dimethyl fumarate: package leaflet

120 mg
‒

120 mg

120 mg

120 mg

9+
120 mg

Your doctor will check how well your condition is improving after you start taking Skilarence and will check for side effects. If you have severe side effects after an increase in dose, your doctor may recommend that you temporarily go back to the last dose. If the side effects are not that troublesome, your dose will be increased until your condition is well controlled. You may not need the maximum dose of 720 mg per day as supplied in the table above. After your condition has improved sufficiently, your doctor will consider how to gradually reduce the daily dose of Skilarence to what you need to maintain your improvement.

Method of administration
Swallow Skilarence tablets whole with liquid. Take your tablet(s) during or immediately after a meal.
Do not crush, break, dissolve or chew the tablet, as they have a special coating to help prevent irritation of your stomach.

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 a forgotten dose. 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.
Please ask your doctor or pharmacist if you are not sure.

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. Some of these side effects, such as reddening of the face or body (flushing), diarrhoea, stomach problems and nausea usually improve as you continue treatment.

The most serious side effects that may occur with Skilarence are allergic or hypersensitivity reactions;
kidney failure or a kidney disease called Fanconi syndrome; or a severe brain infection called progressive multifocal leukoencephalopathy (PML). It is not known how commonly they occur. For symptoms see below.

Allergic or hypersensitivity reactions
Allergic or hypersensitivity reactions are rare but may be very serious. Reddening of the face or body (flushing) is a very common side effect which may affect more than 1 in 10 people. However, if you become flushed and get any of the following signs:
- wheezing, difficulty breathing or shortness of breath,
- swelling of the face, lips, mouth or tongue stop taking Skilarence and call a doctor straight away.

Brain infection called PML
Progressive multifocal leukoencephalopathy (PML) is a rare but serious brain infection that can lead to severe disability or death. If you notice new or worsening weakness on one side of the body;
clumsiness; changes in vision, thinking or memory; confusion; or personality changes lasting several days, stop taking Skilarence and talk to your doctor straight away.

Fanconi syndrome
Fanconi syndrome is a rare but serious kidney disorder which may occur with Skilarence. If you notice you are passing more urine (or more frequently); are more thirsty and drinking more than normal; your muscles seem weaker you break a bone; or just have aches and pains, talk to your doctor as soon as possible so that this can be investigated further.

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

Very common (may affect more than 1 in 10 people)
- decrease in white blood cells called lymphocytes (lymphopenia)
- decrease in all white blood cells (leukopenia)
- reddening of the face or body (flushing)
- diarrhoea
- bloating, stomach pain or stomach cramps
- feeling sick (nausea)

Common (may affect up to 1 in 10 people)
- increase in all white blood cells (leukocytosis)
- increase in specific white blood cells called eosinophils
- increase in certain enzymes in the blood (used for checking the health of your liver)
- being sick
- constipation
- gas (flatulence), stomach discomfort, indigestion
- decreased appetite
- headache
- feeling tired
- weakness
- feeling hot
- abnormal sensations of the skin, such as itching, burning, stinging, tickling or tingling
- pink or red blotches on the skin (erythema)

Uncommon (may affect up to 1 in 100 people)
- dizziness
- excess protein in the urine (proteinuria)
- increase in serum creatinine (a substance in the blood used for measuring how well your kidneys are working)

Rare (may affect up to 1 in 1,000 people)
- allergic skin reaction

Very rare (may affect up to 1 in 10,000 people)
- acute lymphatic leukaemia (a type of blood cancer)
- decrease in all types of blood cells (pancytopenia)

Not known (frequency cannot be estimated from the available data)
- shingles

Reporting of side effects
If you get 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.
How to store 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 the blister after “EXP”.
The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6.
Contents of the pack and other information

What Skilarence 30 mg contains
- the active substance is dimethyl fumarate. One tablet contains 30 mg dimethyl fumarate.
- the other ingredients are: lactose monohydrate, cellulose microcrystalline, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate, methacrylic acid-ethyl acrylate

copolymer (1:1), talc, triethyl citrate, titanium dioxide (E171) and simethicone.

What Skilarence 30 mg looks like and contents of the pack
Skilarence 30 mg is a white, round tablet with a diameter of approximately 6.8 mm.
Skilarence 30 mg is available in packs containing 42, 70 and 210 gastro-resistant tablets. Not all pack sizes may be marketed. The tablets are packed in PVC/PVDC-aluminium blisters.

