Dimethyl fumarate Stadafarma 120 mg gastro-resistant hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Dimethyl fumarate Stadafarma 120 mg gastro-resistant hard capsules EFG

Dimethyl fumarate Stadafarma 240 mg gastro-resistant hard capsules EFG

Read the entire leaflet carefully before you start taking this medicine, as 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 others, even if they have the same symptoms as you, because it may 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.

Package leaflet contents

1. What Fumarato de dimetilo Stadafarma is and what it is used for
2. What you need to know before taking Fumarato de dimetilo Stadafarma
3. How to take Fumarato de dimetilo Stadafarma
4. Possible side effects
5. Storage of Fumarato de dimetilo Stadafarma
6. Package contents and additional information

1. What Fumarate de dimetilo Stadafarma is and what it is used for

Fumarate de dimetilo Stadafarma is a medicine that affects the immune system (immunomodulator). The active substance, dimethyl fumarate, reduces inflammation and immune responses that damage nerve cells.

Fumarate de dimetilo Stadafarma is used in adults with:

• relapsing-remitting multiple sclerosis (a form of multiple sclerosis characterized by periods of worsening symptoms followed by periods of improvement)
• active secondary progressive multiple sclerosis (a form of multiple sclerosis where symptoms gradually worsen over time, with or without relapses)

Fumarate de dimetilo Stadafarma helps reduce the frequency of relapses and delays the progression of physical disability.

What dimethyl fumarate is

Dimethyl fumarate Stadafarma is a medicine that contains dimethyl fumarate as the active substance.

What dimethyl fumarate is used for

Dimethyl fumarate is used to treat relapsing-remitting multiple sclerosis (MS) in patients aged 13 years 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 commonly include: difficulty walking, balance disturbances, and visual problems (e.g., blurred or double vision). These symptoms may completely disappear when a relapse ends, although some problems may persist.

How dimethyl fumarate 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 Fumarato de dimetilo Stadafarma

Do not take Fumarato de dimetilo Stadafarma

• 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 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 testing or discontinuation of 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 to your doctor immediately, 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 called 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 than usual, feel more thirsty and drink more than normal, your muscles seem weaker, you suffer a bone fracture, or simply have aches and pains, inform your doctor as soon as possible so that this can be further investigated.

Children and adolescents

Do not administer this medicine to children under 10 years of age, as there is no available data in this age group.

Other medicines and Dimethyl fumarate Stadafarma

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 chemotherapy, immunosuppressants, or other medicines used to treat multiple sclerosis (MS);
• medicines that affect the kidneys, including certain antibiotics (used to treat infections), "diuretics" (tablets that increase urine elimination), certain types of painkillers (such as ibuprofen or other similar anti-inflammatory drugs, and over-the-counter medications), and medicines containing lithium;
• the use of dimethyl fumarate together with certain types of vaccines (live attenuated vaccines) could cause you to develop an infection and should therefore be avoided. Your doctor will advise you whether other types of vaccines (inactivated vaccines) should be administered.

Taking Dimethyl fumarate Stadafarma with alcohol

After taking dimethyl fumarate, avoid consuming more than a small amount (more than 50 ml) of strong alcoholic beverages (with an alcohol volume of over 30%, such as spirits) during the first hour, as alcohol may interact with this medicine. This may cause stomach inflammation (gastritis), especially in individuals prone to this condition.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

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

Breastfeeding

It is unknown whether the active substance of dimethyl fumarate passes into breast milk. Your doctor will advise you whether you should stop breastfeeding or stop taking dimethyl fumarate. This decision involves weighing the benefits of breastfeeding for your child against the benefits of treatment for you.

Driving and use of machines

Dimethyl fumarate is not expected to affect your ability to drive or operate machinery.

3. How to take Dimethyl fumarate Stadafarma

Follow exactly the instructions for use of this medicine given by your doctor. If you are unsure, consult your doctor again.

Starting dose:

120 mg twice daily.

Take this starting dose for the first 7 days, then take the usual dose.

Recommended dose:

240 mg twice daily.

Dimethyl fumarate is taken orally.

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 Fumarate de dimetilo Stadafarma than you should

If you take too many capsules, contact 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 medication and the amount ingested.

If you forget to take Fumarate de dimetilo Stadafarma

If you miss a dose, do not take a double dose to make up for the missed dose.

You may take the missed dose if at least 4 hours have passed since the next scheduled dose. Otherwise, wait until the time of your 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 decrease 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 the 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.

Symptoms of PML may resemble 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; confusion or personality changes; or difficulty speaking and communicating, which 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 taking dimethyl fumarate. In addition, inform your partner or caregivers about your treatment. Symptoms may arise that you do not notice yourself.

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).

Flushing of the face or body (rubefaction) is a very common adverse effect. However, if flushing is accompanied by a red rash or skin rash 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 severe allergic reaction (anaphylaxis).

Stop taking dimethyl fumarate and call your doctor immediately

Other adverse effects

Very common (may affect more than 1 in 10 people)

• flushing of the face or body, sensation of warmth, heat, 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 on how to manage these adverse effects. Your doctor may reduce your dose. Do not reduce your dose unless instructed by your doctor.

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

Uncommon (may affect up to 1 in 100 people)

• allergic reactions (hypersensitivity)
• reduction in blood platelets

Frequency not known (cannot be estimated from 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 adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect 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 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 the carton after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage temperature.

Store in the original packaging to protect from light.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE Point at your pharmacy. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Dimethyl fumarate Stadafarma

• The active substance is dimethyl fumarate.

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

Each capsule contains 120 mg of dimethyl fumarate.

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

Each capsule contains 240 mg of dimethyl fumarate.

• The other components are:

• Capsule contents: 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)

• Printing ink for capsules: shellac, potassium hydroxide, propylene glycol (E 1520), black iron oxide (E 172), strong ammonia solution.

Appearance of the medicinal product and contents of the pack

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

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

Available in white HDPE 200 ml bottles with PP/HDPE closures and induction seals (PE/PET/Al/cardboard) and container with silica gel desiccant.

Do not swallow the desiccant.

Also available in OPA/Alu/PVC//Alu blisters or unit-dose blisters.

Dimethyl fumarate Stadafarma 120 mg is marketed in pack sizes 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 pack sizes of:

Pack 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 certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer Responsible for Batch Release

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 most recent review of this leaflet: July 2024

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