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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

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

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

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 you should not give it 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 adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What dimethyl fumarate Kern Pharma is and what it is 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. How to store dimethyl fumarate Kern Pharma
6. Contents of the pack and other information

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

What Fumarato de dimetilo Kern Pharma is

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

What Fumarato de dimetilo Kern Pharma is used for

Dimethyl fumarate is 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 (relapses) of neurological symptoms. Symptoms vary from patient to patient but usually include: difficulty walking, balance disturbances, and visual problems (e.g., blurred or double vision). These symptoms may completely disappear when a relapse ends, but some problems may persist.

How Fumarato de dimetilo Kern Pharma works

Dimethyl fumarate 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 to take Fumarate de dimetilo Kern Pharma

Do not take dimethyl fumarate

• 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 treatment with 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 blood tests 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 directly with your doctor, as these could be symptoms of a rare brain infection called progressive multifocal leukoencephalopathy (PML). PML is a serious condition that may result in death or severe disability.

A rare but serious kidney disorder (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 break a bone, or you simply have aches and pains, inform your doctor as soon as possible so this can be further investigated.

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. Data are not available for children under 10 years of age.

Other medicines and dimethyl fumarate

Inform 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 other medicines used to treat MS, such as fingolimod, natalizumab, teriflunomide, alemtuzumab, ocrelizumab, or cladribine, or certain treatments usually used for cancer (rituximab or mitoxantrone)
• medicines that affect the kidneys, including some antibiotics (used to treat infections), "diuretics" (tablets that increase urine elimination), certain types of painkillers (such as ibuprofen or similar anti-inflammatory medicines, and over-the-counter medications), and medicines containing lithium
• The use of dimethyl fumarate 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 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 drinks (with an alcohol volume of more than 30%, such as spirits) for at least one hour, as alcohol may interact with this medicine. It may cause stomach inflammation (gastritis), especially in people 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

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

Breastfeeding

It is unknown whether the active ingredient in 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 to 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

The effect of dimethyl fumarate on the ability to drive and use machines is unknown. Dimethyl fumarate is not expected to affect your ability to drive and use machines.

Dimethyl fumarate Kern Pharma contains Sodium

This medicine 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 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 take the usual dose.

Usual dose

240 mg twice daily.

Dimethyl fumarate is taken by mouth.

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 with food – this helps reduce some of the very common adverse 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 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

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

You may take the missed dose if at least 4 hours remain before the next dose. Otherwise, wait until the time of the 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 everyone experiences them.

Serious adverse effects

Dimethyl fumarate may reduce 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 cause severe disability. PML has occurred after 1 to 5 years of treatment; therefore, 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 impaired the function of your immune system.

The symptoms of PML may be similar to 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; or confusion, personality changes, or difficulty speaking and communicating that may persist for more than several days. Therefore, it is very important that you speak to your doctor as soon as possible if you think your MS is worsening or if you notice any new symptoms while being treated with dimethyl fumarate. In addition, inform your partner or caregivers about your treatment. Symptoms may arise that you yourself do not notice.

• 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 (rubefaction) 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 then indicate a serious allergic reaction (anaphylaxis).

• Stop taking dimethyl fumarate and call your doctor immediately

Very common adverse effects

May affect more than 1 in 10 people:

• flushing of the face or body

• feeling of warmth, warmth, burning sensation, or itching (rubefaction)

• 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 frequently show the presence of ketones, substances that are naturally produced in the body.

Consult your doctor about how to manage these adverse effects. Your doctor may reduce your dose. Do not reduce the dose unless instructed by your doctor.

Common adverse effects

May affect up to 1 in 10 people:

• inflammation of the intestinal mucosa (gastroenteritis)
• vomiting
• indigestion (dyspepsia)
• inflammation of the stomach lining (gastritis)
• gastrointestinal disorders
• burning sensation
• hot flushes, feeling of warmth
• skin itching (pruritus)
• rash
• itchy, rosacea-like or reddish skin patches (erythema)
• hair loss (alopecia)

Adverse effects that may appear in blood or urine tests

• low levels of white blood cells (lymphopenia, leukopenia) in blood. A decrease in white blood cells may reduce the body's ability to fight infections. If you have a serious infection (such as pneumonia), inform your doctor immediately
• presence of proteins (albumin) in urine
• increased liver enzymes (ALT, AST) in blood

Uncommon adverse effects

May affect up to 1 in 100 people:

• allergic reactions (hypersensitivity)
• reduction in blood platelets

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

• inflammation of the liver 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 painful red rashes
• nasal discharge (rhinorrhea)

Children (aged 13 years 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 type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Dimethyl fumarate Kern Pharma

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 the carton after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE Point at your pharmacy. If you are unsure, 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 Kern Pharma

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

Appearance of the product and contents of the pack

Dimethyl fumarate Kern Pharma 120 mg gastro-resistant hard capsules are green and white with the imprint '120 mg' and are available in packs containing 14 capsules in pre-scored unit-dose blisters.

Dimethyl fumarate Kern Pharma 240 mg gastro-resistant hard capsules are green with the imprint '240 mg' and are available in packs containing 56 capsules in pre-scored unit-dose 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 most recent revision of this leaflet: August 2022

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es.