Dimethyl fumarate g.l. pharma

Package leaflet: Information for the patient

Dimethyl fumarate G.L. Pharma, 120 mg enteric hard capsules
Dimethyl fumarate G.L. Pharma, 240 mg enteric hard capsules
Dimethylis fumaras
Please read this leaflet carefully before taking the medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Dimethyl fumarate G.L. Pharma is and what it is used for
2. Important information before taking Dimethyl fumarate G.L. Pharma
3. How to take Dimethyl fumarate G.L. Pharma
4. Possible side effects
5. How to store Dimethyl fumarate G.L. Pharma
6. Contents of the pack and other information

1. What Dimethyl fumarate G.L. Pharma is and what it is used for

What is Dimethyl fumarate G.L. Pharma
Dimethyl fumarate G.L. Pharma is a medicine containing the active substance dimethyl fumarate.

What is Dimethyl fumarate G.L. Pharma used for
Dimethyl fumarate G.L. Pharma is used to treat relapsing-remitting multiple sclerosis (MS, sclerosis multiplex) 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 recurrent episodes of neurological symptoms (called relapses). Symptoms vary between individuals, but usually include walking and balance problems, and impaired vision (e.g. blurred or double vision). These symptoms may completely resolve after a relapse, but some problems may persist.

How Dimethyl fumarate G.L. Pharma works
Dimethyl fumarate G.L. Pharma appears to suppress the immune system from causing damage to the brain and spinal cord, which may also help slow the progression of the disease in the future.

2. Important information before using Dimethyl fumarate G.L. Pharma

When must Dimethyl fumarate G.L. Pharma not be taken:

• if the patient is allergic to dimethyl fumarate or to any of the other ingredients of this medicine (listed in section 6).
• if the patient is suspected of or has been diagnosed with a rare brain infection called progressive multifocal leukoencephalopathy (PML).

Warnings and precautions
Dimethyl fumarate G.L. Pharma may adversely affect white blood cell count, as well as kidney and liver function. Before starting treatment with Dimethyl fumarate G.L. Pharma, the doctor will check the patient's white blood cell levels 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 G.L. Pharma, consult a doctor if the patient has:

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

Shingles (herpes zoster) may occur during treatment with Dimethyl fumarate G.L. Pharma. In some cases, severe complications have been reported. If there is any suspicion of shingles symptoms, the doctor must be informed immediately.
If multiple sclerosis worsens (e.g. the patient experiences weakness or vision disturbances) or new symptoms appear, the patient should contact the doctor immediately, as these may be signs of a rare brain infection called progressive multifocal leukoencephalopathy (PML). PML is a serious condition that may lead to severe disability or death.
Rare but serious kidney disorders (Fanconi syndrome) have been reported during treatment with medicines containing dimethyl fumarate in combination with other fumaric acid esters used in the treatment of psoriasis (a skin disease). If the patient notices increased urination, increased thirst and fluid intake, 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
The warnings and precautions mentioned above also apply to children. Dimethyl fumarate may be used in children and adolescents aged 13 years and older. Data in children under 10 years of age are not available.

Dimethyl fumarate G.L. Pharma and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take, especially:

• medicines containing fumaric acid esters (fumarates) used in the treatment of psoriasis;
• medicines affecting the immune system, including other medicines used in the treatment of multiple sclerosis, such as fingolimod, natalizumab, teriflunomide, alemtuzumab, ocrelizumab or cladribine, and certain medicines commonly used in cancer treatment (rituximab or mitoxantrone);
• medicines affecting the kidneys, including certain antibiotics (used to treat infections), diuretics, certain types of painkillers (such as ibuprofen and similar anti-inflammatory medicines, including over-the-counter products), and medicines containing lithium;
• administration of certain vaccines (live vaccines) during treatment with Dimethyl fumarate G.L. Pharma may lead to infection; therefore, such vaccination should be avoided. The doctor will advise whether other types of vaccines (inactivated vaccines) should be administered.

