Arbicen

Patient Information Leaflet

Arbicen, 120 mg, hard enteric-coated capsules
Arbicen, 240 mg, hard enteric-coated capsules
Dimethyl fumarate
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not share it with others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet Contents

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

1. What Arbicen is and what it is used for

What Arbicen is
Arbicen is a medicine that contains the active substance dimethyl fumarate.
What Arbicen is used for
Arbicen is used to treat relapsing-remitting multiple sclerosis (MS) in patients aged 13 years and older.
Multiple sclerosis is a chronic disease that damages the central nervous system (CNS), including the brain and spinal cord. Relapsing-remitting multiple sclerosis is characterized by repeated episodes of neurological symptoms (called relapses).
Symptoms vary between individuals but usually include problems with walking and balance, and vision impairment (e.g. blurred or double vision). These symptoms may completely resolve after a relapse, but some deficits may persist.
How Arbicen works
Arbicen appears to suppress the immune system from causing damage to the brain and spinal cord, which may also help slow the progression of the disease in the future.

2. Important information before using Arbicen

When not to use Arbicen

• if the patient is allergic to dimethyl fumarate or to any of the other ingredients of this medicine (listed in section 6).
• if progressive multifocal leukoencephalopathy (PML) is suspected or confirmed. PML is a rare and serious brain infection.

Warnings and precautions
Arbicen may have an adverse effect on white blood cell count, as well as on the function of the kidneys and liver.
Before starting treatment with Arbicen, the doctor will check the patient's white blood cell levels and assess whether the kidneys and liver are functioning properly. These tests will be performed periodically during treatment. If the patient's white blood cell count decreases during treatment, the doctor may consider performing additional tests or discontinuing treatment.
Consult a doctor before taking Arbicen if the patient has:

• severe kidney disease
• severe liver disease
• stomach or intestinal disease
• severe infection (e.g. pneumonia).

Herpes zoster (shingles) may occur during treatment with Arbicen. In some cases, serious complications have occurred. If there is any suspicion of shingles symptoms in the patient, the doctor should be informed immediately.
If multiple sclerosis worsens (e.g. the patient experiences weakness or vision disturbances) or new symptoms appear, the patient should contact the doctor immediately, as these may be signs of a rare brain infection called progressive multifocal leukoencephalopathy (PML). PML is a serious condition that may lead to severe disability or death.
Rare but serious kidney disorders, including Fanconi syndrome, have been reported during treatment with dimethyl fumarate in combination with other fumaric acid esters used in the treatment of psoriasis (a skin condition). If the patient notices increased urination, feels more thirsty and drinks more than usual, experiences muscle weakness, bone fractures, or pain, they should consult a doctor as soon as possible for further evaluation of these symptoms.

Children and adolescents
This medicine should not be given to children under 10 years of age, as there is insufficient data available for this age group.

Arbicen and other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take, especially:

• medicines containing fumaric acid esters (fumarates) used in the treatment of psoriasis;
• medicines affecting the immune system, including chemotherapeutic agents, immunosuppressive medicines, or other medicines used in the treatment of multiple sclerosis;
• medicines affecting the kidneys, including certain antibiotics (used to treat infections), diuretics, certain pain medicines (such as ibuprofen and similar anti-inflammatory medicines, including over-the-counter products), and medicines containing lithium.
• administration of certain vaccines (live vaccines) during treatment with Arbicen may lead to infection; therefore, they should be avoided. The doctor will advise whether other types of vaccines (inactivated vaccines) should be administered.

Use of Arbicen with alcohol
Avoid consuming more than a small amount (more than 50 mL) of high-strength alcoholic drinks (over 30% alcohol by volume, e.g. spirits) within one hour of taking Arbicen, as alcohol may interact with this medicine. This may cause stomach inflammation (gastritis), especially in individuals already predisposed to stomach problems.

Pregnancy and breastfeeding
There is limited information on the effects of this medicine on the unborn child when used during pregnancy. This medicine should not be taken during pregnancy unless discussed with the doctor and considered necessary.

Pregnancy
Arbicen should not be taken during pregnancy unless the patient has discussed this with her doctor.

Breastfeeding
It is not known whether the active substance of this medicine passes into breast milk. The doctor will advise the patient whether she should discontinue breastfeeding or stop taking Arbicen. The decision will be based on an assessment of the benefits of breastfeeding for the child compared to the benefits of treatment for the patient.

Driving and operating machinery
Arbicen is not expected to affect the ability to drive or operate machinery.

3. How to take Arbicen

This medicine should always be taken as directed by the physician. In case of doubt, consult your
doctor.
Initial dose
120 mg twice daily.
This initial dose should be taken for the first 7 days, after which the medicine should be used at the
usual recommended dose.
Usual recommended dose
240 mg twice daily.
Arbicen should be taken orally.
Each capsule must be swallowed whole , with water. Capsules must not be divided, crushed,
dissolved, sucked or chewed, as this may increase the risk of certain adverse effects.
Arbicen should be taken with food – this will help reduce the very common adverse effects (listed
in section 4).
Taking more Arbicen than prescribed
If more capsules than recommended have been taken, you must inform your doctor immediately.
Adverse effects similar to those described below in section 4 may occur.
Missing a dose of Arbicen
Do not take a double dose.
A missed dose may be taken, provided there is at least a 4-hour interval before the next scheduled dose.
Otherwise, the patient should wait until the next scheduled dose.
If you have any further questions about the use of this medicine, consult your doctor or
pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get them.

Serious side effects

The medicine Arbicen may reduce the number of lymphocytes (a type of white blood cells). Low numbers of white blood cells may increase the risk of infections, including a rare brain infection called progressive multifocal leukoencephalopathy (PML). PML may lead to severe disability or death. PML has been reported from 1 year to 5 years after starting treatment. Therefore, your doctor should monitor your white blood cell count throughout treatment, and you should be aware of the symptoms described below, which may indicate PML. The risk of developing PML may be higher if you have previously taken medicines that affect the immune system.

Symptoms of PML may resemble a relapse of multiple sclerosis. Symptoms may include new or worsening weakness on one side of the body, problems with coordination, vision, thinking or memory, confusion, or personality changes, speech problems, and difficulties in communicating lasting longer than a few days. Therefore, if you notice worsening of symptoms related to multiple sclerosis or any new symptoms while taking Arbicen, you should contact your doctor as soon as possible. You should also talk to your partner or caregivers and inform them about your treatment, as you may not be aware of some symptoms.

If any of the symptoms listed above occur, contact your doctor immediately.

Severe allergic reactions

The frequency of severe allergic reactions cannot be estimated from the available data (frequency not known).

A very common side effect is sudden (transient) redness of the face or body. If transient redness of the skin is accompanied by a red rash or hives and any of the following symptoms:

• swelling of the face, lips, mouth or tongue (angioedema)
• wheezing, difficulty breathing or breathlessness (dyspnoea, hypoxia)
• dizziness or loss of consciousness (hypotension)

this may indicate a severe allergic reaction (anaphylaxis). You must stop taking Arbicen and contact your doctor immediately.

Other side effects

Very common (may affect more than 1 in 10 people)

• redness of the face or sensation of increased body temperature, hot flushes, burning or itching of the skin (transient flushing)
• loose stools (diarrhoea)
• nausea
• stomach pain or cramps

Taking the medicine with food may help to reduce the side effects listed above.

During treatment with dimethyl fumarate, increased production of ketone bodies (substances normally produced in the body) is very commonly detected in urine tests. You should ask your doctor how to manage these side effects. Your doctor may reduce the dose of the medicine. Do not reduce the dose yourself unless your doctor tells you to do so.

Common (may affect up to 1 in 10 people)

• inflammation of the intestinal mucosa (gastroenteritis)
• vomiting
• indigestion
• inflammation of the stomach mucosa (gastritis)
• gastrointestinal disorders
• burning of the skin
• hot flushes, sensation of warmth
• itching of the skin (pruritus)
• rash
• pink or red spots on the skin (erythema)
• hair loss (alopecia)

Side effects that may cause abnormal results in blood or urine tests:

• low number of white blood cells (lymphopenia, leukopenia). A reduced number of white blood cells may mean that the body is less able to fight infections. If you develop a serious infection (e.g. pneumonia), contact your doctor immediately.
• protein (albumin) in the urine
• increased levels of liver enzymes (AlAT, AspAT) in the blood

Uncommon (may affect up to 1 in 100 people)

• allergic reactions (hypersensitivity)
• decreased number of platelets

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

• hepatitis and increased activity of liver enzymes (AlAT or AspAT together with bilirubin)

Frequency not known (frequency cannot be estimated from the available data)

• shingles, with symptoms such as blisters on the skin, burning, itching or pain of the skin, usually on one side of the upper body or face, and other symptoms such as fever and fatigue in the early stages of infection, followed by numbness, itching or red spots and severe pain
• catarrh (nasal inflammation)

Children (aged 13 years and above) 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, abdominal pain or stomach cramps, vomiting, sore throat, cough and painful menstruation.

