Dimethil fumarate Polpharma

Package Leaflet: Information for the Patient

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

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

Dimethyl Fumarate

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

• You should keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

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

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

What is Dimethyl Fumarate Polpharma

Dimethyl Fumarate Polpharma is a medicine that contains dimethyl fumarate.

What is Dimethyl Fumarate Polpharma used for

Dimethyl Fumarate Polpharma is used to treat relapsing-remitting multiple sclerosis (MS) in patients aged 13 years and older.

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

How does Dimethyl Fumarate Polpharma work

Dimethyl Fumarate Polpharma 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. Before you take Dimethyl Fumarate Polpharma

When not to take Dimethyl Fumarate Polpharma

• If you are allergic to dimethyl fumarate or any of the other ingredients of this medicine(listed in section 6);
• If you suspect or have been diagnosed with a rare brain infection called progressive multifocal leukoencephalopathy (PML)

PML is a serious brain infection that can cause severe disability or death.

Warnings and precautions

Dimethyl Fumarate Polpharma may affect your white blood cell countand kidney and liver function. Before starting treatment with Dimethyl Fumarate Polpharma, your doctor will check your white blood cell count and kidney and liver function. These tests will be repeated periodically during treatment. If your white blood cell count decreases during treatment, your doctor may consider additional tests or stop the treatment.

You should discuss this with your doctorif you have:

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

During treatment with Dimethyl Fumarate Polpharma, shingles (herpes zoster) may occur. In some cases, serious complications have occurred. If you suspect you have any symptoms of shingles, you should contact your doctor immediately. If your multiple sclerosis symptoms worsen (such as weakness or vision problems) or you experience new symptoms, you should contact your doctor immediately, as these may be symptoms of PML. PML is a serious disease that can cause 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 serious kidney problems called Fanconi syndrome have been reported. If you notice that you are urinating more, feeling thirsty, and drinking more than usual, your muscles feel weak, you have a fracture or just feel pain, you should see your 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 Polpharma with other medicines

You should tell your doctor or pharmacistabout all medicines you are taking or have recently taken, and any medicines you plan to 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 certain antibiotics(used to treat infections), diuretics, certain painkillers(such as ibuprofen and similar anti-inflammatory medicines and over-the-counter medicines), and medicines containing lithium
• the use of certain vaccines (live vaccines) during treatment with Dimethyl Fumarate Polpharma may cause infection, so it should be avoided. Your doctor will advise whether to give other types of vaccines (inactivated vaccines)

Dimethyl Fumarate Polpharma with alcohol

You should avoid consuming high-percentage alcoholic beverages (more than 30% alcohol by volume) in amounts greater than 50 ml within 1 hour of taking Dimethyl Fumarate Polpharma, due to the risk of interaction between alcohol and this medicine, which may lead to stomach upset (gastritis), especially in people prone to this disease.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

There is limited data on the use of this medicine in pregnant women. Dimethyl Fumarate Polpharma should not be taken during pregnancy unless your doctor has discussed this with you and the benefits of treatment outweigh the risks.

Breastfeeding

It is not known whether the active substance of Dimethyl Fumarate Polpharma passes into breast milk. Your doctor will advise whether to stop breastfeeding or stop taking Dimethyl Fumarate Polpharma. The decision will be made based on the assessment of the benefits of breastfeeding to the baby compared to the benefits of treatment for the mother.

Driving and using machines

Dimethyl Fumarate Polpharma is unlikely to affect your ability to drive or use machines.

Dimethyl Fumarate Polpharma contains sodium

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

3. How to take Dimethyl Fumarate Polpharma

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your 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 Polpharma 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 Polpharma should be taken with food- this will help reduce the very common side effects (listed in section 4).

If you take more Dimethyl Fumarate Polpharma than you should

If you have taken more capsules than you should, you should contact your doctor immediately. You may experience side effects similar to those described below in section 4.

