Prospect: information for the patient

MethylphenidateVivanta 120 mg hard gastro-resistant EFG capsules

MethylphenidateVivanta 240 mg hard gastro-resistant EFG capsules

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1.What isMethylphenidateVivanta and what is it used for

2.What you need to know before starting to takeMethylphenidateVivanta

3.How to takeMethylphenidateVivanta

4.Possible adverse effects

5.Storage ofMethylphenidateVivanta

6.Contents of the pack and additional information

What isDimethyl FumarateVivanta

Dimethyl FumarateVivantais a medication that containsdimethyl fumarateas the active ingredient.

For what it is usedDimethyl FumarateVivanta

Dimethyl Fumarateis 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 (exacerbations) of neurological symptoms. Symptoms vary from patient to patient, but often include: difficulties walking, balance problems, and visual problems (e.g., blurry or double vision). These symptoms may disappear completely when the exacerbation ends, but some problems may persist.

How it worksDimethyl FumarateVivanta

Dimethyl Fumarateappears to act by preventing the body's defense system from damaging the brain and spinal cord. This may also help to delay future deterioration of MS.

Do not takeDimethyl Fumarate Vivanta

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

Warnings and precautions

Dimethyl fumaratemay affect thenumber of white blood cells, thekidneysand theliver. Before startingdimethyl fumarate, your doctor will do a blood test to get a white blood cell count and check that your kidneys and liver are working properly. Your doctor will do blood tests periodically during treatment. If you experience a decrease in the number of white blood cells during treatment, your doctor may consider additional tests or stop your treatment.

Consult your doctorbefore starting to takedimethyl fumarateif you have:

-severerenal disease

-severehepatic disease

-gastrointestinal disease

-severeinfection(for example, pneumonia)

You may experience herpes zoster (shingles) during treatment withdimethyl fumarate. In some cases, serious complications have occurred.You must inform your doctor immediatelyif you suspect you have any of the symptoms of shingles.

If you think your MS is getting worse (e.g., weakness or changes in vision) or notice the appearance of any new symptoms, speak directly with your doctor, as they may 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 fumaric acid esters, and that is used to treat psoriasis (a skin disease). If you notice that you are urinating more, are more thirsty and drink more than usual, your muscles seem weaker, you break a bone or simply have pain and discomfort, inform your doctor as soon as possible so that this can be investigated further.

Children and adolescents

Do not administer this medicine to children under 10 years of age because there are no available data in this age group.

Other medicines andDimethyl Fumarate Vivanta

Inform your doctor or pharmacistif you are taking, have taken recently or may need to take any other medicine, in particular:

• medicines that containfumaric acid esters(fumarates) used to treat psoriasis;
• medicines that affect the body's immune system,includingchemotherapy, immunosuppressantsand other medicines used to treat MS;
• medicines that affect the kidneys, includingsomeantibiotics(used to treat infections), “diuretics” (tablets that increase urine production),certain types of analgesics(such as ibuprofen or other anti-inflammatory medications, and over-the-counter medications) and medicines that containlithium;
• the use offumarate of dimethyland the administration of certain types of vaccines (attenuated vaccines) may cause an infection and, therefore, should be avoided. Your doctor will inform you if you should receive other types of vaccines (inactivated vaccines).

TakingDimethyl Fumarate Vivantawith alcohol

After takingdimethyl fumarate, 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) during the first hour because 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, or if you think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

The information on the effects of this medicine on the fetus if used during pregnancy is limited. Do not usedimethyl fumarateduring pregnancy unless you have discussed this with your doctor and this medicine is clearly necessary in your case.

Breastfeeding

It is unknown whether the active ingredient ofdimethyl fumaratepasses into breast milk. Your doctor will inform you if you should stop breastfeeding or if you should stop takingdimethyl fumarate. This decision involves weighing the benefits of breastfeeding for your child and the benefits of treatment for you.

Driving and operating machines

It is not expected thatdimethyl fumaratewill affect your ability to drive and operate machines.