Reporting of side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:

Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl

Side effects can also be reported to the marketing authorisation holder.

Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Arbicen

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister, bottle label, and carton after: "EXP". The expiry date refers to the last day of the stated month.
There are no special precautions regarding storage temperature for this medicine.
Store in the original packaging to protect from light.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Arbicen contains
The active substance is dimethyl fumarate.
Arbicen 120 mg, enteric hard capsules
Each enteric hard capsule contains 120 mg of dimethyl fumarate.
Arbicen 240 mg, enteric hard capsules
Each enteric hard capsule contains 240 mg of dimethyl fumarate.
The other ingredients are:

• Capsule contents: microcrystalline cellulose, crospovidone, talc, povidone, colloidal anhydrous silica, magnesium stearate, triethyl citrate, methacrylic acid and ethyl acrylate copolymer (1:1), hypromellose, titanium dioxide (E 171), triacetin.
• Capsule shell: gelatin, titanium dioxide (E171), brilliant blue FCF-FD&C Blue (E133), iron oxide yellow (E172).
• Capsule printing (black ink): shellac, potassium hydroxide, propylene glycol (E1520), iron oxide black (E172), ammonium hydroxide concentrated.

What Arbicen looks like and contents of the pack
Arbicen 120 mg, enteric hard capsules: capsule with green cap and white body,
capsule shell 21.4 mm long, printed with “DMF 120” on the body, containing white or almost white
mini-tablets.
Arbicen 240 mg, enteric hard capsules: capsule with green cap and green body,
capsule shell 23.2 mm long, printed with “DMF 240” on the body, containing white or almost white
mini-tablets.
HDPE bottle with PP/HDPE screw cap, with seal and a container of silica gel as a desiccant.
Do not swallow the desiccant.
Blister packs OPA/Aluminium/PVC//Aluminium or single-dose blister
OPA/Aluminium/PVC//Aluminium.
Arbicen, enteric hard capsules, 120 mg
Pack sizes:
14 capsules (blister packs)
14 x 1 capsule (perforated single-dose blisters)
100 capsules (bottle)
Arbicen, enteric hard capsules, 240 mg
Pack sizes:
56 capsules (blister packs)
56 x 1 capsule (perforated single-dose blisters)
168 capsules (blister packs)
168 capsules (perforated single-dose blisters)
100 capsules (bottle)
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Egis Pharmaceuticals PLC
Keresztúri út 30-38
1106 Budapest
Hungary
Importer
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park
Paola PLA 3000
Malta
Adalvo Ltd (AMOL)
Malta Life Sciences Park
Building 1, Level 4, Sir Temi Zammit Buildings
San Ġwann SĠN 3000
Malta
KeVaRo GROUP Ltd
9, Tzaritza Elenora Str. Office 23
Sofia 1618
Bulgaria
This medicinal product is authorised for sale in the European Economic Area under the following names:
Iceland Arbicen 120 mg magasýruþolin hörð hylki
Arbicen 240 mg magasýruþolin hörð hylki
Bulgaria Arbicen 120 mg стомашно- устойчиви твърди капсули
Arbicen 240 mg стомашно- устойчиви твърди капсули
Czech Republic Arbicen
Hungary Arbicen 120 mg gyomornedvellenálló kemény kapszula
Arbicen 240 mg gyomornedvellenálló kemény kapszula
Poland Arbicen
Slovakia Arbicen 120 mg tvrdé gastrorezistentné kapsuly
Arbicen 240 mg tvrdé gastrorezistentné kapsuly
Romania Arbicen 120 mg capsule gastrorezistente
Arbicen 240 mg capsule gastrorezistente
Lithuania Arbicen 120 mg skrandyje neirios kietosios kapsulės
Arbicen 240 mg skrandyje neirios kietosios kapsulės
Latvia Arbicen 120 mg zarnās šķīstošā kapsula, cietā
Arbicen 240 mg zarnās šķīstošā kapsula, cietā
For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
EGIS Polska Sp. z o.o.
ul. Komitetu Obrony Robotników 45D
02-146 Warsaw
Tel.: +48 22 417 92 00