DIMETHYL FUMARATE GLENMARK 120 mg HARD GASTRO-RESISTANT CAPSULES

Introduction

Patient Information: Summary of Product Characteristics

Dimethyl Fumarate Glenmark 120 mg hard gastro-resistant capsules EFG

Dimethyl Fumarate Glenmark 240 mg hard gastro-resistant capsules EFG

dimethyl fumarate

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 and other information

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

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

What is Dimethyl Fumarate Glenmark

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

What is Dimethyl Fumarate Glenmark used for

Dimethyl fumarate is used to treat 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. 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 Glenmark 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 Glenmark

Do not take Dimethyl Fumarate Glenmark

• if you are allergic to dimethyl fumarateor any of the other ingredients of this medicine (listed in section 6).

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 check your white blood cell count and make sure 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.

Tell your doctorbefore starting dimethyl fumarate if you have:

• severe kidney disease
• severe liver disease
• a stomach or intestinal 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 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, tell 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 Glenmark

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, including some 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 Glenmark 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 may cause stomach inflammation (gastritis), especially in people who are prone to this condition.

Dimethyl Fumarate Glenmark contains sodium

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

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 pregnancy is limited. Do not take dimethyl fumarate during pregnancy unless you have discussed this with your doctor and this medicine is clearly necessary for you.

Breastfeeding

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

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor.

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 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 with food– this helps to reduce some of the very common side effects (listed in section 4)

If you take more Dimethyl Fumarate Glenmark 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 Poison Information Service on 91 562 04 20, stating the medicine and the amount taken.

If you forget to take Dimethyl Fumarate Glenmark

Do not take a double doseto make up for forgotten doses.

You can take the forgotten dose if it is at least 4 hours until the next dose. 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 weakness 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 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 taking dimethyl fumarate. Also, tell your partner or caregivers about your treatment. You may not notice symptoms that they do.

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 rash or hivesandyou have 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 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)

• flushing of the face or body
• feeling of heat, warmth, or burning (flushing)
• loose stools (diarrhea)
• nausea or vomiting
• stomach pain or cramps

?Taking the medicine with foodmay help reduce the above side effects

While taking dimethyl fumarate, it is common for urine tests to show ketones, substances that are produced naturally 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)
• feeling unwell (nausea)
• indigestion (dyspepsia)
• inflammation of the stomach lining (gastritis)
• gastrointestinal disorders
• burning sensation
• hot flashes, feeling of warmth
• itching (pruritus)
• rash (exanthem)
• 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 low white blood cell count can make the body more susceptible to 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 in blood platelets

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

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

Frequency not known(cannot be estimated from the 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 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 Medicines Information System: www.notificaram.es. By reporting side effects, 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 which is stated on the carton after EXP. The expiry date refers to the last day of the month shown.

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. Contents of the pack and other information

Composition of Dimethyl Fumarate Glenmark

• The active ingredient 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 content (enteric-coated mini-tablets): microcrystalline cellulose, sodium croscarmellose, talc (E553b), colloidal anhydrous 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).

120 mg capsule:

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.

240 mg capsule:

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 and packaging of the product

Dimethyl Fumarate Glenmark 120 mg hard gastro-resistant capsules EFG are hard gastro-resistant 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 off-white round mini-tablets and are marketed in:

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

Dimethyl Fumarate Glenmark 240 mg hard gastro-resistant capsules EFG are hard gastro-resistant 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 off-white round mini-tablets and are marketed in:

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

Only some 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

You can request more information about this medicinal product by contacting 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 Member States of the European Economic Area under the following names:

Date of last revision of this leaflet: January 2025.

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/).