Prospect: information for the patient

Dimethyl Fumarate Glenmark 120 mg hard gastro-resistant capsules EFG

Dimethyl Fumarate Glenmark 240 mg hard gastro-resistant capsules EFG

dimethyl fumarate

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed to you alone, 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 prospect. See section 4.

Content of the prospect

1. What is Dimethyl Fumarate Glenmark and for what it is used
2. What you need to know before starting to take Dimethyl Fumarate Glenmark
3. How to take Dimethyl Fumarate Glenmark
4. Possible adverse effects
5. Storage of Dimethyl Fumarate Glenmark
6. Contents of the package and additional information

What is Dimethyl Fumarate Glenmark

Dimethyl Fumarate Glenmark is a medication that contains dimethyl fumarate as the active ingredient..

What is Dimethyl Fumarate Glenmark used for

Dimethyl Fumarate 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 (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 Glenmark 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 Glenmark Dimethyl Fumarate

-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 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 decrease in the number of white blood cells during treatment, your doctor may consider additional tests or interrupt your treatment.

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

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 symptoms of shingles.

If you think your MS is getting worse (e.g., weakness or visual changes) or notice the appearance of any new symptoms, speak directly with your doctor, as they may be symptoms of a rare brain infection called 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, and that is used to treat psoriasis (a skin disease). If you notice that 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 that this can be investigated further.

Children and adolescents

Do not give this medicine to children under 10years old because there are no available data in this age group.

Other medicines and Dimethyl Fumarate Glenmark

Inform your doctor or pharmacistif 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, including chemotherapy, immunosuppressants orother medicines used to treat MS;
• medicines that affect the kidneys, including someantibiotics(used to treat infections), “diuretics” (tablets that increase urine elimination), certain types ofanalgesics(such as ibuprofen or other anti-inflammatory drugs, 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 inform you if you should receive other types of vaccines (inactivated vaccines).

Dimethyl Fumarate Glenmark and alcohol

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

Dimethyl Fumarate Glenmark contains sodium

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

The information on the effects of this medicine on the fetus if used during pregnancy is limited. Do not use dimethyl fumarate during pregnancy unless you have discussed this with your doctor and this 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 inform you if you should stop breastfeeding or if you should stop taking dimethyl fumarate. This decision involves weighing the benefits of breastfeeding for your child and the benefits of treatment for you.

Driving and operating machinery

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

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of 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 Glenmark 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 Glenmark Dimethyl Fumarate

Do not take a double doseto compensate 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 should be 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 may be similar to those of a relapse of MS. 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 talk 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. Also, inform your partner or caregivers about your treatment. You may experience symptoms of which you are not aware 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 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)
• whistling or difficulty breathing, shortness of breath, or lack of air(dyspnea, hypoxia)
• dizziness or loss of consciousness(hypotension)

it may then constitute 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)

• flush (rubefaction)
• sensation of heat, 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 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(may affect up to 1 in 10 people)

• inflammation of the intestinal mucosa (gastroenteritis)
• feeling unwell (vomiting)
• indigestion(dispepsia)
• inflammation of the stomach mucosa (gastritis)
• gastrointestinal disorders
• sensation of burning
• hot flashes, sensation of heat
• skin itching (pruritus)
• exanthema
• rosy or reddish spots accompanied by itching on the skin (erythema)
• hair loss (alopecia)

Side effects that may appear in blood or urine tests

Rare(may affect up to 1 in 1000 people)

• inflammation of the liver and increase in liver enzymes (ALT or AST simultaneously with bilirubin)

Unknown frequency(cannot be estimated from available data)

• 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 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,

for example, headache, stomach pain or cramps, vomiting, sore throat, cough, and painful menstruation.

Reporting side effects

If you experienceany type of side effect, consult your doctor or pharmacist, even if it is apossibleside effect that does not appear in this leaflet.You can also report them directly through theSpanish System for the Vigilance 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 packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. This will help protect the environment.

Composition of Dimethyl Fumarate Glenmark

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.

Content of the capsule (enteric-coated minitablets): microcrystalline cellulose, sodium croscarmellose, talc (E553b), anhydrous colloidal silica, magnesium stearate, triethyl citrate (E1505), copolymer of methacrylic acid and methyl methacrylate (1:1), copolymer of methacrylic acid and ethyl acrylate (1:1) dispersion at 30percent, simethicone (emulsion at 30percent).

Capsule of 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 of 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.

Printing of the capsule (black ink): shellac, propylene glycol, potassium hydroxide, black iron oxide (E172).

Appearance of the product and contents of the package

Dimethyl Fumarate Glenmark 120 mg hard gastro-resistant capsules EFG are hard gastro-resistant capsules, 20 mm in size, 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 round white or off-white minitablets, and are marketed in:

-PVC/PVDC-Aluminum blister packs containing 14, 28, or 56 capsules.

-Pre-cut single-dose PVC/PVDC-Aluminum blister packs containing 14x1, 28x1, or 56x1 capsules.

Dimethyl Fumarate Glenmark 240 mg hard gastro-resistant capsules EFG are hard gastro-resistant capsules, 22 mm in size, size 0, blue, with a blue body printed with “308” in black ink and a blue cap printed with “G” in black ink, containing round white or off-white minitablets, and are marketed in:

-PVC/PVDC-Aluminum blister packs containing 56, 112, 168, or 196 capsules.

-Pre-cut single-dose PVC/PVDC-Aluminum blister packs containing 56x1, 112x1, 168x1, or 196x1 capsules.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Glenmark Arzneimittel GmbH

Industriestr. 31

82194 Gröbenzell

Germany

Responsible manufacturer

Glenmark Pharmaceuticals s.r.o.

Fibichova 143, 56617 Vysoké Mýto

Czech Republic

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

Viso Farmacéutica S.L.U.

c/ Retama 7, 7ª planta

28045 Madrid

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

Last revision date of this leaflet: January 2025.

Further detailed information about this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)(http://www.aemps.gob.es/).