TECFIDERA 120 mg HARD GASTRO-RESISTANT CAPSULES

Introduction

Package Leaflet: Information for the Patient

Tecfidera 120 mg Hard Gastro-Resistant Capsules

Tecfidera 240 mg Hard Gastro-Resistant Capsules

dimethyl fumarate

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Tecfidera and what is it used for
2. What you need to know before you take Tecfidera
3. How to take Tecfidera
4. Possible side effects
5. Storage of Tecfidera
6. Contents of the pack and other information

1. What is Tecfidera and what is it used for

What is Tecfidera

Tecfidera is a medicine that contains dimethyl fumarateas the active substance.

What is Tecfidera used for

Tecfidera is used to treat multiple sclerosis (MS) in patients from 13 years 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. The symptoms vary from person to person but often include: difficulty walking, balance problems, and vision problems (e.g., blurred or double vision). These symptoms can disappear completely when the relapse is over, but some problems may remain.

How Tecfidera works

Tecfidera seems to work by preventing the body's defense system from damaging the brain and spinal cord. This may also help to delay future disability in MS.

2. What you need to know before you take Tecfidera

Do not take Tecfidera

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

Warnings and precautions

Tecfidera may affect your white blood cell count, kidneys, and liver. 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 working properly. Your doctor will do regular blood tests during treatment. If you have a low white blood cell count during treatment, your doctor may consider additional tests or stop your treatment.

Tell your doctorbefore starting Tecfidera if you have:

• severe kidney disease
• severe liver disease
• a stomach or intestinal disease
• a severe infection(e.g., pneumonia)

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

If you think that your MS is getting worse (e.g., weakness or changes in vision) or you notice any new symptoms, talk to your doctor directly, as they could 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 medicine that contains dimethyl fumarate in combination with other fumaric acid esters, which is used to treat psoriasis (a skin disease). If you notice that you are urinating more, are thirstier, and drink more than usual, your muscles seem weaker, you break a bone, or you simply have aches and pains, tell your doctor as soon as possible so that this can be investigated further.

Children and adolescents

Do not give this medicine to children under 10 years of age because there is no data available for this age group.

Other medicines and Tecfidera

Tell your doctor or pharmacistif you are taking, have recently taken, or might take any other medicines, in particular:

• medicines that contain fumaric acid esters(fumarates) used to treat psoriasis
• medicines that affect the immune system, including chemotherapy, immunosuppressants, or other medicines used to treat MS;
• medicines that affect the kidneys, including some antibiotics(used to treat infections), diuretics(tablets that increase urine production), certain types of painkillers(such as ibuprofen or similar anti-inflammatory medicines, and over-the-counter medicines), and medicines that contain lithium;
• the use of Tecfidera and the administration of certain types of vaccines (live vaccines)could cause you to get an infection, and therefore should be avoided. Your doctor will tell you if you should get other types of vaccines (inactivated vaccines).

Taking Tecfidera with alcohol

After taking Tecfidera, you should avoid consuming more than a small amount (more than 50 ml) of strong alcoholic beverages (with an alcohol content of more than 30%, such as spirits) for the first hour because alcohol may interact with this medicine. This may cause stomach inflammation (gastritis), especially in people who are prone to this condition.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Information on the effects of this medicine during pregnancy is limited. Do not use Tecfidera during pregnancy unless you have discussed it with your doctor and this medicine is clearly necessary for you.

Breastfeeding

It is not known if the active substance of Tecfidera passes into breast milk. Your doctor will inform you whether you should stop breastfeeding or stop taking Tecfidera. This decision involves weighing the benefits of breastfeeding for your child and the benefits of treatment for you.

Driving and using machines

Tecfidera is not expected to affect your ability to drive or use machines.

Tecfidera contains sodium

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

3. How to take Tecfidera

Follow the instructions for administration of this medicine exactly as told by your doctor. If you are unsure, consult your doctor again.

Starting dose: 120 mg twice a day.

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

Usual dose: 240 mg twice a day.

Tecfidera is taken orally.

The capsules should be swallowed whole, with some water. Do not split, crush, dissolve, or chew the capsules because this may increase some side effects.

Take Tecfidera with food –this helps to reduce some of the very common side effects (listed in section 4).

If you take more Tecfidera than you should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Tecfidera

Do not take a double doseto make up for forgotten doses.

You can take the forgotten dose if it is at least 4 hours between doses. Otherwise, wait until the next dose.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects

Tecfidera may lower 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 will need to monitor your lymphocytes during treatment, and you should be aware of any possible symptoms of PML, as described below. The risk of PML may be higher if you have previously taken a medicine that has weakened your immune system.

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

Call your doctor immediately if you have any of these symptoms

Severe allergic reactions

The frequency of severe allergic reactions cannot be estimated from the available data (frequency not known).

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

• swelling of the face, lips, mouth, or tongue (angioedema)
• wheezing, difficulty breathing, or shortness of breath (dyspnea, hypoxia)
• dizziness or fainting (hypotension)

this could be 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)

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

Taking the medicine with foodmay help to reduce the above side effects

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

Tell your doctorabout these side effects. Your doctor may reduce your dose. Do not reduce the dose unless your doctor tells you to.

Common(may affect up to 1 in 10 people)

• inflammation of the intestinal mucosa (gastroenteritis)
• vomiting
• indigestion (dyspepsia)
• inflammation of the stomach mucosa (gastritis)
• gastrointestinal disorders
• burning sensation
• hot flashes, feeling of heat
• skin itching (pruritus)
• rash
• red patches or redness 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 (lymphopenia, leucopenia) 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), tell your doctor immediately
• proteins (albumin) in urine
• increased liver enzymes (ALT, AST) in blood

Uncommon(may affect up to 1 in 100 people)

• allergic reactions (hypersensitivity)
• reduction of blood platelets

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

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

Frequency not known(cannot be estimated from the available data)

• herpes zoster (shingles) with symptoms such as blisters, burning, itching, or pain on 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 infection, followed by numbness, itching, or red spots with severe pain.
• nasal discharge (rhinorrhea)

Children (13 years 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, e.g., headache, stomach pain or cramps, vomiting, sore throat, cough, and painful menstruation.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via 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 Tecfidera

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 blister and carton after EXP.

The expiry date is the last day of the month stated.

Do not store above 30°C.

Keep the blisters in the outer packaging to protect them from light.

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. Package Contents and Additional Information

Tecfidera Composition

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 Ingredientsare microcrystalline cellulose, sodium croscarmellose, talc, anhydrous colloidal silica, magnesium stearate, triethyl citrate, methacrylic acid copolymer and methyl methacrylate copolymer (1:1), methacrylic acid copolymer and ethyl acrylate copolymer (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).

Product Appearance and Package Contents

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

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

Only some pack 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 medicinal product, please contact the local representative of the marketing authorization holder:

Date of Last Revision of this Leaflet:12/2024

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