Dimethyl fumarate Tevagen 120 mg gastro-resistant hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Dimethyl fumarate Tevagen 120 mg gastro-resistant hard capsules EFG

Dimethyl fumarate Tevagen 240 mg gastro-resistant hard capsules EFG

dimethyl fumarate

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 must not be given to other people, even if they have the same symptoms as you, because it could 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 Dimethyl fumarate Tevagen is and what it is used for
2. What you need to know before taking Dimethyl fumarate Tevagen
3. How to take Dimethyl fumarate Tevagen
4. Possible adverse effects
5. How to store Dimethyl fumarate Tevagen
6. Contents of the pack and other information

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

What Fumarato de dimetilo Tevagen is

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

What Fumarato de dimetilo Tevagen is used for

Fumarato de dimetilo Tevagen is used to treat relapsing-remitting multiple sclerosis (MS) in patients aged 13 years and older.

MS is a long-term disease affecting 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 problems, and visual disturbances (e.g., blurred or double vision). These symptoms may completely disappear when a relapse ends, although some problems may persist.

How Fumarato de dimetilo Tevagen works

Fumarato de dimetilo Tevagen 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 starting Fumarato de dimetilo Tevagen

Do not take Fumarato de dimetilo Tevagen

• 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, the kidneys, and the 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 testing or interrupt your treatment.

Consult your doctor before starting dimethyl fumarate if you have:

• severe renal disease
• severe hepatic 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 PML. PML is a serious condition 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, feel more thirsty and drink more than usual, your muscles seem weaker, you suffer a bone fracture, 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 are no data available for this age group.

Other medicines and Fumarato de dimetilo Tevagen

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 elimination), 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 this medicine 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 Tevagen with alcohol

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

Breastfeeding

It is unknown whether the active ingredient 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.

3. How to take Dimethyl fumarate Tevagen

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

Starting dose

120 mg twice daily.

Take this starting dose for the first 7 days, then switch to the maintenance dose.

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

If you take more Dimethyl fumarate Tevagen 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 Tevagen

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

You may take the missed dose if there are at least 4 hours until 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 everybody gets 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 result in death or severe disability. PML has occurred 1 to 5 years after starting treatment, so your doctor must continue to monitor 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 weakened 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 taking dimethyl fumarate. Also, 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 (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 indicate a serious allergic reaction (anaphylaxis).

• Stop taking dimethyl fumarate Tevagen 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, warmth, burning sensation, or itching (flushing)

• loose stools (diarrhea)

• nausea or vomiting

• stomach pain or cramps

• Taking the medicine with food may help reduce the above adverse effects

While being treated with dimethyl fumarate, urine tests commonly show the presence of ketones, substances 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 lining (gastroenteritis)
• vomiting
• indigestion (dyspepsia)
• inflammation of the stomach lining (gastritis)
• gastrointestinal disorders
• burning sensation
• hot flushes, feeling of warmth
• skin itching (pruritus)
• rash
• red, itchy patches 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 develop a serious infection (such as pneumonia), inform your doctor immediately.
• protein (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)

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

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

• liver inflammation and increased levels of 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 painful patches
• nasal discharge (rhinorrhea)

Children (13 years of age 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 adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via 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 Tevagen

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

Do not use this medicine after the expiry date stated on the blister, container, and carton after CAD or EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage temperature conditions.

Store in the original packaging to protect from light.

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. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Dimethyl fumarate Tevagen

The active substance is dimethyl fumarate.

Dimethyl fumarate Tevagen 120 mg gastro-resistant hard capsules EFG

Each gastro-resistant hard capsule contains 120 mg of dimethyl fumarate.

Dimethyl fumarate Tevagen 240 mg gastro-resistant hard capsules EFG

Each gastro-resistant hard capsule contains 240 mg of dimethyl fumarate.

The other components are:

• Capsule contents: microcrystalline cellulose, crospovidone, talc, povidone, colloidal anhydrous silica, magnesium stearate, triethyl citrate, methacrylic acid and ethyl acrylate copolymer (1:1), hypromellose, titanium dioxide (E171), triacetin.
• Capsule shell: gelatin, titanium dioxide (E171), brilliant blue FCF-FD&C Blue 1 (E 133), yellow iron oxide (E172).
• Capsule printing: shellac, potassium hydroxide, propylene glycol (E1520), black iron oxide (E172), concentrated ammonia solution.

Nature of the product and pack sizes

Dimethyl fumarate Tevagen 120 mg gastro-resistant hard capsules EFG (gastro-resistant capsules): capsules with a white body and green cap, 21.4 mm in length, printed with “DMF 120” in black ink on the body, containing white or whitish mini-tablets.

Dimethyl fumarate Tevagen 240 mg gastro-resistant hard capsules EFG (gastro-resistant capsules): capsules with green body and cap, 23.2 mm in length, printed with “DMF 240” in black ink on the body, containing white or whitish mini-tablets.

HDPE bottle with tamper-evident PP/HDPE cap and silica gel desiccant containing 100 gastro-resistant hard capsules.

Do not swallow the desiccant.

Blister packs made of oPA/Alu/PVC//Alu or single-dose blisters made of oPA/Alu/PVC//Alu.

Dimethyl fumarate Tevagen 120 mg gastro-resistant hard capsules EFG:

Pack sizes:

14 capsules (blister packs)
14 x 1 capsules (perforated single-dose blisters)
100 capsules (bottle)

Only some pack sizes may be commercially available.

Dimethyl fumarate Tevagen 240 mg gastro-resistant hard capsules EFG

Pack sizes:

56 capsules (blister packs)
56 x 1 capsules (perforated single-dose blisters)
100 capsules (bottle)
168 capsules (blister packs)
168 x 1 capsules (perforated single-dose blisters)
196 capsules (blister packs)
196 x 1 capsules (perforated single-dose blisters)

Only some pack sizes may be commercially available.

Marketing Authorization Holder

Teva Pharma, S.L.U.
C/ Anabel Segura, 11, Edificio Albatros B, 1st floor
Alcobendas (Madrid), 28108, Spain

Manufacturer

Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park,
Paola PLA 3000
Malta

Adalvo Ltd.
Malta Life Sciences Park,
Building 1, Level 4, Sir Temi Zammit Buildings,
San Gwann SGN 3000
Malta

KeVaRo GROUP EOOD
9 Tzaritza Elenora Str., Office 23
Sofia 1618
Bulgaria

Date of the most recent revision of this package leaflet: June 2025

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

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included on the outer packaging. You can also access this information at the following web address: https://cima.aemps.es/cima/dochtml/p/89165/P_89165.html

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