Dimethyl fumarate glenmark

Package leaflet: Information for the user

Dimethyl fumarate Glenmark, 120 mg, enteric hard capsules
Dimethyl fumarate Glenmark, 240 mg, enteric hard capsules
Dimethylis fumaras
Please read this leaflet carefully before 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, please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Leaflet contents

1. What Dimethyl fumarate Glenmark is and what it is used for
2. What you need to know 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 pack and other information

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

What Dimethyl fumarate Glenmark is
Dimethyl fumarate Glenmark is a medicine that contains dimethyl fumarate as the active substance.
What Dimethyl fumarate Glenmark is used for
Dimethyl fumarate Glenmark is used to treat relapsing-remitting multiple sclerosis (MS) in patients aged 13 years and older.
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 episodes of neurological symptoms (called relapses). Symptoms vary between patients but usually include walking and balance difficulties, and vision problems (e.g. blurred or double vision). These symptoms may completely resolve after a relapse, but some problems may persist.
How Dimethyl fumarate Glenmark works
Dimethyl fumarate Glenmark appears to suppress the immune system from causing damage to the brain and spinal cord, which may also help delay the future progression of disease symptoms.

2. Important information before using Dimethyl fumarate Glenmark

When not to use Dimethyl fumarate Glenmark

• if the patient is allergic to dimethyl fumarate or 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 in the patient.

Warnings and precautions

Dimethyl fumarate Glenmark may have an adverse effect on the white blood cell count, as well as on the function of the kidneys and liver. Before starting treatment with Dimethyl fumarate Glenmark, the doctor will check the patient's white blood cell count and assess whether 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 performing additional tests or discontinuing treatment.

Before starting treatment with Dimethyl fumarate Glenmark, discuss this with the doctor if the patient has:

• severe kidney disease
• severe liver disease
• stomach or intestinal disease
• severe infection (e.g. pneumonia).

Shingles (herpes zoster) may occur during treatment with Dimethyl fumarate Glenmark. In some cases, serious complications have occurred. If there is any suspicion of shingles in the patient, the doctor should be informed immediately.

If multiple sclerosis worsens (e.g. weakness or vision disturbances occur) or any other new symptoms appear, the patient should contact the doctor immediately, as these may be symptoms of a rare brain infection called progressive multifocal leukoencephalopathy (PML). PML is a serious illness that may lead to severe disability or death.

When fumaric acid esters, including dimethyl fumarate, have been used in combination with other fumaric acid esters for the treatment of psoriasis (a skin condition), rare but serious kidney disorders called Fanconi syndrome have been reported. If the patient notices increased urination, feels more thirsty and drinks more than usual, experiences muscle weakness, bone fractures, or general pain, they should consult a doctor as soon as possible for further evaluation of these symptoms.

Children and adolescents

This medicine should not be given to children under 10 years of age, as data in this age group are not available.

Dimethyl fumarate Glenmark and other medicines

Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, especially:

• medicines containing fumaric acid esters (fumarates) used in the treatment of psoriasis;
• medicines affecting the immune system, including chemotherapeutic agents, immunosuppressants, or other medicines used in the treatment of multiple sclerosis;
• medicines affecting the kidneys, including certain antibiotics (used to treat infections), diuretics (water pills), certain types of painkillers (such as ibuprofen and other similar anti-inflammatory medicines, including over-the-counter products), and medicines containing lithium.
• using Dimethyl fumarate Glenmark together with some vaccines (vaccines containing live microorganisms) may lead to the development of an infection and should therefore be avoided. The doctor will advise whether other types of vaccines should be administered (vaccines containing inactivated microorganisms).

Dimethyl fumarate Glenmark and alcohol

High-strength alcoholic beverages (over 30% alcohol by volume, e.g. spirits) should be avoided in amounts exceeding 50 ml within one hour of taking Dimethyl fumarate Glenmark, due to the risk of interaction between alcohol and this medicine. This may lead to gastric irritation (inflammation of the stomach lining), especially in individuals susceptible to this condition.

