TECFIDERA 120 mg Kapsułka Twarda Powlekana

Treść ulotki

1. Tecfidera 120 mg hard gastro-resistant capsules, 240 mg hard gastro-resistant capsules
   1. What is Tecfidera and what is it used for
   2. What you need to know before taking Tecfidera
   3. How to take Tecfidera
   4. Possible side effects
   5. How to store Tecfidera
   6. Package contents and other information

Tecfidera 120 mg hard gastro-resistant capsules, 240 mg hard gastro-resistant capsules

dimethyl fumarate

Read 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.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What Tecfidera is and what it is used for
• 2. What you need to know before you take Tecfidera
• 3. How to take Tecfidera
• 4. Possible side effects
• 5. How to store 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 the active ingredient dimethyl fumarate.

What is Tecfidera used for
Tecfidera is used to treat relapsing-remitting multiple sclerosis (RRMS) in patients aged
13 years or older.
Multiple sclerosis is a chronic disease that affects the central nervous system (CNS), i.e. the
brain and spinal cord. Relapsing-remitting multiple sclerosis is characterized by repeated attacks
(relapses) of symptoms affecting the nervous system. Symptoms vary from patient to
patient, but generally include difficulty walking, a feeling of imbalance and vision problems
(e.g. blurred or double vision). These symptoms may disappear completely when
the relapse resolves, but some problems may remain.

How Tecfidera works
Tecfidera appears to work by preventing the body's defense system from damaging the brain and the
spinal cord. This may also help to delay future worsening of the disease.

2. What you need to know before taking Tecfidera

Do not take Tecfidera

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

Warnings and precautions
Tecfidera can affect the number of white blood cells in the blood, the kidneysand the liver. Before
starting to take Tecfidera, your doctor will perform a blood test to count the number of your
white blood cells and will check that your kidneys and liver are working properly. Your doctor
will perform the tests periodically during treatment. If the number of your white blood cells
decreases during treatment, your doctor may consider further tests or
stopping therapy.

Talk to your doctorbefore taking Tecfidera if you have:

• a serious disease of the kidneys
• a serious disease of the liver
• a disease of the stomachor the intestine
• a serious infection(such as pneumonia)

Cases of herpes zoster infection (shingles) can occur with Tecfidera treatment. In some cases, serious
complications have occurred. Tell your doctorimmediately if
you suspect you have any symptoms of herpes zoster infection.
If you believe that your MS is worsening (for example, if you experience weakness or changes in vision)
or if you notice new symptoms, contact your doctor immediately as these may be
symptoms of a rare brain infection called PML. PML is a serious condition that can
lead to severe disability or death.
With a medicine containing dimethyl fumarate in combination with other fumaric acid esters,
used for the treatment of psoriasis (a skin disease), a rare but serious kidney disorder
called Fanconi syndrome has been observed. If you notice that you are urinating more often, if you are
more thirsty and drink more than usual, if your muscles are weaker, or in case of fracture or just pain,
contact your doctor as soon as possible so that further investigations can be carried out.

Children and adolescents
Do not give this medicine to children under 10 years of age because no data are available in
this age group.

Other medicines and Tecfidera
Tell your doctor or pharmacistif you are taking, have recently taken or might take
any other medicines, especially:

• medicines that contain fumaric acid esters(fumarates) used for the treatment of psoriasis
• medicines that affect the immune system,including chemotherapeutic agents, immunosuppressantsor other medicines used for the treatment of MS;
• medicines that affect the kidneys, including some antibiotics(used for the treatment of infections), diuretics, some types of pain relievers(such as ibuprofen and other similar anti-inflammatory drugs and over-the-counter medicines) and medicines that contain lithium;
• taking Tecfidera with certain types of vaccines (live vaccines) could cause you to develop an infection and should therefore be avoided. Your doctor will tell you if other types of vaccines (non-live vaccines) should be given.

Tecfidera with alcohol
Consumption of beverages with a high alcohol content (more than 30% alcohol by volume, e.g. spirits) greater
than a small amount (more than 50 mL) should be avoided within one hour of taking Tecfidera,
because alcohol can interact with this medicine. This could cause inflammation of the
stomach (gastritis), particularly in people already prone to gastritis.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are
breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
There is limited information on the effects of this medicine on the unborn child if used during
pregnancy. Do not use Tecfidera if you are pregnant, unless you have discussed this with your doctor
and this medicine is clearly necessary for you.
Breastfeeding
It is not known whether the active ingredient of Tecfidera passes into breast milk. Your doctor will advise you whether to
stop breastfeeding or the treatment with Tecfidera. This involves
assessing the benefit of breastfeeding for your baby against the benefit of therapy for you.

