MUSTEF 120 mg Enteric-Coated Hard Capsule

Содержание инструкции

1. Mustef 120 mg hard gastro-resistant capsules, 240 mg hard gastro-resistant capsules
   1. What is Mustef and what is it used for
   2. What you need to know before you take Mustef
   3. How to take Mustef
   4. Possible side effects
   5. How to store Mustef
   6. Package Contents and Other Information

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

Dimethyl fumarate
Generic medicine

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

1. What is Mustef and what is it used for

What is Mustef
Mustef is a medicine that contains the active substance dimethyl fumarate.

What is Mustef used for
Mustef 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, feeling unbalanced and difficulty
with vision (e.g. blurred or double vision). These symptoms may disappear completely when
the relapse resolves, but some problems may remain.

How Mustef works
It appears that Mustef 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 you take Mustef

Do not take Mustef

• 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
Mustef can affect the number of white blood cells in the blood, the kidneysand the liver. Before
starting to take Mustef, your doctor will perform a blood test to count your white blood cells and check that your kidneys and liver are functioning 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 Mustef 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)

Cases of herpes zoster infection (shingles) can occur with treatment with Mustef. 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 because these may be
symptoms of a rare brain infection called progressive multifocal leukoencephalopathy (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 are urinating more frequently, if you are more thirsty and 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 carried out.

Children and adolescents
The warnings and precautions listed above also apply to children. Mustef 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 Mustef
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 other medicines used forthe treatment of multiple sclerosis,such as fingolimod, natalizumab, teriflunomide, alemtuzumab, ocrelizumab or cladribine, or some treatments commonly used for cancer(rituximab or mitoxantrone)
• medicines that affect the kidneys, including some antibiotics(used to treat infections), diuretics, some types of painkillers(such as ibuprofen and other similar anti-inflammatory drugs and over-the-counter medicines) and medicines that contain lithium
• Taking this medicine 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.

Mustef with alcohol
The consumption of alcoholic beverages should be avoided within two hours of taking this medicine,
because alcohol can increase the frequency of gastrointestinal adverse reactions.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning to become pregnant or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Do not use Mustef if you are pregnant, unless you have discussed this with your doctor.
Breastfeeding
It is not known whether the active ingredient of Mustef passes into breast milk. Mustef should not be used
during breastfeeding. Your doctor will help you decide whether to stop breastfeeding or the treatment with Mustef. This involves assessing the benefit of breastfeeding for your
child against the benefit of therapy for you.

Driving and using machines
The effect of this medicine on the ability to drive and operate machines is unknown.
This medicine is not expected to affect the ability to drive and operate machinery.

3. How to take Mustef

Take this medicine following the instructions of your doctor exactly. 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.
Mustef is for oral use.

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

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

If you take more Mustef 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 Mustef
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
Mustef can reduce the levels of lymphocytes (a type of white blood cell). Persistently low white blood cell levels 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 Mustef, it is very important that you contact your doctor as soon as possible. Also inform your
partner or caregiver about your treatment. Symptoms may develop 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 urticarial 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 be a serious allergic reaction (anaphylaxis)

Stop taking Mustef and call a doctor immediately
Very common side effects
These may affect more than 1 in 10 people:

• 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 food may help reduce the above side effectsThe presence of substances called ketones, which are produced naturally by the body, is very commonly revealed in urine tests during the administration of dimethyl fumarate. Contact your doctor for 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 side effects
These 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 flashes, feeling of heat
• itching
• 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 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), contact your doctor immediately
• protein ( albumin) in the urine
• increased levels of liver enzymes ( alanine-aminotransferase, ALTand aspartate-aminotransferase, AST) in the blood

Uncommon side effects
These may affect up to 1 in 100 people:

• allergic reactions (hypersensitivity)
• decreased 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 incombination 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 stomach cramps, vomiting, sore
throat, cough and painful menstruation.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly through
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Mustef

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, the bottle and the
pack after 'EXP.'.
The expiry date refers to the last day of that month.
This medicine does not require any particular storage temperature.
Store the blisters in the original 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 Mustef Contains
The active ingredient is dimethyl fumarate.

Mustef 120 mg hard gastro-resistant capsules: each capsule contains 120 mg of dimethyl fumarate.

Mustef 240 mg hard gastro-resistant capsules: each capsule contains 240 mg of dimethyl fumarate.
The other ingredients are

• Capsule contents: microcrystalline cellulose, crospovidone type A, talc, povidone K-30, anhydrous colloidal silica, magnesium stearate, triethyl citrate, methacrylic acid-ethyl acrylate copolymer (1:1), hypromellose, titanium dioxide (E 171), triacetin.
• Capsule shell: gelatin, titanium dioxide (E171), Brilliant Blue FCF (E133), yellow iron oxide (E172)
• Printing on the capsule (black ink) shellac, potassium hydroxide, propylene glycol (E1520), black iron oxide (E172), concentrated ammonia solution.

Description of the Appearance of Mustef and Package Contents
Mustef 120 mg hard gastro-resistant capsules: capsules with a capsule shell of 21.4 mm with an opaque green cap and an opaque white body, imprinted on the body with “DMF 120 mg”, containing whitish-white minitablets.
Mustef 240 mg hard gastro-resistant capsules: capsules with a capsule shell of 21.4 mm with an opaque green cap and an opaque white body, imprinted on the body with “DMF 240 mg”, containing whitish-white minitablets.
Blisters in OPA/Alu/PVC//Alu or unit dose blisters in OPA/Alu/PVC//Alu.
Mustef 120 mg hard gastro-resistant capsules
Package sizes:
14 capsules (7 capsules x 2 blisters)
14 x 1 capsule (unit dose blister)
Mustef 240 mg hard gastro-resistant capsules
56 capsules (7 capsules x 8 blisters)
56 x 1 capsule (unit dose blister)
168 capsules (7 capsules x 24 blisters)
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Adalvo Limited
Malta Life Science Park,
Building 1, Level 4
Sir Temi Zammit Buildings,
San Gwann, SGN 3000, Malta

Manufacturer
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park,
Paola PLA 3000, Malta
KeVaRo GROUP Ltd
9 Tzaritza Elenora Str. Office 23
Sofia 1618 Bulgaria
Adalvo Limited
Malta Life Science Park,
Building 1, Level 4
Sir Temi Zammit Buildings,
San Gwann, SGN 3000, Malta

is authorised in the member states of the European Economic Area and in the United Kingdom (Northern Ireland) with the following denominations:
Germany Mustef 120 mg, 240 mg magensaftresistente Hartkapseln
Iceland Mustef 120 mg, 240 mg magasýruþolin hörð hylki
Italy Mustef
Spain Mustef 120 mg, 240 mg cápsulas duras gastrorresistentes