Marketing Authorisation Holder
Almirall, S.A.
Ronda General Mitre, 151
E-08022 Barcelona
Spain
Tel. +34 93 291 30 00

Manufacturer
Industrias Farmacéuticas Almirall, S.A.
Ctra. de Martorell 41-61
E-08740 Sant Andreu de la Barca, Barcelona
Spain

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien/ Luxembourg/Luxemburg
Almirall N.V., Tél/Tel: +32 (0)2 771 86 37

България/ Eesti/ España/ Hrvatska/ Κύπρος/ Latvija/ Lietuva/ Magyarország/ Malta/ România/ Slovenija Almirall, S.A., Teл/Tel/Τηλ: +34 93 291 30 00

Česká republika/ Slovenská republika
Almirall s.r.o, Tel: +420 739 686 638

Danmark/ Norge/ Sverige
Almirall ApS, Tlf/Tel: +45 70 25 75 75

Deutschland
Almirall Hermal GmbH, Tel: +49 (0)40 72704-0

Ελλάδα
Galenica A.E., Tηλ: +30 210 52 81 700

France
Almirall SAS, Tél: +33(0)1 46 46 19 20

Ireland
Almirall, S.A., Tel: +353 1800 849322

Ísland
Vistor hf., Sími: +354 535 70 00

Italia
Almirall SpA, Tel: +39 02 346181

Nederland
Almirall B.V., Tel: +31 (0) 30 711 15 10

Österreich
Almirall GmbH, Tel: +43 (0)1/595 39 60

Polska
Almirall Sp. z o.o., Tel.: +48 22 330 02 57

Portugal
Almirall - Produtos Farmacêuticos, Lda., Tel: +351 21 415 57 50

Suomi/Finland
Orion Pharma, Puh/Tel: +358 10 4261

This leaflet was last revised in .

Other sources of information
Detailed information on this medicine is available on the European Medicines Agency web site:
https://www.ema.europa.eu.

120 mg
‒

120 mg

120 mg

120 mg

9+
120 mg

Your doctor will check how well your condition is improving after you start taking Skilarence and will check for side effects. If you have severe side effects after an increase in dose, your doctor may recommend that you temporarily go back to the last dose. If the side effects are not that troublesome, your dose will be increased until your condition is well controlled. You may not need the maximum dose of 720 mg per day as supplied in the table above. After your condition has improved sufficiently, your doctor will consider how to gradually reduce the daily dose of Skilarence to what you need to maintain your improvement.

Method of administration
Swallow Skilarence tablets whole with liquid. Take your tablet(s) during or immediately after a meal.
Do not crush, break, dissolve or chew the tablet, as they have a special coating to help prevent irritation of your stomach.

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 a forgotten dose. 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.
Please ask your doctor or pharmacist if you are not sure.

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. Some of these side effects, such as reddening of the face or body (flushing), diarrhoea, stomach problems and nausea usually improve as you continue treatment.

The most serious side effects that may occur with Skilarence are allergic or hypersensitivity reactions;
kidney failure or a kidney disease called Fanconi syndrome; or a severe brain infection called progressive multifocal leukoencephalopathy (PML). It is not known how commonly they occur. For symptoms see below.

Allergic or hypersensitivity reactions
Allergic or hypersensitivity reactions are rare but may be very serious. Reddening of the face or body (flushing) is a very common side effect which may affect more than 1 in 10 people. However, if you become flushed and get any of the following signs:
- wheezing, difficulty breathing or shortness of breath,
- swelling of the face, lips, mouth or tongue stop taking Skilarence and call a doctor straight away.

Brain infection called PML
Progressive multifocal leukoencephalopathy (PML) is a rare but serious brain infection that can lead to severe disability or death. If you notice new or worsening weakness on one side of the body;
clumsiness; changes in vision, thinking or memory; confusion; or personality changes lasting several days, stop taking Skilarence and talk to your doctor straight away.

Fanconi syndrome
Fanconi syndrome is a rare but serious kidney disorder which may occur with Skilarence. If you notice you are passing more urine (or more frequently); are more thirsty and drinking more than normal; your muscles seem weaker; you break a bone; or just have aches and pains, talk to your doctor as soon as possible so that this can be investigated further.

