Dimethyl fumarate olpha

Patient Information Leaflet

Dimethyl Fumarate Olpha, 120 mg, hard enteric-coated capsules
Dimethyl Fumarate Olpha, 240 mg, hard enteric-coated capsules
Dimethylis fumaras
Please read this leaflet carefully before taking this 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 ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents

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

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

What Dimethyl Fumarate Olpha is
Dimethyl Fumarate Olpha is a medicine containing dimethyl fumarate as the active substance.
What Dimethyl Fumarate Olpha is used for
Dimethyl Fumarate Olpha 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 neurological symptom flare-ups (called relapses).
Symptoms vary between patients but usually include problems with walking and balance, and visual disturbances (e.g. blurred or double vision). These symptoms may completely resolve after a relapse, but some issues may persist.
How Dimethyl Fumarate Olpha works
Dimethyl Fumarate Olpha appears to prevent the immune system from causing damage to the brain and spinal cord. It may also help slow the future progression of multiple sclerosis.

2. Important information before using Dimethyl Fumarate Olpha

When not to take Dimethyl Fumarate Olpha

• if the patient is allergic to dimethyl fumarate or 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 Olpha may have an adverse effect on white blood cell count as well as on kidney and liver function. Before starting treatment with Dimethyl Fumarate Olpha, the doctor will check the patient's white blood cell count and assess whether the kidneys and liver are functioning properly. These tests will also 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 Olpha, discuss this with the doctor if the patient has:

• 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 Olpha. In some cases, severe complications have occurred. If the patient suspects any symptoms of shingles, they should immediately inform the doctor.
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 which may lead to severe disability or death.
Rare but serious kidney problems known as Fanconi syndrome have been reported during treatment with dimethyl fumarate in combination with other fumaric acid esters used to treat psoriasis (a skin condition). If the patient notices that they are passing more urine, feel thirsty and drink more than usual, their muscles seem weaker, experience bone fractures or simply feel pain, they should see a doctor 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 Olpha with other medicines
Tell the doctor or pharmacist about all other medicines the patient is currently taking, has recently taken, or plans to take, especially:

• medicines containing fumaric acid esters (fumarates) used to treat psoriasis;
• medicines affecting the immune system, including chemotherapy agents, immunosuppressive medicines, or other medicines used to treat multiple sclerosis;
• medicines affecting the kidneys, including certain antibiotics (used to treat infections), diuretics, certain types of painkillers (such as ibuprofen and other similar anti-inflammatory medicines) and medicines containing lithium.
• Administration of certain vaccines (vaccines containing live organisms) during treatment with Dimethyl Fumarate Olpha may lead to development of infection and should therefore be avoided. The doctor will advise whether other types of vaccines (vaccines containing inactivated organisms) should be given.

Dimethyl Fumarate Olpha and alcohol
The consumption of high-strength alcoholic drinks (over 30% alcohol by volume, e.g. spirits) in amounts exceeding 50 ml within one hour of taking Dimethyl Fumarate Olpha should be avoided due to the risk of interaction between alcohol and this medicine. This 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, thinks 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 information on the effects of this medicine on the unborn child when used during pregnancy. Dimethyl Fumarate Olpha should not be used during pregnancy unless the patient has discussed this with her doctor and its use is considered necessary.

Breastfeeding
It is not known whether the active ingredient of Dimethyl Fumarate Olpha passes into human milk. The doctor will advise the patient whether she should discontinue breastfeeding or discontinue/abstain from treatment with Dimethyl Fumarate Olpha. The decision will be based on an assessment of the benefit of breastfeeding for the child compared to the benefit of treatment for the patient.

Driving and operating machinery
No effects of Dimethyl Fumarate Olpha on the ability to drive and operate machinery are expected.

Dimethyl Fumarate Olpha contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. this medicine is considered "sodium-free".

3. How to use Dimethyl Fumarate Olpha

This medicine should always be taken exactly as prescribed by your doctor. In case of any doubts,
consult your doctor.
Starting dose: 120 mg twice daily.
This starting dose should be taken for the first 7 days, after which the medicine should be used at the
usual maintenance dose.
Usual maintenance dose: 240 mg twice daily.
Dimethyl Fumarate Olpha should be taken orally.
Each capsule must be swallowed whole with water. Do not divide, crush, dissolve, chew or suck the
capsules, as this may increase the occurrence of certain adverse effects.
Dimethyl Fumarate Olpha should be taken with food – this will help reduce the very common
adverse effects (listed in section 4).
Taking more Dimethyl Fumarate Olpha than recommended
If you take more capsules than recommended, inform your doctor immediately.
Adverse effects similar to those described below in section 4 may occur.
Missing a dose of Dimethyl Fumarate Olpha
Do not take a double dose to make up for a missed dose.
A missed dose may be taken later, provided there is at least a 4-hour interval before the next dose.
If it is too late, do not take the missed dose; instead, take the next dose at the usual time.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

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

Serious adverse reactions

Dimethyl Fumarate Olpha may reduce the number of lymphocytes, which are a type of white blood cells. 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 reported after 1 to 5 years of treatment; therefore, your doctor should monitor your white blood cell count throughout the entire treatment period, 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.