Dimethyl fumarate Glenmark contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per capsule, meaning the medicine is considered "sodium-free".

Pregnancy and breastfeeding

If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.

Pregnancy

There is limited information on the effects of this medicine on the unborn child when used during pregnancy. Dimethyl fumarate Glenmark should not be used during pregnancy unless discussed with the doctor and deemed 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 she should discontinue breastfeeding or continue taking Dimethyl fumarate Glenmark. The decision will be based on an assessment of the benefits of breastfeeding for the child compared to the benefits of treatment for the patient.

Driving and using machines

No effects on the ability to drive or operate machinery are expected with Dimethyl fumarate Glenmark.

3. How to use Dimethyl fumarate Glenmark

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor.
Starting dose:
120 mg twice daily.
This starting dose should be taken for the first 7 days, after which the usual maintenance dose should be used.
Usual maintenance dose:
240 mg twice daily.
Dimethyl fumarate Glenmark should be taken orally.
Each capsule must be swallowed whole with water. Do not divide, crush, dissolve, suck or chew the capsules, as this may increase the risk of certain adverse reactions.
Dimethyl fumarate Glenmark should be taken with food – this will help reduce the very common adverse reactions (listed in section 4).
Taking more Dimethyl fumarate Glenmark than prescribed
If you take more capsules than prescribed, you must inform your doctor immediately. Adverse reactions similar to those described below in section 4 may occur.
Missing a dose of Dimethyl fumarate Glenmark
Do not take a double dose to make up for a missed dose.
A missed dose may be taken if at least 4 hours remain before the next scheduled dose. Otherwise, take the next dose at the usual time.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Serious adverse reactions
Dimethyl fumarate Glenmark may reduce the number of lymphocytes (a type of white blood cells). A low number of white blood cells may 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 observed after 1 to 5 years of treatment; therefore, the doctor should monitor the patient's white blood cell count throughout the treatment period, and the patient should be aware of the symptoms described below, which may indicate PML.
The risk of developing PML may be higher if the patient has previously taken medicines affecting the immune system.
Symptoms of PML may resemble a multiple sclerosis relapse. These include new symptoms or worsening of existing symptoms such as weakness on one side of the body, coordination problems, vision disturbances, thinking or memory problems, confusion (disorientation), personality changes, or speech and communication difficulties lasting longer than a few days.
For this reason, if the patient notices worsening of symptoms related to multiple sclerosis or the onset of any new symptoms while taking Dimethyl fumarate Glenmark, they should contact their doctor as soon as possible. The patient should also talk to a partner or caregiver and inform them about their treatment. Symptoms may occur that the patient may not be aware of.
→If any of the symptoms listed above occur, contact a doctor immediately
Severe allergic reactions
The frequency of severe allergic reactions cannot be determined from available data (unknown).
A very common adverse reaction is sudden ( flushing ) redness of the face or body. However, if flushing is accompanied by a red rash or hives and 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 may indicate a severe allergic reaction ( anaphylaxis ).
→The patient must stop taking Dimethyl fumarate Glenmark and contact a doctor immediately
Other adverse reactions
Very common (may occur in more than 1 in 10 people)

• redness of the face or sensation of increased body temperature, hot flushes, burning of the skin, or itching ( flushing )
• loose stools ( diarrhea )
• nausea
• stomach pain or cramps

→Taking the medicine with food will help reduce the adverse reactions listed above.
During treatment with Dimethyl fumarate Glenmark, ketone bodies (substances normally produced in the body) are very commonly detected in urine tests.
The patient should consult their doctor on how to manage these adverse reactions. The doctor may reduce the dose of the medicine. The dose must not be reduced by the patient unless instructed by the doctor.
Common (may occur in 1 in 10 people)

