DIMETILFUMARATO 120 mg Энтеросолюбильные Твердые Капсулы

Содержание инструкции

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

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

dimethyl fumarate

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

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

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

What is Dimetilfumarato Accord used for
Dimetilfumarato Accord 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, i.e. the brain and the
spinal cord. Relapsing-remitting multiple sclerosis is characterized by repeated attacks
(relapses) of symptoms that affect the nervous system. The symptoms vary from patient to patient, but
generally include difficulty walking, a feeling of imbalance and visual disturbances (e.g.
blurred or double vision). These symptoms may disappear completely when the relapse
resolves, but some problems may remain.

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

2. What you need to know before taking Dimetilfumarato Accord

Do not take Dimetilfumarato Accord

• 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 the diagnosis of PML has been confirmed.

Warnings and precautions
Dimetilfumarato Accord can affect the number of white blood cells in the blood, the kidneysand the

liver. Before starting to take Dimetilfumarato Accord, your doctor will perform a blood test to count your white blood cells and check that your kidneys and liver are working
correctly. 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 discontinuation of therapy.

Talk to your doctorbefore taking Dimetilfumarato Accord if you have:

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

With treatment with Dimetilfumarato Accord, cases of herpes zoster infection
(shingles) can occur. In some cases, serious complications have occurred. Tell your doctor
immediately if you suspect you have any symptoms of herpes zoster infection.
If you believe that your multiple sclerosis 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
(Fanconi syndrome) has been observed. If you notice that you urinate more frequently, if you are more thirsty and if
you drink more than usual, your muscles are weaker, or in case of fracture or just pain, contact your
doctor as soon as possible so that thorough investigations can be initiated.

Children and adolescents
The warnings and precautions listed above also apply to children. Dimetilfumarato Accord
can be used in children and adolescents aged 13 years and over. No data are available
in children under 10 years of age.

Other medicines and Dimetilfumarato Accord
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 for the treatment of multiple sclerosis;
• 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 Dimetilfumarato Accord with certain types of vaccines (live vaccines) may cause an infection and should therefore be avoided. Your doctor will tell you if other types of vaccines (non-live vaccines) should be administered.

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

Pregnancy and breastfeeding
If you are pregnant, suspect you may be 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 Dimetilfumarato Accord 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 Dimetilfumarato Accord passes into breast milk. Your doctor
will help you decide whether to stop breastfeeding or treatment with Dimetilfumarato
Accord. This involves assessing the benefit of breastfeeding for the baby against the
benefit of therapy for you.

Driving and using machines
It is not expected that Dimetilfumarato Accord will affect your ability to drive and operate
machinery.

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

3. How to take Dimetilfumarato Accord

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask 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 Accord is for oral use.

Swallow each capsule whole, with a little water. You must not split, crush, dissolve,
suck or chew the capsule, because this could increase some undesirable effects.

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

If you take more Dimetilfumarato Accord 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 Dimetilfumarato Accord
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 everyone will experience them.

Serious side effects
Dimethyl fumarate Accord can reduce the levels of lymphocytes (a type of white blood cell). Persisting
low levels of white blood cells 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 manifested after 1-5 years of treatment, so the
doctor must continue to monitor white blood cells 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
functionality 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; confusion or changes in personality or
difficulty with speech and communication lasting more than a few days. Therefore, if you believe
that multiple sclerosis is worsening or if you notice any new symptom during therapy with
Dimethyl fumarate Accord, it is very important that you contact your doctor as soon as possible. Also,
inform your partner or caregiver about your treatment. Symptoms may arise 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 the 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 Dimethyl fumarate Accord and call a doctor immediately

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

• facial or body flushing, sensation of warmth, intense heat, burning or itching
• 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 Dimethyl fumarate Accord.

Contact your doctorfor information on how to manage these side effects. Your 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)
• vomiting
• indigestion (dyspepsia)
• inflammation of the stomach (gastritis)
• gastrointestinal disorder
• burning sensation
• hot flush, 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, leucopenia)in the blood. A reduction in the number of white blood cells in the blood may indicate that you are unable to fight 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)
• 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 inassociation with bilirubin)
• herpes zoster infection (shingles) with symptoms such as blisters, burning, itching or pain on the skin, 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
than in adults, such as headache, stomach pain or cramps, vomiting, sore
throat, cough and painful menstruation.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please 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 contribute
to providing more information on the safety of this medicine.

5. How to store Dimetilfumarato Accord

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
Expiry./EXP. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how
to eliminate medicines that you no longer use. This will help to protect the environment.

6. Package contents and other information

What Dimetilfumarato Accord contains
The active ingredientis dimethyl fumarate.
Dimetilfumarato Accord 120 mg: each capsule contains 120 mg of dimethyl fumarate.
Dimetilfumarato Accord 240 mg: each capsule contains 240 mg of dimethyl fumarate.

Other ingredientsare:
Capsule contents (mini enteric-coated tablets): microcrystalline cellulose
silicified, talc, sodium croscarmellose, colloidal anhydrous silica, magnesium stearate, acid
methacrylic-methyl methacrylate copolymer (1:1), triethyl citrate, acid methacrylic-ethyl acrylate
copolymer (1:1) dispersion 30%.
Capsule shell: gelatin, titanium dioxide (E171), brilliant blue FCF (E133), iron oxide
black (E172), iron oxide yellow (E172).
Printing on the capsule (black ink): shellac (E904), iron oxide black (E172), potassium hydroxide
(E525).

Description of the appearance of Dimetilfumarato Accord and contents of the pack
Dimetilfumarato Accord 120 mg gastro-resistant hard capsules are hard gelatin capsules of
size “0” (approximately 21.3 x 7.5 mm) with a green cap and white body, imprinted with “HR1” in
black ink on the capsule body, containing mini enteric-coated tablets of color
from white to off-white, round, biconvex, smooth on both sides.
Dimetilfumarato Accord 240 mg gastro-resistant hard capsules are hard gelatin capsules of
size “0” (approximately 21.3 x 7.5 mm) with a green cap and body, imprinted with “HR2” in black ink
on the capsule body, containing mini enteric-coated tablets of color from white to
off-white, round, biconvex, smooth on both sides.
120 mg capsules:
14 capsules in blister PVC/PE/PVDC-Alu packs.
14x1 capsules in perforated blister packs for a unit dose of PVC/PE/PVDC-Alu.
240 mg capsules:
56 or 168 capsules in blister PVC/PE/PVDC-Alu packs.
56x1 or 168x1 capsules in perforated blister packs for a unit dose of PVC/PE/PVDC-Alu.
Not all pack sizes may be marketed.

Marketing authorisation holder
Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona, s/n,
Edifici Est, 6 Planta,
08039 Barcelona,
Spain

Manufacturer
Accord Healthcare Polska Sp. z.o.o.
ul.Lutomierska 50,
95-200, Pabianice, Poland
Pharmadox Healthcare Limited
KW20A Kordin Industrial Park,
Paola PLA 3000, Malta
Accord Healthcare B.V.
Winthontlaan 200,
3526 KV Utrecht,
Netherlands
For further information on this medicine, contact the local representative of the marketing
authorisation holder:
AT / BE / BG / CY / CZ / DE / DK / EE / ES / FI / FR / HR / HU / IE / IS / IT / LT / LV / LX / MT /
NL / NO / PL / PT / RO / SE / SI / SK
Accord Healthcare S.L.U.
Tel: +34 93 301 00 64
EL
Win Medica Α.Ε.
Τηλ: +30 210 74 88 821
More detailed information on this medicine is available on the website of the European
Medicines Agency, http://www.ema.europa.eu.