Driving and using machines
Tecfidera is not expected to affect your ability to drive and use machines.

Tecfidera contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. essentially ‘sodium-free’.

3. How to take Tecfidera

Take this medicine following exactly the instructions of your doctor. If you have any doubts, consult your
doctor.

Initial dose: 120 mg twice a day.
Take this initial dose for the first 7 days, and then take the regular dose.

Regular dose: 240 mg twice a day.
Tecfidera is for oral use.

Swallow each capsule wholewith a little water. You must not divide, crush, dissolve,
suck or chew the capsule, as this could increase certain undesirable effects.

Take Tecfidera with food– this may help to reduce some of the more common undesirable effects (listed in
paragraph 4).

If you take more Tecfidera than you should
If you have taken too many capsules, seek immediate medical advice. You may experience undesirable effects
similar to those described below in paragraph 4.

If you forget to take Tecfidera
If you forget or miss a dose, do not take a double dose to make up for a missed dose.
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 further questions on 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 can reduce the levels of lymphocytes (a type of white blood cell). Persistently low levels of
white blood cells can increase the risk of infections, including the risk of a rare brain infection
called progressive multifocal leukoencephalopathy (PML). PML can cause
severe disability or death. PML has been reported after 1 - 5 years of treatment, so the doctor
must continue to monitor white blood cell counts throughout the duration of treatment. Pay attention to
carefully observe any potential symptom of PML, as described below. The risk of PML
may be higher if you have previously taken medicines that compromise the function of the
immune system.
The symptoms of PML can be similar to those of a relapse of multiple sclerosis. Symptoms
may include the onset or worsening of weakness on one side of the body;
clumsiness; changes in vision, thinking, or memory; or confusion or changes in
personality or difficulty with speech and communication lasting more than a few days.
Therefore, if you believe that your MS is worsening or if you notice any new symptoms during therapy
with Tecfidera, it is very important that you contact your doctor as soon as possible. Also inform your
partner or caregiver about your treatment. Symptoms may occur that you may not
be aware of.

• If you experience any of these symptoms, call your doctor immediately

Serious allergic reactions
The frequency of serious allergic reactions cannot be defined based on available data (not
known).
Facial or body flushing is a very common side effect .However, if
flushing is accompanied by a red or urticaria rash andyou have
any of these symptoms:

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

this may represent a serious allergic reaction (anaphylaxis).

• Stop taking Tecfidera and call a doctor immediately

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

• facial or body flushing, feeling of warmth, heat, burning or itching (flushing)
• loose stools (diarrhea)
• feeling of impending vomiting (nausea)
• stomach pain or stomach cramps
• Taking the medicine with foodmay help reduce the above side effects

The presence of substances called ketones, which are produced naturally by the body, is very commonly revealed
in urine tests during the intake of Tecfidera.

Contact your doctorfor information on how to manage these side effects. The doctor may reduce
your dose. Do not reduce the dose unless your doctor tells you to do so.

Common(may affect up to 1 in 10 people)

• inflammation of the lining of the intestine (gastroenteritis)
• feeling unwell ( vomiting)
• indigestion (dyspepsia)
• inflammation of the stomach (gastritis)
• gastrointestinal illness
• burning sensation
• hot flush, feeling of heat
• itching
• skin rash
• pink or red spots on the skin ( erythema)
• hair loss (alopecia)

Side effects that can emerge from blood or urine tests

• low levels of white blood cells ( lymphocytopenia, leucopenia) in the blood. A decrease in the number of white blood cells in the blood may indicate that you are unable to fight an infection adequately. If you have a serious infection (such as pneumonia), contact your doctor immediately
• protein ( albumin) in the urine
• increased levels of liver enzymes ( alanine-aminotransferase, ALTand aspartate-aminotransferase, AST) in the blood

Uncommon(may affect up to 1 in 100 people)

• allergic reactions (hypersensitivity)
• decreased platelets in the blood

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

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

Not known(frequency cannot be estimated based on available data)

