Package Insert: Information for the Patient

Methylphenidate Kern Pharma 120 mg Hard Gastric-Resistant Capsules EFG

Methylphenidate Kern Pharma 240 mg Hard Gastric-Resistant Capsules EFG

Read this package insert carefully before starting to take this medication, because

it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, 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 any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

What is Dimethyl Fumarate Kern Pharma

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

What is Dimethyl Fumarate Kern Pharma used for

Dimethyl Fumarate is used to treat relapsing-remitting multiple sclerosis (MS) in patients13 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 (exacerbations) of neurological symptoms. Symptoms vary from patient to patient but often include: difficulties walking, balance problems, and visual problems (e.g., blurred vision or double vision). These symptoms may disappear completely when the exacerbation ends, but some problems may persist.

How Dimethyl Fumarate Kern Pharma works

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

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 you have a rare brain infection called progressive multifocal leukoencephalopathy (PML) or if PML has been confirmed.

Warnings and precautions

Dimethyl fumarate may affect thenumber of white blood cells, thekidneysand theliver. Before starting treatment with 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 blood tests periodically during treatment. If you experience a decrease in the number of white blood cells during treatment, your doctor may consider additional blood tests or stop your treatment.

Consult your doctorbefore starting to take dimethyl fumarate if you have:

• severerenal disease
• severehepatic disease
• gastrointestinal disease
• severe infection (e.g. pneumonia)

You may experience herpes zoster (shingles) during treatment with dimethyl fumarate. In some cases, serious complications have occurred.You must inform your doctor immediatelyif you suspect you have any of the symptoms of shingles.

If you think your MS is getting worse (e.g. weakness or changes in vision) or notice the appearance of any new symptoms, speak directly with your doctor, as they may 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 that contains dimethyl fumarate in combination with other fumaric acid esters, and is used to treat psoriasis (a skin disease). If you notice you are urinating more, are more thirsty and drink more than usual, your muscles seem weaker, you break a bone or simply have pain and discomfort, inform your doctor as soon as possible so this can be investigated further.

Children and adolescents

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

Other medicines and dimethyl fumarate

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medicine, in particular:

• medicines that containfumaric acid esters(fumarates) used to treat psoriasis
• medicines that affect the body's immune system, includingothermedicines used to treat MS,such as fingolimod, natalizumab, teriflunomide, alemtuzumab, ocrelizumab or cladribine,or some treatments normally used for cancer (rituximab or mitoxantrone)
• medicines that affect the kidneys, includingsomeantibiotics(used to treat infections), “diuretics” (tablets that increase urine elimination),certain types of analgesics(such as ibuprofen or other anti-inflammatory medications, and over-the-counter medications) and medicines that containlithium
• The use of dimethyl fumarate and the administration of certain types ofvaccines(attenuated vaccines) may cause an infection and, therefore, should be avoided. Your doctor will indicate if you should receive other types of vaccines (inactivated vaccines).

Dimethyl fumarate Kern Pharma contains Sodium

This medicine contains less than 23 mg of sodium (1 mmol) per capsule; this is, essentially “sodium-free”.

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor again.

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, or chew or suck on the capsules because some adverse effects may increase.

Take dimethyl fumarate with food –helps to reduce some very frequent 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 in section 4.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20 indicating the medication and the amount ingested.

If you forgot to take dimethyl fumarate

Do not take a double doseto make up for the missed doses.

You can take the missed dose if at least 4 hours have passed between doses. Otherwise, wait until the next scheduled dose.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Severe 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 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 must continue to monitor your white blood cells throughout treatment and you must 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 your immune system function.

The symptoms of PML can be similar to those of an MS relapse. Symptoms may include new or worsening weakness on one side of the body; clumsiness; changes in vision, thinking, or memory; or confusion or changes in personality, or difficulty speaking and communicating that may persist for more than a few days. Therefore, it is very important to speak with 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. New symptoms may arise that you may not be 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 (unknown frequency).

Flush (rubefaction) is a very common side effect. However, if the flush 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 may then constitute 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:

• Flush (rubefaction)
• Sensation of heat, heat, burning sensation, or itching (rubefaction)
• Loose stools (diarrhea)
• Nausea or vomiting
• Abdominal pain or cramping

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

While taking dimethyl fumarate, it is common for urine tests to show ketones, substances that are naturally produced in the body.

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

Common side effects

May affect up to 1 in 10 people:

• Intestinal mucosa inflammation (gastroenteritis)
• Vomiting
• Indigestion (dyspepsia)
• Stomach mucosa inflammation (gastritis)
• Gastrointestinal disorders
• Burning sensation
• Heat, flushes
• Skin itching (pruritus)
• Rash
• Red or pink spots or patches on the skin with itching (erythema)
• Hair loss (alopecia)

Side effects that may appear in blood or urine tests

• Low white blood cell count (lymphopenia, leukopenia) in blood. A decrease in white blood cells may make the body less able to fight infections. If you have a severe infection (such as pneumonia) inform your doctor immediately
• Proteins (albumin) in urine
• Increased liver enzymes (ALT, AST) in blood

Rare side effects

May affect up to 1 in 100 people:

• Allergic reactions (hypersensitivity)
• Decreased platelet count

Unknown frequency (cannot be estimated from available data)

• Liver inflammation and increased liver enzyme levels(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 the infection, followed by numbness, itching, or red spots with intense pain.
• Nasal secretion (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, for example, headache, stomach pain or cramping, vomiting, sore throat, cough, and painful menstruation.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the blister pack and on the box after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

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 componentsare sodium croscarmellose, anhydrous colloidal silica, fumarate estearate and sodium, copolymer of methacrylic acid and methyl methacrylate (1:1), talc, triethyl citrate, isopropyl alcohol copolymer of methacrylic acid and ethyl acrylate (1:1), 30% dispersion (also containing polysorbate 80 and sodium lauryl sulfate), citrate triethyl citrate mixture, polysorbate 80 and monoester of glycerol monostearate, gelatin, titanium dioxide (E171), Brilliant Blue FCF (E133) and yellow iron oxide (E172).

Appearance of the product and content of the container

Dimethyl Fumarate Kern Pharma 120 mg hard gastro-resistant capsules are green and white with the imprint ‘120 mg’ and are marketed in containers that contain 14 capsules in pre-cut single-dose blisters.

Dimethyl Fumarate Kern Pharma 240 mg hard gastro-resistant capsules are green with the imprint ‘240 mg’ and are marketed in containers that contain 56 capsules in pre-cut single-dose blisters.

Marketing Authorization Holder

Kern Pharma, S.L.

Venus, 72 - Pol. Ind.Colón II

08228 Terrassa - Barcelona

Spain

Responsible for manufacturing

Zaklady Farmaceutyczne POLPHARMA, S.A

2 Metalowa Street

39-460 Nowa Deba

Poland

Last review date of this leaflet: August 2022

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