DIMETHYL FUMARATE AUROVITAS 240 mg HARD GASTRO-RESISTANT CAPSULES

Introduction

Package Leaflet: Information for the User

Dimethyl Fumarate Aurovitas 240 mg Hard Gastro-Resistant Capsules EFG

Read all of this leaflet carefully before you start taking 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Dimethyl Fumarate Aurovitas and what is it used for
2. What you need to know before you take Dimethyl Fumarate Aurovitas
3. How to take Dimethyl Fumarate Aurovitas
4. Possible side effects
5. Storage of Dimethyl Fumarate Aurovitas
6. Contents of the pack 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 dimethyl fumarateas the active substance.

What is Dimethyl Fumarate Aurovitas used for

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

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. The symptoms vary from person to person but often include: difficulties with walking, balance problems, and vision problems (e.g., blurred or double vision). These symptoms can disappear completely when the relapse is over, but some problems may remain.

How Dimethyl Fumarate Aurovitas works

Dimethyl fumarate seems to work by preventing the body's defense system from damaging the brain and spinal cord. This may also help to delay future disability in MS.

2. What you need to know before you take Dimethyl Fumarate Aurovitas

Do not take Dimethyl Fumarate Aurovitas

• If you are allergic to dimethyl fumarate or 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 PML has been confirmed.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take dimethyl fumarate:

Dimethyl fumarate may affect your white blood cell count, kidneys, and liver. Before starting to take dimethyl fumarate, your doctor will do a blood test to check your white blood cell count and make sure your kidneys and liver are working properly. Your doctor will do regular blood tests during treatment. If you have a low white blood cell count during treatment, your doctor may consider additional tests or stop your treatment.

Talk to your doctorbefore starting to take dimethyl fumarate if you have:

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

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

If you think your MS is getting worse (e.g., weakness or changes in vision) or you notice any new symptoms, talk to your doctor directly, as they could be symptoms of a rare brain infection called progressive multifocal leukoencephalopathy (PML). PML is a serious disease that can cause death or severe disability.

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

Children and adolescents

Do not give this medicine to children under 10 years of age because there is no data available for this age group.

Other medicines and Dimethyl Fumarate Aurovitas

Tell your doctor or pharmacistif you are taking, have recently taken, or might take any other medicines, in particular:

• Medicines that contain 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 some antibiotics (used to treat infections), diuretics (pills that increase urine production), certain types of painkillers (such as ibuprofen or similar anti-inflammatory medicines, and over-the-counter medicines), and medicines that contain lithium.
• Taking dimethyl fumarate and receiving certain types of vaccines (live vaccines) could cause you to get an infection, and therefore, should be avoided. Your doctor will tell you if you should receive other types of vaccines (inactivated vaccines).

Taking Dimethyl Fumarate Aurovitas with alcohol

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

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.

Pregnancy

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

Breast-feeding

It is not known if the active substance of this medicine passes into breast milk. Your doctor will inform you if you should stop breast-feeding, or if you should stop taking dimethyl fumarate. This decision will involve weighing the benefits of breast-feeding for your child and the benefits of treatment for you.

Driving and using machines

Dimethyl fumarate is not expected to affect your ability to drive and use machines.

Dimethyl Fumarate Aurovitas contains sodium

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

3. How to take Dimethyl Fumarate Aurovitas

Follow the instructions for administration of this medicine exactly as told by your doctor. If you are unsure, ask your doctor or pharmacist again.

Starting dose: 120 mg twice a day.

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

Usual dose: 240 mg twice a day.

Dimethyl fumarate is taken orally.

The capsules should be swallowed whole, with some water. Do not break, crush, dissolve, suck, or chew the capsules, as this may increase some side effects.

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

If you take more Dimethyl Fumarate Aurovitas than you should

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

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

If you forget to take Dimethyl Fumarate Aurovitas

Do not take a double doseto make up for forgotten doses.

You can take the forgotten dose if at least 4 hours have passed between doses. Otherwise, wait until the next dose.

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

4. Possible side effects

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

Serious side effects

Dimethyl fumarate may lower the count of lymphocytes (a type of white blood cell). A low white blood cell count can increase the risk of infection, including a rare brain infection called progressive multifocal leukoencephalopathy (PML). PML can cause death or severe disability. PML has occurred after 1 to 5 years of treatment, so your doctor will continue to monitor your white blood cells during treatment, and you should be 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 has weakened your immune system.

The symptoms of PML can be similar to those of an MS relapse. The symptoms can include new or worsening 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 talk to your doctor as soon as possible if you think your MS is getting worse or if you notice any new symptoms while being treated with dimethyl fumarate. Also, inform your partner or caregivers about your treatment. It is possible that symptoms may arise that you are not aware of on your own.

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

Severe allergic reactions

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

Flushing of the face or body (flushing) is a very common side effect. However, if the flushing 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)
• wheezing, difficulty breathing, or shortness of breath (dyspnea, hypoxia)
• dizziness or fainting (hypotension)

this could be a severe allergic reaction (anaphylaxis).

?Stop taking this medicine and call your doctor immediately.

Other side effects

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

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

?Taking the medicine with foodmay help to reduce the above side effects.

While being treated with dimethyl fumarate, it is common for urine tests to show ketones, substances that are naturally produced by the body.

Talk to your doctorabout how to treat these side effects. Your doctor may reduce your dose. Do not reduce the dose unless your doctor tells you to.

Common(may affect up to 1 in 10 people)

• inflammation of the intestinal mucosa (gastroenteritis).
• vomiting.
• indigestion (dyspepsia).
• inflammation of the stomach mucosa (gastritis).
• gastrointestinal disorders.
• burning sensation.
• hot flashes, feeling of heat.
• itching of the skin (pruritus).
• rash.
• red patches or redness of the skin accompanied by itching (erythema).
• hair loss (alopecia).

Side effects that may appear in blood or urine tests

• low levels of white blood cells (lymphopenia, leucopenia) in blood. A decrease in white blood cells may make the body less able to fight infections. If you have a severe infection (such as pneumonia), tell 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 of blood platelets.

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

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

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

• herpes zoster (shingles) with symptoms such as blisters, burning, itching, or pain of 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.
• nasal discharge (rhinorrhea).

Children (13 years of age and older) and adolescents

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

Some side 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 side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly to the Spanish Medicines Monitoring System for Human Use: www.notificaram.es. By reporting side 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 which is stated on the carton and blister, after “EXP”. The expiry date is the last day of the month stated.

This medicine does not require any special storage conditions.

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. Container Content and Additional Information

Composition ofDimethyl Fumarate Aurovitas

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

Capsule Content:silicified microcrystalline cellulose (grade 90), sodium croscarmellose, anhydrous colloidal silica, magnesium stearate, methacrylic acid-methyl methacrylate copolymer (1:1), methacrylic acid-ethyl acrylate copolymer (1:1) dispersion at 30% (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 Container Content

Gastro-resistant hard capsules.

Size “0” hard gelatin capsules, with the cap and body green in color, with “DMT 240” printed on the body in black ink. Each capsule contains six enteric-coated, biconvex, round, white or off-white tablets.

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

Container Sizes:

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

Only some container 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 Member States of the European Economic Area 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 Last Revision of this Leaflet: February 2025

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