Dimethyl fumarate Aequilbrium Pharma: detailed information

Patient Information Leaflet: Information for the User

Dimetilfumarato Aequilibrium Pharma 120 mg gastro-resistant hard capsules, 240 mg gastro-resistant hard capsules

dimethyl fumarate
Equivalent medicinal product
Please read this leaflet carefully before 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 give it to others, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Dimetilfumarato Aequilibrium Pharma is and what it is used for
What you need to know before taking Dimetilfumarato Aequilibrium Pharma
How to take Dimetilfumarato Aequilibrium Pharma
Possible side effects
How to store Dimetilfumarato Aequilibrium Pharma
Contents of the pack and other information

1. What Dimetilfumarato Aequilibrium Pharma is and what it is used for

What Dimetilfumarato Aequilibrium Pharma is
Dimetilfumarato Aequilibrium Pharma is a medicine containing the active substance
dimethyl fumarate.
What Dimetilfumarato Aequilibrium Pharma is used for
Dimetilfumarato Aequilibrium Pharma is used to treat relapsing-remitting multiple sclerosis (MS) in patients aged 13 years and older.
Multiple sclerosis is a chronic disease affecting the central nervous system (CNS), namely 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, a sense of imbalance, and vision problems (e.g. blurred or double vision). These symptoms may completely disappear when a relapse resolves, but some deficits may persist.
How Dimetilfumarato Aequilibrium Pharma works
Dimetilfumarato Aequilibrium Pharma appears to work by preventing the body's immune system from damaging the brain and spinal cord. This may also help delay future worsening of the disease.

2. What you need to know before taking Dimetilfumarato Aequilibrium Pharma

Do not take Dimetilfumarato Aequilibrium Pharma

if you are allergic to dimethyl fumarate or to any of the other ingredients of this medicine (listed in section 6)
if a rare brain infection called progressive multifocal leukoencephalopathy (PML) is suspected or if PML has been confirmed.

Warnings and precautions
Dimetilfumarato Aequilibrium Pharma may affect the number of white blood cells in your blood,
your kidneys, and your liver. Before you start taking Dimetilfumarato Aequilibrium Pharma, 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 carry out these tests periodically during treatment. If your
white blood cell count decreases during treatment, your doctor may consider further testing or discontinuation of therapy.
Contact your doctor before taking Dimetilfumarato Aequilibrium Pharma if you have:

severe kidney disease
severe liver disease
a stomach or intestinal disorder
a serious infection (such as pneumonia).

Treatment with Dimetilfumarato Aequilibrium Pharma may lead to cases of herpes zoster infection (shingles). In some cases, serious complications have occurred. Contact your doctor immediately if you suspect you may have any symptoms of herpes zoster infection.
If you believe your MS is worsening (for example, if you experience weakness or visual disturbances) or if you notice new symptoms, contact your doctor immediately, as these could be signs of a rare brain infection called PML. PML is a serious condition that may 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 increased urination, increased thirst and fluid intake, muscle weakness, or experience fractures or pain, contact your doctor as soon as possible so that appropriate investigations can be carried out.
Children and adolescents
Do not give this medicine to children under 10 years of age, as there are no data available in this age group.
Other medicines and Dimetilfumarato Aequilibrium Pharma
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, especially:

medicines containing fumaric acid esters (fumarates) used for the treatment of psoriasis;
medicines that affect the immune system, including chemotherapeutic agents, immunosuppressants, or other medicines used to treat MS;
medicines that affect the kidneys, including certain antibiotics (used to treat infections), diuretics, some types of analgesics (such as ibuprofen and other similar anti-inflammatory medicines and medicines purchased without a prescription), and medicines containing lithium;
taking Dimetilfumarato Aequilibrium Pharma together with certain types of vaccines (live vaccines) could cause you to develop an infection and should therefore be avoided. Your doctor will advise you whether other types of vaccines (non-live vaccines) should be administered.

Dimetilfumarato Aequilibrium Pharma and alcohol
Consumption of beverages with high alcohol content (more than 30% alcohol by volume, e.g., spirits) in amounts exceeding a small quantity (more than 50 mL) should be avoided within one hour of taking Dimetilfumarato Aequilibrium Pharma, as alcohol may interact with this medicine. This could cause inflammation of the stomach (gastritis), particularly in individuals already prone to gastritis.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or 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 when used during pregnancy. Do not use Dimetilfumarato Aequilibrium Pharma during pregnancy unless you have discussed it with your doctor and the medicine is clearly necessary for you.
Breastfeeding
It is not known whether the active substance of Dimetilfumarato Aequilibrium Pharma passes into breast milk. Your doctor will advise you whether you should stop breastfeeding or stop treatment with Dimetilfumarato Aequilibrium Pharma. This decision will take into account the benefit of breastfeeding for your child versus the benefit of therapy for you.
Driving and using machines
Dimetilfumarato is not expected to affect the ability to drive or use machines.
Dimetilfumarato Aequilibrium Pharma 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 Aequilibrium Pharma

Take this medicine exactly as directed by your doctor or pharmacist. If you
have
any doubts, consult your doctor.
Initial dose: 120 mg twice daily.
Take this initial dose for the first 7 days, then proceed to the regular dose.
Regular dose: 240 mg twice daily.
Dimetilfumarato Aequilibrium Pharma is for oral use.
Swallow each capsule whole, with some water. Do not split, crush, dissolve,
suck or chew the capsule, as this could increase certain side effects.
Take Dimetilfumarato Aequilibrium Pharma with food – this may help reduce some of the
more common side effects (listed in section 4).
If you take more Dimetilfumarato Aequilibrium Pharma than you should
If you have taken too many capsules, contact your doctor immediately. You may experience side
effects similar to those described below in section 4.
If you forget to take Dimetilfumarato Aequilibrium Pharma
Do not take a double dose to make up for a missed dose.
You may take the missed dose if at least 4 hours will elapse between doses. Otherwise, wait until the
next scheduled dose.
If you have any doubts about how to use this medicine, consult 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
Dimetilfumarato Aequilibrium Pharma may reduce 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; therefore, your doctor must continue
to monitor your white blood cells throughout the duration of treatment. Be sure to carefully observe any
potential symptoms of PML, as described below. The risk of PML may be higher if you have previously
taken medicines that impair immune system function.
Symptoms of PML may resemble those of a multiple sclerosis relapse. Symptoms may include the onset
or worsening of weakness on one side of the body; clumsiness; changes in vision, thinking, or memory;
or confusion, personality changes, or difficulty with language and communication lasting longer than a
few days.
Therefore, if you feel your MS is worsening or if you notice any new symptoms during treatment with
Dimetilfumarato Aequilibrium Pharma, 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
might not notice yourself.
➢ If you experience any of these symptoms, call your doctor immediately
Severe allergic reactions
The frequency of severe allergic reactions cannot be determined from the available data (not known).
Flushing (redness of the face or body) is a very common side effect. However, if flushing is accompanied
by a red skin rash or hives and you have any of the following symptoms:

swelling of the face, lips, mouth, or tongue ( angioedema )
shortness of breath, difficulty breathing, or breathlessness ( dyspnea , hypoxia )
dizziness or loss of consciousness ( hypotension ),

this may indicate a severe allergic reaction ( anaphylaxis ).
➢ Stop taking Dimetilfumarato Aequilibrium Pharma and call a doctor immediately
Other side effects
Very common (may affect more than 1 in 10 people)

redness of the face or body, sensation of warmth, intense heat, burning, or itching ( flushing )
loose stools ( diarrhea )
feeling of imminent vomiting ( nausea )
stomach ache or stomach cramps. ➢ Taking the medicine with food may help reduce the above-mentioned side effects.

The presence of substances called ketones, which are naturally produced by the body, is very commonly
detected in urine tests during treatment with Dimetilfumarato Aequilibrium Pharma.
Contact your doctor for advice 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 intestinal lining ( gastroenteritis )
feeling unwell ( vomiting )
indigestion ( dyspepsia )
inflammation of the stomach ( gastritis )
gastrointestinal disorder
burning sensation
hot flush, feeling of warmth
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 ( lymphopenia , leukopenia ) in the blood. A reduced number of white blood cells in the blood may indicate that you are not able to fight infections adequately. If you develop a serious infection (such as pneumonia), contact your doctor immediately
presence of 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 100 people)

allergic reactions ( hypersensitivity )
reduced platelet count in the blood.

Rare (may affect up to 1 in 1,000 people)

inflammation of the liver and increased levels of liver enzymes ( ALT or AST in combination with bilirubin )

Not known (frequency cannot be estimated from the available data)

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 infection, followed by numbness, red or itchy spots with severe pain
runny nose ( rhinorrhea ).

Children (aged 13 years 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 ache or stomach cramps, vomiting, sore throat, cough, and painful
menstruation.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or
pharmacist. You may also report side effects directly via the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Dimethylfumarate Aequilibrium Pharma

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and the outer packaging after
Exp. The expiry date refers to the last day of that month.
Do not store above 30°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Dimetilfumarato Aequilibrium Pharma contains

The active substance is dimethyl fumarate. Each gastro-resistant hard capsule contains 120 mg or 240 mg of dimethyl fumarate.
The other components 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 (E133), shellac (E904), potassium hydroxide (E525).

Description of the appearance of Dimetilfumarato Aequilibrium Pharma and package contents
Dimetilfumarato Macloeds 120 mg gastro-resistant hard capsules are size “0”, with a light green opaque cap and a white opaque body, printed with “I 65” and “120 mg” in black ink on the body, containing film-coated microtablets ranging from white to off-white. They are available in blister packs (white opaque PVC/PE/PVDC blisters with aluminium foil).
Blister pack – 14 (1 x 14 capsules)
Unit-dose divisible blister pack – 14 x 1 (1 x 14 capsules)

Dimetilfumarato Macloeds 240 mg gastro-resistant hard capsules are size “0”, with a light green opaque cap and a light green opaque body, printed with “I 66” and “240 mg” in black ink on the body, containing film-coated microtablets ranging from white to off-white. They are available in blister packs (white opaque PVC/PE/PVDC blisters with aluminium foil).
Blister packs – 56 (4 x 14 capsules) and 168 (12 x 14 capsules)
Unit-dose divisible blister packs – 56 x 1 (4 x 14 capsules) and 168 x 1 (12 x 14 capsules)

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Aequilibrium Pharma Srl
Via Podgora, 11
Milan
Lombardy
20122 - Italy

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

This medicinal product is authorised in the European Economic Area countries under the following names:
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 Aequilibrium Pharma

This patient information leaflet was last revised in November