelling, pain, or stomach cramps
• Nausea

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

• Increase in all white blood cells (leukocytosis)
• Increase in specific white blood cells (eosinophils)
• Increase in certain enzymes in the blood (used to check liver health)
• Vomiting
• Constipation
• Gas (flatulence), stomach discomfort, indigestion
• Decreased appetite
• Headache
• Feeling tired
• Weakness
• Feeling hot
• Abnormal sensations in the skin, such as itching, burning, tingling, or numbness
• Red patches on the skin (erythema)

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

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

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

• Allergic reaction on the skin

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

• Acute lymphocytic leukemia (a type of blood cancer)
• Decrease in all types of blood cells (pancytopenia)

Not known(cannot be estimated from the available data):

• Herpes zoster (shingles)

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet.

You can also report side effects directly through the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Skilarence

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

Do not use this medicine after the expiry date which is stated on the carton and blister after "EXP". The expiry date is the last day of the month shown.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Packaging Contents and Additional Information

Composition of Skilarence 120 mg

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

Appearance and Packaging of the Product

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

Package sizes: 40, 70, 90, 100, 120, 180, 200, 240, 300, 360, and 400 gastro-resistant tablets. Not all package 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

Manufacturer

Industrias Farmacéuticas Almirall, S.A.

Ctra. de Martorell 41-61

08740 Sant Andreu de la Barca, Barcelona

Spain

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

Date of Last Revision of this Leaflet

Other Sources of Information

Detailed information on this medicinal product is available on the European Medicines Agency website: https://www.ema.europa.eu.