The symptoms of PML may resemble a relapse of multiple sclerosis. These include new or worsening weakness on one side of the body, problems with coordination, vision disturbances, changes in thinking or memory, confusion (disorientation), personality changes, speech problems, and communication difficulties 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 Olpha, 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 the available data (frequency unknown).

A very common adverse reaction 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 (dyspnea, hypoxia);
• dizziness or loss of consciousness (hypotension),

this may indicate a severe allergic reaction (anaphylaxis).

➢ You must stop taking Dimethyl Fumarate Olpha and contact your doctor immediately

Other adverse reactions

Very common (may affect 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 (diarrhea)
• nausea
• stomach pain or cramps

➢ Taking the medicine with food may help reduce the adverse reactions listed above

During treatment with Dimethyl Fumarate Olpha, ketone bodies (substances normally produced in the body) are very commonly detected in urine tests.

Talk to your doctor about how to manage adverse reactions. Your doctor may reduce the dose of the medicine. Do not reduce the dose yourself unless your doctor advises you to do so.

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 heat
• itching of the skin (pruritus)
• rash
• pink or red skin patches (erythema)
• hair loss (alopecia)

Adverse reactions that may lead to abnormal blood or urine test results:

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

Uncommon (may affect up to 1 in 100 people)

• allergic reactions (hypersensitivity)
• decreased platelet count

Rare (may affect up to 1 in 1000 people)

• hepatitis and increased liver enzyme activity (AlAT or AspAT together with bilirubin)

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

• shingles, with symptoms such as: skin blisters, burning, itching, or skin pain, 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 patches with severe accompanying pain
• cold (nasopharyngitis)

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, for example: 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, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of 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 the medicine.

5. How to store Dimethyl Fumarate Olpha

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and the cardboard
pack after: EXP. The expiry date refers to the last day of the stated month.
Do not store above 30 °C.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. Proper disposal helps protect
the environment.

6. Contents of the packaging and other information

What Dimethyl Fumarate Olpha contains
The active substance is dimethyl fumarate.
Dimethyl Fumarate Olpha 120 mg: each enteric hard capsule (capsule) contains 120 mg of dimethyl fumarate.
Dimethyl Fumarate Olpha 240 mg: each enteric hard capsule (capsule) contains 240 mg of dimethyl fumarate.
Other ingredients are: microcrystalline cellulose, sodium croscarmellose, colloidal anhydrous silica, magnesium stearate, methacrylic acid and ethyl acrylate copolymer (1:1) type A, triethyl citrate, talc, 30% dispersion of methacrylic acid and ethyl acrylate copolymer (1:1) (containing sodium lauryl sulfate and polysorbate 80), brilliant blue FCF (E 133), black iron oxide (E 172), yellow iron oxide (E 172), titanium dioxide (E 171), gelatin, shellac (E 904), propylene glycol, concentrated ammonium hydroxide and potassium hydroxide.

What Dimethyl Fumarate Olpha looks like and contents of the pack
Dimethyl Fumarate Olpha 120 mg enteric hard capsules with a light green, opaque cap and a white, opaque body, printed in black with "I 65" and "120 mg", containing white or almost white coated mini-tablets. Available in cardboard packs containing 14 capsules (approximate capsule length: 21 mm).
Dimethyl Fumarate Olpha 240 mg enteric hard capsules with a light green, opaque cap and a light green, opaque body, printed in black with "I 66" and "240 mg", containing white or almost white coated mini-tablets. Available in cardboard packs containing 56 or 168 capsules (approximate capsule length: 21 mm).
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Olpha AS,
Rupnicu iela 5,
Olaine, Olaines novads, LV-2114,
Latvia
E-mail: [email protected]

Manufacturer
Olpha AS,
Rupnicu iela 5,
Olaine, Olaines novads, LV-2114,
Latvia

This medicinal product is authorised in the European Economic Area under the following names:
Croatia: Dimetilfumarat Olpha 120 mg tvrde želučanootporne kapsule
Dimetilfumarat Olpha 240 mg tvrde želučanootporne kapsule
Estonia: Dimethyl fumarate Olpha
France: DIMETHYL FUMARATE OLPHA 120 mg, gélule gastro-résistante
DIMETHYL FUMARATE OLPHA 240 mg, gélule gastro-résistante
Spain: Fumarato de dimetilo Olpha
Lithuania: Dimethyl fumarate Olpha 120 mg skrandyje neširios kietosios kapsulės
Dimethyl fumarate Olpha 240 mg skrandyje neširios kietosios kapsulės
Latvia: Dimethyl fumarate Olpha 120 mg zarnās šķīstošās cietās kapsulas
Dimethyl fumarate Olpha 240 mg zarnās šķīstošās cietās kapsulas
Germany: Dimethylfumarat Olpha 120 mg
Dimethylfumarat Olpha 240 mg
Poland, Czech Republic, Slovakia: Dimethyl Fumarate Olpha
Italy: Dimetilfumarato Olpha