• herpes zoster infection (shingles) with symptoms such as blisters, burning, itching or skin pain, usually on one side of the torso or face, and other symptoms such as fever and weakness in the early stages of the infection, followed by numbness, red or itchy spots with severe pain
• runny nose ( rhinorrhea)

Children (13 years of age and older) and adolescents
The side effects listed above also apply to children and adolescents.
Some side effects have been reported more frequently in children and adolescents
compared to adults, such as headache, stomach pain or cramps, vomiting, sore throat, cough and painful periods.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system reported in Annex V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store 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 the package after
'Exp.'.
The expiry date refers to the last day of that month.
Do not store at a temperature above 30°C.
Keep the blisters in the outer packaging to protect the medicine from light.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Tecfidera contains
The active substanceis dimethyl fumarate.
Tecfidera 120 mg: each capsule contains 120 mg of dimethyl fumarate.
Tecfidera 240 mg: each capsule contains 240 mg of dimethyl fumarate.

Other ingredientsare microcrystalline cellulose, sodium croscarmellose, talc, colloidal silicon dioxide
anhydrous, magnesium stearate, triethyl citrate, acrylic acid-methyl methacrylate copolymer (1:1),
acrylic acid-ethyl acrylate copolymer (1:1) dispersion 30%, 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).

Description of Tecfidera and package contents
Tecfidera 120 mg hard gastro-resistant capsules are green and white and printed with ‘BG-12 120 mg’
and are available in packs containing 14 capsules.
Tecfidera 240 mg hard gastro-resistant capsules are green and printed with ‘BG-12 240 mg’ and are
available in packs containing 56 or 168 capsules.
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer
Biogen Netherlands B.V.
Prins Mauritslaan 13
1171 LP Badhoevedorp
Netherlands
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

Lietuva
Biogen Lithuania UAB
Tel: +370 5 259 6176

België/Belgique/Belgien
Biogen Belgium NV/SA
Tél/Tel: +32 2 2191218

България
ЕВОФАРМА ЕООД
Teл: +359 2 962 12 00

Luxembourg/Luxemburg
Biogen Belgium NV/SA
Tél/Tel: +32 2 2191218

Česká republika
Biogen (Czech Republic) s.r.o.
Tel: +420 255 706 200

Magyarország
Biogen Hungary Kft.
Tel: + 36 1 899 9883

Malta
Pharma. MT Ltd.
Tel: +356 21337008

Danmark
Biogen (Denmark) A/S
Tlf.: +45 77 41 57 57

Nederland
Biogen Netherlands B.V.
Tel: +31 20 542 2000

Deutschland
Biogen GmbH
Tel: +49 (0) 89 99 6170

Eesti
Biogen Estonia OÜ
Tel: +372 618 9551

Norge
Biogen Norway AS
Tlf: +47 23 40 01 00

Ελλάδα
Genesis Pharma SA
Τηλ: +30 210 8771500

Österreich
Biogen Austria GmbH
Tel: +43 1 484 46 13

España
Biogen Spain, S.L.
Tel: +34 91 310 7110

Polska
Biogen Poland Sp. z o.o.
Tel: +48 22 351 51 00

France
Biogen France SAS
Tél: +33 (0)1 41 37 95 95

Portugal
Biogen Portugal Sociedade Farmacêutica
Unipessoal, Lda.
Tel: +351 21 318 8450

Hrvatska
Biogen Pharma d.o.o.
Tel: +385 (0) 1 775 73 22

România
Johnson & Johnson Romania S.R.L.
Tel: +40 21 207 18 00

Ireland
Biogen Idec (Ireland) Ltd.
Tel: +353 (0)1 463 7799

Slovenija
Biogen Pharma d.o.o.
Tel: +386 1 511 02 90

Ísland
Icepharma hf
Sími: +354 540 8000

Slovenská republika
Biogen Slovakia s.r.o.
Tel: +421 2 323 340 08

Italia
Biogen Italia s.r.l.
Tel: +39 02 5849901

Suomi/Finland
Biogen Finland Oy
Puh/Tel: +358 207 401 200

Sverige
Biogen Sweden AB
Tel: +46 8 594 113 60

Κύπρος
Genesis Pharma Cyprus Ltd
Τηλ: +3572 2 765715

Latvija
Biogen Latvia SIA
Tel: +371 68 688 158
More detailed information on this medicinal product is available on the website of the European
Medicines Agency, https://www.ema.europa.eu/.