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

Very common (may affect more than 1 in 10 people)
- decrease in white blood cells called lymphocytes (lymphopenia)
- decrease in all white blood cells (leukopenia)
- reddening of the face or body (flushing)
- diarrhoea
- bloating, stomach pain or stomach cramps
- feeling sick (nausea)

Common (may affect up to 1 in 10 people)
- increase in all white blood cells (leukocytosis)
- increase in specific white blood cells called eosinophils
- increase in certain enzymes in the blood (used for checking the health of your liver)
- being sick
- constipation
- gas (flatulence), stomach discomfort, indigestion
- decreased appetite
- headache
- feeling tired
- weakness
- feeling hot
- abnormal sensations of the skin, such as itching, burning, stinging, tickling or tingling
- pink or red blotches on the skin (erythema)

Uncommon (may affect up to 1 in 100 people)
- dizziness
- excess protein in the urine (proteinuria)
- increase in serum creatinine (a substance in the blood used for measuring how well your kidneys are working)

Rare (may affect up to 1 in 1,000 people)
- allergic skin reaction

Very rare (may affect up to 1 in 10,000 people)
- acute lymphatic leukaemia (a type of blood cancer)
- decrease in all types of blood cells (pancytopenia)

Not known (frequency cannot be estimated from the available data)
- shingles

Reporting of side effects
If you get 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.
How to store 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 the blister after “EXP”.
The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6.
Contents of the pack and other information

What Skilarence 120 mg contains
- the active substance is dimethyl fumarate. One tablet contains 120 mg dimethyl fumarate.
- the other ingredients are: lactose monohydrate, cellulose microcrystalline, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate, methacrylic acid-ethyl acrylate

copolymer (1:1), talc, triethyl citrate, titanium dioxide (E171), simethicone, indigo carmine (E132) and sodium hydroxide.

What Skilarence 120 mg looks like and contents of the pack
Skilarence 120 mg is a blue, round tablet with a diameter of approximately 11.6 mm.
Pack sizes: 40, 70, 90, 100, 120, 180, 200, 240, 300, 360 and 400 gastro-resistant tablets. Not all pack sizes may be marketed. The tablets are packed in PVC/PVDC-aluminium blisters.

Marketing Authorisation Holder
Almirall, S.A.
Ronda General Mitre, 151
E-08022 Barcelona
Spain
Tel. +34 93 291 30 00

Manufacturer
Industrias Farmacéuticas Almirall, S.A.
Ctra. de Martorell 41-61
E-08740 Sant Andreu de la Barca, Barcelona
Spain

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien/ Luxembourg/Luxemburg
Almirall N.V., Tél/Tel: +32 (0)2 771 86 37

България/ Eesti/ España/ Hrvatska/ Κύπρος/ Latvija/ Lietuva/ Magyarország/ Malta/ România/ Slovenija Almirall, S.A., Teл/Tel/Τηλ: +34 93 291 30 00

Česká republika/ Slovenská republika
Almirall s.r.o, Tel: +420 739 686 638

Danmark/ Norge/ Sverige
Almirall ApS, Tlf/Tel: +45 70 25 75 75

Deutschland
Almirall Hermal GmbH, Tel: +49 (0)40 72704-0

Ελλάδα
Galenica A.E., Tηλ: +30 210 52 81 700

France
Almirall SAS, Tél: +33(0)1 46 46 19 20

Ireland
Almirall, S.A., Tel: +353 1800 849322

Ísland
Vistor hf., Sími: +354 535 70 00

Italia
Almirall SpA, Tel: +39 02 346181

Nederland
Almirall B.V., Tel: +31 (0) 30 711 15 10

Österreich
Almirall GmbH, Tel: +43 (0)1/595 39 60

Polska
Almirall Sp. z o.o., Tel.: +48 22 330 02 57

Portugal
Almirall - Produtos Farmacêuticos, Lda., Tel: +351 21 415 57 50

Suomi/Finland
Orion Pharma, Puh/Tel: +358 10 4261

This leaflet was last revised in .

Other sources of information
Detailed information on this medicine is available on the European Medicines Agency web site:
https://www.ema.europa.eu.

What Tecfidera is
Tecfidera is a medicine that contains the active substance dimethyl fumarate.
What Tecfidera is used for
Tecfidera is used to treat relapsing-remitting multiple sclerosis (MS) in patients aged 13 years and older.
MS is a long-term condition that affects the central nervous system (CNS), including the brain and the spinal cord. Relapsing-remitting MS is characterised by repeated attacks (relapses) of nervous system symptoms. Symptoms vary from patient to patient, but typically include walking difficulties, feeling off balance and visual difficulties (e.g. blurred or double vision). These symptoms may disappear completely when the relapse is over, but some problems may remain.
How Tecfidera works
Tecfidera seems to work by stopping the body’s defence system from damaging your brain and spinal cord. This may also help to delay future worsening of your MS.