If you forget to take Dimethyl Fumarate Polpharma

Do not take a double doseto make up for a forgotten 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, do not take the missed dose, but take the next dose at the usual time.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Severe side effects

Dimethyl Fumarate Polpharma may decrease the number of lymphocytes, which are 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 cause severe disability or death. PML has been reported after 1 to 5 years of treatment, so your doctor should monitor your white blood cell count throughout treatment, and you should be aware of the symptoms described below, which may indicate PML. The risk of PML may be higher if you have taken medicines that affect the immune system in the past.

Symptoms of PML may be similar to those of a multiple sclerosis relapse. They include weakness or increased weakness on one side of the body, coordination problems, vision problems, speech or thinking problems, confusion (disorientation), or personality changes, speech problems, and communication difficulties lasting more than a few days. Therefore, if you experience worsening of your multiple sclerosis symptoms or new symptoms while taking Dimethyl Fumarate Polpharma, you should contact your doctor immediately. You should also discuss this with your partner or caregivers and inform them about your treatment. You may experience symptoms that you are not aware of.

→ If you experience any of the above symptoms, you should contact your doctor 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 (flushing) redness of the face or body. 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, hypoxia);
• dizziness or loss of consciousness (hypotension), this may indicate a severe allergic reaction (anaphylaxis)

→ You should stop taking Dimethyl Fumarate Polpharma and contact your doctor immediately

Other side effects

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

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

→ Taking the medicine with foodwill help reduce the above side effects

During treatment with Dimethyl Fumarate Polpharma, urine tests often show increased production of ketone bodies (substances normally produced in the body).

You should ask your doctorhow to deal with side effects. Your doctor may reduce the dose of the medicine. You should not reduce the dose yourself unless your doctor advises you to.

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)
• gastrointestinal disorders
• burning sensation of the skin
• hot flashes
• 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). A low white blood cell count may mean that your body is less able to fight infection. If you have a severe infection (such as pneumonia), you should contact your doctor immediately;
• 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

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

• liver inflammation and increased liver enzyme activity (ALT or ASTtogether 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, and then numbness, itching, or 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.

Certain 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 you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in the websiteor contact your local health authority for information on how to report side effects.

5. How to store Dimethyl Fumarate Polpharma

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.

The packaging is labeled with the expiration date and batch number.

Do not store above 30°C.

Medicines should 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 Polpharma contains

• The active substance is dimethyl fumarate. Dimethyl Fumarate Polpharma 120 mg: each capsule contains 120 mg of dimethyl fumarate. Dimethyl Fumarate Polpharma 240 mg: each capsule contains 240 mg of dimethyl fumarate.
• The other ingredients are: capsule filling: croscarmellose sodium, colloidal anhydrous silica, sodium stearyl fumarate, methacrylic acid, and methyl methacrylate copolymer (1:1), talc, triethyl citrate, methacrylic acid, and ethyl acrylate copolymer (1:1), glycerol monostearate 40-55, polysorbate 80; capsule: gelatin, titanium dioxide (E171), yellow iron oxide (E172), brilliant blue FCF (E133); ink for printing: shellac, propylene glycol (E1520), black iron oxide (E172), concentrated ammonia solution (28%).

What Dimethyl Fumarate Polpharma looks like and contents of the pack

Dimethyl Fumarate Polpharma 120 mg hard gastro-resistant capsules, 19.4 mm in length and 8.53 mm in width, white body, light green cap, with printing on the body "120 mg". Available in aluminum/PVC/PVDC blisters in packs of 14 or 56 capsules.

Dimethyl Fumarate Polpharma 240 mg hard gastro-resistant capsules, 23.3 mm in length and 8.53 mm in width, light green, with printing on the body "240 mg". Available in aluminum/PVC/PVDC blisters in packs of 56 or 168 capsules.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Zakłady Farmaceutyczne POLPHARMA S.A.

Pelplińska 19, 83-200 Starogard Gdański

Phone: +48 22 364 61 01

Manufacturer

Zakłady Farmaceutyczne POLPHARMA S.A.

Production Plant in Nowa Dęba

Metalowca 2, 39-460 Nowa Dęba

Date of last revision of the leaflet: