DIMETILFUMARATO 120 mg Enteric-Coated Hard Capsule

Зміст інструкції

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

Dimetilfumarato Neuraxpharm 120 mg hard gastro-resistant capsules, 240 mg hard gastro-resistant capsules

dimetilfumarato

Read this leaflet carefully before you start taking this medicine as 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 could 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 Dimetilfumarato Neuraxpharm is and what it is used for
• 2. What you need to know before you take Dimetilfumarato Neuraxpharm
• 3. How to take Dimetilfumarato Neuraxpharm
• 4. Possible side effects
• 5. How to store Dimetilfumarato Neuraxpharm
• 6. Contents of the pack and other information

1. What is Dimetilfumarato Neuraxpharm and what it is used for

What is Dimetilfumarato Neuraxpharm
Dimetilfumarato Neuraxpharm is a medicine that contains the active ingredient dimetilfumarato.

What is Dimetilfumarato Neuraxpharm used for
Dimetilfumarato Neuraxpharm is used to treat relapsing-remitting multiple sclerosis (RRMS) in patients aged 13 years and older.
Multiple sclerosis is a chronic disease that affects the central nervous system (CNS), that is, 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, feeling unbalanced and visual impairment
(e.g. blurred or double vision). These symptoms may disappear completely when
the relapse resolves, but some problems may remain.

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

2. What you need to know before taking Dimetilfumarato Neuraxpharm

Do not take Dimetilfumarato Neuraxpharm

• 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
Dimetilfumarato Neuraxpharm can affect the number of white blood cells in the blood, the kidneysand the

liver. Before starting to take Dimetilfumarato Neuraxpharm, your doctor will perform a
blood test to count the number of white blood cells and will check that your kidneys and liver
are functioning properly. Your doctor will perform the tests periodically during treatment. If
the number of white blood cells decreases during treatment, your doctor may consider further
tests or discontinuation of therapy.

Talk to your doctorbefore taking Dimetilfumarato Neuraxpharm if you have:

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

With treatment with dimethyl fumarate, cases of herpes zoster infection (shingles) can occur.
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 undertaken.

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

Other medicines and Dimetilfumarato Neuraxpharm
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 chemotherapy drugs, immunosuppressants or other medicines used to treat MS;
• medicines that affect the kidneys, including some antibiotics(used to treat 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 Dimetilfumarato Neuraxpharm with certain types of vaccines (live vaccines) can 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.

Dimetilfumarato Neuraxpharm 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
Dimetilfumarato Neuraxpharm, because alcohol can interact with this medicine. This can
cause stomach inflammation (gastritis), especially in people already prone to gastritis.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, 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 Dimetilfumarato Neuraxpharm if you are pregnant unless you have
discussed with your doctor that this medicine is clearly necessary for you.
Breastfeeding
It is not known whether the active ingredient of Dimetilfumarato Neuraxpharm passes into breast milk. Your doctor
will advise you whether to stop breastfeeding or treatment with Dimetilfumarato
Neuraxpharm. This involves assessing the benefit of breastfeeding for the baby against
the benefit of therapy for you.

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

Dimetilfumarato Neuraxpharm contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per capsule, i.e. essentially “sodium-free”.

3. How to take Dimetilfumarato Neuraxpharm

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

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

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

Swallow each capsule wholewith a little water. You must not split, crush, dissolve,
suck or chew the capsule, because this can increase certain undesirable effects.

Take Dimetilfumarato Neuraxpharmwith food– this may help to reduce some of the more
common undesirable effects (listed in section 4).

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

If you forget to take Dimetilfumarato Neuraxpharm
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.
li manifestino.

Serious side effects
Dimetilfumarato Neuraxpharm can lower the levels of lymphocytes (a type of white blood cell). Persistently low white blood cell levels may 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 dimethyl fumarate, it is very important that you see 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 hives 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 Dimetilfumarato Neuraxpharm and call your doctor immediately
Other side effects
Very common (may affect more than 1 in 10people):

• facial or body flushing, feeling of warmth, intense 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-mentioned side effects
The presence of substances called ketones, which are naturally produced by the body, is commonly revealed
in urine tests during the intake of Dimetilfumarato Neuraxpharm.

See your doctorfor information on how to manage these side effects. The doctor may reduce
the dose. Do not reduce the dose unless your doctor tells you to do so.
Common (may affect up to 1 in 10people):

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

Side effects that may emerge from blood or urine tests

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

Uncommon(may affect up to 1 in 100people):

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

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

• inflammation of the liver and increased levels of liver enzymes (ALT or AST in association with bilirubin)
• 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 over) 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 than in 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, talk to 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 Dimetilfumarato Neuraxpharm

