Scleryda: detailed information

Patient Information Leaflet

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

dimethyl fumarate
Generic medicine
Please read all of 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 other people, 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 Scleryda is and what it is used for
What you need to know before taking Scleryda
How to take Scleryda
Possible side effects
How to store Scleryda
Contents of the pack and other information

1. What Scleryda is and what it is used for

What Scleryda is
Scleryda is a medicine that contains the active substance dimethyl fumarate.
What Scleryda is used for
Scleryda 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), i.e. the brain and spinal cord. Relapsing-remitting multiple sclerosis is characterized by repeated attacks (relapses) of neurological symptoms. 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 the relapse resolves, although some problems may persist.
How Scleryda works
Scleryda 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 Scleryda

Do not take Scleryda

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

Warnings and precautions
Scleryda may affect the number of white blood cells in your blood, your kidneys, and your liver. Before starting Scleryda, 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 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.
Talk to your doctor before taking Scleryda if you have:

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

Cases of herpes zoster infection (shingles) may occur during treatment with Scleryda. In some cases, serious complications may arise. You must inform your doctor immediately if you suspect you have any symptoms of herpes zoster infection.
If you think 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 may lead to severe disability or death.
With a medicine containing dimethyl fumarate in combination with other fumaric acid esters used to treat psoriasis (a skin disease), a rare but serious kidney disorder called Fanconi syndrome has been observed. If you notice that you are urinating more than usual, are more thirsty and drinking more than normal, have weaker muscles, or experience a fracture or even pain, contact your doctor as soon as possible so that thorough investigations can be carried out.
Children and adolescents
Do not give this medicine to children under 10 years of age, as data are not available in this age group.
Other medicines and Scleryda
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, especially:
Tell 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 to treat 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", certain types of painkillers (such as ibuprofen and other similar anti-inflammatory medicines and medicines purchased without a prescription), and medicines containing lithium
taking Scleryda together with certain types of vaccines ( live vaccines ) may 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.

Scleryda and alcohol
You should avoid drinking beverages with high alcohol content (more than 30% alcohol by volume, e.g., spirits) in amounts greater than a small quantity (more than 50 ml) within one hour of taking Scleryda, as alcohol may interact with this medicine. This may cause inflammation of the stomach ( gastritis ), particularly in people who are already prone to gastritis.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
There is limited information on the adverse effects of this medicine on the unborn child when used during pregnancy. Do not use Scleryda 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 ingredient of Scleryda passes into breast milk. Your doctor will advise you whether you should stop breastfeeding or stop treatment with Scleryda. This involves weighing the benefit of breastfeeding for your child against the benefit of therapy for you.
Driving and using machines
Scleryda is not expected to affect your ability to drive or use machinery.
Scleryda contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e., essentially “sodium-free”.

3. How to take Scleryda

Take this medicine exactly as your doctor has told you. If you are unsure, 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.
Scleryda is for oral use.

Swallow each capsule whole with some water. Do not divide, crush, dissolve, suck, or chew the capsule, as this may increase certain side effects.

Take Scleryda with food – this may help reduce some of the more common side effects (listed in section 4).

If you take more Scleryda 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 Scleryda
If you miss or skip a dose, do not take a double dose to make up for the missed dose.
You may take the missed dose if at least 4 hours will separate the doses. Otherwise, wait until your 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 everyone experiences them.
Serious side effects
Scleryda may lower lymphocyte levels (a type of white blood cell). Persistently 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 lead to severe disability or death. PML has occurred after 1 to 5 years of treatment; therefore, your doctor must continue monitoring white blood cells throughout the duration of treatment. Be alert for 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; confusion or personality changes; or language and communication difficulties lasting longer than a few days.
Therefore, if you think your MS is worsening or if you notice any new symptoms during treatment with Scleryda, it is very important to contact your doctor as soon as possible. Also inform your partner or caregiver about your treatment. Symptoms may occur that you might not be aware of.
→ 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).
Redness of the face or body (flushing) is a very common side effect. However, if redness is accompanied by a red 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 Scleryda 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 Scleryda.
Contact your doctor for advice on managing 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 lining (gastritis)
gastrointestinal disorder
burning sensation
hot flush, sensation of warmth
itching
skin rash
pink or red spots on the skin (erythema)
hair loss (alopecia)

Side effects that may be detected through 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 unable to adequately fight infections. 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)

liver inflammation and increased liver enzyme levels (ALT or AST in association with bilirubin)

Not known (frequency cannot be determined from 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 compared to adults, such as 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, contact 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Scleryda

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 carton 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 you no longer use. This will help protect the environment.

6. Package contents and other information

What Scleryda contains
The active substance is dimethyl fumarate.
Scleryda 120 mg: each capsule contains 120 mg of dimethyl fumarate.
Scleryda 240 mg: each capsule contains 240 mg of dimethyl fumarate.
The other ingredients are microcrystalline cellulose, sodium croscarmellose (see section 2 “Scleryda contains sodium”), talc, anhydrous colloidal silica, magnesium stearate, triethyl citrate, methacrylic acid–methyl methacrylate copolymer (1:1), methacrylic acid–ethyl acrylate copolymer (1:1) dispersion 30%, gelatin, titanium dioxide (E171), Brilliant Blue FD&C #2 (E132), yellow iron oxide (E172), shellac, propylene glycol, ammonium hydroxide, black iron oxide (E172), and purified water (only in 240 mg capsules).

Description of the appearance of Scleryda and package contents
Scleryda 120 mg gastro-resistant hard capsules are blue-green and white gastro-resistant hard capsules, printed with 'MYLAN' above 'DF 120', containing enteric-coated granules of white to off-white colour. They are available in blister packs containing 14 gastro-resistant hard capsules, and in divisible unit-dose blister packs containing 14 gastro-resistant hard capsules.
Scleryda 240 mg gastro-resistant hard capsules are blue-green gastro-resistant hard capsules, printed with 'MYLAN' above 'DF 240', containing enteric-coated granules of white to off-white colour. They are available in blister packs containing 56 gastro-resistant hard capsules, and in divisible unit-dose blister packs containing 56 gastro-resistant hard capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Mylan S.p.A.
Via Vittor Pisani, 20
20124 Milan
Italy

Manufacturer
Mylan Hungary Kft.
H-2900 Komárom,
Mylan utca. 1,
Hungary

This medicinal product is authorised in Member States under the following names:
Cyprus Scleryda 120 mg gastro-resistant hard capsules
Scleryda 240 mg gastro-resistant hard capsules
Greece Scleryda 120 mg gastro-resistant hard capsules
Scleryda 240 mg gastro-resistant hard capsules
Italy Scleryda
Malta Scleryda 120 mg Gastro-Resistant Hard Capsules
Scleryda 240 mg Gastro-Resistant Hard Capsules
Netherlands Scleryda 120 mg, maagsapresistente harde capsules
Scleryda 240 mg, maagsapresistente harde capsules