Patient Information Leaflet

Dimforda, 120 mg, hard enteric-coated capsules
Dimforda, 240 mg, hard enteric-coated capsules
Dimethyl fumarate
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 questions, please consult 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 reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents

What Dimforda is and what it is used for
What you need to know before taking Dimforda
How to take Dimforda
Possible side effects
How to store Dimforda
Contents of the pack and other information

1. What Dimforda is and what it is used for

What Dimforda is
Dimforda is a medicine that contains dimethyl fumarate as the active substance.
What Dimforda is used for
Dimforda is used in the treatment of relapsing-remitting multiple sclerosis
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 problems (e.g. blurred or double vision). These symptoms may completely resolve after the relapse ends, but some problems may persist.
How Dimforda works
Dimforda appears to suppress the immune system from causing damage to the brain and spinal cord. This may also help slow the future progression of multiple sclerosis.

2. Important information before taking Dimforda

When not to take Dimforda

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
Dimforda may adversely affect the number of white blood cells and the function of the kidneys and liver. Before starting treatment with Dimforda, 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.
Before starting Dimforda, the patient should discuss 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 Dimforda. In some cases, severe 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 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 condition that may lead to severe disability or death.
Rare but serious kidney problems (Fanconi syndrome) have 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 that they are passing more urine, feel increased thirst and drink more than usual, their muscles seem weaker, they experience bone fractures, or simply feel pain, they should contact their 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.
Dimforda with other medicines
The patient should tell their doctor or pharmacist about 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 in the treatment of psoriasis
medicines affecting the immune system, including chemotherapy, 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 similar anti-inflammatory medicines, including over-the-counter medicines) and medicines containing lithium
administration of certain vaccines ( live vaccines ) during treatment with Dimforda may lead to the development of infection; therefore, these should be avoided. The doctor will advise whether other types of vaccines ( inactivated vaccines ) should be given.

Dimforda and alcohol
The patient should avoid consuming high-strength alcoholic drinks (over 30% alcohol by volume, e.g. spirits) in quantities exceeding 50 ml within one hour of taking Dimforda, 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 or 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, when used during pregnancy, on the unborn child. Dimforda 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 not known whether the active substance of Dimforda passes into human milk. The doctor will advise the patient whether she should discontinue breastfeeding or stop taking Dimforda. The decision will be based on an assessment of the benefit of breastfeeding for the child versus the benefit of treatment for the patient.
Driving and operating machinery
No effect of Dimforda on the ability to drive or operate machinery is expected.
Dimforda contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule; therefore, this medicine is considered "sodium-free".

3. How to take Dimforda

This medicine should always be taken as directed by the physician. 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 medicine should be continued at the
usual maintenance dose.
Usual maintenance dose
240 mg twice daily.
Dimforda should be taken orally.
Each capsule should be swallowed whole with water. Capsules must not be divided, crushed,
dissolved, sucked, or chewed, as this may increase the risk of certain adverse reactions.
Dimforda should be taken with food – this may help reduce the very common adverse reactions
(listed in section 4).
Taking more Dimforda than prescribed
If more capsules have been taken than prescribed, inform the doctor immediately. Adverse reactions
similar to those described below in section 4 may occur.
Missing a dose of Dimforda
Do not take a double dose to make up for a missed dose.
A missed dose may be taken if there is at least a 4-hour interval before the next scheduled dose.
Otherwise, the missed dose should not be taken; instead, take the next dose at the regular 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
Dimforda 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 between 1 and 5 years after starting treatment. Therefore, 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 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, problems with coordination, vision disturbances, 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 any new symptoms while taking Dimforda, you should contact your doctor immediately. 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.
Serious allergic reactions
The frequency of serious allergic reactions cannot be determined from available data (frequency unknown).
A very common adverse reaction is sudden (episodic) redness of the face or body. If this 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 serious anaphylactic reaction (anaphylaxis).
→ Stop taking Dimforda immediately and contact your doctor immediately.

Other adverse reactions
Very common: may occur in more than 1 in 10 people:

redness of the face or sensation of increased body temperature, warmth, skin burning or itching ( episodic skin redness )
loose stools ( diarrhea )
nausea
stomach pain or cramps

→ Taking the medicine with food may help reduce the adverse reactions listed above.
During treatment with Dimforda, 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 occur in 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 ) in blood. 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 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

Frequency unknown (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 skin pain, usually on one side of the upper body or face, and other symptoms such as fever and fatigue in early stages of infection, followed by numbness, itching or red spots with 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 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
Tel.: +48 22 49 21 301, fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl.
Adverse reactions can also be reported directly to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Dimforda

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton following EXP:
The expiry date refers to the last day of the stated month.
No special storage instructions apply for this medicine.
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 Dimforda contains

The active substance is dimethyl fumarate. Dimforda 120 mg: each capsule contains 120 mg of dimethyl fumarate. Dimforda 240 mg: each capsule contains 240 mg of dimethyl fumarate.
The other ingredients are: microcrystalline cellulose (E460i), sodium croscarmellose (E468), talc (E553b), silicon dioxide microcrystalline cellulose, colloidal anhydrous silica (E551), magnesium stearate (E470b), triethyl citrate (E1505), copolymer of methacrylic acid and methyl methacrylate (1:1) (E1207), copolymer of methacrylic acid and ethyl acrylate (1:1), 30% dispersion (E1207), sodium lauryl sulfate, polysorbate 80, gelatin, titanium dioxide (E171), brilliant blue FCF (E133), yellow iron oxide (E172), black iron oxide (E172), shellac 45% ethanolic solution (E904), propylene glycol (E1520), concentrated ammonium hydroxide (E527).

What Dimforda looks like and contents of the pack
Dimforda 120 mg gastro-resistant hard capsules are hard gelatin capsules with a diameter of 7.6 mm and an overall length of 21.7 mm, printed with “120 mg”, consisting of a white opaque body and a light green opaque cap, containing white to off-white mini-tablets, available in a pack containing 14 capsules.
Dimforda 240 mg gastro-resistant hard capsules are hard gelatin capsules with a diameter of 7.6 mm and an overall length of 21.7 mm, printed with “240 mg”, consisting of a light green opaque body and a light green opaque cap, containing white to off-white mini-tablets, available in a pack containing 56 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland
Tel: +48 17 865 51 00

Importer
Bausch Health Poland Sp. z o.o.
ul. Przemysłowa 2
35-959 Rzeszów
Bausch Health Poland Sp. z o.o.
ul. Kosztowska 21
41-409 Mysłowice

This medicinal product is authorised in the European Economic Area countries under the following names:
Bulgaria Димфорда 120 mg твърди стомашно-устойчиви капсули
Димфорда 240 mg твърди стомашно-устойчиви капсули
Czech Republic Dimforda
Denmark Dimforda
Finland Dimforda
Greece Dimforda
Spain Dimforda
Lithuania Dimforda 120 mg skrandyje neirios kietosios kapsulės
Dimforda 240 mg skrandyje neirios kietosios kapsulės
Latvia Dimforda 120 mg zarnās šķīstošā kapsula, cietā
Dimforda 240 mg zarnās šķīstošā kapsula, cietā
Norway Dimforda
Poland Dimforda
Slovakia Dimforda
Slovenia Dimforda 120 mg trde gastrorezistentne kapsule
Dimforda 240 mg trde gastrorezistentne kapsule
Sweden Dimforda
Hungary Dimforda 120 mg gyomornedv-ellenálló kemény kapszula
Dimforda 240 mg gyomornedv-ellenálló kemény kapszula
Italy Dimforda