Package Insert: Information for the Patient

Tecfidera 120 mg Hard-Gastroresistant Capsules

Tecfidera 240 mg Hard-Gastroresistant Capsules

Dimethyl Fumarate

Read this package insert carefully before you start taking this medicine because

it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should 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 package insert. See section 4.

What is Tecfidera

Tecfidera is a medication that containsdimethyl fumarateas the active ingredient.

What is Tecfidera used for

Tecfidera is used to treat relapsing-remitting multiple sclerosis (MS) in patients 13years of age and older.

MS is a long-term disease that affects the central nervous system (CNS), which includes the brain and spinal cord. Relapsing-remitting MS is characterized by repeated attacks (relapses) of neurological symptoms. Symptoms vary from patient to patient but often include: difficulty walking, balance problems, and visual problems (e.g., blurry or double vision). These symptoms may disappear completely when the relapse ends, but some problems may persist.

How Tecfidera works

Tecfidera appears to act by preventing the body's defense system from damaging the brain and spinal cord. This may also help to delay future deterioration of MS.

Do not take Tecfidera

• If you are allergic to dimethyl fumarateor to any of the other components of this medication (listed in section 6).
• If you suspect you have a rare brain infection called progressive multifocal leukoencephalopathy (PML) or if PML has been confirmed.

Warnings and precautions

Tecfidera may affect thenumber of white blood cells, thekidneysand theliver. Before starting Tecfidera, your doctor will do a blood test to get a white blood cell count and check that your kidneys and liver are functioning correctly. Your doctor will do blood tests periodically during treatment. If you experience a decrease in the number of white blood cells during treatment, your doctor may consider additional tests or interrupt your treatment.

Consult your doctorbefore starting to take Tecfidera if you have:

• severerenal disease
• severehepatic disease
• gastrointestinal disease
• severeinfection(for example, pneumonia)

Herpes zoster (shingles) may occur during treatment with Tecfidera. In some cases, serious complications have occurred.You must inform your doctor immediatelyif you suspect you have any of the symptoms of shingles.

If you think your MS is worsening (e.g., weakness or visual changes) or notice the appearance of any new symptoms, speak directly with your doctor, as they may be symptoms of a rare brain infection called PML. PML is a serious disease that can cause death or severe disability.

A rare but serious kidney disorder called Fanconi syndrome has been reported with a medication that contains dimethyl fumarate in combination with other fumaric acid esters, and that is used to treat psoriasis (a skin disease). If you notice that you are urinating more, are more thirsty and drink more than usual, your muscles seem weaker, you break a bone or simply have pain and discomfort, inform your doctor as soon as possible so that this can be investigated further.

Children and adolescents

Do not give this medication to children under 10years of age because there are no available data in this age group.

Other medications and Tecfidera

Inform your doctor or pharmacistif you are taking, have taken recently or may need to take any other medication, in particular:

• medications that containfumaric acid esters(fumarates) used to treat psoriasis
• medications that affect the body's immune system, includingchemotherapy, immunosuppressantsand othermedications used to treat MS;
• medications that affect the kidneys, includingsomeantibiotics(used to treat infections), “diuretics” (tablets that increase urine elimination), certain types ofanalgesics(such as ibuprofen or other anti-inflammatory medications, and over-the-counter medications) and medications that containlithium;
• the use of Tecfidera and the administration of certain types ofvaccines(attenuated vaccines) may cause an infection and, therefore, should be avoided. Your doctor will indicate if you should receive other types of vaccines (inactivated vaccines).

Tecfidera and alcohol

After taking Tecfidera, avoid consuming more than a small amount (more than 50 ml) of strong alcoholic beverages (with a volume of alcohol greater than 30%, such as spirits) during the first hour because alcohol may interact with this medication. It may causegastritis, especially in people with a tendency to suffer from this condition.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication.

Pregnancy

The information on the effects of this medication on the fetus if used during pregnancy is limited. Do not use Tecfidera during pregnancy unless you have discussed this with your doctor and this medication is clearly necessary in your case.

Breastfeeding

It is unknown whether the active ingredient in Tecfidera passes into breast milk. Your doctor will inform you if you should stop breastfeeding or if you should stop taking Tecfidera. This decision involves weighing the benefits of breastfeeding for your child and the benefits of treatment for you.

Driving and operating machinery

Tecfidera is not expected to affect your ability to drive and operate machinery.

Tecfidera contains sodium

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

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor again.

Starting dose: 120 mg twice a day.

Take this starting dose for the first 7 days, then take the regular dose.

Regular dose: 240 mg twice a day.

Tecfidera is taken orally.

The capsules must be swallowed whole, with some water. Do not break, crush, dissolve, or chew or suck on the capsules because some adverse effects may increase.

Take Tecfidera with food –it helps to reduce some very common adverse effects (listed in section 4).

If you take more Tecfidera than you should

If you take too many capsules,inform your doctor immediately. You may experience adverse effects similar to those described in section 4.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20 indicating the medication and the amount ingested.

If you forgot to take Tecfidera

Do not take a double doseto compensate for the missed doses.

