Dimethyl fumarate Glenmark 120 mg gastro-resistant hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Dimethyl fumarate Glenmark 120 mg gastro-resistant hard capsules EFG

Dimethyl fumarate Glenmark 240 mg gastro-resistant hard capsules EFG

dimethyl fumarate

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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, 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 these effects are not listed in this leaflet. See section 4.

Package leaflet contents

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

1. What Fumarate dimethyl Glenmark is and what it is used for

What Fumarate de dimetilo Glenmark is

Fumarate de dimetilo Glenmark is a medicine that contains dimethyl fumarate as the active substance.

What Fumarato de dimetilo Glenmark is used for

Fumarate de dimetilo is used to treat relapsing-remitting multiple sclerosis (MS) in patients 13 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 (relapses) of neurological symptoms. Symptoms vary from patient to patient but typically include: difficulty walking, balance disturbances, and visual problems (e.g., blurred or double vision). These symptoms may completely disappear when a relapse ends, but some problems may persist.

How Fumarate de dimetilo Glenmark 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 to take Dimethyl fumarate Glenmark

Do not take Dimethyl fumarate Glenmark

• if you are allergic to dimethyl fumarate or to 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 your white blood cell count, kidneys, and 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 regular blood tests during treatment. If you develop a reduced white blood cell count during treatment, your doctor may consider additional testing or interrupt your treatment.

Consult your doctor before starting dimethyl fumarate if you have:

• severe renal disease
• severe hepatic disease
• a stomach or intestinal disorder
• 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 immediately if you suspect you have symptoms of shingles.

If you think your MS is worsening (e.g., weakness or visual changes) or you experience any new symptoms, speak to your doctor immediately, as these could be signs of a rare brain infection called PML. PML is a serious condition that may lead to 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 frequently, feel unusually 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 give this medicine to children under 10 years of age because there is no available data in this age group.

Other medicines and Dimethyl fumarate Glenmark

Tell 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 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 medicines, and over-the-counter medicines), and medicines containing lithium;
• using dimethyl fumarate together with certain types of vaccines (attenuated vaccines) could cause you to develop an infection, and therefore should be avoided. Your doctor will advise you whether you should receive other types of vaccines (inactivated vaccines).

Alcohol consumption with Dimethyl fumarate Glenmark

After taking dimethyl fumarate, you should 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. It may cause inflammation of the stomach (gastritis), especially in individuals predisposed to this condition.

Dimethyl fumarate Glenmark contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per capsule; hence, it is essentially "sodium-free".

Pregnancy and lactation

If you are pregnant or breastfeeding, think you may 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 ingredient 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 operating machinery

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

3. How to take Dimethyl fumarate Glenmark

Follow exactly the instructions for use of this medicine given by your doctor. If in doubt, consult your doctor again.

Initial dose

120 mg twice daily.

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

Recommended dose

240 mg twice daily.

Dimethyl fumarate is taken orally.

Capsules must be swallowed whole with water. Do not cut, crush, dissolve, chew, or suck the capsules, as this could increase certain adverse effects.

Take dimethyl fumarate with food – this helps reduce some of the very common side effects (listed in section 4).

If you take more Fumarate dimethyl Glenmark than you should

If you take too many capsules, inform your doctor immediately. You may experience adverse 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 at telephone number 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Dimethyl fumarate Glenmark

Do not take a double dose to make up for missed doses.

You may take the missed dose if at least 4 hours have passed between doses. 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 may cause adverse effects, although not everyone will experience them.

Serious adverse 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 result in death or cause severe disability. Cases of PML have 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 vigilant for any possible symptoms of PML, as described below. The risk of PML may be higher if you have previously taken a medication that weakened 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 contact your doctor as soon as possible if you think your MS is worsening or if you notice any new symptoms while being treated with dimethyl fumarate. In addition, inform your partner or caregivers about your treatment, as symptoms may arise that you might 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).