Use of Dimethyl fumarate G.L. Pharma with alcohol
Avoid consuming high-strength alcoholic beverages (over 30% alcohol by volume, e.g. spirits) in amounts exceeding 50 ml within one hour after taking Dimethyl fumarate G.L. Pharma, due to the risk of interaction between alcohol and this medicine, which may lead to stomach upset (gastritis, inflammation of the stomach lining), especially in individuals susceptible to this condition.

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

Pregnancy
Dimethyl fumarate G.L. Pharma should not be taken during pregnancy unless discussed with the doctor.

Breastfeeding
It is not known whether the active substance of Dimethyl fumarate G.L. Pharma passes into breast milk. Dimethyl fumarate G.L. Pharma should not be taken during breastfeeding. The doctor will help the patient decide whether to discontinue breastfeeding or the use of Dimethyl fumarate G.L. Pharma. 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 operating machinery
The effect of Dimethyl fumarate G.L. Pharma on the ability to drive and operate machinery is unknown. No effect of Dimethyl fumarate G.L. Pharma on the ability to drive and operate machinery is expected.

3. How to take Dimethyl fumarate G.L. Pharma

This medicine should always be taken as directed by your doctor. If you have any doubts, you should
consult your doctor.
Initial dose
120 mg twice daily.
This initial dose should be taken for the first 7 days, after which the medicine should be continued at the
recommended dose.
Usual dose
240 mg twice daily.
Dimethyl fumarate G.L. Pharma should be taken orally.
Each capsule should be swallowed whole with water. Do not divide, crush, dissolve, chew, or suck the capsules,
as this may increase certain adverse effects.
Dimethyl fumarate G.L. Pharma should be taken with food – this will help reduce the very common
adverse effects (listed in section 4).
Taking more Dimethyl fumarate G.L. Pharma than recommended
If you take more capsules than recommended, you should inform your doctor immediately.
Adverse effects similar to those described below in section 4 may occur.
Missed dose of Dimethyl fumarate G.L. Pharma
Do not take a double dose to make up for a missed dose.
A missed dose may be taken later, provided that a 4-hour interval is maintained before the next dose.
If it is too late, do not take the missed dose, but take the next dose at the usual time.
If you have any further questions regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Serious side effects

The medicine Dimethyl fumarate G.L. Pharma may reduce the number of lymphocytes, which are a type of white blood cell. A low number of white blood cells may increase the risk of infections, including a rare brain infection called progressive multifocal leukoencephalopathy (PML). PML may lead to severe disability or death. PML has been observed after 1 to 5 years of treatment; therefore, your doctor should monitor your white blood cell count throughout the duration of treatment, and you should pay attention to the symptoms described below, which may indicate PML. The risk of developing PML may be higher if you have previously taken medicines that affect the immune system.

Symptoms of PML may resemble a relapse of multiple sclerosis. They include new or worsening weakness on one side of the body, coordination problems, vision, thinking or memory disturbances, confusion (disorientation), personality changes, speech difficulties, and problems communicating lasting longer than a few days. Therefore, if during treatment with Dimethyl fumarate G.L. Pharma you notice worsening of symptoms related to multiple sclerosis or the occurrence of any new symptoms, you should contact your doctor immediately. You should also talk to your partner or caregivers and inform them about your treatment, as they may notice symptoms you might not be aware of.

If any of the symptoms listed above occur, contact your doctor immediately.

Severe allergic reactions

The frequency of severe allergic reactions cannot be determined from available data (frequency unknown).

A very common side effect is sudden (episodic) redness of the face or body. If episodic skin redness 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 (dyspnoea);
• dizziness or loss of consciousness (hypotension), this may indicate a severe allergic reaction (anaphylaxis). You must stop taking Dimethyl fumarate G.L. Pharma and contact your doctor immediately.

Very common side effects (may occur in more than 1 in 10 people)

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

Taking the medicine with food may help reduce the side effects listed above.

During treatment with Dimethyl fumarate G.L. Pharma, increased production of ketone bodies (substances normally produced in the body) is very frequently observed in urine tests.

Ask your doctor how to manage side effects. Your doctor may reduce the dose of the medicine. Do not reduce the dose yourself unless advised by your doctor.

