Dimethil fumarate Sandoz

Package Leaflet: Information for the Patient

Dimethyl Fumarate Sandoz, 120 mg, Gastro-Resistant Hard Capsules

Dimethyl Fumarate Sandoz, 240 mg, Gastro-Resistant Hard Capsules

Dimethyl Fumarate

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

• Keep this package leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed to you by a doctor, do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any not listed in this package leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

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

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

What is Dimethyl Fumarate Sandoz

Dimethyl Fumarate Sandoz is a medicine that contains the active substance dimethyl fumarate.

What is Dimethyl Fumarate Sandoz used for

Dimethyl Fumarate Sandoz 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 episodes of neurological symptoms (called relapses). The symptoms vary from patient to patient, but usually include difficulty walking, balance problems, and vision problems (such as blurred or double vision). These symptoms can completely disappear after the relapse, but some problems may persist.

How does Dimethyl Fumarate Sandoz work

Dimethyl Fumarate Sandoz seems to prevent the immune system from causing damage to the patient's brain and spinal cord, which may also help slow down the progression of the disease in the future.

2. Important information before taking Dimethyl Fumarate Sandoz

When not to take Dimethyl Fumarate Sandoz

• -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 Sandoz may have a negative effect on white blood cell countand kidney and liver function. Before starting treatment with Dimethyl Fumarate Sandoz, 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 Sandoz, the patient should discuss with their doctorif they have:

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

During treatment with Dimethyl Fumarate Sandoz, shingles may occur. In some cases, severe complications have occurred. If the patient suspects any symptoms of shingles, they should immediately inform their doctor.
If the patient feels that their multiple sclerosis is worsening (e.g., weakness or vision problems) or new symptoms appear, they 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.
During treatment with 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 that 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 to investigate 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 Sandoz 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 esters(fumarates) used 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 some antibiotics(used to treat infections), diuretics, some types of painkillers(such as ibuprofen and similar anti-inflammatory medicines), and lithium;
• the use of certain vaccines (live vaccines) during treatment with Dimethyl Fumarate Sandoz may lead to infection, so they should be avoided. The doctor will advise on whether to use a different type of vaccine (inactivated vaccines).

Dimethyl Fumarate Sandoz 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 Sandoz, due to the risk of interaction between alcohol and this medicine, which may lead to stomach upset (gastritis), especially in people prone to this condition.

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 Sandoz 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 Sandoz passes into human milk. The doctor will advise the patient whether to stop breastfeeding or stop taking Dimethyl Fumarate Sandoz. The decision will be based on the assessment of the benefits of breastfeeding for the baby and the benefits of treatment for the patient.

Driving and using machines

The patient should not expect Dimethyl Fumarate Sandoz to affect their ability to drive or use machines.

Dimethyl Fumarate Sandoz contains sodium

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

3. How to take Dimethyl Fumarate Sandoz

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 Sandoz 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 Sandoz should be taken with food- this may help alleviate very common side effects (listed in section 4).

Taking more than the prescribed dose of Dimethyl Fumarate Sandoz

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

Missing a dose of Dimethyl Fumarate Sandoz

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 missed dose should not be taken, and the next dose should be taken at the usual time.
In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Dimethyl Fumarate Sandoz can cause side effects, although not everybody gets them.

Severe side effects

Dimethyl Fumarate Sandoz 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 weakness or increased weakness on one side of the body, coordination problems, vision problems, thinking or memory problems, confusion (disorientation), or personality changes, speech problems, and communication difficulties lasting more than a few days. Therefore, if the patient experiences worsening of multiple sclerosis symptoms or new symptoms while taking Dimethyl Fumarate Sandoz, 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 following symptoms, they should immediately contact their doctor

Severe allergic reactions

The frequency of severe allergic reactions cannot be estimated from the available data (frequency not known).
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 Sandoz 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 increased body temperature, heat, burning of the skin, or itching of the skin ( flushing)
• loose stools ( diarrhea)
• nausea ( nausea)
• stomach pain or cramps
• Taking the medicine with foodmay help alleviate the above side effects.

During treatment with Dimethyl Fumarate Sandoz, the presence of ketone bodies (substances normally produced in the body) is very commonly found in urine tests.
The patient should discuss with their doctorhow to manage these side effects. The doctor may reduce the dose of the medicine. The patient should not reduce the dose themselves unless the doctor advises them to do so.
Common side effects(may affect up to 1 in 10 people)

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

Side effects that may affect the results of blood or urine tests

• low white blood cell count ( lymphopenia, leukopenia) in the blood. 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 ( ALAT, AspAT) in the blood

Uncommon(may affect up to 1 in 100 people)

• allergic reactions (hypersensitivity)
• decreased platelet count

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

• inflammation of the liver and increased liver enzyme activity ( ALAT or AspATtogether with bilirubin)
• 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, or red spots and severe pain
• common cold ( 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, abdominal pain, or stomach cramps, vomiting, sore throat, cough, and painful menstruation.

