DIMETHYL FUMARATE TEVAGEN 120 mg HARD GASTRO-RESISTANT CAPSULES

Introduction

Package Leaflet: Information for the Patient

Dimethyl Fumarate Tevagen 120mg Hard Gastro-Resistant Capsules EFG

Dimethyl Fumarate Tevagen 240mg Hard Gastro-Resistant Capsules EFG

dimethyl fumarate

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

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

What is Dimethyl Fumarate Tevagen

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

What is Dimethyl Fumarate Tevagen used for

Dimethyl Fumarate Tevagen 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 Tevagen works

Dimethyl Fumarate Tevagen 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 Tevagen

Do not take Dimethyl Fumarate Tevagen

• 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 Fumarate can affect your white blood cell count, kidneys, and liver. Before starting Dimethyl 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 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.

Tell your doctorbefore starting Dimethyl Fumarate if you have:

• severe kidney disease
• severe liver disease
• a stomach or intestine 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 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 containing dimethyl fumarate in combination with other fumaric acid esters, which is 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 aches and pains, 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 Tevagen

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 this medicine and the administration of 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 get other types of vaccines (inactivated vaccines).

Taking Dimethyl Fumarate Tevagen with alcohol

After taking Dimethyl Fumarate, you should avoid consuming 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 because alcohol may interact with this medicine. This can 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 when used during pregnancy is limited. Do not use Dimethyl Fumarate during pregnancy unless you have discussed this with your doctor and this medicine is clearly necessary for you.

Breastfeeding

It is not known if the active substance of Dimethyl Fumarate passes into breast milk. Your doctor will inform you whether you should stop breastfeeding, or stop taking Dimethyl Fumarate. This decision will involve weighing the benefits of breastfeeding 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 or use machines.

3. How to take Dimethyl Fumarate Tevagen

Take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor again.

Starting dose

120mg twice a day.

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

Usual dose

240mg twice a day.

Dimethyl Fumarate is taken by mouth.

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

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

If you take more Dimethyl Fumarate Tevagen 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 Tevagen

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

You can take the missed dose if it is at least 4 hours 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 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 will continue to monitor your white blood cell count during 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 weakened your immune system.

The symptoms of PML can be similar to those of an MS relapse. The symptoms can include new weakness 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).

Facial or body redness (flushing) is a very common side effect.However, if the redness is accompanied by a skin rash or hivesandyou 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 loss of consciousness (hypotension)

this could be a severe allergic reaction (anaphylaxis).

• Stop taking Dimethyl Fumarate Tevagen and call your doctor immediately

Other side effects

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

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

• Taking the medicine with foodmay help 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.

Tell your doctor about 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 1in 10people)

• inflammation of the intestinal mucosa (gastroenteritis)
• 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 can 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 1in 100people)

• allergic reactions (hypersensitivity)
• reduction of blood platelets

Rare(may affect up to 1in 1000people)

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

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 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 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. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Medicines Monitoring System for Human Use: 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 Tevagen

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, bottle, and carton after EXP. The expiry date is the last day of the month stated.

This medicine does not require any special storage temperature.

Keep the medicine in the original packaging to protect it from light.

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 Contents and Additional Information

Composition of Dimethyl Fumarate Tevagen

The active ingredient is dimethyl fumarate.

Dimethyl Fumarate Tevagen 120mg hard gastro-resistant capsules EFG

Each hard gastro-resistantcapsule contains 120 mg of dimethyl fumarate.

Dimethyl Fumarate Tevagen 240mg hard gastro-resistant capsules EFG

Each hard gastro-resistantcapsule contains 240 mg of dimethyl fumarate.

The other ingredients are:

• Capsule content: microcrystalline cellulose, crospovidone, talc, povidone, colloidal anhydrous silica, magnesium stearate, triethyl citrate, copolymer of methacrylic acid and ethyl acrylate (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.

Appearance of the Product and Container Contents

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

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

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

Do not swallow the desiccant.