Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - tecfidera

Document Subject

Generated Narrative: MedicinalProductDefinition mpeb26fa1671149a9a84afe4c1bb85528a

identifier: http://ema.europa.eu/identifier/EU/1/13/837/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Tecfidera 120 mg gastro-resistant hard capsules

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-eb26fa1671149a9a84afe4c1bb85528a

identifier: http://ema.europa.eu/identifier/EU/1/13/837/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - tecfidera

Attesters

What is in 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

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

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

• liver inflammation and increase in levels of liver enzymes (ALT or AST in combination with bilirubin)
• 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 30 C. 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

Biogen Netherlands B.V. Prins Mauritslaan 1171 LP Badhoevedorp The Netherlands

Manufacturer

FUJIFILM Diosynth Biotechnologies Denmark ApS Biotek All 1 DK-3400 Hiller d Denmark

Biogen Netherlands B.V. Prins Mauritslaan 1171 LP Badhoevedorp The Netherlands

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

Belgi /Belgique/Belgien Biogen Belgium NV/SA T l/Tel: +32 2 2191Lietuva Biogen Lithuania UAB Tel: +370 5 259 6

Te : +359 2 962 12 Luxembourg/Luxemburg Biogen Belgium NV/SA T l/Tel: +32 2 2191 esk republika Biogen (Czech Republic) s.r.o. Tel: +420 255 706 Magyarorsz g Biogen Hungary Kft. Tel: + 36 1 899 9Danmark Biogen (Denmark) A/S Tlf: +45 77 41 57 Malta Pharma. MT Ltd.
Tel: +356 21337Deutschland Biogen GmbH Tel: +49 (0) 89 99 6Nederland Biogen Netherlands B.V. Tel: +31 20 542 2Eesti Biogen Estonia O
Tel: +372 618 9Norge Biogen Norway AS Tlf: +47 23 40 01
Genesis Pharma SA
T : +30 210 8771 sterreich Biogen Austria GmbH Tel: +43 1 484 46 Espa a Biogen Spain, S.L. Tel: +34 91 310 7Polska Biogen Poland Sp. z o.o.
Tel: +48 22 351 51 France Biogen France SAS T l: +33 (0)1 41 37 95 Portugal Biogen Portugal Sociedade Farmac utica, Unipessoal, Lda. Tel: +351 21 318 8Hrvatska Biogen Pharma d.o.o
Tel: +385 (0) 1 775 73 Rom nia Johnson & Johnson Romania S.R.L.
Tel: +40 21 207 18 Ireland Biogen Idec (Ireland) Ltd. Tel: +353 (0)1 463 7Slovenija Biogen Pharma d.o.o. Tel: +386 1 511 02 sland Icepharma hf S mi: +354 540 8Slovensk republika Biogen Slovakia s.r.o. Tel: +421 2 323 340 Italia Biogen Italia s.r.l. Tel: +39 02 5849Suomi/Finland Biogen Finland Oy Puh/Tel: +358 207 401
Genesis Pharma Cyprus Ltd
T : +3572 2 765Sverige Biogen Sweden AB Tel: +46 8 594 113 Latvija Biogen Latvia SIA Tel: +371 68 688 United Kingdom (Northern Ireland) Biogen Idec (Ireland) Limited Tel: +44 (0) 1628 50 1This leaflet was last revised in {MM YYYY}.

Detailed information on this medicine is available on the European Medicines Agency web site: