Dimethyl fumarate Aurovitas 240 mg gastro-resistant hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Dimethyl fumarate Aurovitas 240 mg gastro-resistant hard capsules EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Fumarato de dimetilo Aurovitas is and what it is used for

What Fumarato de dimetilo Aurovitas is

Fumarato de dimetilo Aurovitas is a medicine that contains dimethyl fumarate as the active substance.

What Fumarato de dimetilo Aurovitas is used for

Dimethyl fumarate is used to treat relapsing-remitting multiple sclerosis (MS) in patients 13 years of age and older.

MS is a long-term disease that affects the central nervous system (CNS), which includes the brain and spinal cord. Relapsing-remitting MS is characterized by repeated attacks (relapses) of neurological symptoms. Symptoms vary from patient to patient but usually include: difficulty walking, balance disturbances, and vision problems (e.g., blurred or double vision). These symptoms may completely disappear when a relapse ends, although some problems may persist.

How Fumarato de dimetilo Aurovitas works

Dimethyl fumarate appears to work by preventing the body's immune system from damaging the brain and spinal cord. This may also help delay future progression of your MS.

2. What you need to know before taking Fumarate de dimetilo Aurovitas

Do not take Fumarate de dimetilo Aurovitas

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

Warnings and precautions

Talk to your doctor or pharmacist before starting dimethyl fumarate:

Dimethyl fumarate may affect the number of white blood cells, kidneys, and liver. Before starting dimethyl fumarate, your doctor will perform a blood test to check your white blood cell count and to ensure your kidneys and liver are functioning properly. Your doctor will carry out periodic blood tests during treatment. If you experience a decrease in white blood cells during treatment, your doctor may consider additional testing or interrupt your treatment.

Talk to your doctor before starting dimethyl fumarate if you have:

• Severe kidney disease.
• Severe liver disease.
• A stomach or intestinal disorder.
• A serious infection (e.g., pneumonia).

Herpes zoster (shingles) may occur during treatment with dimethyl fumarate. In some cases, serious complications have occurred. You must inform your doctor immediately if you suspect you have any symptoms of shingles.

If you think your MS is worsening (e.g., weakness or visual changes) or you develop any new symptoms, speak directly with your doctor, as these could be symptoms of a rare brain infection called progressive multifocal leukoencephalopathy (PML). PML is a serious condition that may lead to death or severe disability.

A rare but serious kidney disorder called Fanconi syndrome has been reported with a medicine containing dimethyl fumarate in combination with other fumaric acid esters, used to treat psoriasis (a skin disease). If you notice that you are urinating more, feel more thirsty and drink more than usual, your muscles seem weaker, you break a bone, or simply have aches and pains, inform your doctor as soon as possible so this can be further investigated.

Children and adolescents

Do not give this medicine to children under 10 years of age, as there is no available data in this age group.

Other medicines and Fumarate de dimetilo Aurovitas

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, especially:

• Medicines containing fumaric acid esters (fumarates) used to treat psoriasis.
• Medicines that affect the body's immune system, including chemotherapy, immunosuppressants, or other medicines used to treat MS.
• Medicines that affect the kidneys, including certain antibiotics (used to treat infections), diuretics (tablets that increase urine output), certain types of painkillers (such as ibuprofen or other similar anti-inflammatory medicines), and medicines containing lithium.
• Using dimethyl fumarate together with certain types of vaccines (live attenuated vaccines) could cause you to develop an infection and should therefore be avoided. Your doctor will advise you whether other types of vaccines (inactivated vaccines) should be administered.

Taking Fumarate de dimetilo Aurovitas with alcohol

After taking dimethyl fumarate, you should avoid consuming more than a small amount (more than 50 ml) of strong alcoholic drinks (with an alcohol volume of more than 30%, such as spirits) during the first hour, because alcohol may interact with this medicine. This may cause stomach inflammation (gastritis), especially in people who are prone to this condition.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine.

Pregnancy

Information on the effects of this medicine on the fetus when used during pregnancy is limited. Do not use dimethyl fumarate during pregnancy unless you have discussed it with your doctor and the medicine is clearly necessary in your case.

Breastfeeding

It is unknown whether the active ingredient of this medicine passes into breast milk. Your doctor will advise you whether you should stop breastfeeding or stop taking dimethyl fumarate. This decision involves weighing the benefits of breastfeeding for your child against the benefits of treatment for you.

Driving and using machines

Dimethyl fumarate is not expected to affect your ability to drive or operate machinery.

Fumarate de dimetilo Aurovitas contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per capsule; i.e., essentially “sodium-free”.

3. How to take Dimethyl fumarate Aurovitas

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Starting dose: 120 mg twice daily.

Take this starting dose for the first 7 days, then take the usual dose.

Usual dose: 240 mg twice daily.

Dimethyl fumarate is taken orally.

The capsules must be swallowed whole, with some water. Do not split, crush, dissolve, suck or chew the capsules, as this could increase certain adverse effects.

Take dimethyl fumarate with food – this helps reduce some of the very common adverse effects (listed in section 4).

If you take more Dimethyl fumarate Aurovitas than you should

If you take too many capsules, inform your doctor immediately. You may experience adverse effects similar to those described below in section 4.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Dimethyl fumarate Aurovitas

Do not take a double dose to make up for missed doses.