• inflammation of the intestinal mucosa ( gastroenteritis )
• vomiting
• indigestion
• inflammation of the stomach mucosa ( gastritis )
• gastrointestinal disorders
• burning sensation of the skin
• hot flushes, feeling of warmth
• itching ( pruritus )
• rash
• pink or red spots on the skin ( flush )
• hair loss ( alopecia )

Adverse reactions that may be observed in blood or urine tests:

• low number of white blood cells ( lymphopenia, leukopenia ). A reduced number of white blood cells may mean the body is less able to fight infections. In case of severe infection (e.g. pneumonia), contact a doctor immediately;
• protein ( albumin ) in urine;
• increased liver enzyme activity ( AlAT, AspAT ) in blood.

Uncommon (may occur in 1 in 100 people)

• allergic reactions (hypersensitivity)
• decreased platelet count

Rare (may occur in 1 in 1,000 people)

• hepatitis and increased liver enzyme activity ( AlAT or AspAT together with bilirubin )

Frequency not known (frequency cannot be determined from available data)

• shingles, with symptoms such as: skin blisters, burning, itching, or skin pain, usually on one side of the upper body or face, and other symptoms such as fever and fatigue in the early stages of infection, followed by numbness, itching, red spots, and severe pain
• nasal congestion ( rhinitis )

Children (aged 13 years and above) and adolescents
The adverse reactions listed above also apply to children and adolescents. Some adverse reactions have been reported more frequently in children and adolescents than in adults, e.g. headache, abdominal pain or stomach cramps, vomiting, sore throat, cough, and painful menstruation.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse symptoms not listed in this leaflet, the patient should inform their doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
tel.: +48 22 49 21 301, fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Dimethyl fumarate Glenmark

• Keep this medicine out of sight and reach of children.
• Do not use this medicine after the expiry date stated on the cardboard box and blister pack following the abbreviation EXP, which refers to the expiry date. The expiry date represents the last day of the stated month.
• There are no special storage instructions for this medicine.
• Medicines must 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

What Dimethyl fumarate Glenmark contains
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.
Other ingredients include:
Capsule contents (mini-tablets in enteric 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), 30% dispersion, simethicone.
Dimethyl fumarate Glenmark, 120 mg
Capsule cap: gelatin, yellow iron oxide (E 172), titanium dioxide (E 171), brilliant blue FD & C Blue 1 (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 FD & C Blue 1 (E 133), black iron oxide (E 172), purified water.
Capsule body: gelatin, yellow iron oxide (E 172), titanium dioxide (E 171), brilliant blue FD & C Blue 1 (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, enteric hard capsules: 20 mm hard gelatin capsule, size “1”, with a white body printed in black ink with “307” and a blue cap printed in black ink with “G”, containing white to off-white round mini-tablets.
Pack sizes available:
14, 28, 56 capsules packed in PVC/PVDC-Aluminium blisters, in a cardboard box.
14x1, 28x1, 56x1 capsules packed in single-dose perforated blisters made of PVC/PVDC-Aluminium, in a cardboard box.

Dimethyl fumarate Glenmark, 240 mg, enteric hard capsules: 22 mm hard gelatin capsule, size “0”, with a blue body printed in black ink with “308” and a blue cap printed in black ink with “G”, containing white to off-white round mini-tablets.
Pack sizes available:
56, 112, 168, 196 capsules packed in PVC/PVDC-Aluminium blisters, in a cardboard box.
56x1, 112x1, 168x1, 196x1 capsules packed in single-dose perforated blisters made of PVC/PVDC-Aluminium, in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation 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 Vysoke Myto
Czech Republic

This medicinal product is authorised for marketing in the European Economic Area under the following names:

For more detailed information about the medicinal product, please contact the local representative of the marketing authorisation holder:
Glenmark Pharmaceuticals Sp. z o.o.
Dziekonskiego 3
00-728 Warsaw
Email: [email protected]