Dimethyl fumarate polpharma

Package leaflet: Information for the patient

Dimethyl fumarate Polpharma, 120 mg, enteric hard capsules
Dimethyl fumarate Polpharma, 240 mg, enteric hard capsules
Dimethylis fumaras
Please read carefully all the information in this leaflet before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, 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.

Table of contents

1. What is Dimethyl fumarate Polpharma and what is it used for
2. Important information before taking 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 containing dimethyl fumarate.
What Dimethyl fumarate Polpharma is 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 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 individuals, but usually include walking and balance problems, and vision impairment (e.g. blurred or double vision). These symptoms may completely resolve after a relapse, but some problems may persist.
How Dimethyl fumarate Polpharma works
Dimethyl fumarate Polpharma appears to suppress the immune system from causing damage to the brain and spinal cord, which may also help slow the future progression of the disease.

2. Important information before using Dimethyl fumarate Polpharma

When not to use Dimethyl fumarate Polpharma

• 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 Polpharma may adversely affect the white blood cell count, as well as the function of the kidneys and liver. Before starting treatment with Dimethyl fumarate Polpharma, 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 white blood cell count decreases during treatment, the doctor may consider performing additional tests or discontinuing treatment.

Before starting treatment with Dimethyl fumarate Polpharma, the patient should discuss this with the doctor if they have:

• 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 Polpharma. 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. the patient experiences weakness or vision disturbances) or 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.

Rare but serious kidney dysfunction, known as Fanconi syndrome, has been reported during treatment with dimethyl fumarate in combination with other fumaric acid esters used in the treatment of psoriasis (a skin disease). If the patient notices increased urination, feels thirsty and drinks more than usual, their muscles seem weaker, there is a bone fracture, or they simply feel pain, they should seek medical advice 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 Polpharma 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 they plan 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, certain painkillers (such as ibuprofen and similar anti-inflammatory medicines, including over-the-counter products), and medicines containing lithium;
• administration of certain vaccines ( live organism vaccines ) during treatment with Dimethyl fumarate Polpharma may lead to infection and should therefore be avoided. The doctor will advise whether other types of vaccines ( inactivated organism vaccines ) should be given.

Dimethyl fumarate Polpharma and alcohol

Avoid consuming high-strength alcoholic beverages (over 30% alcohol by volume) in quantities exceeding 50 ml within one hour of taking Dimethyl fumarate Polpharma, due to the risk of interaction between alcohol and this medicine, which may lead to gastric irritation (inflammation of the stomach lining), especially in individuals susceptible to this condition.

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 data on the effects of this medicine on the unborn child when used during pregnancy. Dimethyl fumarate Polpharma should not be used during pregnancy unless discussed with the doctor and deemed necessary.

Breastfeeding

It is unknown whether the active substance of Dimethyl fumarate Polpharma passes into human milk. The doctor will advise the patient whether she should discontinue breastfeeding or the use of Dimethyl fumarate Polpharma. 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

Dimethyl fumarate Polpharma is not expected to affect the ability to drive or operate machinery.

Dimethyl fumarate Polpharma contains sodium

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

3. How to use Dimethyl fumarate Polpharma

This medicine should always be taken as directed by the physician. If in doubt, consult the physician.
Initial dose: 120 mg twice daily.
This initial dose should be taken for the first 7 days, after which the medicine should be used at the usual maintenance dose.
Usual dose: 240 mg twice daily.
Dimethyl fumarate Polpharma should be taken orally.
Each capsule must be swallowed whole with water. Capsules must not be divided, crushed, dissolved, sucked or chewed, as this may increase certain adverse effects.
Dimethyl fumarate Polpharma should be taken with food – this helps to reduce the very common adverse effects (listed in section 4).
Taking more than the recommended dose of Dimethyl fumarate Polpharma
If more capsules than recommended have been taken, inform the physician immediately. Adverse effects similar to those described below in section 4 may occur.
Missing a dose of Dimethyl fumarate Polpharma
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, the missed dose should not be taken; instead, take the next dose at the usual time.
If there are any further doubts regarding the use of this medicine, consult the physician or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.

Serious adverse reactions

Dimethyl fumarate Polpharma 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 can lead to severe disability or death. PML has been observed between 1 and 5 years after starting treatment; therefore, your doctor should monitor your white blood cell count throughout the entire duration of treatment, and you should be aware of 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. These include new or worsening weakness on one side of the body, loss of coordination, vision problems, changes in thinking or memory, confusion (disorientation), personality changes, speech difficulties, and communication problems lasting longer than a few days. For this reason, if you notice worsening of symptoms related to multiple sclerosis or the appearance of any new symptoms while taking Dimethyl fumarate Polpharma, you should contact your doctor as soon as possible. You should also talk to your partner or caregivers and inform them about your treatment. Symptoms may occur that you yourself may 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 adverse reaction is sudden (paroxysmal) redness of the face or body. If this paroxysmal 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 (dyspnea, hypoxia);
• dizziness or loss of consciousness (hypotension),

this may indicate a severe allergic reaction (anaphylaxis).

→ Stop taking Dimethyl fumarate Polpharma and contact your doctor immediately

Other adverse reactions

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

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

→ Taking the medicine with food may help reduce the above-mentioned adverse reactions.

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

Ask your doctor how to manage adverse reactions. Your doctor may reduce the dose of the medicine. Do not reduce the dose yourself unless instructed by your doctor.

Common (may affect up to 1 in 10 people)

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

Adverse reactions 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. If you develop a serious infection (e.g. pneumonia), contact your doctor immediately;
• protein (albumin) in urine;
• increased liver enzyme activity (AlAT, AspAT) in blood.

Uncommon (may affect up to 1 in 100 people)

• allergic reactions (hypersensitivity)
• decreased platelet count

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

• hepatitis and increased liver enzyme activity (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 numbness, itching or red spots and severe pain
• nasal inflammation (rhinitis)

Children (aged 13 years and older) 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 reactions not listed in this leaflet, tell your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the 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

Adverse reactions can also be reported to the marketing authorization holder.

Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Dimethyl fumarate Polpharma

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard packaging and blister. The expiry date refers to the last day of the stated month.
The labelling on the packaging shows the expiry date after the abbreviation EXP, and the batch number after the abbreviation Lot/LOT.
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. Such measures 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: sodium croscarmellose, colloidal anhydrous silica, sodium stearyl fumarate, copolymer of methacrylic acid and methyl methacrylate (1:1), talc, triethyl citrate, copolymer of methacrylic acid and ethyl acrylate (1:1), glycerol monostearate 40-55, polysorbate 80; capsule shell: gelatin, titanium dioxide (E171), yellow iron oxide (E172), brilliant blue FCF (E133); printing ink: shellac, propylene glycol (E1520), black iron oxide (E172), concentrated ammonium hydroxide (28%).

What Dimethyl fumarate Polpharma looks like and contents of the pack
Dimethyl fumarate Polpharma 120 mg hard gelatin capsules, 19.4 mm in length and 8.53 mm in diameter, white body and light green cap, printed on the body with "120 mg".
Available in aluminium/PVC/PVDC blisters in pack sizes of 14 or 56 capsules.
Dimethyl fumarate Polpharma 240 mg hard gelatin capsules, 23.3 mm in length and 8.53 mm in diameter, light green in colour, printed on the body with "240 mg".
Available in aluminium/PVC/PVDC blisters in pack sizes of 56 or 168 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. +48 22 364 61 01

Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
Production Plant in Nowa Dęba
ul. Metalowca 2, 39-460 Nowa Dęba