Do not take Tecfidera
- if you are allergic to dimethyl fumarate or any of the other ingredients of this medicine (listed in section 6).

- if you are suspected to suffer from 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 counts, your kidneys and liver. Before you start Tecfidera, your doctor will do 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 test these periodically during treatment. If your number of white blood cells decreases during treatment, your doctor may consider additional tests or discontinue your treatment.
Talk to your doctor before taking Tecfidera if you have:
- severe kidney disease
- severe liver disease
- a disease of the stomach or bowel
- a serious infection (such as pneumonia)
Herpes zoster (shingles) may occur with Tecfidera treatment. In some cases, serious complications have occurred. You should inform your doctor immediately if you suspect you have any symptoms of shingles.
If you believe your MS is getting worse (e.g. weakness or visual changes) or if you notice any new symptoms, talk to your doctor straight away because these may be the symptoms of a rare brain infection called PML. PML is a serious condition that may lead to severe disability or death.
A rare but serious kidney disorder called Fanconi syndrome has been reported with a medicine containing dimethyl fumarate, in combination with other fumaric acid esters, used to treat psoriasis (a skin disease). If you notice you are passing more urine, are thirstier and drinking more than normal, your muscles seem weaker, you break a bone, or just have aches and pains, talk to your doctor as soon as possible so that this can be investigated further.
Children and adolescents
Do not give this medicine to children below 10 years of age because no data are available in this age group.
Other medicines and Tecfidera
Tell your doctor or pharmacist if 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 body’s immune system including chemotherapy, immunosuppressants, or other medicines used to treat MS;
- medicines that affect the kidneys including some antibiotics (used to treat infections), “water tablets” (diuretics), certain types of painkillers (such as ibuprofen and other similar anti- inflammatories and medicines purchased without a doctor’s prescription) and medicines that contain lithium;
- taking Tecfidera with certain types of vaccines (live vaccines) may cause you to get an infection and should, therefore, be avoided. Your doctor will advise whether other types of vaccines (non- live vaccines) should be given.
Tecfidera with alcohol
Consumption of more than a small amount (more than 50 ml) of strong alcoholic drinks (more than 30% alcohol by volume, e.g. spirits) should be avoided within an hour of taking Tecfidera, as alcohol can interact with this medicine. This could cause inflammation of the stomach (gastritis), especially in people already prone to gastritis.

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
There is limited information about 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.
Breast-feeding
It is not known whether the active substance of Tecfidera passes into breast milk. Your doctor will advise whether you should stop breast-feeding, or stop using Tecfidera. This involves balancing the benefit of breast-feeding for your child, and 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 sodium (23 mg) per capsule, that is to say essentially ‘sodium free’.

Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.
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 for oral use.
Swallow each capsule whole, with some water. Do not divide, crush, dissolve, suck or chew the capsule as this may increase some side effects.
Take Tecfidera with food – it may help to reduce some of the very common side effects (listed in section 4).
If you take more Tecfidera than you should
If you have taken too many capsules, talk to your doctor straight away. You may experience side effects similar to those described below in section 4.
If you forget to take Tecfidera
If you forget or miss a dose, do not take a double dose.
You may take the missed dose if you leave at least 4 hours between the doses. Otherwise wait until your next planned dose.

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

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects
Tecfidera may lower lymphocyte counts (a type of white blood cell). Having a low white blood cell count can increase your risk of infection, including the risk of a rare brain infection called progressive multifocal leukoencephalopathy (PML). PML may lead to severe disability or death. PML has occurred after 1 to 5 years of treatment and so your physician should continue to monitor your white blood cells throughout your treatment, and you should remain observant of any potential symptoms of PML as described below. The risk of PML may be higher if you have previously taken a medicine impairing the functionality of your body’s immune system.
The symptoms of PML may be similar to an MS relapse. Symptoms may include new or worsening weakness on one side of the body; clumsiness; changes in vision, thinking, or memory; or confusion or personality changes, or speech and communication difficulties lasting for more than several days.
Therefore, if you believe your MS is getting worse or if you notice any new symptoms while you are on Tecfidera treatment, it is very important that you speak to your doctor as soon as possible. Also speak with your partner or caregivers and inform them about your treatment. Symptoms might arise that you might not become aware of by yourself.

Call your doctor straight away if you experience any of these symptoms
Severe allergic reactions
The frequency of severe allergic reactions cannot be estimated from the available data (not known).
Reddening of the face or body (flushing) is a very common side effect. However, should flushing be accompanied by a red rash or hives and you get any of these symptoms:
- swelling of the face, lips, mouth or tongue (angioedema)
- wheezing, difficulty breathing or shortness of breath (dyspnoea, hypoxia)
- dizziness or loss of consciousness (hypotension) then this may represent a severe allergic reaction (anaphylaxis).

Stop taking Tecfidera and call a doctor straight away
Other side effects
Very common (may affect more than 1 in 10 people)
- reddening of the face or body feeling warm, hot, burning or itchy (flushing)
- loose stools (diarrhoea)
- feeling sick (nausea)
- stomach pain or stomach cramps

Taking your medicine with food can help to reduce the side effects above
Substances called ketones, which are naturally produced in the body, very commonly show up in urine tests while taking Tecfidera.
Talk to your doctor about how to manage these side effects. Your doctor may reduce your dose. Do

not reduce your dose unless your doctor tells you to.
Common (may affect up to 1 in 10 people)
- inflammation of the lining of the intestines (gastroenteritis)
- being sick (vomiting)
- indigestion (dyspepsia)
- inflammation of the lining of the stomach (gastritis)
- gastrointestinal disorder
- burning sensation
- hot flush, feeling hot
- itchy skin (pruritus)
- rash
- pink or red blotches on the skin (erythema)
- hair loss (alopecia)
Side effects which may show up in your blood or urine tests
- low levels of white blood cells (lymphopenia, leucopenia) in the blood. Reduced white blood cells could mean your body is less able to fight an infection. If you have a serious infection (such as pneumonia), talk to your doctor immediately
- proteins (albumin) in urine
- increase in levels of liver enzymes (ALT, AST) in the blood
Uncommon (may affect up to 1 in 100 people)
- allergic reactions (hypersensitivity)
- reduction in blood platelets
Rare (may affect up to 1 in 1,000 people)
- liver inflammation and increase in levels of liver enzymes (ALT or AST in combination with bilirubin) Not known (frequency cannot be estimated from the available data)
- herpes zoster (shingles) with symptoms such as blisters, burning, itching or pain of the skin, typically on one side of the upper body or the face, and other symptoms, like fever and weakness in the early stages of infection, followed by numbness, itching or red patches with severe pain
- runny nose (rhinorrhoea)
Children (13 years of age and above) and adolescents
The side effects listed 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 stomach cramps, being sick (vomiting), throat pain, cough, and painful menstrual periods.
Reporting of side effects
If you get 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.

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 carton after “EXP”.
The expiry date refers to the last day of that month.

Do not store above 30ºC.
Keep the blisters in the outer carton in order to protect from light.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.

What Tecfidera contains
The active substance is 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 ingredients are microcrystalline cellulose, croscarmellose sodium, talc, silica colloidal anhydrous, magnesium stearate, triethyl citrate, methacrylic acid – methyl methacrylate copolymer (1:1), methacrylic acid – ethyl acrylate copolymer (1:1) dispersion 30%, simeticone, sodium laurilsulfate, polysorbate 80, gelatin, titanium dioxide (E171), brilliant blue FCF (E133), yellow iron oxide (E172), shellac, potassium hydroxide and black iron oxide (E172).
What Tecfidera looks like and contents of the pack
Tecfidera 120 mg gastro-resistant hard capsules are green and white and printed with ‘BG-12 120 mg’ and are available in packs containing 14 capsules.
Tecfidera 240 mg gastro-resistant hard 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
The Netherlands
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder België/Belgique/Belgien Biogen Belgium NV/SA Tél/Tel: +32 2 2191218 Lietuva Biogen Lithuania UAB Tel: +370 5 259 6176 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
Danmark
Biogen (Denmark) A/S
Tlf.: +45 77 41 57 57
Malta
Pharma. MT Ltd.
Tel: +356 21337008

Deutschland
Biogen GmbH
Tel: +49 (0) 89 99 6170
Nederland
Biogen Netherlands B.V.
Tel: +31 20 542 2000
Eesti
Biogen Estonia OÜ
Tel: +372 618 9551
Norge
Biogen Norway AS
Tlf: +47 23 40 01 00
Ελλάδα
Genesis Pharma SA
Tηλ: +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
Κύπρος
Genesis Pharma Cyprus Ltd
Tηλ: +3572 2 765715
Sverige
Biogen Sweden AB
Tel: +46 8 594 113 60
Latvija
Biogen Latvia SIA
Tel: +371 68 688 158
This leaflet was last revised in {MM YYYY}.
Detailed information on this medicine is available on the European Medicines Agency web site:
https://www.ema.europa.eu