Keep this medicine out of the sight and reach of children.
Do not store at a temperature above 30°C.
Do not use this medicine after the expiry date which is stated on the pack after “Exp”. The expiry
date refers to the last day of that month.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Dimetilfumarato Neuraxpharm contains
The active ingredient is dimethyl fumarate.
Dimetilfumarato Neuraxpharm 120 mg: each capsule contains 120 mg of dimethyl fumarate.
Dimetilfumarato Neuraxpharm 240 mg: each capsule contains 240 mg of dimethyl fumarate.
The other ingredients are:
Capsule contents: sodium croscarmellose, anhydrous colloidal silica, sodium stearyl fumarate,
acrylic acid-methyl methacrylate copolymer (1:1), acrylic acid-ethyl acrylate copolymer (1:1)
dispersion 30%, talc, triethyl citrate, Glycerol Monostearate 40-55
Capsule: gelatin, titanium dioxide (E171), yellow iron oxide (E172), Brilliant Blue FCF (E133)
Ink on the capsule: shellac, black iron oxide (E172), propylene glycol (E1520),
ammonium hydroxide 28%

Description of the appearance of Dimetilfumarato Neuraxpharm and contents of the pack
Dimetilfumarato Neuraxpharm 120 mg: hard gastro-resistant gelatin capsules, length: 19 mm,
with a white body and light green cap, with “120 mg” printed on the body and available in packs
of 14 or 56 capsules and 14 x 1 capsules in perforated single-dose blisters.
Dimetilfumarato Neuraxpharm 240 mg: hard gastro-resistant gelatin capsules, length: 23 mm,
light green with “240 mg” printed on the body and available in packs of 14, 56, 168 and 196 capsules and
56 x 1 capsules in perforated single-dose blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Neuraxpharm Pharmaceuticals, S.L.
Avda. Barcelona 69
08970 Sant Joan Despí - Barcelona
Spain
Tel: +34 93 475 96 00
E-mail: [email protected]

Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
Poland
Zakłady Farmaceutyczne POLPHARMA S.A.
Production Plant in Nowa Dęba
ul. Metalowca 2, 39-460 Nowa Dęba
Poland
Neuraxpharm Pharmaceuticals, S.L.
Avda. Barcelona 69
08970 Sant Joan Despí
Barcelona - Spain
neuraxpharm Arzneimittel GmbH
Elisabeth-Selbert-Straße 23
40764 Langenfeld - Germany
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

Lietuva
Neuraxpharm Pharmaceuticals, S.L.
Tel:+34 93 475 96 00

България
Neuraxpharm Pharmaceuticals, S.L.
Тел.: +34 93 475 96 00

België/Belgique/Belgien
Neuraxpharm Belgium
Tél/Tel: +32 (0)2 732 56 95

Luxembourg/Luxemburg
Neuraxpharm France
Tél/Tel: +32 474 62 24 24

Česká republika
Neuraxpharm Bohemia s.r.o.
Tel: +420 739 232 258

Magyarország
Neuraxpharm Hungary Kft.
Tel.: +3630 464 6834

Danmark
Neuraxpharm Sweden AB
Tlf: +46 (0)8 30 91 41
(Sverige)

Malta
Neuraxpharm Pharmaceuticals, S.L.
Tel.:+34 93 475 96 00

Nederland
Neuraxpharm Netherlands B.V.
Tel.: +31 70 208 5211

Eesti
Neuraxpharm Pharmaceuticals, S.L.
Tel: +34 93 475 96 00

Deutschland
neuraxpharm Arzneimittel GmbH
Tel: +49 2173 1060 0

Norge
Neuraxpharm Sweden AB
Tlf:+46 (0)8 30 91 41
(Sverige)

Österreich
Neuraxpharm Austria GmbH
Tel.: + 43 (0) 2236 320038

España
Neuraxpharm Spain, S.L.U.
Tel: +34 93 475 96 00

Ελλάδα
Brain Therapeutics PC
Τηλ: +302109931458

Polska
Neuraxpharm Polska Sp. z.o.o.
Tel.: +48 783 423 453

France
Neuraxpharm France
Tél: +33 1.53.62.42.90

Portugal
Neuraxpharm Portugal, Unipessoal Lda
Tel: +351 910 259 536

Hrvatska
Neuraxpharm Pharmaceuticals, S.L.
T +34 93 475 96 00

Ireland
Neuraxpharm Ireland Ltd.
Tel: +353 (0)1 428 7777

România
Neuraxpharm Pharmaceuticals, S.L.
Tel: +34 93 475 96 00

Slovenija
Neuraxpharm Pharmaceuticals, S.L.
T +34 93 475 96 00

Ísland
Neuraxpharm Sweden AB
Sími: +46 (0)8 30 91 41
(Svíþjóð)

Slovenská republika
Neuraxpharm Slovakia a.s.
Tel: +421 255 425 562

Italia
Neuraxpharm Italy S.p.A.
Tel: +39 0736 980619

Suomi/Finland
Neuraxpharm Sweden AB
Puh/Tel: +46 (0)8 30 91 41
(Ruotsi/Sverige)

Κύπρος
Brain Therapeutics PC
Τηλ: +302109931458

Sverige
Neuraxpharm Sweden AB
Tel: +46 (0)8 30 91 41

Latvija
Neuraxpharm Pharmaceuticals, S.L.
Tel: +34 93 475 96 00
More detailed information on this medicinal product is available on the website of the European Medicines
Agency, http://www.ema.europa.eu.