DIMETHYL FUMARATE VIVANTA 120 mg HARD GASTRO-RESISTANT CAPSULES

Introduction

Package Leaflet: Information for the Patient

Dimethyl FumarateVivanta 120 mg Hard Gastro-Resistant Capsules EFG

Dimethyl FumarateVivanta 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 Dimethyl Fumarate Vivanta is and what it is used for
2. What you need to know before you take Dimethyl Fumarate Vivanta
3. How to take Dimethyl Fumarate Vivanta
4. Possible side effects
5. Storage of Dimethyl Fumarate Vivanta
6. Contents of the pack and other information

1. What Dimethyl Fumarate Vivanta is and what it is used for

What isDimethyl FumarateVivanta

Dimethyl FumarateVivanta is a medicine that contains dimethyl fumarateas the active substance.

What it is used forDimethyl FumarateVivanta

Dimethyl Fumarateis used to treat multiple sclerosis (MS) with relapses in patients from 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 MS is characterized by repeated attacks (relapses) of neurological symptoms. The symptoms vary from patient to patient, but often include: difficulty walking, balance disturbances, and vision problems (e.g., blurred or double vision). These symptoms can disappear completely when the relapse is over, but some problems may persist.

How it worksDimethyl FumarateVivanta

Dimethyl Fumarateseems 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 Vivanta

Do not takeDimethyl FumarateVivanta

• If you are allergic to dimethyl fumarateor any of the other ingredients of this medicine (listed in section 6).
• If you suspect that you have a rare brain infection called progressive multifocal leukoencephalopathy (PML) or if PML has been confirmed.

Warnings and precautions

Dimethyl Fumaratemay affect your white blood cell count, kidneys, and liver. Before starting dimethyl fumarate, your doctor will perform a blood test to obtain a white blood cell count and check that your kidneys and liver are working properly. Your doctor will perform periodic tests during treatment. If you have a low white blood cell count during treatment, your doctor may consider additional tests or interrupt your treatment.

Tell your doctorbefore starting to take dimethyl fumarateif 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 inform your doctor immediatelyif you suspect that you have any symptoms of shingles.

If you think that your MS is getting worse (e.g., weakness or changes in vision) or you notice the appearance of 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 for a medicine that contains dimethyl fumarate in combination with other esters of fumaric acid, 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, inform 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 available data for this age group.

Other medicines andDimethyl FumarateVivanta

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;
• the use of dimethyl fumarateand the administration of certain types of vaccines (live vaccines) could cause you to become infected, and therefore, should be avoided. Your doctor will tell you if you should receive other types of vaccines (inactivated vaccines).

TakingDimethyl FumarateVivantawith 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 liqueurs) for 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 have a baby, ask your doctor or pharmacist 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 use dimethyl fumarateduring pregnancy unless you have discussed it with your doctor and this medicine is clearly necessary for you.

Breastfeeding

It is not known if the active substance of dimethyl fumaratepasses into breast milk. Your doctor will inform you whether you should stop breastfeeding or stop taking dimethyl fumarate. This decision involves weighing the benefits of breastfeeding for your child and the benefits of treatment for you.

Driving and using machines

Dimethyl Fumarateis not expected to affect your ability to drive or use machines.

Dimethyl FumarateVivanta 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 Vivanta

Follow exactly the administration instructions of this medicine given by your doctor. If you are unsure, consult your doctor 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.

This medicineis taken orally.

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

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

If you take moreDimethyl FumarateVivanta 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 ingested.

If you forget to takeDimethyl FumarateVivanta

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 Fumaratemay lower your lymphocyte count (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 must continue to monitor your white blood cells during treatment, and you must 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 has worsened the functioning of your immune system.

The symptoms of PML can be similar to those of an MS relapse. The symptoms may include new weakness or worsening weakness on one side of the body; clumsiness; changes in vision, thinking, or memory; or confusion or changes in personality, 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 that your MS is getting worse or if you notice any new symptoms while taking 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).

Facial or body redness (flushing) is a very common side effect. However, if the redness is accompanied by a red skin rash or hivesandyou have any of these 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 be a severe allergic reaction (anaphylaxis).

• Stop taking Dimethyl Fumarate Vivanta and call your doctor immediately

Other side effects

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

• facial or body redness, feeling of heat, heat, burning sensation, or itching (flushing)
• loose stools (diarrhea)
• feeling sick (nausea)
• stomach pain or cramps

• Taking the medicine with foodmay help reduce the above side effects

While taking dimethyl fumarate, it is common for urine tests to show ketones, substances that are naturally produced in the body.

Tell your doctorabout 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)
• feeling sick (vomiting)
• indigestion (dyspepsia)
• inflammation of the stomach mucosa (gastritis)
• gastrointestinal disorders
• burning sensation
• hot flashes, feeling of heat
• skin itching (pruritus)
• rash
• red or pink patches on the skin accompanied by itching (erythema)
• hair loss (alopecia)

Side effects that may appear in blood or urine tests

• low white blood cell count (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

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

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

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 spots with severe pain

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, nausea (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 it is possible that they are not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side 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 which is stated on the blister and carton after “EXP”. The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at the pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Container Content and Additional Information

Composition ofDimethyl FumarateVivanta

The active ingredientis dimethyl fumarate.

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

The other components are:

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

Appearance of the Product and Container Content

Dimethyl FumarateVivanta 120 mg: Hard gastro-resistant capsules of green and white color, approximately 22 mm in length, and printed with "M" and "120 mg".

Dimethyl FumarateVivanta 240 mg: Hard gastro-resistant capsules of green color, approximately 22 mm in length, and printed with "M" and "240 mg".

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

Package sizes:

120 mg:

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

PVC/PE/PVdC-Al unit dose precut blisters containing 14x1 and 56x1 hard gastro-resistant capsules.

240 mg:

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

PVC/PE/PVdC-Al unit dose precut blisters containing 56x1, 168x1, and 196x1 hard gastro-resistant capsules.

Only some package sizes may be marketed.

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

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Local Representative:

Vivanta Generics s.r.o., branch in Spain

C/Guzmán el Bueno, 133, Britannia building

28003 Madrid

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

Germany: Dimethylfumarat Vivanta 120 mg Magensaftresistente Hartkapseln

Dimethylfumarat Vivanta 240 mg Magensaftresistente Hartkapseln

Cyprus: Dimethyl fumarate MSN 120 mg gastro-resistant hard capsules

Dimethyl fumarate MSN 240 mg gastro-resistant hard capsules

Spain: Fumarato de dimetilo Vivanta 120 mg cápsulas duras gastrorresistentes EFG

Fumarato de dimetilo Vivanta 240 mg cápsulas duras gastrorresistentes EFG

Ireland: Dimethyl fumarate MSN 120 mg gastro-resistant hard capsules

Dimethyl fumarate MSN 240 mg gastro-resistant hard capsules

Malta: Dimethyl fumarate MSN 120 mg gastro-resistant hard capsules

Dimethyl fumarate MSN 240 mg gastro-resistant hard capsules

Netherlands: Dimethylfumaraat Vivanta 120 mg maagsapresistente harde capsules

Dimethylfumaraat Vivanta 240 mg maagsapresistente harde capsules

Date of the last revision of this prospectus: April 2024

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