You may take the missed dose if at least 4 hours have passed between doses. Otherwise, wait until the time of your next scheduled dose.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Serious adverse effects

Dimethyl fumarate may decrease the lymphocyte count (a type of white blood cell in the blood). A low white blood cell count can increase the risk of infection, including a rare brain infection called progressive multifocal leukoencephalopathy (PML). PML can lead to death or cause severe disability. PML has occurred after 1 to 5 years of treatment; therefore, your doctor must continue to monitor your white blood cells throughout treatment, and you should remain alert to any possible symptoms of PML, as described below. The risk of PML may be higher if you have previously taken a medicine that impaired the function of your immune system.

The symptoms of PML may resemble those of an MS relapse. Symptoms may include new weakness or worsening of weakness on one side of the body; clumsiness; changes in vision, thinking, or memory; or confusion or personality changes, or difficulty speaking and communicating that may persist for more than several days. Therefore, it is very important that you speak to your doctor as soon as possible if you think your MS is worsening or if you notice any new symptoms while being treated with dimethyl fumarate. In addition, inform your partner or caregivers about your treatment. Symptoms may arise that you do not notice yourself.

?Call your doctor immediately if you experience any of these symptoms.

Serious allergic reactions

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

Flushing of the face or body (rubefaction) is a very common adverse effect. However, if flushing is accompanied by a red rash or skin eruption and you experience any 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)

this could then constitute a serious allergic reaction (anaphylaxis).

?Stop taking this medicine and call your doctor immediately.

Other adverse effects

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

• flushing of the face or body, feeling of warmth, heat, burning sensation, or itching (rubefaction).
• loose stools (diarrhea).
• nausea.
• stomach pain or cramps.

?Taking the medicine with food may help reduce the above adverse effects.

While being treated with dimethyl fumarate, urine tests may frequently show the presence of ketones, substances naturally produced in the body.

Consult your doctor about how to manage these adverse effects. Your doctor may reduce your dose. Do not reduce the dose unless instructed by your doctor.

Common (may affect up to 1 in 10 people)

• inflammation of the intestinal mucosa (gastroenteritis).
• vomiting.
• indigestion (dyspepsia).
• inflammation of the stomach lining (gastritis).
• gastrointestinal disorders.
• burning sensation.
• hot flushes, feeling of warmth.
• skin itching (pruritus).
• rash.
• itchy, rosy or reddish skin patches (erythema).
• hair loss (alopecia).

Adverse effects that may appear in blood or urine tests

• low levels of white blood cells (lymphopenia, leukopenia) in blood. A decrease in white blood cells may reduce the body's ability to fight infections. If you have a serious infection (such as pneumonia), inform your doctor immediately.
• proteins (albumin) in urine.
• increased liver enzymes (ALT, AST) in blood.

Uncommon (may affect up to 1 in 100 people)

• allergic reactions (hypersensitivity).
• reduction in blood platelets.

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

• inflammation of the liver and increased levels of liver enzymes (ALT or AST together with bilirubin).

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

• herpes zoster (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 patches with severe pain.
• nasal discharge (rhinorrhea).

Children (aged 13 years and older) and adolescents

The adverse effects described above also apply to children and adolescents.

Some adverse effects were reported more frequently in children and adolescents than in adults, e.g., headache, stomach pain or cramps, vomiting, sore throat, cough, and painful menstruation.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Dimethyl fumarate Aurovitas

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the outer packaging and blister, following "EXP". The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Dimethyl fumarate Aurovitas

• The active substance is dimethyl fumarate. Each gastro-resistant hard capsule contains 240 mg of dimethyl fumarate.
• The other components are:

Capsule contents: silicified microcrystalline cellulose (grade 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) dispersion 30% (containing 0.7% sodium lauryl sulfate and 2.3% polysorbate 80), triethyl citrate and talc.

Capsule shell (body and cap): indigo carmine (E132), yellow iron oxide (E172), titanium dioxide (E171), gelatin, purified water and sodium lauryl sulfate.

Printing ink: shellac (E904), black iron oxide (E172) and potassium hydroxide.

Appearance of the product and contents of the pack

Gastro-resistant hard capsules.

Hard gelatin capsules of size “0”, with green cap and body, printed with “DMT 240” in black ink on the body. Each capsule contains six enteric-coated tablets, biconvex, round, white or almost white in colour.

Dimethyl fumarate Aurovitas gastro-resistant hard capsules are available in blister packs.

Pack sizes:

Blister packs: 14, 28, 56, 60, 98, 100, 112, 120, 168 and 196 gastro-resistant hard capsules.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

or

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

or

Arrow Génériques

26 Avenue Tony Garnier

69007 Lyon

France

This medicinal product is authorized in the European Economic Area member states under the following names:

Germany: Dimethylfumarat PUREN 240 mg magensaftresistente Hartkapseln

Belgium: Dimethyl fumarate AB 240 mg harde maagsapresistente capsules/gélules gastro-résistantes/magensaftresistente Hartkapseln

Spain: Fumarato de dimetilo Aurovitas 240 mg cápsulas duras gastrorresistentes EFG

France: Dimethyl fumarate Arrow 240 mg gélule gastro-résistante

Netherlands: Dimethylfumaraat Aurobindo 240 mg, harde maagsapresistente capsules

Poland: Dimethyl fumarate Aurovitas

Portugal: Fumarato de dimetilo Aurobindo

Date of the most recent review of this leaflet: February 2025

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).