Dimethyl fumarate medical valley

Package leaflet: Information for the patient

Dimethyl fumarate Medical Valley, 120 mg, hard enteric capsules
Dimethyl fumarate Medical Valley, 240 mg, hard enteric capsules
Dimethylis fumaras
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet. 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 someone else even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents

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

1. What Dimethyl fumarate Medical Valley is and what it is used for

What Dimethyl fumarate Medical Valley is
Dimethyl fumarate Medical Valley is a medicine containing dimethyl fumarate as the active substance.

What Dimethyl fumarate Medical Valley is used for
Dimethyl fumarate Medical Valley 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 patients but usually include problems with walking and balance, and vision impairment (e.g. blurred or double vision). These symptoms may completely resolve after a relapse, but some deficits may persist.

How Dimethyl fumarate Medical Valley works
Dimethyl fumarate Medical Valley appears to work by protecting 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 Medical Valley

When not to take Dimethyl fumarate Medical Valley

• 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 Medical Valley may affect white blood cell count as well as the function of the kidneys and liver. Before starting treatment with Dimethyl fumarate Medical Valley, 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 patient's white blood cell count decreases during treatment, the doctor may consider performing additional tests or discontinuing treatment.
The patient should discuss this with the doctor before starting Dimethyl fumarate Medical Valley if they have:

• severe kidney disease
• severe liver disease
• stomach or intestinal disease
• severe infection (e.g. pneumonia).

Herpes zoster (shingles) may occur during treatment with Dimethyl fumarate Medical Valley. In some cases, serious complications have occurred. If the patient suspects any symptoms of shingles, they should inform the doctor immediately.
If multiple sclerosis worsens (e.g. the patient experiences weakness or vision disturbances) or any other new symptoms appear, the patient should contact their doctor immediately, as these may be signs of a rare brain infection called progressive multifocal leukoencephalopathy (PML). PML is a serious condition 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-containing medicines used in combination with other fumaric acid esters for psoriasis (a skin disease). If the patient notices that they are urinating more than usual, feel increased thirst and drink more than normal, their muscles seem weaker, experience bone fractures, or 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 there is insufficient data available for this age group.
Dimethyl fumarate Medical Valley 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, used in the treatment of psoriasis;
• medicines affecting the immune system, including chemotherapeutic agents, immunosuppressive medicines, or other medicines used in the treatment of 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, including over-the-counter products), and medicines containing lithium;
• the use of certain vaccines (vaccines containing live microorganisms) during treatment with Dimethyl fumarate Medical Valley may lead to the development of infection; therefore, they should be avoided. The doctor will advise whether other types of vaccines (vaccines containing inactivated microorganisms) should be administered.

Dimethyl fumarate Medical Valley and alcohol
The consumption of high-strength alcoholic beverages (above 30% alcohol by volume) in amounts exceeding 50 mL within one hour of taking Dimethyl fumarate Medical Valley should be avoided due to the risk of interaction between alcohol and this medicine. This may lead to gastric irritation (inflammation of the gastric mucosa), 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 information on the effects of this medicine on the unborn child when used during pregnancy. Dimethyl fumarate Medical Valley should not be used during pregnancy unless the patient has discussed this with her doctor and the use of the medicine is considered necessary.
Breastfeeding
It is unknown whether the active substance of Dimethyl fumarate Medical Valley passes into human milk. The doctor will advise the patient whether she should discontinue breastfeeding or the administration of Dimethyl fumarate Medical Valley. 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 Medical Valley is not expected to affect the ability to drive or operate machinery.
Dimethyl fumarate Medical Valley 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 Medical Valley

This medicine should always be taken exactly as prescribed by your doctor. If in doubt,
consult your doctor.
Initial dose: 120 mg twice daily.
This initial dose should be taken for the first 7 days, after which the usual maintenance dose should be used.
Usual maintenance dose: 240 mg twice daily.
Dimethyl fumarate Medical Valley 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 the occurrence of certain adverse effects.
Dimethyl fumarate Medical Valley should be taken with food – this helps to reduce the very common adverse effects (listed in section 4).
Taking more Dimethyl fumarate Medical Valley than prescribed
If more capsules than prescribed have been taken, you must immediately inform your doctor.
Adverse effects similar to those described below in section 4 may occur.
Missing a dose of Dimethyl fumarate Medical Valley
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 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 Medical Valley may reduce the number of lymphocytes (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, the doctor should monitor the patient's white blood cell count throughout the entire treatment period, 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 affecting 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. Therefore, if the patient notices worsening of symptoms related to multiple sclerosis or the appearance of any new symptoms while taking Dimethyl fumarate Medical Valley, they should contact their doctor immediately. The patient should also talk to their partner or caregivers and inform them about their treatment. Symptoms may occur that the patient may not be aware of.
→ If any of the symptoms listed above occur, contact a doctor immediately
Serious allergic reactions
The frequency of serious allergic reactions cannot be determined from available data (frequency unknown).
A very common adverse reaction is sudden (transient) redness of the face or body skin. If transient 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 serious allergic reaction ( anaphylaxis ).
→ The use of Dimethyl fumarate Medical Valley must be discontinued and medical advice must be sought immediately
Other adverse reactions
Very common ( may occur in more than 1 in 10 people):

• sudden redness of the face or sensation of increased body temperature, hot flushes, burning or itching of the skin ( 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 Medical Valley, ketone bodies, which are naturally produced in the body, are very commonly detected in urine tests.
Ask your doctor how to manage these adverse reactions. The doctor may reduce the dose of the medicine. The dose should not be reduced independently unless advised by the doctor.
Common (may occur in up to 1 in 10 people)

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

Adverse reactions that may be observed in 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 a doctor immediately;
• protein ( albumin ) in urine;
• increased liver enzyme activity ( AlAT, AspAT ) in blood.

Uncommon (may occur in up to 1 in 100 people)

• allergic reactions ( hypersensitivity )
• decreased platelet count

Rare (may occur in up to 1 in 1,000 people)

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

Frequency not known (frequency cannot be estimated from 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, red spots, and severe pain
• nasal congestion ( rhinitis ) Children (aged 13 years and above) 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, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products, Medical Devices and Biocidal 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 the medicine.

5. How to store Dimethyl fumarate Medical Valley

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
box following: Expiry (EXP). The expiry date refers to the last day of the stated month.
Do not store above 30ºC.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Dimethyl fumarate Medical Valley contains
The active substance is dimethyl fumarate.
Dimethyl fumarate Medical Valley, 120 mg, hard enteric capsules
Each capsule contains 120 mg of dimethyl fumarate.
Dimethyl fumarate Medical Valley, 240 mg, hard enteric capsules
Each capsule contains 240 mg of dimethyl fumarate.

Other components are:
Capsule contents: sodium croscarmellose, microcrystalline cellulose (PH 102), colloidal anhydrous silica, magnesium stearate, methacrylic acid and methyl methacrylate copolymer (1:1), triethyl citrate, talc, methacrylic acid and ethyl acrylate copolymer (1:1), dispersion 30%, containing sodium dodecyl sulfate and polysorbate 80.
Capsule shell: gelatin, titanium dioxide (E 171), yellow iron oxide (E 172), patent blue V (E 131).

What Dimethyl fumarate Medical Valley looks like and contents of the pack
Dimethyl fumarate Medical Valley, 120 mg, hard enteric capsules
Hard gelatin capsules (approximately 22 mm in length) with an opaque green cap and an opaque white body, containing white to off-white, round enteric mini-tablets.
Single-dose perforated blister made of opaque PVC/PE/PVDC/Aluminum foil, containing:
14 x 1 capsule, in a cardboard box
56 x 1 capsule, in a cardboard box.

Dimethyl fumarate Medical Valley, 240 mg, hard enteric capsules
Hard gelatin capsules (approximately 22 mm in length) with an opaque green cap and an opaque green body, containing white to off-white, round enteric mini-tablets.
Single-dose perforated blister made of opaque PVC/PE/PVDC/Aluminum foil, containing:
56 x 1 capsule, in a cardboard box
196 x 1 capsule, in a cardboard box
HDPE bottle with a polypropylene screw cap with tamper-evident seal, containing a moisture-absorbing agent (silica gel) placed in the cap, containing:
168 capsules, in a cardboard box.

Not all pack sizes may be marketed.

Marketing Authorization Holder
Medical Valley Invest AB
Brädgårdsvägen 28
236 32 Höllviken
Sweden
email: [email protected]

Manufacturer/Importer
Laboratorios Liconsa S.A.
Avenida De Miralcampo 7
Poligono Industrial Miralcampo
19200 Azuqueca De Henares, Guadalajara
Spain

This medicinal product is authorised in the member states of the European Economic Area under the following names:
Denmark Dimethyl Fumarate “Medical Valley”
Netherlands Dimethylfumaraat Xiromed 120 mg hard maagsapresistente capsules
Dimethylfumaraat Xiromed 240 mg hard maagsapresistente capsules
Iceland Dimethyl fumarate Medical Valley
Germany Dimethylfumarat AXiromed 120 mg magensaftresistente Hartkapseln
Dimethylfumarat AXiromed 240 mg magensaftresistente Hartkapseln
Norway Dimethyl fumarate Medical Valley
Poland Dimethyl fumarate Medical Valley
Sweden Dimethyl fumarate Medical Valley

Other sources of information:
Detailed information on this medicinal product is available on the website of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, www.urpl.gov.pl