DIMETILFUMARATO 120 mg Enteric-Coated Hard Capsule

Зміст інструкції

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

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

dimethyl fumarate

Generic medicine

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

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

Dimetilfumarato Piramal
Dimetilfumarato Piramal is a medicine that contains the active substance dimethyl fumarate.

What is Dimetilfumarato Piramal used for
Dimetilfumarato Piramal 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 that affect the nervous system. Symptoms vary from patient to
patient, but generally include difficulty walking, a feeling of imbalance and vision problems (e.g. blurred or double vision). These symptoms may disappear completely when
the relapse resolves, but some problems may remain.

How does Dimetilfumarato Piramal work
It appears that Dimetilfumarato Piramal 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 Piramal

Do not take Dimetilfumarato Piramal

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

liver. Before you start taking Dimetilfumarato Piramal, your doctor will perform a blood test to count your 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 your white blood cells decreases during treatment, your doctor may consider
further tests or discontinuation of therapy.

Talk to your doctorbefore taking Dimetilfumarato Piramal 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 Piramal, 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 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 if
you drink more than usual, the 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. Dimetilfumarato Piramal
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 Piramal
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 Dimetilfumarato Piramal with certain types of vaccines (live vaccines) could cause you to become infected and should therefore be avoided. Your doctor will tell you if other types of vaccines (non-live vaccines) should be given.

Dimetilfumarato Piramal with alcohol
You should avoid consuming alcoholic beverages within two hours of taking this medicine, as
alcohol can lead to a higher frequency of gastrointestinal adverse reactions.

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

Driving and using machines
The effect of Dimetilfumarato Piramal on the ability to drive and operate machines is
not known. Dimetilfumarato Piramal is not expected to affect the ability to drive and
operate machines.

3. How to take Dimetilfumarato Piramal

Take this medicine following the instructions of your doctor exactly. 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 Piramal 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 Dimetilfumarato Piramal with food– this may help to reduce some of the more common undesirable effects
(listed in paragraph 4).

If you take more Dimetilfumarato Piramal 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 Piramal
If you forget or miss a dose, do not take a double doseto 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
Dimethyl fumarate Piramal can reduce the levels of lymphocytes (a type of white blood cell). Prolonged
low levels of white blood cells 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 occurred 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 your MS is worsening or if you notice any new symptoms during therapy
with Dimethyl fumarate Piramal, 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
the 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 represent a serious allergic reaction (anaphylaxis)

Stop taking Dimethyl fumarate Piramal and call your 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 foodmay help reduce the above side effects

The presence of substances called ketones, which are produced naturally by the body, is commonly revealed
in urine tests during the intake of Dimethyl fumarate.

See your doctorfor information on how to manage these side effects. The doctor may reduce
your dose. Do not reduce the dose unless your doctor tells you to.

Common side effects
These may affect up to 1 in 10 people:

• inflammation of the intestinal lining (gastroenteritis)
• feeling unwell (vomiting)
• indigestion (dyspepsia)
• inflammation of the stomach (gastritis)
• gastrointestinal illness
• 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, leukopenia) in the blood. A reduction 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
• 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)
• reduction of 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 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, for example headache, stomach pain or 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 the national reporting system 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 Dimetilfumarato Piramal

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
'Exp.'. The expiry date refers to the last day of that month.
This medicine does not require any particular storage temperature.
Store in the original package to protect it 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 Dimetilfumarato Piramal contains
The active ingredient is dimethyl fumarate.

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

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

• Capsule content: 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 (E 171), brilliant blue FCF (E 133), yellow iron oxide (E 172).
• Capsule printing ink: shellac, potassium hydroxide, propylene glycol (E 1520), black iron oxide (E 172), strong ammonia solution.

Description of the appearance of Dimetilfumarato Piramal and package contents
Dimetilfumarato Piramal 120 mg gastro-resistant hard capsules: opaque green cap and opaque white body
capsule shell of 21.4 mm, imprinted with black ink "DMF 120" on the body
containing white to off-white minitablets
Dimetilfumarato Piramal 240 mg gastro-resistant hard capsules: opaque green cap and body,
capsule shell of 23.2 mm, imprinted with black ink “DMF 240” on the body
containing white to off-white minitablets.
OPA/Alu/PVC//Alu blisters or unit-dose OPA/Alu/PVC//Alu blisters
14 gastro-resistant capsules (7 capsules X 2 blisters)
56 gastro-resistant capsules (7 capsules X 8 blisters)
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Piramal Critical Care Italia S.p.A
Via XXIV Maggio 62/A, 37057
San Giovanni Lupatoto (VR)
37057, Italy

Manufacturer
Pharmadox Healthcare Ltd.
Kordin Industrial Park KW20A,
Paola PLA 3000, Malta
Adalvo Limited
Malta Life Sciences Park,
Building 1, Level 4, Sir Temi Zammit Buildings,
San Gwann, SGN 3000 Malta
KeVaRo GROUP Ltd
9 Zaritza Elenora Str. Office 23
Sofia 1618 Bulgaria
More detailed information on this medicine is available on the website of the European
Medicines Agency, http://www.ema.europa.eu. Furthermore, links to other websites on rare diseases and
related therapeutic treatments are provided.
This medicine is authorised in the Member States of the European Economic Area (EEA) with the
following denominations:
Denmark: Dimethyl Fumarate Piramal 120 mg Magasýruþolið hart hylki
Dimethyl Fumarate Piramal 240 mg Magasýruþolið hart hylki
Germany: Dimethylfumarat Piramal 120 mg magensaftresistente Hartkapseln
Dimethylfumarat Piramal 240 mg magensaftresistente Hartkapseln
Spain: Dimethyl Fumarate Piramal 120 mg cápsulas duras gastrorresistentes EFG
Dimethyl Fumarate Piramal 240 mg cápsulas duras gastrorresistentes EFG
France: Dimethyl Fumarate Zydus 120 mg, gélule gastro-résistante
Dimethyl Fumarate Zydus 240 mg, gélule gastro-résistante
Italy: Dimetilfumarato Piramal