Noroplex

Leaflet attached to the packaging: patient information

Noroplex, 120 mg, gastro-resistant hard capsules

Noroplex, 240 mg, gastro-resistant hard capsules

Dimethyl fumarate

You should carefully read the contents of this leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should 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 as yours.
• If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Noroplex and what is it used for

What is Noroplex

Noroplex is a medicine that contains the active substance dimethyl fumarate.

What is Noroplex used for

Noroplex is used to treat the relapsing-remitting form of 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. The relapsing-remitting form of multiple sclerosis is characterized by recurring episodes of neurological symptoms (called relapses). The symptoms vary from person to person, but usually include problems with walking and balance, as well as vision problems (such as blurred or double vision). These symptoms may completely disappear after a relapse, but some problems may persist.

How does Noroplex work

Noroplex seems to prevent the immune system from causing damage to the brain and spinal cord, which may also help slow down the progression of the disease in the future.

2. Important information before taking Noroplex

When not to take Noroplex

• - 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

Noroplex may have a negative effect on white blood cell countand kidney and liver function. Before starting treatment with Noroplex, 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 taking Noroplex, the patient should consult a doctorif they have:

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

During treatment with Noroplex, 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 the patient's multiple sclerosis worsens (e.g., they experience 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 progressive multifocal leukoencephalopathy (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 (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 a doctor as soon as possible to investigate these symptoms.

Children and adolescents

The above warnings and precautions also apply to children. Noroplex can be used in children and adolescents aged 13 and over. Data on children under 10 years of age are not available.

Noroplex and other medicines

The patient should tell their doctor or pharmacistabout all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, especially:

• medicines containing fumaric acid esters(fumarates) used to treat psoriasis
• medicines that affect the immune system, including other medicines used to treat multiple sclerosis, such as fingolimod, natalizumab, teriflunomide, alemtuzumab, ocrelizumab, or cladribine, as well as some medicines commonly used to treat cancer (rituximab or mitoxantrone)
• medicines that affect the kidneys, including certain antibiotics(used to treat infections), diuretics, certain painkillers(such as ibuprofen and similar anti-inflammatory medicines, as well as over-the-counter medicines), and medicines containing lithium
• the use of certain types of vaccines (live vaccines) during treatment with Noroplex may cause infection, so they should be avoided. The doctor will advise whether other types of vaccines (inactivated vaccines) can be given.

Taking Noroplex with alcohol

The patient should avoid consuming high-percentage alcoholic beverages (over 30% alcohol by volume) in excess of 50 ml within an hour of taking Noroplex, due to the risk of interaction between alcohol and this medicine, which may lead to stomach inflammation (gastritis), especially in people prone to this disease.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before taking this medicine.
Pregnancy
Noroplex should not be taken during pregnancy, unless the patient has discussed it with their doctor.
Breastfeeding
It is not known whether the active substance of Noroplex passes into breast milk. Noroplex should not be taken during breastfeeding. The doctor will help the patient decide whether to stop breastfeeding or stop taking Noroplex. The decision will be based on the assessment of the benefits of breastfeeding for the child compared to the benefits of treatment for the patient.

Driving and using machines

The effect of Noroplex on the ability to drive and use machines is not known. It is not expected that this medicine will affect the ability to drive and use machines.

3. How to take Noroplex

This medicine should always be taken exactly as prescribed by the doctor. In case of doubt, 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 recommended dose should be taken.

Usual dose

240 mg twice a day

Noroplex 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.
Noroplex should be taken with food– this will help alleviate very common side effects (listed in section 4).

Taking a higher dose of Noroplex than recommended

If more capsules than recommended are taken, the doctor should be informed immediately. Side effects similar to those described below in section 4 may occur.

Missing a dose of Noroplex

A double dose should not be takento make up for a missed dose.
A missed dose can be taken later, provided that a 4-hour interval is maintained before the next dose. If it is too late, the missed dose should not be taken, but the next dose should be taken at the usual time.
In case of further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Noroplex can cause side effects, although not everybody gets them.

