Dimethil fumarate Glenmark

Leaflet attached to the packaging: information for the user

Dimethyl fumarate Glenmark, 120 mg, gastro-resistant hard capsules

Dimethyl fumarate Glenmark, 240 mg, gastro-resistant hard capsules

Dimethyl fumarate

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Dimethyl fumarate Glenmark and what is it used for
• 2. Important information before taking Dimethyl fumarate Glenmark
• 3. How to take Dimethyl fumarate Glenmark
• 4. Possible side effects
• 5. How to store Dimethyl fumarate Glenmark
• 6. Contents of the packaging 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 the active substance dimethyl fumarate.

What is Dimethyl fumarate Glenmark used for

Dimethyl fumarate Glenmark is used to treat relapsing-remitting multiple sclerosis (MS) in patients aged 13 and over.

Multiple sclerosis is a chronic disease that damages the central nervous system (CNS), including the brain and spinal cord. Relapsing-remitting multiple sclerosis is characterized by recurring, periodic worsening of neurological symptoms (called relapses). Symptoms vary from person to person but usually include walking, balance, and vision problems (such as blurred or double vision). These symptoms may completely disappear after a relapse, but some problems may persist.

How does Dimethyl fumarate Glenmark work

Dimethyl fumarate Glenmark seems to prevent the immune system from causing damage to the brain and spinal cord, which may also help delay the onset of symptoms in the future.

2. Important information before taking Dimethyl fumarate Glenmark

When not to take Dimethyl fumarate Glenmark

• If the patient is allergic to dimethyl fumarateor any of the other ingredients of this medicine (listed in section 6).
• If the patient is suspected or confirmed to have a rare brain infection called progressive multifocal leukoencephalopathy (PML).

Warnings and precautions

Dimethyl fumarate Glenmark may have a negative effect on white blood cell countand kidney and liver function. Before starting treatment with Dimethyl fumarate Glenmark, the doctor will check the patient's white blood cell count and ensure that the kidneys and liver are functioning properly. These tests will be performed periodically during treatment. If the patient's white blood cell count decreases during treatment, the doctor may consider additional tests or discontinuation of treatment.
Before starting Dimethyl fumarate Glenmark, the patient should discuss the following with their doctor:

• severe kidney disease
• severe liver disease
• stomach or intestinal disease
• severe infection(such as pneumonia).

During treatment with Dimethyl fumarate Glenmark, shingles may occur. In some cases, severe complications have occurred. If the patient suspects they have any symptoms of shingles, they should immediately inform their doctor.
If multiple sclerosis worsens (e.g., weakness or vision problems occur) or any new symptoms appear, the patient should contact their doctor immediately, as these may be symptoms of a rare brain infection called PML. PML is a serious disease that can lead to severe disability or death.
When taking a medicine containing dimethyl fumarate in combination with other fumaric acid esters used to treat psoriasis (a skin disease), rare but severe kidney damage called Fanconi syndrome has been reported. If the patient notices they are urinating more, feeling thirstier, and drinking more than usual, their muscles seem weaker, they have a bone fracture, or they simply feel pain, they should see their doctor as soon as possible for further examination of these symptoms.

Children and adolescents

This medicine should not be given to children under 10 years of age, as there is no data available for this age group.

Dimethyl fumarate Glenmark and other medicines

The patient should tell their doctor or pharmacistabout all medicines they are taking, have recently taken, or might take, especially:

• medicines containing fumaric acid estersused to treat psoriasis
• medicines that affect the immune system, including chemotherapy, immunosuppressants, or other medicines used to treat multiple sclerosis
• medicines that affect the kidneys, including certain antibiotics(used to treat infections), diuretics, certain types of painkillers(such as ibuprofen and other similar anti-inflammatory medicines, including over-the-counter medicines), and lithium
• using Dimethyl fumarate Glenmark with certain vaccines (live vaccines)may cause infection, so this should be avoided. The doctor will advise whether other types of vaccines (inactivated vaccines) can be given.

Dimethyl fumarate Glenmark and alcohol

The patient should avoid consuming high-percentage alcoholic beverages (over 30% alcohol by volume, e.g., spirits) in excess of 50 ml within an hour of taking Dimethyl fumarate Glenmark, due to the risk of interaction between alcohol and this medicine. This may lead to stomach upset (gastritis), especially in people prone to this condition.

Dimethyl fumarate Glenmark contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per capsule, which means it is essentially 'sodium-free'.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
There is limited data on the use of this medicine in pregnant women. Dimethyl fumarate Glenmark should not be taken during pregnancy unless the patient has discussed it with their doctor and the use of the medicine is necessary.
Breastfeeding
It is not known whether the active substance of Dimethyl fumarate Glenmark passes into breast milk. The doctor will advise the patient whether to stop breastfeeding or stop taking Dimethyl fumarate Glenmark. The decision will be based on the assessment of the benefit of breastfeeding to the baby and the benefit of treatment to the patient.

Driving and using machines

The patient should not expect Dimethyl fumarate Glenmark to affect their ability to drive or use machines.

3. How to take Dimethyl fumarate Glenmark

This medicine should always be taken exactly as prescribed by the doctor. In case of doubts, the patient should consult their doctor.

Initial dose:

120 mg twice a day.

This initial dose should be taken for the first 7 days, and then the usual dose should be taken.

Usual dose:

240 mg twice a day.

Dimethyl fumarate Glenmark should be taken orally.
Each capsule should be swallowed whole, with a glass of water. The capsules should not be divided, crushed, dissolved, sucked, or chewed, as this may increase certain side effects.
Dimethyl fumarate Glenmark should be taken with food- this will help alleviate very common side effects (listed in section 4).

Taking a higher dose of Dimethyl fumarate Glenmark than recommended

In case of taking more capsules than recommended, the patient should immediately tell their doctor. Side effects similar to those described below in section 4 may occur.

Missing a dose of Dimethyl fumarate Glenmark

The patient should not take a double doseto make up for a missed dose.
A missed dose can be taken if there is a 4-hour interval before the next dose. Otherwise, the patient should take the next dose at the usual time.
In case of further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Dimethyl fumarate Glenmark can cause side effects, although not everybody gets them.

Severe side effects

Dimethyl fumarate Glenmark may decrease the number of lymphocytes (a type of white blood cell). A low white blood cell count can increase the risk of infections, including a rare brain infection called progressive multifocal leukoencephalopathy (PML). PML can lead to severe disability or death. PML has been reported after 1 to 5 years of treatment, so the doctor should monitor the patient's white blood cell count throughout treatment, and the patient should be aware of the symptoms described below, which may indicate PML.
The risk of PML may be higher if the patient has previously taken medicines that affect the immune system.
Symptoms of PML may resemble a relapse of multiple sclerosis. They include new or worsening symptoms such as weakness on one side of the body, coordination problems, vision problems, changes in thinking or memory, confusion (disorientation), or personality changes, or speech and communication problems lasting more than a few days.
If the patient experiences worsening of multiple sclerosis symptoms or any new symptoms while taking Dimethyl fumarate Glenmark, they should contact their doctor immediately. They should also discuss their treatment with their partner or caregivers and inform them about their treatment. The patient may not be aware of some symptoms.
If the patient experiences any of the above symptoms, they should immediately contact their doctor

Severe allergic reactions

The frequency of severe allergic reactions cannot be estimated from the available data (unknown).
A very common side effect is sudden (flushing) redness of the face or body. However, if flushing is accompanied by a red rash or hives andany of the following symptoms:

• swelling of the face, lips, mouth, or tongue (angioedema)
• wheezing, difficulty breathing, or shortness of breath (dyspnea)
• dizziness or loss of consciousness (hypotension)

it may indicate a severe allergic reaction (anaphylaxis).
The patient should stop taking Dimethyl fumarate Glenmark and immediately contact their doctor

Other side effects

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

• redness of the skin on the face or a feeling of warmth, heat, burning, or itching of the skin (flushing)
• diarrhea
• nausea
• stomach pain or cramps

Taking the medicine with foodwill help alleviate the above side effects
During treatment with Dimethyl fumarate Glenmark, the presence of ketone bodies (substances normally produced in the body) in the urine is very common.
The patient should ask their doctorhow to deal with these side effects. The doctor may reduce the dose of the medicine. The patient should not reduce the dose themselves unless their doctor advises them to do so.
Common(may affect up to 1 in 10 people)

• inflammation of the lining of the intestines (gastroenteritis)
• vomiting
• indigestion
• inflammation of the stomach lining (gastritis)
• stomach and intestinal problems
• burning sensation on the skin
• hot flashes, feeling of warmth
• itching (pruritus)
• rash
• pink or red spots on the skin (erythema)
• hair loss (alopecia)

Side effects that may be seen in blood or urine test results

• low white blood cell count (lymphopenia, leukopenia). A low white blood cell count may mean that the body is less able to fight infection. In case of severe infection (e.g., pneumonia), the patient should immediately contact their doctor;
• protein (albumin) in the urine;
• increased liver enzyme activity (ALT, AST) in the blood.

