Dimethyl fumarate Vivanta 120 mg gastro-resistant hard capsules EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Dimethyl fumarate Vivanta 120 mg gastro-resistant hard capsules EFG
Dimethyl fumarate Vivanta 240 mg gastro-resistant hard capsules EFG

Read the entire leaflet carefully before you start taking this medicine, as 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 others, 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 effects not listed in this leaflet. See section 4.

Leaflet Contents

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

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

What Fumarato de dimetilo Vivanta is

Fumarato de dimetilo Vivanta is a medicine that contains dimethyl fumarate as its active substance.

What Fumarato de dimetilo Vivanta is used for

Dimethyl fumarate is used to treat relapsing-remitting multiple sclerosis (MS) in patients aged 13 years 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 commonly include: difficulty walking, balance disturbances, and visual 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 Vivanta 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 worsening of your MS.

2. What you need to know before taking Fumarato de dimetilo Vivanta

Do not take Fumarato de dimetilo Vivanta

• 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

Dimethyl fumarate may affect the number of white blood cells, as well as the kidneys and liver. Before starting dimethyl fumarate, your doctor will perform a blood test to determine your white blood cell count and to check that 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 cell count during treatment, your doctor may consider additional tests or interrupt your treatment.

Consult 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 notice any new symptoms, speak to your doctor immediately, as these could be symptoms of a rare brain infection called progressive multifocal leukoencephalopathy (PML). PML is a serious illness that can be fatal or cause 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 frequently, are more thirsty and drinking more than usual, your muscles seem weaker, you suffer a bone fracture, or you 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 Fumarato de dimetilo Vivanta

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 drugs, and over-the-counter medicines), and medicines containing lithium;
• the use of dimethyl fumarate together with certain types of vaccines (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 Fumarato de dimetilo Vivanta with alcohol

After taking dimethyl fumarate, you should avoid consuming more than a small amount (more than 50 ml) of strong alcoholic drinks (containing more than 30% alcohol by volume, such as spirits) for at least one hour, as alcohol may interact with this medicine. This may cause stomach inflammation (gastritis), especially in people 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 or pharmacist 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 this medicine is clearly necessary in your case.

Breastfeeding

It is unknown whether the active substance of dimethyl fumarate 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 use machines.

Fumarato de dimetilo Vivanta contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per capsule; hence, it is essentially "sodium-free".

3. How to take Dimethyl fumarate Vivanta

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor 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.

This medicine is taken orally.

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

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

If you take more Dimethyl fumarate Vivanta 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 Vivanta

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

You may take the missed dose if at least 4 hours remain before the next scheduled dose. Otherwise, wait until the time of your next 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 your 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 monitoring your white blood cells throughout treatment, and you should remain alert for 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.

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; confusion or personality changes; or difficulty speaking and communicating, which may persist for more than several days. Therefore, it is very important that you contact 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 yourself do not notice.

• Call your doctor immediately if you experience 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 adverse effect. However, if flushing is accompanied by a red rash or hives 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 severe allergic reaction (anaphylaxis).

• Stop taking Dimethyl Fumarate Vivanta and call your doctor immediately

Other adverse effects

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

• flushing of the face or body, sensation of warmth, heat, burning sensation, or itching (flushing)

• loose stools (diarrhea)

• feeling unwell (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 that are naturally produced in the body.

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

Common (may affect up to 1 in 10 people)

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

Adverse 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 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 1000 people)

• liver inflammation and increased levels of 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 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 painful red spots
• 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, malaise (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 it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Dimethyl fumarate Vivanta

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

Do not use this medicine after the expiry date stated on the blister pack and the carton after “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 packaging at the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Package contents and other information

Composition of Dimethyl fumarate Vivanta

The active substance is dimethyl fumarate.

Dimethyl fumarate Vivanta 120 mg: each capsule contains 120 mg of dimethyl fumarate.
Dimethyl fumarate Vivanta 240 mg: each capsule contains 240 mg of dimethyl fumarate.

The other components are:

• Capsule contents (enteric-coated microtablets): microcrystalline cellulose (E460), sodium croscarmellose, colloidal hydrated silica, magnesium stearate (E470b), methacrylic acid and methyl methacrylate copolymer (1:1), methacrylic acid and ethyl acrylate copolymer (1:1), 30% dispersion, triethyl citrate (E1505), talc (E553b), sodium lauryl sulfate, polysorbate 80 (E433).
• Capsule shell contains gelatin, titanium dioxide (E171), brilliant blue FCF (E133), black iron oxide (E172), and yellow iron oxide (E172).
• Black printing ink contains shellac (E904), black iron oxide (E172), potassium hydroxide (E525), and propylene glycol (E1520).

Appearance of the product and contents of the pack

Dimethyl fumarate Vivanta 120 mg: Gastric-resistant hard capsules, approximately 21 mm long, with a green cap printed with a black "M" and a black band, and a white body printed with "120 mg" in black.

Dimethyl fumarate Vivanta 240 mg: Gastric-resistant hard capsules, approximately 21 mm long, with a green cap printed with a black "M" and a black band, and a green body printed with "240 mg" in black.

The capsules contain white to off-white enteric-coated microtablets.

Pack sizes:

120 mg:

PVC/PE/PVdC-Al blisters containing 14 and 56 gastric-resistant hard capsules.

Single-dose perforated PVC/PE/PVdC-Al blisters containing 14x1 and 56x1 gastric-resistant hard capsules.

240 mg:

PVC/PE/PVdC-Al blisters containing 56, 168, and 196 gastric-resistant hard capsules.

Single-dose perforated PVC/PE/PVdC-Al blisters containing 56x1, 168x1, and 196x1 gastric-resistant hard capsules.

Only certain pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Vivanta Generics s.r.o.
Trtinova 260/1, Cakovice,
196 00, Prague 9
Czech Republic

Manufacturer

Pharmadox Healthcare Limited
KW20A Kordin Industrial Park, Paola,
PLA3000,
Malta

or

MSN Labs Europe Limited
KW20A Corradino Park, Paola,
PLA3000,
Malta

For more information about this medicine, please contact the local representative of the Marketing Authorization Holder:

Local Representative:

Vivanta Generics s.r.o. Spanish branch
C/Guzmán el Bueno, 133, edificio Britannia
28003 Madrid, Spain

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

Germany: Dimethylfumarat Vivanta 120 mg, 240 mg Magensaftresistente Hartkapseln
Cyprus: Dimethyl fumarate MSN 120 mg, 240 mg gastro-resistant hard capsules
Spain: Fumarato de dimetilo Vivanta 120 mg, 240 mg cápsulas duras gastrorresistentes EFG
Ireland: Dimethyl fumarate MSN 120 mg, 240 mg gastro-resistant hard capsules
Malta: Dimethyl fumarate MSN 120 mg, 240 mg gastro-resistant hard capsules
Netherlands: Dimethylfumaraat Vivanta 120 mg, 240 mg maagsapresistente harde capsules
Denmark: Dimethyl fumarate Vivanta
Finland: Dimethyl fumarate Vivanta 120 mg, 240 mg enterokapseli, kova
Norway: Dimethyl fumarate Vivanta
Sweden: Dimethyl fumarate Vivanta 120 mg, 240 mg hård enterokapsel
Italy: Dimetilfumarato Vivanta
Portugal: Fumarato de dimetilo Vivanta 120 mg, 240 mg cápsulas gastrorresistentes

Date of the most recent review of this leaflet: January 2026

Detailed information about this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/