Redness of the face or body (rubefaction) is a very common adverse effect. However, if redness is accompanied by a red rash or hives and any of the following symptoms occur:

• 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)

• redness of the face or body
• sensation of warmth, flushing, 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, it is common for urine tests to show the presence of ketones, substances that are naturally produced in the body.

Consult your doctor about how to manage these adverse effects. Your doctor may reduce your dose. Do not reduce the dose unless instructed by your doctor.

Common (may affect up to 1 in 10 people)

• inflammation of the intestinal mucosa (gastroenteritis)
• feeling of discomfort (vomiting)
• indigestion (dyspepsia)
• inflammation of the stomach lining (gastritis)
• gastrointestinal disorders
• burning sensation
• hot flushes, sensation of heat
• skin itching (pruritus)
• rash
• rose-colored or reddish itchy 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

Rare (may affect up to 1 in 1,000 people)

• inflammation of the liver and increased levels of liver enzymes (ALT or AST together with bilirubin)

Frequency not known (cannot be estimated from available data)

• 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 reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaram.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Dimethyl fumarate Glenmark

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

Do not use this medicine after the expiry date stated on the pack after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Dimethyl fumarate Glenmark

• The active substance is dimethyl fumarate.

Dimethyl fumarate Glenmark 120 mg: each capsule contains 120 mg of dimethyl fumarate.

Dimethyl fumarate Glenmark 240 mg: each capsule contains 240 mg of dimethyl fumarate.

• The other components are:

Capsule contents (enteric-coated mini-tablets): microcrystalline cellulose, sodium croscarmellose, talc (E553b), anhydrous colloidal silica, magnesium stearate, triethyl citrate (E1505), methacrylic acid-methyl methacrylate copolymer (1:1), methacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30 percent, simethicone (30 percent emulsion).

Capsule for 120 mg:

Cap: gelatin, yellow iron oxide (E172), titanium dioxide (E171), brilliant blue FCF (E133), black iron oxide (E172), purified water.

Body: gelatin, titanium dioxide (E171), purified water.

Capsule for 240 mg:

Cap: gelatin, yellow iron oxide (E172), titanium dioxide (E171), brilliant blue FCF (E133), black iron oxide (E172), purified water.

Body: gelatin, yellow iron oxide (E172), titanium dioxide (E171), brilliant blue FCF (E133), black iron oxide (E172), purified water.

Capsule printing (black ink): shellac, propylene glycol, potassium hydroxide, black iron oxide (E172).

Appearance of the product and contents of the pack

Dimethyl fumarate Glenmark 120 mg gastro-resistant hard capsules EFG are gastro-resistant hard capsules, 20 mm, size 1, white and blue, with an opaque white body printed with “307” in black ink and a blue cap printed with “G” in black ink, containing white or almost white round mini-tablets, available in:

• PVC/PVDC-Aluminum blister packs containing 14, 28 or 56 capsules.
• Single-dose precut PVC/PVDC-Aluminum blister packs containing 14x1, 28x1 or 56x1 capsules.

Dimethyl fumarate Glenmark 240 mg gastro-resistant hard capsules EFG are gastro-resistant hard capsules, 22 mm, size 0, blue, with a blue body printed with “308” in black ink and a blue cap printed with “G” in black ink, containing white or almost white round mini-tablets, available in:

• PVC/PVDC-Aluminum blister packs containing 56, 112, 168 or 196 capsules.
• Single-dose precut PVC/PVDC-Aluminum blister packs containing 56x1, 112x1, 168x1 or 196x1 capsules.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Glenmark Arzneimittel GmbH
Industriestr. 31
82194 Gröbenzell
Germany

Manufacturer:

Glenmark Pharmaceuticals s.r.o.
Fibichova 143
56617 Vysoké Mýto
Czech Republic

Further information on this medicinal product is available from the local representative of the Marketing Authorization Holder:

Glenmark Farmacéutica, S.L.U.
C/ Retama 7, 7th floor
28045 Madrid
Spain

This medicinal product is authorized in the European Economic Area member states under the following names:

Date of the most recent review of this leaflet: January 2025.

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