Common side effects (may occur in 1 in 10 people)

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

Side effects that may cause abnormal blood or urine test results:

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

Uncommon side effects (may occur in 1 in 100 people)

• allergic reactions (hypersensitivity)
• decreased number of platelets

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

• liver inflammation and increased activity of liver enzymes (AlAT or AspAT together with bilirubin)
• shingles with symptoms such as: skin blisters, burning, itching or pain of the skin, 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 tingling, itching, red spots and severe pain
• cold (nasal inflammation)

Children (aged 13 years and older) and adolescents

The side effects listed above also apply to children and adolescents. Some side effects 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 side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. Side effects can also be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:

Al. Jerozolimskie 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 responsible entity.

Reporting side effects helps to provide more information on the safety of the medicine.

5. How to store Dimethyl fumarate G.L. Pharma

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister, bottle, and carton after "EXP". The expiry date refers to the last day of the stated month.
There are no special storage temperature requirements for this medicine.
Store in the original packaging to protect from light.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Dimethyl fumarate G.L. Pharma contains
The active substance is dimethyl fumarate.
Dimethyl fumarate G.L. Pharma, 120 mg – Each capsule contains 120 mg of dimethyl fumarate.
Dimethyl fumarate G.L. Pharma, 240 mg – Each capsule contains 240 mg of dimethyl fumarate.
The other ingredients are:

• Capsule contents: microcrystalline cellulose, crospovidone, talc, povidone, colloidal anhydrous silica, magnesium stearate, triethyl citrate, methacrylic acid and ethyl acrylate copolymer (1:1), hypromellose, titanium dioxide (E 171), triacetin,
• Capsule shell: gelatin, titanium dioxide (E 171), brilliant blue FCF (E 133), yellow iron oxide (E 172),
• Printing ink: shellac, potassium hydroxide, propylene glycol (E 1520), black iron oxide (E172), concentrated ammonium hydroxide.

What Dimethyl fumarate G.L. Pharma looks like and contents of the pack
Dimethyl fumarate G.L. Pharma 120 mg gastro-resistant hard capsules
Green cap and white body, 21.4 mm capsules, printed in black with "DMF 120" on the body,
containing white or almost white gastro-resistant mini-tablets.
Dimethyl fumarate G.L. Pharma 240 mg gastro-resistant hard capsules
Green cap and green body, 23.2 mm capsules, printed in black with "DMF 240" on the body,
containing white or almost white gastro-resistant mini-tablets.
HDPE bottle with PP/HDPE screw cap, sealing gasket and desiccant container
containing silica gel, holding 100 capsules.
Do not swallow the desiccant.
Blisters OPA/Aluminium/PVC/Aluminium or single-dose blisters
OPA/Aluminium/PVC/Aluminium.
Dimethyl fumarate G.L. Pharma, 120 mg gastro-resistant hard capsules
Pack sizes containing:
14 capsules (blisters)
14 x 1 capsule (perforated single-dose blister)
100 capsules (bottle)
Dimethyl fumarate G.L. Pharma, 240 mg gastro-resistant hard capsules
Pack sizes containing:
56 capsules (blisters)
56 x 1 capsule (perforated single-dose blister)
168 capsules (blisters)
168 x 1 capsule (perforated single-dose blister)
100 capsules (bottle)
Not all pack sizes may be marketed.

Marketing Authorisation Holder
G.L. Pharma GmbH
Schlossplatz 1
8502 Lannach
Austria

Importer
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park
Paola PLA 3000, Malta
Adalvo Limited
Malta Life Sciences Park
Building 1, Level 4, Sir Temi Zammit Buildings
San Gwann, SGN 3000, Malta
KeVaRo GROUP Ltd
9 Tzaritza Elenora Str. Office 23
Sofia 1618, Bulgaria

For more detailed information about this medicine, contact the
Marketing Authorisation Holder's representative:
G.L. PHARMA POLAND Sp. z o.o.
Al. Jana Pawła II 61/313
01-031 Warsaw, Poland
Tel: 022/ 636 52 23; 636 53 02
[email protected]