Dimethil fumarate Aurovitas

Leaflet accompanying the packaging: information for the user

Dimethyl fumarate Aurovitas, 120 mg, gastro-resistant hard capsules

Dimethyl fumarate Aurovitas, 240 mg, gastro-resistant hard capsules

Dimethyl fumarate

You should read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Dimethyl fumarate Aurovitas and what is it used for
• 2. Important information 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 packaging and other information

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

What is Dimethyl fumarate Aurovitas

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

What is Dimethyl fumarate Aurovitas used for

Dimethyl fumarate Aurovitas is used to treat relapsing-remitting multiple sclerosis (MS) in patients aged 13 and over.

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 recurring episodes of neurological symptoms. The symptoms vary from person to person but usually include difficulty walking, loss of balance, and vision problems (such as blurred or double vision). These symptoms can completely disappear after an episode, but some problems may persist.

How Dimethyl fumarate Aurovitas works

Dimethyl fumarate Aurovitas seems to work by preventing the immune system from causing damage to the brain and spinal cord. This may also help slow down the progression of multiple sclerosis in the future.

2. Important information before taking Dimethyl fumarate Aurovitas

When not to take Dimethyl fumarate Aurovitas:

• or any of the other ingredients of this medicine (listed in section 6).
• .

Warnings and precautions

Before starting treatment with Dimethyl fumarate Aurovitas, you should discuss it with your doctor or pharmacist.
Dimethyl fumarate Aurovitas may affect your white blood cell count, kidney function, and liver function. Before starting treatment with Dimethyl fumarate Aurovitas, your doctor will check your white blood cell count and ensure that your kidneys and liver are functioning properly. These tests will be performed periodically during treatment. If your white blood cell count decreases during treatment, your doctor may consider additional tests or discontinuation of treatment.
Before starting treatment with Dimethyl fumarate Aurovitas, you should discuss it with your doctor if you have:

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

During treatment with Dimethyl fumarate Aurovitas, shingles (herpes zoster) may occur. In some cases, serious complications have occurred. If you suspect you have any symptoms of shingles, such as blisters, burning, itching, or pain on one side of the body, you should immediately inform your doctor.
If your multiple sclerosis worsens (such as weakness or vision problems) or you experience new symptoms, you should contact your doctor immediately, as these may be symptoms of a rare brain infection called PML. PML is a serious disease that can lead to severe disability or death.
During treatment with a medicine containing dimethyl fumarate in combination with other fumaric acid esters used to treat psoriasis (a skin disease), rare but serious kidney damage called Fanconi syndrome has been reported. If you notice that you are urinating more, feeling thirsty, and drinking more than usual, your muscles seem weaker, you have a bone fracture, or you simply feel pain, you should see your doctor as soon as possibleto investigate these symptoms.

Children and adolescents

This medicine should not be given to children under 10 years of age, as there is no data available for this age group.

Dimethyl fumarate Aurovitas and other medicines

You should tell your doctor or pharmacistabout all medicines you are taking, have recently taken, or plan to take, especially:

• medicines containing fumaric acid esters(fumarates) used to treat psoriasis
• medicines that affect the immune system, including chemotherapy, immunosuppressants, or other medicines used to treat multiple sclerosis
• medicines that affect the kidneys, such as certain antibiotics(used to treat infections), diuretics, certain types of painkillers(such as ibuprofen and other similar anti-inflammatory medicines and over-the-counter medicines), and lithium
• the use of certain vaccines( live vaccines) during treatment with Dimethyl fumarate Aurovitas, which may lead to infection and should be avoided. Your doctor will advise whether to administer other types of vaccines (inactivated vaccines).

Dimethyl fumarate Aurovitas and alcohol

You should avoid consuming high-percentage alcoholic beverages (over 30% alcohol by volume) (in amounts greater than 50 mL) within an hour of taking Dimethyl fumarate Aurovitas, due to the risk of interaction between alcohol and this medicine. This may lead to stomach upset ( gastritis), especially in people prone to this disease.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before taking this medicine.
Pregnancy
There is limited data on the use of this medicine in pregnant women. Dimethyl fumarate Aurovitas should not be taken during pregnancy unless you have discussed it with your doctor and the use of the medicine is necessary.
Breastfeeding
It is not known whether the active substance of Dimethyl fumarate Aurovitas passes into breast milk. Your doctor will advise whether to stop breastfeeding or stop taking Dimethyl fumarate Aurovitas. The decision will be based on the assessment of the benefit to the baby from breastfeeding compared to the benefit to the patient from treatment.

Driving and using machines

You should not expect Dimethyl fumarate Aurovitas to affect your ability to drive or use machines.

Dimethyl fumarate Aurovitas contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per capsule, which means Dimethyl fumarate Aurovitas is considered "sodium-free".

3. How to take Dimethyl fumarate Aurovitas

This medicine should always be taken as directed by your doctor. If you are unsure, you should consult your doctor.

Initial dose: 120 mg twice a day.

This initial dose should be taken for the first 7 days, and then the recommended dose should be taken.

Recommended dose: 240 mg twice a day.

Dimethyl fumarate Aurovitas should be taken orally.
Each capsule should be swallowed whole, with a glass of water. The capsules should not be divided, crushed, dissolved, sucked, or chewed, as this may increase certain side effects.
Dimethyl fumarate Aurovitas should be taken with food– this will help alleviate very common side effects (listed in section 4).

Taking a higher dose of Dimethyl fumarate Aurovitas than recommended

If you take more Dimethyl fumarate Aurovitas capsules than recommended, you should immediately contact your doctor. Side effects may occur that are similar to those described below in section 4.

