Dimethyl fumarate aurovitas

Package leaflet: Information for the user

Dimethyl fumarate Aurovitas, 120 mg, hard enteric-coated capsules
Dimethyl fumarate Aurovitas, 240 mg, hard enteric-coated capsules
Dimethyl fumarate
Read all of this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to 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.

Contents of the leaflet:

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

1. What Dimethyl fumarate Aurovitas is and what it is used for

What Dimethyl fumarate Aurovitas is
Dimethyl fumarate Aurovitas is a medicine that contains the active substance dimethyl fumarate.

What Dimethyl fumarate Aurovitas is used for
Dimethyl fumarate Aurovitas 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), including the brain and spinal cord. Relapsing-remitting multiple sclerosis is characterized by recurring, periodic episodes of neurological symptoms. Symptoms vary between patients but usually include walking difficulties, loss of balance, and vision problems (e.g. blurred or double vision). These symptoms may completely resolve after a relapse, but some problems may persist.

How Dimethyl fumarate Aurovitas works
Dimethyl fumarate Aurovitas appears to work by suppressing the immune system from causing damage to the brain and spinal cord. This may also help slow the future progression of multiple sclerosis.

2. Important information before using Dimethyl fumarate Aurovitas

When not to use Dimethyl fumarate Aurovitas:

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

Warnings and precautions
Before starting treatment with Dimethyl fumarate Aurovitas, discuss this with your doctor or
pharmacist.
Dimethyl fumarate Aurovitas may affect the number of white blood cells, kidney function, and
liver function. Before starting treatment with Dimethyl fumarate Aurovitas, your doctor will check
the patient's white blood cell count and assess whether the kidneys and liver are functioning properly.
These tests will be repeated periodically during treatment. If the patient's white blood cell count
decreases during treatment, the doctor may consider performing additional tests or discontinuing
treatment.
Before starting treatment with Dimethyl fumarate Aurovitas, discuss this with your doctor if the
patient has:

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

Shingles (herpes zoster) may occur during treatment with Dimethyl fumarate Aurovitas. In some
cases, severe complications have occurred. If the patient suspects any symptoms of shingles, the doctor should be informed immediately.
If multiple sclerosis worsens (e.g. the patient experiences weakness or vision problems) or new
symptoms appear, the patient should contact the doctor immediately, as these may be signs of a rare
brain infection called PML. PML is a serious condition that may lead to severe disability or death.
Rare but serious kidney dysfunction called Fanconi syndrome has been reported during treatment with
medicines containing dimethyl fumarate in combination with other fumaric acid esters used in the
treatment of psoriasis (a skin disease). If the patient notices increased urination, feels thirsty and drinks
more than usual, experiences muscle weakness, bone fractures, or general pain, they should see 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 data in this age group are not
available.
Dimethyl fumarate Aurovitas and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently
taken, as well as any medicines the patient 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 to treat multiple sclerosis,
• medicines affecting the kidneys, such as certain antibiotics (used to treat infections), diuretics, certain types of painkillers (such as ibuprofen and other similar anti-inflammatory medicines, including over-the-counter products), and medicines containing lithium,
• use of certain vaccines (vaccines containing live microorganisms) during treatment with Dimethyl fumarate Aurovitas, which may lead to infection and therefore should be avoided. Your doctor will advise whether other types of vaccines (vaccines containing inactivated microorganisms) should be given.

Dimethyl fumarate Aurovitas and alcohol
Avoid consuming high-strength alcoholic drinks (more than 30% alcohol by volume) (in quantities
greater than 50 mL) within one hour of taking Dimethyl fumarate Aurovitas, due to the risk of
interaction between alcohol and this medicine. This may lead to gastric irritation (inflammation of the stomach lining), especially in individuals susceptible to this condition.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become
pregnant, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
There is limited data on the effects of this medicine on the unborn child when used during
pregnancy. Dimethyl fumarate Aurovitas should not be used during pregnancy unless the patient has
discussed this with her doctor and the use of the medicine is considered necessary.
Breastfeeding
It is not known whether the active substance of Dimethyl fumarate Aurovitas passes into human
breast milk. The doctor will advise the patient whether she should discontinue breastfeeding or
discontinue treatment with Dimethyl fumarate Aurovitas. 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 using machines
No effects of Dimethyl fumarate Aurovitas on the ability to drive and use machines are expected.
Dimethyl fumarate Aurovitas contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule; therefore, Dimethyl
fumarate Aurovitas is considered "sodium-free".

3. How to use Dimethyl fumarate Aurovitas

This medicine should always be taken as prescribed by your doctor. If in 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 taken at the recommended dose.
Recommended dose: 240 mg twice daily.
Dimethyl fumarate Aurovitas 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 certain adverse effects.
Dimethyl fumarate Aurovitas should be taken with food – this will help reduce the very common adverse effects listed in section 4.
Use of a higher than recommended dose of Dimethyl fumarate Aurovitas
If more capsules of Dimethyl fumarate Aurovitas than recommended have been taken, contact your doctor immediately. Adverse effects similar to those described below in section 4 may occur.
Missed dose of Dimethyl fumarate Aurovitas
Do not take a double dose to make up for a missed dose.
A missed dose may be taken if at least a 4-hour interval is maintained between doses. If it is too late, do not take the missed dose; instead, take the next dose at the usual time.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
Serious adverse reactions
Dimethyl fumarate Aurovitas 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 after 1 to 5 years of treatment; therefore, the physician should monitor the patient's white blood cell count throughout the entire treatment period, and the patient should be aware of the symptoms described below, which may indicate PML. The risk of developing PML may be higher if the patient has previously taken medicines that impair the immune system.
Symptoms of PML may resemble a relapse of multiple sclerosis. These include new or worsening weakness on one side of the body, problems with coordination, vision disturbances, thinking or memory problems, confusion (disorientation), personality changes, speech difficulties, and communication problems lasting longer than a few days. For this reason, if a patient notices worsening of symptoms related to multiple sclerosis or the occurrence of any new symptoms while taking Dimethyl fumarate Aurovitas, they should contact their doctor as soon as possible. Patients should also talk to their partner or caregivers and inform them about their treatment. Symptoms may occur that the patient may not be aware of.

