DIMETHYL FUMARATE STADAFARMA 240 mg HARD GASTRO-RESISTANT CAPSULES

Introduction

Package Leaflet: Information for the Patient

Dimethyl Fumarate Stadafarma 120 mg Hard Gastroresistant Capsules EFG

Dimethyl Fumarate Stadafarma 240 mg Hard Gastroresistant 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 Package Leaflet

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

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

What is Dimethyl Fumarate

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

What Dimethyl Fumarate is used for

Dimethyl Fumarate is used to treat multiple sclerosis (MS) in patients from 13 years of age and older with relapsing-remitting MS.

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 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 Stadafarma

Do not take Dimethyl Fumarate Stadafarma

• If you are allergic to dimethyl fumarateor 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 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 regular blood tests during treatment. If you have a low white blood cell count during treatment, your doctor may consider additional tests or stop your treatment.

Consult 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 inform 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 called Fanconi syndrome has been reported with a medicine 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 aches and pains, inform your doctor as soon as possible so that this can be investigated further.

Children and adolescents

Do not give this medicine to children under 10 years of age because there is no data available for this age group.

Other medicines and Dimethyl Fumarate Stadafarma

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 chemotherapy, immunosuppressants, or other medicines used to treat MS;
• medicines that affect the kidneys, includingsome 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 get an infection, and therefore, should be avoided. Your doctor will tell you if you should receive other types of vaccines (inactivated vaccines).

Taking Dimethyl Fumarate Stadafarma 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 liquor) for the first hour because alcohol may interact with this medicine. 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 are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Information on the effects of this medicine in the fetus if used during pregnancy is limited. Do not use dimethyl fumarate during pregnancy unless you have discussed it with your doctor and this medicine is clearly necessary for you.

Breastfeeding

It is not known if the active substance of dimethyl fumarate passes into breast milk. Your doctor will inform you if you should 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

Dimethyl fumarate is not expected to affect your ability to drive or use machines.

3. How to take Dimethyl Fumarate Stadafarma

Follow the instructions for administration of this medicine exactly as told by your doctor. If you are unsure, ask 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 split, crush, dissolve, or chew the capsules because 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 Stadafarma 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 Stadafarma

If you forget to take a dose, do not take a double doseto make up for the missed 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 other questions about 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 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 cell count during 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 weakened your immune system.

The symptoms of PML can be similar to those of an MS relapse. The symptoms may 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 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 hivesandyou 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 fainting (hypotension)

this could be a severe allergic reaction (anaphylaxis).

Stop taking dimethyl fumarate and call your doctor immediately

Other side effects

Very common(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 ketones, substances that are naturally produced by the body.

Consult your doctor about how to treat 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
• 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 may 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

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 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 or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Dimethyl Fumarate Stadafarma

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 temperature.

Store in the original packaging to protect from light.

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. Contents of the pack and other information

Composition of Dimethyl Fumarate Stadafarma

• The active ingredient is dimethyl fumarate.

Dimethyl Fumarate Stadafarma 120 mg hard gastro-resistant capsules EFG:

Each capsule contains 120 mg of dimethyl fumarate.

Dimethyl Fumarate Stadafarma 240 mg hard gastro-resistant capsules EFG:

Each capsule contains 240 mg of dimethyl fumarate.

• The other ingredients are:

• Capsule content: microcrystalline cellulose (E 460), crospovidone, talc (E 553b), povidone K30 (E 1201), colloidal anhydrous silica (E 551), magnesium stearate (E 470b), triethyl citrate, methacrylic acid/ethyl acrylate copolymer (1:1), hypromellose, titanium dioxide (E 171), triacetin.
• Capsule shell: gelatin, titanium dioxide (E 171), brilliant blue FCF (E 133), yellow iron oxide (E 172)
• Capsule printing ink: shellac, potassium hydroxide, propylene glycol (E 1520), black iron oxide (E 172), strong ammonia solution.

Appearance and Packaging of the Product

Dimethyl Fumarate Stadafarma 120 mg are hard gastro-resistant capsules of 120 mg with a green cap and white body, with a capsule shell of 21.4 mm, with "DMF 120" printed in black ink on the body, which contains white to off-white mini-tablets.

Dimethyl Fumarate Stadafarma 240 mg are hard gastro-resistant capsules of 240 mg with a green cap and body, with a capsule shell of 23.2 mm, with "DMF 240" printed in black ink on the body, which contains white to off-white mini-tablets.

It is available in 200 ml white HDPE bottles with PP/HDPE caps with a seal (PE/PET/Al/carton) and a container with silica gel desiccant.

Do not swallow the desiccant.

It is also available in OPA/Alu/PVC//Alu blisters or unit-dose blisters.

Dimethyl Fumarate Stadafarma 120 mg is marketed in packages of:

14 gastro-resistant capsules (blisters)

14 x 1 gastro-resistant capsules (perforated unit-dose blisters)

100 gastro-resistant capsules (bottle)

Dimethyl Fumarate Stadafarma 240 mg is marketed in packages of:

Package sizes:

56 gastro-resistant capsules (blisters)

56 x 1 gastro-resistant capsules (perforated unit-dose blisters)

168 gastro-resistant capsules (blisters)

168 x 1 gastro-resistant capsules (perforated unit-dose blisters)

100 gastro-resistant capsules (bottle)

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratory STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

info@stada.es

Manufacturer

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park

Paola PLA 3000

Malta

or

Adalvo Limited

Malta Life Sciences Park

Building 1, Level 4, Sir Temi Zammit Buildings

San Gwann, SGN 3000

Malta

or

KeVaRo GROUP Ltd

9 Tzaritza Elenora Str. Office 23

Sofia 1618

Bulgaria

Date of the Last Revision of this Prospectus: July 2024

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/)