Missing a dose of Dimethyl fumarate Aurovitas

You should not take a double doseto make up for a missed dose.
A missed dose can be taken if there is at least a 4-hour interval between doses. If it is too late, you should not take the missed dose, but take the next dose at the usual time.
If you have any further doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Dimethyl fumarate Aurovitas can cause side effects, although not everyone gets them.

Severe side effects

Dimethyl fumarate Aurovitas may decrease the number of lymphocytes (a type of white blood cell). A low white blood cell count can increase the risk of infections, including a rare brain infection called progressive multifocal leukoencephalopathy (PML). PML can lead to severe disability or death. PML has been reported after 1 to 5 years of treatment, so 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 PML may be higher if you have taken medicines that affect the immune system in the past. Symptoms of PML may resemble a relapse of multiple sclerosis and include weakness or increased weakness on one side of the body, coordination problems, vision problems, speech or thinking problems, confusion (disorientation), or personality changes, speech and communication difficulties lasting more than a few days. Therefore, if you experience worsening of multiple sclerosis symptoms or new symptoms while taking Dimethyl fumarate Aurovitas, you should contact your doctor immediately. You should also talk to your partner or caregivers and inform them about your treatment. There may be symptoms that you are not aware of.

• If you experience any of the following symptoms, you should contact your doctor immediately

Severe allergic reactions

The frequency of severe allergic reactions cannot be estimated from the available data (frequency unknown).
A very common side effect is sudden flushing of the face or body. If sudden flushing is accompanied by a red rash or hives andany of the following symptoms:

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

it may indicate a severe allergic reaction ( anaphylaxis).

You should stop taking Dimethyl fumarate Aurovitas and contact your doctor immediately

Other side effects

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

• sudden flushing of the skin on the face or feeling of increased body temperature, heat, burning, or itching of the skin
• diarrhea
• nausea
• stomach pain or cramps
• Taking the medicine with foodwill help alleviate the above side effects

During treatment with Dimethyl fumarate Aurovitas, substances called ketone bodies are very commonly detected in urine tests, which are naturally produced in the body.
You should talk to your doctorabout how to deal with side effects. Your doctor may reduce the dose of the medicine. You should not reduce the dose of the medicine unless your doctor advises you to.
Common(may affect up to 1 in 10 people)

• inflammation of the lining of the intestines ( gastroenteritis)
• vomiting
• indigestion
• inflammation of the stomach lining ( gastritis)
• stomach and intestinal disorders
• skin burning
• hot flashes, feeling of heat
• itching ( pruritus)
• rash
• pink or red spots on the skin ( erythema)
• excessive hair loss ( alopecia)

Side effects that may appear in blood or urine tests

• low white blood cell count ( lymphopenia, leukopenia). A decreased white blood cell count may mean that the body is less able to fight infection. In the event of a severe infection (such as pneumonia), you should contact your doctor immediately.
• protein ( albumin) in the urine
• increased liver enzyme activity ( ALT, AST) in the 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)

• liver inflammation and increased liver enzyme activity ( ALT or AST in combination with bilirubin)

Frequency unknown(frequency cannot be estimated from available data)

• shingles, with symptoms such as blisters, burning, itching, or pain on the skin, 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
• cold ( rhinitis)

Children (13 years and older) and adolescents

The above side effects also apply to children and adolescents.
Some side effects have been reported more frequently in children and adolescents than in adults, such as headache, stomach pain or cramps, nausea (vomiting), throat pain, cough, and painful menstruation.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, 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 authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Dimethyl fumarate Aurovitas

The medicine should be stored out of 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 the month.
There are no special precautions for storing the medicine.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Dimethyl fumarate Aurovitas contains

• The active substance of Dimethyl fumarate Aurovitas is dimethyl fumarate. Each capsule contains 120 mg of dimethyl fumarate. Each capsule contains 240 mg of dimethyl fumarate.
• Other ingredients are:capsule content:microcrystalline cellulose, silicon dioxide, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate, methacrylic acid and methyl methacrylate copolymer (1:1), methacrylic acid and ethyl acrylate copolymer (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 240 mg dose), yellow iron oxide (E 172) (only for 240 mg dose), titanium dioxide (E 171), gelatin, purified water, and sodium lauryl sulfate.
Black ink for printing:shellac (E 904), black iron oxide (E 172), and potassium hydroxide (E 525).

What Dimethyl fumarate Aurovitas looks like and contents of the pack

Gastro-resistant hard capsules
Dimethyl fumarate Aurovitas, 120 mg, gastro-resistant hard capsules
Hard gelatin capsules, size "0", with a white cap and white body, with "DMT 120" printed on the body in black ink. Each capsule contains three white or almost white, round, biconvex, gastro-resistant tablets.
Dimethyl fumarate Aurovitas, 240 mg, gastro-resistant hard capsules
Hard gelatin capsules, size "0", with a green cap and green body, with "DMT 240" printed on the body in black ink. Each capsule contains six white or almost white, round, biconvex, gastro-resistant tablets.

Pack sizes:

Blisters:14, 28, 56, 60, 98, 100, 112, 120, 168, and 196 gastro-resistant hard capsules.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer/importer

Marketing authorization holder:

Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 27
01-909 Warsaw
e-mail: medicalinformation@aurovitas.pl

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 medicine is authorized in the Member States of the European Economic Area under the following names:

Belgium:
Dimethyl fumarate AB 120 mg/240 mg hard gastro-resistant capsules / gastro-résistantes / magensaftresistente Hartkapseln
France:
Dimethyl fumarate Arrow 120 mg/240 mg gastro-résistantes
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

Date of last revision of the leaflet: 02/2025