Serious side effects

Noroplex may lower 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 a worsening of multiple sclerosis symptoms or new symptoms while taking Noroplex, they should contact their doctor as soon as possible. They should also talk to their partner or caregivers and inform them about their treatment. Some symptoms may not be noticeable to the patient.

If any of the above symptoms occur, the doctor should be contacted immediately.

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 (paroxysmal) flushing of the skin of the face or body. If the 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, hypoxia)
• dizziness or loss of consciousness (hypotension) may indicate a severe allergic reaction (anaphylaxis).

Noroplex should be discontinued, and the doctor should be contacted immediately.

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

• flushing of the skin of the face or a feeling of increased body temperature, heat, burning, or itching of the skin (paroxysmal flushing)
• diarrhea
• nausea
• stomach pain or cramps

Taking Noroplex with food will help alleviate the above side effects

During treatment with dimethyl fumarate, urine tests very often show increased production of ketone bodies (substances normally produced by the body).
The patient should ask their doctor how to deal with side effects. The doctor may reduce the dose of Noroplex. The patient should not reduce the dose of Noroplex themselves, unless advised to do so by their doctor.
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
• skin burning
• heat waves, feeling hot
• itching of the skin (pruritus)
• rash
• pink or red spots on the skin (erythema)
• hair loss (alopecia)

Side effects that may cause abnormal blood or urine test results

• low white blood cell count in the blood (lymphopenia, leucopenia). 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 doctor should be contacted immediately.
• protein (albumin) in the urine
• increased liver enzyme levels (ALT, AST) in the blood Uncommon side effects(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)

• liver inflammation and increased liver enzyme activity (ALT or AST together 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, as well as other symptoms, such as: fever and weakness in the early stages of infection, and then 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 side effects occur, including those not listed in this leaflet, the doctor or pharmacist should be informed. Side effects can be reported directly to 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 Noroplex

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, bottle label, and carton after: “EXP”. The expiry date refers to the last day of the month stated.
This medicine does not require any special storage conditions.
Store in the original packaging to protect from light.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Noroplex contains

• The active substance is dimethyl fumarate.

Noroplex, 120 mg, gastro-resistant hard capsules
Each capsule contains 120 mg of dimethyl fumarate.
Noroplex, 240 mg, gastro-resistant hard capsules
Each capsule contains 240 mg of dimethyl fumarate.

• Other ingredients are: microcrystalline cellulose, crospovidone, talc, povidone, colloidal silicon dioxide, 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) Ink: shellac, potassium hydroxide, propylene glycol (E 1520), black iron oxide (E 172), concentrated ammonia

What Noroplex looks like and contents of the pack

Noroplex, 120 mg, gastro-resistant hard capsules (gastro-resistant hard capsules)
A hard gelatin capsule, 21.4 mm in size, consisting of a white body with black printing “DMF 120” and a green cap, containing white to almost white mini-tablets.
Noroplex is available in OPA/Aluminum/PVC/Aluminum blisters or single-dose OPA/Aluminum/PVC/Aluminum blisters packaged in a carton containing 14 gastro-resistant hard capsules.
Noroplex, 240 mg, gastro-resistant hard capsules (gastro-resistant hard capsules)
A hard gelatin capsule, 23.2 mm in size, consisting of a green body with black printing “DMF 240” and a green cap, containing white to almost white mini-tablets.
Noroplex is available in OPA/Aluminum/PVC/Aluminum blisters or single-dose OPA/Aluminum/PVC/Aluminum blisters packaged in a carton containing 56 gastro-resistant hard capsules.

Marketing authorization holder

+pharma arzneimittel gmbh
Hafnerstrasse 211
8054 Graz
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

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

Iceland
Noroplex 120 mg magasýruþolin hörð hylki
Noroplex 240 mg magasýruþolin hörð hylki
Poland/Czech Republic
Noroplex
To obtain more detailed information on this medicine, the patient should contact the representative of the marketing authorization holder:
+pharma Polska sp. z o.o.
ul. Podgórska 34
31-536 Kraków, Poland
tel. +48 12 262 32 36

Date of last revision of the leaflet: