DIMETHYL FUMARATE PHARMATHEN 240 mg HARD GASTRO-RESISTANT CAPSULES

Introduction

Package Leaflet: Information for the Patient

Dimethyl Fumarate Pharmathen 120mg hard gastro-resistant capsules EFG

Dimethyl Fumarate Pharmathen 240mg 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.
• 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 Pharmathen and what is it used for
2. What you need to know before you take Dimethyl Fumarate Pharmathen
3. How to take Dimethyl Fumarate Pharmathen
4. Possible side effects
5. Storage of Dimethyl Fumarate Pharmathen
6. Contents of the pack and other information

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

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

What Dimethyl Fumarate Pharmathen is used for

Dimethyl Fumarate Pharmathen is used to treat multiple sclerosis (MS) with relapses in patients from 13years 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. The symptoms vary from person to person but often include: difficulties in walking, balance disturbances, and visual 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 Pharmathen 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 Pharmathen

Do not take Dimethyl Fumarate Pharmathen

• 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 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 blood tests periodically 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 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, 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, tell 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 Pharmathen can be used in children and adolescents from 13 years of age and older. There is no data available in children under 10 years of age.

Other medicines and Dimethyl Fumarate Pharmathen

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 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 drugs, and over-the-counter medicines), and medicines that contain lithium
• The use of Dimethyl Fumarate Pharmathen 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 Pharmathen 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 Pharmathen during pregnancy unless you have discussed it with your doctor.

Breastfeeding

It is not known if the active substance of Dimethyl Fumarate Pharmathen 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 Pharmathen contains sodium

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

3. How to take Dimethyl Fumarate Pharmathen

Always 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, as this may increase some side effects.

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

If you take more Dimethyl Fumarate Pharmathen 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.

If you forget to take Dimethyl Fumarate Pharmathen

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 further questions on 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 lymphocyte 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 lymphocytes 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 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).

Flushing of the face or body (flushing) is a very common side effect.However, if the flushing is accompanied by a red rash or hives and you have any of these 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 Pharmathen and call your doctor immediately

Very common:may affect more than 1 in 10 people:

• flushing of the face or body, 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 in the body.

Tell your doctorabout 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 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
• 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:may affect up to 1 in 100 people:

• allergic reactions (hypersensitivity)
• reduction of blood platelets

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 (13years 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, even if it is possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Pharmacovigilance System for Human Use Medicines: 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 Pharmathen

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 is the last day of the month stated.

This medicine does not require any special storage conditions.

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 Content and Additional Information

Composition of Dimethyl Fumarate Pharmathen

The active ingredientis dimethyl fumarate.

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

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

The other componentsare: Capsule content (enteric-coated mini-tablets): microcrystalline cellulose, sodium croscarmellose, talc, anhydrous colloidal silica, magnesium stearate, triethyl citrate, methacrylic acid-methyl methacrylate copolymer (1:1), methacrylic acid-ethyl acrylate copolymer (1:1), 30% dispersion

Capsule shell: gelatin, titanium dioxide (E171), brilliant blue FCF (E133), yellow iron oxide (E172), black iron oxide (E172)

Capsule printing (black ink): lacquer (20% esterified), propylene glycol (E1520), and black iron oxide (E172).

Appearance of the Product and Container Content

Dimethyl Fumarate Pharmathen 120 mg hard gastro-resistant capsules have a light green opaque cap: hard gelatin capsules with a white opaque body, with dimensions of length: 21.4 ± 0.4 mm, width: 7.4 ± 0.4 mm, printed with "120" in black ink on the body containing mini-tablets.

Dimethyl Fumarate Pharmathen 240 mg hard gastro-resistant capsules have a light green opaque cap: hard gelatin capsules with a light green opaque body, with dimensions of length: 21.4 ± 0.4 mm, width: 7.4 ± 0.4 mm, printed with "240" in black ink on the body containing mini-tablets.

Package sizes:

120 mg capsules: 14 capsules

240 mg capsules: 56 or 168 capsules

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Pharmathen S.A.

Dervenakion 6

153 51 Pallini Attiki,

Greece

Manufacturer

Pharmathen International S.A.,

Industrial Park Sapes,

Rodopi Prefecture, Block No 5,

69300 Rodopi,

Greece

or

Pharmathen S.A.

Dervenakion 6

153 51 Pallini Attiki,

Greece

This medicinal product is authorized in the Member States of the European Economic Area under the following names

Date of the last revision of this leaflet:June 2023

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