Dimethyl Fumarate Vivanta contains sodium

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

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor again.

Initial dose: 120 mg twice a day.

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

Usual dose: 240 mg twice a day.

This medicationis taken orally.

The capsules must be swallowed whole, with some water. Do not break, crush, dissolve, or chew or suck on the capsule because some adverse effects may be increased.

TakeDimethyl FumarateVivanta with food– helps to reduce some very frequent adverse effects (including in section 4).

If you take moreDimethyl FumarateVivanta than you should

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

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

If you forgot to takeDimethyl FumarateVivanta

Do not take a double doseto compensate for the missed doses.

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

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

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

Severe side effects

Dimethyl fumaratemay decrease 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 throughout treatment and you should be aware of 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 your immune system function.

The symptoms of PML can be similar to those of a relapse of MS. Symptoms may include new 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 a few days. Therefore, it is very important to talk to your doctor as soon as possible if you think your MS is worsening or if you notice any new symptoms while taking dimethyl fumarate. Also, inform your partner or caregivers about your treatment. You may experience symptoms of which you are not aware.

• 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 (unknown frequency).

Flush (rubefaction) is a very common side effect. However, if the flush is accompanied by a red rash or hivesandyou experience any of the following symptoms:

-swelling of the face, lips, mouth, or tongue(angioedema)

-whistling or difficulty breathing, or shortness of breath(dyspnea, hypoxia)

-dizziness or loss of consciousness(hypotension)

it may then constitute a severe allergic reaction (anaphylaxis).

• Stop taking Vivanta Dimethyl Fumarate and call your doctor immediately

Other side effects

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

-flush (rubefaction), feeling hot, heat, burning sensation, or itching

-diarrhea(diarrhea)

-nausea(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.

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

Common(may affect up to 1 in 10 people)

-inflammation of the intestinal mucosa (gastroenteritis)

-nausea(vomiting)

-indigestion(dyspepsia)

-inflammation of the stomach mucosa (gastritis)

-gastrointestinal disorders

-burning sensation

-sweating, feeling hot

-itching (pruritus)

-exanthema

-rosy or reddish spots accompanied by itching on the skin (erythema)

-hair loss (alopecia)

Side effects that may appear in blood or urine tests

• low white blood cell count (lymphopenia, leukopenia) in blood. A decrease in white blood cells can make the body less able to fight infections. If you have a severe infection (such as pneumonia) inform your doctor immediately
• protein (albumin) in urine
• increase in liver enzymes (ALT, AST) in blood

Rare(may affect up to 1 in 100 people)

-allergic reactions (hypersensitivity)

-reduction of platelets

Unknown frequency(cannot be estimated from the available data)

• inflammation of the liver and increase in liver enzymes (ALT or AST) simultaneously with bilirubin
• herpes zoster (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 the infection, followed by numbness, itching, or red spots with intense pain
• nasal secretion (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, for example, headache, stomach pain or cramps, nausea, vomiting, sore throat, cough, and painful menstruation.

Reporting side effects

If you experience any type of side effect, consult your doctororpharmacist,even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the blister pack and on the box after “CAD”. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

Medications should not be disposed of through drains or in the trash.Deposit the packaging and medications that you no longer need at the SIGRE collection pointat the pharmacy. In case of doubtask your pharmacist how to dispose of the packaging and medications that you no longer need. By doing so, you will help protect the environment.

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:

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

Appearance of the product and contents of the package

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

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

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

Pack sizes:

120 mg:

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

Pre-cut, single-dose PVC/PE/PVdC-Al 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.

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

Only some pack sizes may be marketed.

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder

Vivanta Generics s.r.o

Trtinova 260/1, Cakovice,

196 00, Prague 9

Czech Republic

Responsible 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 medicine by contacting the local representative of the marketing authorization holder:

Local Representative:

Vivanta Generics s.r.o. subsidiary in Spain

C/Guzmán el Bueno, 133, edificio Britannia

28003 Madrid

This medicine is authorized in the member states of the European Economic Area with 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

Last review date of this leaflet: April 2024

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