Dimforda

Patient Information Leaflet

Dimforda 120 mg gastro-resistant hard capsules, 240 mg gastro-resistant hard capsules

dimethyl fumarate
Generic medicine
Please read all of this leaflet carefully before you start taking this medicine, as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Dimforda is and what it is used for
2. What you need to know before taking Dimforda
3. How to take Dimforda
4. Possible side effects
5. How to store Dimforda
6. 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 the active substance dimethyl fumarate.
What Dimforda is used for
Dimforda is used to treat relapsing-remitting multiple sclerosis (MS) in patients aged 13 years and older.
Multiple sclerosis is a chronic disease affecting the central nervous system (CNS), i.e. the brain and spinal cord. Relapsing-remitting multiple sclerosis is characterized by repeated attacks (relapses) of neurological symptoms. Symptoms vary from patient to patient, but generally include difficulty walking, feelings of imbalance, and vision problems (e.g. blurred or double vision). These symptoms may completely disappear when a relapse resolves, but some problems may persist.
How Dimforda works
Dimforda appears to work by preventing the body’s immune system from damaging the brain and spinal cord. This may also help delay future worsening of the disease.

2. What you need to know before taking Dimforda

Do not take Dimforda

• if you are allergic to dimethyl fumarate or to any of the other ingredients of this medicine (listed in section 6).
• if you suspect you have a rare brain infection called progressive multifocal leukoencephalopathy (PML), or if a diagnosis of PML has been confirmed.

Warnings and precautions
Dimforda may affect the number of white blood cells in your blood, your kidneys, and your liver. Before starting Dimforda, your doctor will perform a blood test to count your white blood cells and check that your kidneys and liver are functioning properly. Your doctor will carry out regular tests during treatment. If your white blood cell count decreases during treatment, your doctor may consider further investigations or discontinuation of therapy.

Talk to your doctor before taking Dimforda if you have:

• a serious kidney disease
• a serious liver disease
• a disease of the stomach or intestines
• a serious infection (such as pneumonia)

Herpes zoster infection (shingles) may occur during treatment with Dimforda. In some cases, serious complications have occurred. Tell your doctor immediately if you suspect you have any symptoms of herpes zoster infection.

If you think your multiple sclerosis is worsening (for example, if you experience weakness or changes in vision) or if you notice new symptoms, contact your doctor immediately, as these could be symptoms of a rare brain infection called progressive multifocal leukoencephalopathy (PML). PML is a life-threatening condition that may lead to severe disability or death.

A rare but life-threatening kidney disorder (Fanconi syndrome) has been observed with a medicine containing dimethyl fumarate in combination with other fumaric acid esters, used for the treatment of psoriasis (a skin disease). If you notice that you are urinating more than usual, feel more thirsty and drink more than normal, experience increased muscle weakness, or have a fracture or even just pain, contact your doctor as soon as possible so that appropriate investigations can be carried out.

Children and adolescents
Do not give this medicine to children under 10 years of age, as there is no available data in this age group.

Other medicines and Dimforda
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, especially:

• medicines containing fumaric acid esters (fumarates) used for the treatment of psoriasis
• medicines that affect the immune system, including chemotherapy, immunosuppressants, or other medicines used to treat MS
• medicines that affect the kidneys, including certain antibiotics (used to treat infections), diuretics, certain types of painkillers (such as ibuprofen and other similar anti-inflammatory medicines and over-the-counter medicines), and medicines containing lithium
• taking Dimforda together with certain types of vaccines ( live vaccines ) could cause you to develop an infection and should therefore be avoided. Your doctor will advise you whether other types of vaccines (non-live vaccines) should be administered.

Dimforda and alcohol
Consumption of alcoholic beverages with high alcohol content (more than 30% alcohol by volume, e.g. spirits) in amounts larger than a small quantity (more than 50 mL) should be avoided within one hour of taking Dimforda, as alcohol may interact with this medicine. This could cause stomach inflammation ( gastritis ), particularly in people already prone to gastritis.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
There is limited information on the effects of this medicine on the unborn child when used during pregnancy. Do not use Dimforda during pregnancy unless you have discussed it with your doctor and the medicine is clearly necessary for you.

Breastfeeding
It is not known whether the active ingredient of Dimforda passes into breast milk. Your doctor will advise you whether you should stop breastfeeding or stop treatment with Dimforda. This decision will be based on weighing the benefit of breastfeeding for your child against the benefit of therapy for you.

Driving and using machines
Dimforda is not expected to affect your ability to drive or operate machinery.

Dimforda contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e., essentially ‘sodium-free’.

3. How to take Dimforda

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor.

Initial dose
120 mg twice daily.
Take this initial dose for the first 7 days, then switch to the regular dose.

Regular dose
240 mg twice daily.
Dimforda is for oral use.

Swallow each capsule whole with some water. Do not split, crush, dissolve, suck or chew the capsule, as this could increase certain side effects.

Take Dimforda with food – this may help reduce some of the more common side effects (listed in section 4).

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

If you forget to take Dimforda
If you forget or miss a dose, do not take a double dose to make up for the missed dose.
You may take the missed dose if at least 4 hours have passed since the last dose. Otherwise, wait until your next scheduled dose.

If you have any doubts about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects

Dimforda may reduce levels of lymphocytes (a type of white blood cell). Persistently low levels of white blood cells may increase the risk of infections, including the risk of a rare brain infection called progressive multifocal leukoencephalopathy (PML). PML can lead to severe disability or death. PML has occurred after 1 to 5 years of treatment, so your doctor must continue to monitor your white blood cell counts throughout the duration of treatment. Pay close attention to any potential symptoms of PML, as described below. The risk of PML may be higher if you have previously taken medicines that impair immune system function.

Symptoms of PML may resemble those of a multiple sclerosis relapse. Symptoms may include the onset or worsening of weakness on one side of the body, clumsiness, changes in vision, thinking, memory, confusion, personality changes, or difficulties with language and communication lasting longer than a few days.

Therefore, if you feel your MS is worsening or if you notice any new symptoms during treatment with Dimforda, it is very important to contact your doctor as soon as possible. Also, inform your partner or caregiver about your treatment. They may notice symptoms you might not be aware of.

→ If you experience any of these symptoms, call your doctor immediately.

Severe allergic reactions

The frequency of severe allergic reactions cannot be determined from the available data (not known).

Flushing (redness of the face or body) is a very common side effect. However, if flushing is accompanied by a red rash or hives and you have any of the following symptoms:

• swelling of the face, lips, mouth, or tongue (angioedema)
• shortness of breath, difficulty breathing, or breathlessness (dyspnea, hypoxia)
• dizziness or loss of consciousness (hypotension)

this may indicate a severe allergic reaction (anaphylaxis).

→ Stop taking Dimforda and call a doctor immediately.

Other side effects

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

• redness of the face or body, feeling of warmth, intense heat, burning sensation, or itching (flushing)
• loose stools (diarrhea)
• feeling of imminent vomiting (nausea)
• stomach ache or stomach cramps

→ Taking the medicine with food may help reduce the above-mentioned side effects.

The presence of substances called ketones is very commonly detected in urine tests during treatment with Dimforda.

Contact your doctor for advice on managing these side effects. Your doctor may reduce your dose. Do not reduce the dose unless your doctor tells you to do so.

Common (may affect up to 1 in 10 people)

• inflammation of the intestinal lining (gastroenteritis)
• feeling of discomfort (vomiting)
• indigestion (dyspepsia)
• inflammation of the stomach (gastritis)
• gastrointestinal disorder
• burning sensation
• hot flush, feeling of warmth
• itching
• skin rash
• pink or red spots on the skin (erythema)
• hair loss (alopecia)

Side effects that may emerge from blood or urine tests:

• low levels of white blood cells (lymphopenia, leukopenia) in the blood. A reduced number of white blood cells may mean you are unable to fight infections adequately. If you develop a serious infection (such as pneumonia), contact your doctor immediately.
• presence of protein (albumin) in the urine
• increased levels of liver enzymes (alanine aminotransferase, ALT and aspartate aminotransferase, AST) in the blood

Uncommon (may affect up to 1 in 100 people)

• allergic reactions (hypersensitivity)
• reduced platelet count in the blood

Not known (frequency cannot be estimated from the available data)

• inflammation of the liver and increased liver enzyme levels (ALT or AST in combination with bilirubin)
• herpes zoster infection (shingles), with symptoms such as blisters, burning, itching, or skin pain, usually on one side of the back or face, and other symptoms such as fever and weakness in the early stages of infection, followed by numbness, red or itchy spots with severe pain
• runny nose (rhinorrhea)

Children (aged 13 years and older) and adolescents

The side effects listed above also apply to children and adolescents. Some side effects have been reported more frequently in children and adolescents than in adults, such as headache, stomach ache or stomach cramps, feeling of discomfort (vomiting), sore throat, cough, and painful menstruation.

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help 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 which is stated on the blister and the outer packaging after 'Exp.'.
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents 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 components are microcrystalline cellulose (E460i), sodium croscarmellose (E468), talc (E553b), silicified microcrystalline cellulose, anhydrous colloidal silica (E551), magnesium stearate, triethyl citrate (E1505), methacrylic acid-methyl methacrylate copolymer (1:1) (E1207), methacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30% (E1207), sodium lauryl sulfate, polysorbate 80, gelatin, titanium dioxide (E171), brilliant blue FCF (E133), yellow iron oxide (E172), black iron oxide (E172), shellac (E904), propylene glycol, ammonium hydroxide 28% (E527).

Description of the appearance of Dimforda and the contents of the pack
Dimforda 120 mg gastro-resistant hard capsules are 21.7 mm long and 7.6 mm in diameter, printed with “120 mg”, with an opaque light green cap and an opaque white body, containing white or almost white gastro-resistant mini-tablets, and are available in packs containing 14 capsules.
Dimforda 240 mg gastro-resistant hard capsules are 21.7 mm long and 7.6 mm in diameter, printed with “240 mg”, with an opaque light green cap and body, containing white or almost white gastro-resistant mini-tablets, and are available in packs containing 56 capsules.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland

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

This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
Denmark Dimforda
Belgium Dimforda
Czech Republic Dimforda
Finland Dimforda
Greece Dimforda
Hungary Dimforda gyomornedv-ellenálló kemény kapszula
Italy Dimforda capsule rigide gastroresistenti
Latvia Dimforda zarnās šķīstošā kapsula, cietā
Lithuania Dimforda skrandyje neirios kietosios kapsulės
Norway Dimforda
Poland Dimforda
Slovak Republic Dimforda
Sweden Dimforda trde gastrorezistentne kapsule
Spain Dimforda
Slovenia Dimforda