• If any of the symptoms listed above occur, contact a doctor immediately

Serious allergic reactions
The frequency of serious allergic reactions cannot be determined from the available data (frequency unknown).
A very common adverse reaction is sudden redness of the skin of the face or body. If sudden skin redness is accompanied by a red rash or hives and any of the following symptoms:

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

this may indicate a serious allergic reaction (anaphylaxis).

• Stop taking Dimethyl fumarate Aurovitas and contact a doctor immediately

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

• sudden redness of the skin of the face or sensation of increased body temperature, hot flushes, skin burning or itching
• loose stools (diarrhea)
• nausea (nausea)
• stomach pain or cramps
• Taking the medicine with food may help reduce the above-mentioned adverse reactions

During treatment with Dimethyl fumarate Aurovitas, substances called ketone bodies, which are naturally produced in the body, are very commonly detected in urine tests.
Talk to your doctor about how to manage adverse reactions. The doctor may reduce the dose of the medicine. Do not reduce the dose of the medicine unless advised by your doctor.
Common (may affect up to 1 in 10 people)

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

Adverse reactions that may appear in blood or urine test results

• low number of white blood cells ( lymphopenia, leukopenia ). Reduced numbers of white blood cells may mean the body is less able to fight infections. In case of severe infection (such as pneumonia), contact a doctor immediately.
• proteins ( albumin ) in urine
• increased liver enzyme activity ( AlAT, AspAT ) in blood

Uncommon (may affect up to 1 in 100 people)

• allergic reactions ( hypersensitivity )
• decreased platelet count

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

• hepatitis and increased liver enzyme activity ( AlAT or AspAT in combination with bilirubin )

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

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

Children (aged 13 years and older) and adolescents
The adverse reactions listed above also apply to children and adolescents.
Some adverse reactions have been reported more frequently in children and adolescents than in adults, e.g., headache, stomach pain or cramps, nausea (vomiting), sore throat, cough and painful menstruation.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Dimethyl fumarate Aurovitas

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and carton after: EXP.
The expiry date refers to the last day of the stated month.
No special storage instructions apply.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the packaging and other information

What Dimethyl fumarate Aurovitas contains

• The active substance is dimethyl fumarate. Each capsule contains 120 mg of dimethyl fumarate. Each capsule contains 240 mg of dimethyl fumarate.
• Other ingredients are: Capsule contents: Silicified microcrystalline cellulose (Type - 90), sodium croscarmellose, colloidal anhydrous silica, magnesium stearate, copolymer of methacrylic acid and methyl methacrylate (1:1), copolymer of methacrylic acid and ethyl acrylate (1:1), 30% dispersion (0.7% sodium lauryl sulfate and 2.3% polysorbate 80), triethyl citrate and talc.

Capsule shell:
Cap and body:
Brilliant blue FCF (E 132) (only for the 240 mg dose), yellow iron oxide (E 172) (only for the 240 mg dose), titanium dioxide (E 171), gelatin, purified water and sodium lauryl sulfate.
Black printing ink: shellac (E 904), black iron oxide (E 172) and potassium hydroxide (E 525).
What Dimethyl fumarate Aurovitas looks like and contents of the pack
Enteric hard capsules
Dimethyl fumarate Aurovitas, 120 mg, enteric hard capsules
Hard gelatin capsules of size “0”, with a white cap and white body, printed with “DMT 120” on the body in black ink. Each capsule contains three white or almost white, round, biconvex enteric-coated tablets.
Dimethyl fumarate Aurovitas, 240 mg, enteric hard capsules
Hard gelatin capsules of size “0”, with a green cap and green body, printed with “DMT 240” on the body in black ink. Each capsule contains six white or almost white, round, biconvex enteric-coated tablets.
Pack sizes:
Blister packs: 14, 28, 56, 60, 98, 100, 112, 120, 168 and 196 enteric hard capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer/Importer
Marketing Authorisation Holder:
Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 27
01-909 Warsaw
e-mail: [email protected]
Manufacturer/Importer:
APL Swift Services (Malta) Ltd.
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
Generis Farmacêutica, S.A.
Rua João de Deus n° 19, Venda Nova
2700-487 Amadora
Portugal
Arrow Génériques
26 Avenue Tony Garnier
69007 Lyon
France
This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Belgium: Dimethyl fumarate AB 120 mg/240 mg harde maagsapresistente capsules / gélules gastro-résistantes / magensaftresistente Hartkapseln
France: Dimethyl fumarate Arrow 120 mg/240 mg gélule gastro-résistante
Germany: Dimethylfumarat PUREN 120 mg/240 mg magensaftresistente Hartkapseln
Netherlands: Dimethylfumaraat Aurobindo 120mg/240mg, harde maagsapresistente capsules
Poland: Dimethyl fumarate Aurovitas
Portugal: Fumarato de dimetilo Aurobindo
Spain: Fumarato de dimetilo Aurovitas 240 mg cápsulas duras gastrorresistentes EFG