DIMETILFUMARATO 120 mg Enteric-Coated Hard Capsules

Содержание инструкции

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

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

dimetilfumarato

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

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

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

What Dimetilfumarato Macleods is used for
Dimetilfumarato Macleods is used to treat relapsing-remitting multiple sclerosis (MS) in patients aged 13 years and 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 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 Dimetilfumarato Macleods works
Dimetilfumarato Macleods appears to work 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 Macleods

Do not take Dimetilfumarato Macleods

• if you are allergic to dimethyl fumarate or 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
Talk to your doctor or pharmacist before taking Dimetilfumarato Macleods.
Dimetilfumarato Macleods can affect the number of white blood cells in your blood, your kidneysand your
liver. Before you start taking Dimetilfumarato Macleods, your doctor will perform a blood test to count your white blood cells and check that your kidneys and liver
are working properly. Your doctor will perform the tests periodically during treatment. If your white blood cell count decreases during treatment, your doctor may consider further tests or stopping therapy.

Talk to your doctorbefore taking Dimetilfumarato Macleods 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 Dimetilfumarato Macleods.
In some cases, serious complications have occurred. Tell your doctor
immediatelyif 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 urinate more often, 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 further investigations can be carried out.

Children and adolescents
Do not give this medicine to children under 10 years of age because data are not available in this
age group.

Other medicines and Dimetilfumarato Macleods
Tell your doctor or pharmacist if 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, immunosuppressantsor other medicines used for the treatment of MS;
• medicines that affect the kidneys, includingsome antibiotics(used to treat infections), diuretics, certain types of painkillers(such as ibuprofen and other similar anti-inflammatory drugs and over-the-counter medicines) and medicines that contain lithium;
• taking Dimetilfumarato Macleods 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 Macleods 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 Macleods, because alcohol can interact with this medicine. This could
cause inflammation of the stomach (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 Macleods 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 Macleods passes into breast milk. Your doctor will
advise you whether to stop breastfeeding or treatment with Dimetilfumarato
Macleods. This involves assessing the benefit of breastfeeding for your baby against the
benefit of therapy for you.

Driving and using machines
It is not expected that dimethyl fumarate will affect your ability to drive and operate machines.

Dimetilfumarato Macleods 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 Macleods

Take this medicine following exactly the instructions of your doctor or pharmacist. 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.
Dimetilfumarato Macleods is for oral use.

Swallow each capsule wholewith a little water. You must not split, crush, dissolve,
suck or chew the capsule, because this could increase some undesirable effects.
Take Dimetilfumarato Macleods with food– this may help to reduce some more
common undesirable effects (listed in paragraph 4).

If you take more Dimetilfumarato Macleods than you should
If you have taken too many capsules, seek immediate medical attention. You may experience
undesirable effects similar to those described below in paragraph 4.

If you forget to take Dimetilfumarato Macleods
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 questions about using 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 Macleods 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 been reported after 1-5 years of treatment, so your doctor must
continue to monitor white blood cell counts throughout the duration of treatment. Be careful to observe
carefully for any potential symptoms 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 think your MS is getting worse or if you notice any new symptoms during therapy
with Dimethyl fumarate Macleods, 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
the 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 be a serious allergic reaction ( anaphylaxis).
➢ Stop taking Dimethyl fumarate Macleods 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 ( flushing)
• loose stools ( diarrhea)
• feeling of impending vomiting ( nausea)
• stomach pain or stomach cramps. ➢ Taking the medicine with foodmay help reduce the side effects mentioned above.

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 Macleods.

Talk to 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)
• feeling unwell ( vomiting)
• indigestion ( dyspepsia)
• inflammation of the stomach ( gastritis)
• gastrointestinal discomfort
• burning sensation
• hot flush, 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, leukopenia) in the blood. A reduction in the number of white blood cells in the blood may indicate that you are unable to fight an infection adequately. If you have a serious infection (such as pneumonia), contact your doctor immediately
• proteins ( 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 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 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
compared to 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 at 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 Macleods

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 box after Exp.
The expiry date refers to the last day of that month.
Do not store at a temperature above 30°C.
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 protect the environment.

6. Contents of the pack and other information

What Dimetilfumarato Macleods contains

• The active ingredient is dimethyl fumarate. Each hard gastro-resistant capsule contains 120 mg and 240 mg of dimethyl fumarate.
• The other ingredients are: microcrystalline cellulose (E460), sodium croscarmellose (E468), anhydrous colloidal silica (E551), magnesium stearate (E470b), methacrylic acid - ethyl acrylate copolymer (1:1) type A dispersion 30% (sodium lauryl sulfate and polysorbate 80), triethyl citrate, talc (E553b), methacrylic acid - ethyl acrylate copolymer (1:1) dispersion 30% (sodium lauryl sulfate and polysorbate 80), gelatin, titanium dioxide (E171), yellow iron oxide (E172), black iron oxide (E172), brilliant blue FCF (E13), shellac (E904), potassium hydroxide (E525).

Description of the appearance of Dimetilfumarato Macleods and contents of the pack
Dimetilfumarato Macloeds 120 mg gastro-resistant hard capsules are size “0”, light opaque green cap
and opaque white body with the printing “I 65” and “120 mg” on the body in black ink,
containing film-coated microtablets from white to opaque white. They are available in blister packs
(opaque white PVC/PE/PVDC blister with aluminum foil) containing 14 capsules.
Dimetilfumarato Macloeds 240 mg gastro-resistant hard capsules are size “0”, light opaque green cap
and opaque light green body with the printing “I 66” and “240 mg” on the body in black ink,
containing film-coated microtablets from white to opaque white. They are available in blister packs
(opaque white PVC/PE/PVDC blister with aluminum foil) containing 56 and 168 capsules.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Macleods Pharma España S.L.U.
Avenida Diagonal, 409, 1 Planta
08008 Barcelona, Spain

Manufacturer
Synoptis Industrial Sp. z o.o
ul. Rabowicka 15, Swarzędz,
62-020, Poland

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
Netherlands: Dimethylfumaraat Macleods 120 mg maagsapresistente harde capsules
Dimethylfumaraat Macleods 240 mg maagsapresistente harde capsules
Germany: Dimethylfumarat Macleods 120 mg magensaftresistente Hartkapseln
Dimethylfumarat Macleods 240 mg magensaftresistente Hartkapseln
Spain: Fumarato de dimetilo Macleods 120 mg cápsulas duras gastrorresistentes EFG
Fumarato de dimetilo Macleods 240 mg cápsulas duras gastrorresistentes EFG
Italy: Dimetilfumarato Macleods