You can take the missed dose if at least 4 hours have passed between doses. Otherwise, wait until the next scheduled dose.

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.

Severe side effects

Tecfidera may decrease your lymphocyte count (a type of white blood cell). A low white blood cell count can increase the risk of infection, including a rare brain infection called progressive multifocal leukoencephalopathy (PML). PML can cause death or severe disability. PML has occurred after 1 to 5 years of treatment, so your doctor must continue to monitor your white blood cells throughout treatment and you should remain alert to any possible symptoms of PML, as described below. The risk of PML may be higher if you have previously taken a medicine that has worsened your immune system function.

The symptoms of PML can be similar to those of a relapse of MS. Symptoms may include new or worsening weakness on one side of the body; clumsiness; changes in vision, thinking, or memory; or confusion or changes in personality, or difficulty speaking and communicating that may persist for more than a few days. Therefore, it is very important that you speak with your doctor as soon as possible if you think your MS is worsening or if you notice any new symptoms while taking Tecfidera. Also, inform your partner or caregivers about your treatment. You may experience symptoms of which you are not aware on your own.

Call your doctor immediately if you experience any of these symptoms

Severe allergic reactions

The frequency of severe allergic reactions cannot be estimated from available data (unknown frequency).

Facial or body flushing (flushing) is a very common side effect. However, if flushing is accompanied by a red rash or hives and presents any of the following symptoms:

• swelling of the face, lips, mouth, or tongue (angioedema)
• whistling or difficulty breathing, or shortness of breath (breathlessness, hypoxia)
• dizziness or loss of consciousness (hypotension)

it may then constitute a severe allergic reaction (anaphylaxis).

Stop taking Tecfidera and call your doctor immediately

Other side effects

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

• flushing of the face or body, feeling hot, heat, burning sensation, or itching (flushing)
• loose stools (diarrhea)
• nausea or vomiting
• stomach pain or cramps

Taking the medicine with food may help reduce the above side effects

While taking Tecfidera, it is common for urine tests to show ketones, substances that are naturally produced in the body.

Consult your doctorabout how to treat these side effects. Your doctor may reduce your dose. Do not reduce your dose unless your doctor tells you to.

Frequent(may affect up to 1 in 10 people)

• inflammation of the intestinal mucosa (gastroenteritis)
• vomiting
• indigestion (indigestion)
• inflammation of the stomach mucosa (gastritis)
• gastrointestinal disorders
• burning sensation
• sweating, feeling hot
• itching of the skin (pruritus)
• exanthema
• rosy or reddish patches accompanied by itching on the skin (erythema)
• hair loss (alopecia)

Side effects that may appear in blood or urine tests

• low white blood cell count (leukopenia) in blood. A decrease in white blood cells can make the body less able to fight infections. If you have a severe infection (such as pneumonia) inform your doctor immediately
• protein (albumin) in urine
• increase in liver enzymes (ALT, AST) in blood

Rare(may affect up to 1 in 1000 people)

• inflammation of the liver and increase in liver enzymes (ALT or AST simultaneously with bilirubin)

Frequency unknown(cannot be estimated from available data)

• herpes zoster (shingles) with symptoms such as blisters, burning, itching, or pain of the skin, usually on one side of the upper body or face, and other symptoms, such as fever and weakness in the early stages of the infection, followed by numbness, itching, or red patches with intense pain.
• nasal discharge (rhinorrhea)

Children (13years of age and older) and adolescents

The side effects described above also apply to children and adolescents.

Some side effects were reported more frequently in children and adolescents than in adults, p.eg., headache, stomach pain or cramps, vomiting, sore throat, cough, and painful menstruation.

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 leaflet. You can also report them directly through the national reporting system included in theAppendix V.By reporting side effects, you can contribute to providing more information about 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 blister pack and on the box after CAD.

The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C.

Store the blister packs in the outer packaging to protect them from light.

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

Composition of Tecfidera

The active ingredientis dimethyl fumarate.

Tecfidera 120 mg: each capsule contains 120 mg of dimethyl fumarate.

Tecfidera 240 mg: each capsule contains 240 mg of dimethyl fumarate.

The other componentsare microcrystalline cellulose, sodium croscarmellose, talc, anhydrous colloidal silica, magnesium stearate, triethyl citrate, copolymer of methacrylic acid and methyl methacrylate (1:1), copolymer of methacrylic acid and ethyl acrylate (1:1), 30% dispersion, simethicone, sodium lauryl sulfate, polysorbate 80, gelatin, titanium dioxide (E171), Brilliant Blue FCF (E133), yellow iron oxide (E172), shellac, potassium hydroxide, and black iron oxide (E172).

Appearance of the product and contents of the package

Tecfidera 120 mg hard-gastrorresistant capsules are green and white with the imprint ‘BG-12 120 mg’ and are marketed in packages containing 14 capsules.

Tecfidera 240 mg hard-gastrorresistant capsules are green with the imprint ‘BG-12 240 mg’ and are marketed in packages containing 56 or 168 capsules.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

Biogen Netherlands B.V.

Prins Mauritslaan 13

1171 LP Badhoevedorp

Netherlands

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

Last update of this leaflet:12/2024

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