Reporting side effects

If the patient experiences any side effects, including any not listed in this package leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring 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.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Dimethyl Fumarate Sandoz

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after: EXP.
The expiry date refers to the last day of the month.
Do not store above 30°C.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Dimethyl Fumarate Sandoz contains

The active substance is dimethyl fumarate.
Dimethyl Fumarate Sandoz, 120 mg: each capsule contains 120 mg of dimethyl fumarate.
Dimethyl Fumarate Sandoz, 240 mg: each capsule contains 240 mg of dimethyl fumarate.
Other ingredients are:capsule content: croscarmellose sodium (E 468), colloidal anhydrous silica (E 551), sodium stearyl fumarate (E 470A), methacrylic acid and methyl methacrylate copolymer (1:1), methacrylic acid and ethyl acrylate copolymer (1:1), dispersion 30%, talc (E 553B), triethyl citrate (E 1505), polysorbate 80 (E 443), glycerol monostearate 40-55; capsule shell: gelatin (E 441), titanium dioxide (E 171), yellow iron oxide (E 172), brilliant blue FCF (E 133); capsule print: shellac (20% esterified) ethanol solution 45% (E904), black iron oxide (E 172), propylene glycol (E 1520), ammonium hydroxide 28%.

What Dimethyl Fumarate Sandoz looks like and contents of the pack

Gastro-resistant hard capsules (gastro-resistant hard capsules)
Dimethyl Fumarate Sandoz, 120 mg, gastro-resistant hard capsules.
The gastro-resistant hard capsule is white with a light green cap, with the print "120 mg" on the body, approximately 19 mm long and 9 mm wide.
Dimethyl Fumarate Sandoz, 240 mg, gastro-resistant hard capsules.
The gastro-resistant hard capsule is light green, with the print "240 mg" on the body, approximately 23 mm long and 9 mm wide.
Dimethyl Fumarate Sandoz is packaged in blisters or calendar blisters or perforated single-dose blisters made of aluminum/PVC/PVDC, in a cardboard box.
Dimethyl Fumarate Sandoz, 120 mg, gastro-resistant hard capsules
Blisters - 14 gastro-resistant hard capsules.
Calendar blisters - 14 gastro-resistant hard capsules.
Perforated single-dose blisters - 14 x 1 gastro-resistant hard capsule.
Dimethyl Fumarate Sandoz, 240 mg, gastro-resistant hard capsules
Blisters - 56 gastro-resistant hard capsules.
Calendar blisters - 56 gastro-resistant hard capsules.
Perforated single-dose blisters - 56 x 1 gastro-resistant hard capsule or 168 x 1 gastro-resistant hard capsule.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
tel. 22 209 70 00
Manufacturer
LEK farmacevtska družba d.d.
Verovškova ulica 57
1526 Ljubljana, Slovenia
Zakłady Farmaceutyczne Polpharma S.A.
ul. Metalowca 2
39-460 Nowa Dęba

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

Austria
Dimethylfumarat Sandoz 120 mg - magensaftresistente Hartkapseln;
Dimethylfumarat Sandoz 240 mg - magensaftresistente Hartkapseln
Belgium
Dimethyl fumarate Sandoz 120 mg harde maagsapresistente capsules/gélules gastrorésistantes/magensaftresistente Hartkapseln;
Dimethyl fumarate Sandoz 240 mg harde maagsapresistente capsules/gélules gastrorésistantes/magensaftresistente Hartkapseln
Bulgaria
Dimethyl fumarate Sandoz 120 mg gastro-resistant hard capsule;
Dimethyl fumarate Sandoz 240 mg gastro-resistant hard capsule
Croatia
Dimetilfumarat Sandoz 120 mg tvrde želučanootporne kapsule;
Dimetilfumarat Sandoz 240 mg tvrde želučanootporne kapsule
Cyprus
Dimethyl fumarate/EBEWE 120 mg γαστροανθεκτικό καψάκιο, σκληρό
Dimethyl fumarate/EBEWE 240 mg γαστροανθεκτικό καψάκιο, σκληρό
Czech Republic
Dimethyl fumarate Sandoz
Estonia
Dimethyl fumarate Sandoz
France
DIMETHYL FUMARATE SANDOZ 120 mg, gélule gastro-résistante,
DIMETHYL FUMARATE SANDOZ 240 mg, gélule gastro-résistante
Greece
Dimethyl fumarate/EBEWE
Lithuania
Dimethyl fumarate Sandoz120 mg skrandyje neirios kietosios kapsulės;
Dimethyl fumarate Sandoz 240 mg skrandyje neirios kietosios kapsulės
Latvia
Dimethyl fumarate Sandoz 120 mg zarnās šķīstošās cietās kapsulas;
Dimethyl fumarate Sandoz 240 mg zarnās šķīstošās cietās kapsulas
Malta
DIMETHYL FUMARATE SANDOZ 120mg gastro-resistant hard capsules;
DIMETHYL FUMARATE SANDOZ 240mg gastro-resistant hard capsules
Germany
Dimethylfumarat - 1 A Pharma 120 mg magensaftresistente Hartkapseln;
Dimethylfumarat - 1 A Pharma 240 mg magensaftresistente Hartkapseln
Poland
Dimethyl fumarate Sandoz
Romania
Dimetil fumarat Sandoz 120 mg capsule gastrorezistente;
Dimetil fumarat Sandoz 240 mg capsule gastrorezistente
Slovakia
Dimetyl-fumarát Sandoz 120 mg;
Dimetyl-fumarát Sandoz 240 mg
Slovenia
Dimetilfumarat Sandoz 120 mg gastrorezistentne trde kapsule;
Dimetilfumarat Sandoz 240 mg gastrorezistentne trde kapsule
Italy
Dimetilfumarato Sandoz

Date of last revision of the package leaflet:

{logo of the marketing authorization holder}