Uncommon(may affect up to 1 in 100 people)

• allergic reactions (hypersensitivity)
• decreased platelet count

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

• liver inflammation and increased liver enzyme activity (ALT or AST, along with bilirubin)

Frequency not known(frequency cannot be estimated from the available data)

• shingles, with symptoms such as blisters on the skin, 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, and red spots, and severe pain
• runny nose (rhinitis)

Children (aged 13 and over) and adolescents

The above side effects also apply to children and adolescents. Some side effects have been reported more frequently in children and adolescents than in adults, such as headache, stomach pain or cramps, vomiting, sore throat, cough, and painful menstruation.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw
phone: +48 22 49 21 301, fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of this medicine.

5. How to store Dimethyl fumarate Glenmark

• The medicine should be stored out of sight and reach of children.
• Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month.
• There are no special storage instructions for this medicine.
• Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the packaging and other information

What Dimethyl fumarate Glenmark contains

The active substance of Dimethyl fumarate Glenmark 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.

Other ingredients are:

Contents of the capsule (mini-tablets in the gastro-resistant capsule): microcrystalline cellulose, sodium croscarmellose, talc, colloidal anhydrous silica, magnesium stearate, triethyl citrate, methacrylic acid and methyl methacrylate copolymer (1:1), methacrylic acid and ethyl acrylate copolymer (1:1), dispersion 30%, simethicone.
Dimethyl fumarate Glenmark, 120 mg
Capsule cap: gelatin, yellow iron oxide (E 172), titanium dioxide (E 171), brilliant blue FCF (E 133), black iron oxide (E 172), purified water.
Capsule body: gelatin, titanium dioxide (E 171), purified water.
Dimethyl fumarate Glenmark, 240 mg:
Capsule cap: gelatin, yellow iron oxide (E 172), titanium dioxide (E 171), brilliant blue FCF (E 133), black iron oxide (E 172), purified water.
Capsule body: gelatin, yellow iron oxide (E 172), titanium dioxide (E 171), brilliant blue FCF (E 133), black iron oxide (E 172), purified water.
Printing ink: shellac, propylene glycol, potassium hydroxide, black iron oxide (E 172).

What Dimethyl fumarate Glenmark looks like and contents of the pack

Dimethyl fumarate Glenmark, 120 mg, gastro-resistant hard capsules, are white, size 1, hard gelatin capsules with a black ink print "307" on the body and a blue cap with a black ink print "G", containing white to off-white round mini-tablets.
Available pack sizes:
14, 28, 56 capsules in PVC/PVDC-Aluminum blisters, in a cardboard box.
14x1, 28x1, 56x1 capsules in perforated unit dose blisters, in a cardboard box.
Dimethyl fumarate Glenmark, 240 mg, gastro-resistant hard capsules, are blue, size 0, hard gelatin capsules with a black ink print "308" on the body and a blue cap with a black ink print "G", containing white to off-white round mini-tablets.
Available pack sizes:
56, 112, 168, 196 capsules in PVC/PVDC-Aluminum blisters, in a cardboard box.
56x1, 112x1, 168x1, 196x1 capsules in perforated unit dose blisters, in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder

Glenmark Pharmaceuticals s.r.o.
Hvězdova 1716/2b
140 78 Prague 4
Czech Republic

Manufacturer and importer

Glenmark Pharmaceuticals s.r.o.
Fibichova 143
566 17 Vysoké Mýto
Czech Republic

This medicine is authorized in the Member States of the European Economic Area under the following names:

For further information on this medicine, the patient should contact their local representative of the marketing authorization holder:

Glenmark Pharmaceuticals Sp. z o.o.
Dziekońskiego 3
00-728 Warsaw
Email: poland.receptionist@glenmarkpharma.com
Date of last revision of the leaflet:January 2025