DIMETHYL FUMARATE KERN PHARMA 120 mg HARD GASTRO-RESISTANT CAPSULES

Introduction

Package Leaflet: Information for the Patient

Dimethyl Fumarate Kern Pharma 120 mg hard gastro-resistant capsules EFG

Dimethyl Fumarate Kern Pharma 240 mg hard gastro-resistant capsules EFG

Read the entire package leaflet carefully before starting to take this medication, because it contains important information for you.

It contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the package leaflet

1. What is Dimethyl Fumarate Kern Pharma and what is it used for
2. What you need to know before taking Dimethyl Fumarate Kern Pharma
3. How to take Dimethyl Fumarate Kern Pharma
4. Possible side effects
5. Storage of Dimethyl Fumarate Kern Pharma
6. Package contents and further information

1. What is Dimethyl Fumarate Kern Pharma and what is it used for

What is Dimethyl Fumarate Kern Pharma

Dimethyl Fumarate Kern Pharma is a medication that contains dimethyl fumarateas the active ingredient.

What is Dimethyl Fumarate Kern Pharma 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. The symptoms vary from person to person 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 Dimethyl Fumarate Kern Pharma works

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

2. What you need to know before taking Dimethyl Fumarate Kern Pharma

Do not take dimethyl fumarate

• if you are allergic to dimethyl fumarate or any of the other ingredients of this medication (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 may affect your white blood cell count, kidneys, and liver. Before starting treatment with dimethyl fumarate, your doctor will perform a blood test to obtain a white blood cell count and check that your kidneys and liver are functioning properly. Your doctor will perform periodic 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 doctorbefore starting to take dimethyl fumarate if 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 should 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 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 (Fanconi syndrome) has been reported for a medication that contains 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 pains and discomfort, inform your doctor as soon as possible so that this can be investigated further.

Children and adolescents

The warnings and precautions described above also apply to children. Dimethyl fumarate can be used in children and adolescents aged 13 years and older. There is no data available for children under 10 years of age.

Other medications and dimethyl fumarate

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medication, in particular:

• medications that contain fumaric acid esters(fumarates) used to treat psoriasis
• medications that affect the body's immune system, including other medications used to treat MS, such as fingolimod, natalizumab, teriflunomide, alemtuzumab, ocrelizumab, or cladribina, or some cancer treatments (rituximab or mitoxantrone)
• medications that affect the kidneys, including some antibiotics(used to treat infections), diuretics(pills that increase urine production), certain types of pain relievers(such as ibuprofen or similar anti-inflammatory medications, and over-the-counter medications), and medications that contain lithium
• The use of dimethyl fumarate and the administration of certain types of vaccines(live vaccines) could cause you to become infected, and therefore, should be avoided. Your doctor will indicate if you should receive other types of vaccines (inactivated vaccines).

Taking dimethyl fumarate with 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, as alcohol may interact with this medication. 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 plan to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

Do not use dimethyl fumarate during pregnancy unless you have discussed it with your doctor.

Breastfeeding

It is not known if the active ingredient of dimethyl fumarate passes into breast milk. Dimethyl fumarate should not be used during breastfeeding. Your doctor will help you decide whether to 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

The effect of dimethyl fumarate on the ability to drive and use machines is not known. It is not expected that dimethyl fumarate will affect your ability to drive and use machines.

Dimethyl Fumarate Kern Pharma contains sodium

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

3. How to take Dimethyl Fumarate Kern Pharma

Follow the administration instructions of this medication exactly as indicated by your doctor. In case of 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.

Dimethyl fumarate is taken orally.

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

Take dimethyl fumarate with food –it helps reduce some of the very common side effects (listed in section 4)

If you take more dimethyl fumarate than you should

If you take too many capsules, inform 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 medication and the amount ingested.

If you forget to take dimethyl fumarate

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 scheduled dose.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Serious side effects

Dimethyl fumarate may decrease your lymphocyte count (a type of white blood cell). A low white blood cell count can increase the risk of infection, including the 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 should continue to monitor your white blood cell count during treatment, and you should remain alert to any possible symptoms of PML, as described below. The risk of PML may be higher if you have previously taken a medication that has worsened the function 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 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 that your MS is getting worse or if you notice any new symptoms while being treated with dimethyl fumarate. Additionally, 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 experience 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 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 be a severe allergic reaction (anaphylaxis).

• Stop taking dimethyl fumarate and call your doctor immediately

Very common side effects

May affect more than 1 in 10 people:

• 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 medication with foodmay help reduce the above side effects

While being treated with dimethyl fumarate, it is common for urine tests to show the presence of ketones, substances that are naturally produced by the body.

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

Common side effects

May affect up to 1 in 10 people:

• 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), inform your doctor immediately
• protein (albumin) in urine
• increased liver enzymes (ALT, AST) in blood

Uncommon side effects

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 enzyme levels (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.
• 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 side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Dimethyl Fumarate Kern Pharma

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

Do not use this medication after the expiration date stated on the blister pack and carton after EXP. The expiration date is the last day of the month indicated.

Do not store above 30°C.

Medications should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medication in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package contents and further information

Composition of Dimethyl Fumarate Kern Pharma

The active ingredientis dimethyl fumarate.

Dimethyl Fumarate Kern Pharma 120 mg: each capsule contains 120 mg of dimethyl fumarate.

Dimethyl Fumarate Kern Pharma 240 mg: each capsule contains 240 mg of dimethyl fumarate.

The other ingredientsare croscarmellose sodium, colloidal anhydrous silica, sodium stearyl fumarate, methacrylic acid-methyl methacrylate copolymer (1:1), talc, triethyl citrate, isopropyl alcohol, methacrylic acid-ethyl acrylate copolymer (1:1), 30% dispersion (also contains polysorbate 80 and sodium lauryl sulfate), triethyl citrate mixture, polysorbate 80, and glycerol monostearate, gelatin, titanium dioxide (E171), brilliant blue FCF (E133), and yellow iron oxide (E172).

Appearance and package contents

Dimethyl Fumarate Kern Pharma 120 mg hard gastro-resistant capsules are green and white with the imprint '120 mg' and are marketed in packs containing 14 capsules in single-dose precut blisters.

Dimethyl Fumarate Kern Pharma 240 mg hard gastro-resistant capsules are green with the imprint '240 mg' and are marketed in packs containing 56 capsules in single-dose precut blisters.

Marketing authorization holder

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Manufacturer

Zaklady Farmaceutyczne POLPHARMA, S.A.

2 Metalowa Street

39-460 Nowa Deba

Poland

Date of the last revision of this package leaflet: August 2022

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