DIMETHYL FUMARATE KERN PHARMA 240 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 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.

• Keep this leaflet, as 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 Kern Pharma and what is it used for
2. What you need to know before you take Dimethyl Fumarate Kern Pharma
3. How to take Dimethyl Fumarate Kern Pharma
4. Possible side effects
5. Storage of Dimethyl Fumarate Kern Pharma
6. Contents of the pack and other 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 medicine that contains dimethyl fumarateas the active substance.

What is Dimethyl Fumarate Kern Pharma used for

Dimethyl fumarate is used to treat multiple sclerosis (MS) in patients with relapsing-remitting MS aged 13 years and over.

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 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 Kern Pharma works

Dimethyl fumarate 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 Kern Pharma

Do not take dimethyl fumarate

• if you are allergic to dimethyl fumarate or 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 may affect your white blood cell count, kidneys, and liver. Before starting treatment with dimethyl fumarate, your doctor will perform a blood test to check your white blood cell count and ensure that your kidneys and liver are working properly. Your doctor will perform regular blood tests during treatment. If you experience a decrease in white blood cell count during treatment, your doctor may consider additional blood tests or stop your treatment.

Talk to your doctorbefore taking 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 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 if 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 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 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 over. There is no data available in children under 10 years of age.

Other medicines and dimethyl fumarate

Tell your doctor or pharmacist if 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 immune system, including other medicines used to treat MS, such as fingolimod, natalizumab, teriflunomide, alemtuzumab, ocrelizumab, or cladribine, or some cancer treatments (rituximab or mitoxantrone)
• 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 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 tell you 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 spirits) for the first hour, as 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

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

Breastfeeding

It is not known if the active substance 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 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

Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.

Starting dose

120 mg twice a day.

Take this starting 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, suck, or chew the capsules, as this may increase some side effects.

Take dimethyl fumarate with food– it helps to 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, 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

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

You can take the forgotten dose if it is at least 4 hours before the next dose. Otherwise, wait until the next dose.

If you have any further questions on the use of this product, 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 cells 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 medicine that has worsened the function of 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 that 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.

• Tell 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 red skin rash or hives and you 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 and tell 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 medicine 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.

Talk to 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 patches or redness 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, 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 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 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 over) 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 via the Spanish Medicines Monitoring System for Human Use: www.notificaRAM.es. By reporting side 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 carton after EXP. The expiry date refers to the last day of the month shown.

Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicines to the pharmacy. If you are unsure, ask your pharmacist how to dispose of the containers and any unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Dimethyl Fumarate Kern Pharma

The active substanceis 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 copolymer, talc, triethyl citrate, isopropyl alcohol, methacrylic acid - 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 and packaging

Dimethyl Fumarate Kern Pharma 120 mg hard gastro-resistant capsules are green and white with the imprint ‘120 mg’ and are available in packs containing 14 capsules in unit dose precut blisters.

Dimethyl Fumarate Kern Pharma 240 mg hard gastro-resistant capsules are green with the imprint ‘240 mg’ and are available in packs containing 56 capsules in unit dose precut blisters.

Marketing Authorisation 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 last revision of this leaflet: August 2022

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