Dimethyl fumarate Dr. Reddy's: detailed information

Patient Information Leaflet

Dimetilfumarato Dr. Reddy’s 120 mg gastro-resistant hard capsules

Dimetilfumarato Dr. Reddy’s 240 mg gastro-resistant hard capsules
Dimethyl fumarate
Equivalent medicine
Please read all of this leaflet carefully before you start taking this medicine because 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 they have the same symptoms as you, because 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

What Dimetilfumarato Dr. Reddy’s is and what it is used for
What you need to know before taking Dimetilfumarato Dr. Reddy’s
How to take Dimetilfumarato Dr. Reddy’s
Possible side effects
How to store Dimetilfumarato Dr. Reddy’s
Contents of the pack and other information

1. What Dimetilfumarato Dr. Reddy’s is and what it is used for

What Dimetilfumarato Dr. Reddy’s is
Dimetilfumarato Dr. Reddy’s is a medicine that contains the active substance dimethyl fumarate.
What Dimetilfumarato Dr. Reddy’s is used for
Dimetilfumarato Dr. Reddy’s 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 symptoms affecting the nervous system. Symptoms vary from patient to patient but generally include difficulty walking, a sense of imbalance, and vision problems (e.g. blurred or double vision). These symptoms may completely disappear when the relapse resolves, although some problems may persist.
How Dimetilfumarato Dr. Reddy’s works
Dimetilfumarato Dr. Reddy’s 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 MS.

2. What you should know before taking Dimetilfumarato Dr. Reddy’s

Do not take Dimetilfumarato Dr. Reddy’s

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

Warnings and precautions
Dimetilfumarato Dr. Reddy’s may affect the number of white blood cells in your blood, your kidneys, and your liver. Before starting Dimetilfumarato Dr. Reddy’s, your doctor will perform a blood test to count your white blood cells and will check that your kidneys and liver are functioning properly. Your doctor will carry out these tests periodically during treatment. If your white blood cell count decreases during treatment, your doctor may consider further testing or discontinuation of therapy.
Contact your doctor before taking Dimetilfumarato Dr. Reddy’s if you have:

a serious kidney disease
a serious liver disease
a stomach or intestinal disease
a serious infection (such as pneumonia)

Cases of herpes zoster infection (shingles) may occur during treatment with dimethyl fumarate. In some cases, severe complications have occurred. Inform your doctor immediately if you suspect you have any symptoms of herpes zoster infection.
If you think your MS 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 serious condition that may lead to severe disability or death.
With a medicine containing dimethyl fumarate in combination with other esters of fumaric acid, used for the treatment of psoriasis (a skin disease), a rare but serious kidney disorder called Fanconi syndrome has been observed. If you notice increased urination, increased thirst, increased fluid intake, muscle weakness, or bone fracture or 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 Dimetilfumarato Dr. Reddy’s
Inform 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 chemotherapeutic agents, immunosuppressants, or other medicines used to treat MS;
medicines that affect the kidneys, including certain antibiotics (used to treat infections), diuretics, certain types of analgesics (such as ibuprofen and other similar anti-inflammatory medicines and medicines purchased without a prescription), and medicines containing lithium;
taking Dimetilfumarato Dr. Reddy’s together with certain types of vaccines (live vaccines) could cause you to develop an infection and should therefore be avoided. Your doctor will inform you whether other types of vaccines (non-live vaccines) should be administered.

Dimetilfumarato Dr. Reddy’s and alcohol
Consumption of alcoholic beverages with high alcohol content (more than 30% alcohol by volume, e.g. spirits) in amounts exceeding a small quantity (more than 50 mL) should be avoided within one hour of taking dimethyl fumarate, as alcohol may interact with this medicine. This could cause inflammation of the stomach (gastritis), especially in people already prone to gastritis.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are 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 dimethyl fumarate if you are pregnant unless you have discussed this with your doctor and the medicine is clearly necessary for you.

Breastfeeding
It is not known whether dimethyl fumarate passes into breast milk. Your doctor will advise you whether you should stop breastfeeding or stop treatment with dimethyl fumarate. This decision will involve weighing the benefit of breastfeeding for your child against the benefit of therapy for you.

Driving and using machines
Dimetilfumarato Dr. Reddy’s is not expected to affect your ability to drive or use machines.

Dimetilfumarato Dr. Reddy’s contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. essentially "sodium-free".

3. How to take Dimetilfumarato Dr. Reddy’s

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor.
Starting dose: 120 mg twice daily.
Take this starting dose for the first 7 days, then take the maintenance dose.
Maintenance dose: 240 mg twice daily.
Dimetilfumarato Dr. Reddy’s is for oral use.
Swallow each capsule whole with some water. Do not divide, crush, dissolve, suck or chew the capsule, as this could increase the risk of certain side effects.
Take Dimetilfumarato Dr. Reddy’s with food – this may help reduce some of the more common side effects (listed in section 4).
If you take more Dimetilfumarato Dr. Reddy’s 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 Dimetilfumarato Dr. Reddy’s
If you miss or forget a dose, do not take a double dose. You may take the missed dose if at least 4 hours remain before the next scheduled dose. Otherwise, wait and take the next dose at the usual time.
If you have any doubts about how to use this medicine, consult 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

Dimethyl fumarate can 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; therefore, your doctor must continue to monitor your white blood cell counts throughout the duration of treatment. You should carefully watch for any potential symptoms of PML, as described below. The risk of PML may be higher if you have previously taken medicines that impair the immune system function.

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

Therefore, if you feel that your MS is worsening or if you notice any new symptoms during treatment with dimethyl fumarate, it is very important to contact your doctor as soon as possible. Also inform your partner or caregiver about your treatment, as symptoms may occur that you might not notice yourself.

→ 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 Dimethylfumarate Dr. Reddy’s 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, 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, which are naturally produced by the body, is very commonly detected in urine tests during treatment with dimethyl fumarate.

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

Common (may affect up to 1 in 10 people)

inflammation of the intestinal lining (gastroenteritis)
feeling unwell (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 be detected in blood or urine tests:

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

Uncommon (may affect up to 1 in 100 people)

allergic reactions (hypersensitivity)
reduced platelet count in blood

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

inflammation of the liver and increased levels of liver enzymes (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 torso or face, and other symptoms such as fever and weakness in the early stages of infection, followed by numbness, red or itchy rash 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, for example headache, stomach ache or stomach cramps, vomiting, sore throat, cough, and painful menstruation.

Reporting of side effects

If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the website: 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 Dimetilfumarato Dr. Reddy’s

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 after "Exp.".
The expiry date refers to the last day of that month.
No special storage conditions are required for this medicine.
Do not dispose of medicines 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 Dimetilfumarato Dr. Reddy’s contains
The active substance is dimethyl fumarate.
Dimetilfumarato Dr. Reddy’s 120 mg: each capsule contains 120 mg of dimethyl fumarate.
Dimetilfumarato Dr. Reddy’s 240 mg: each capsule contains 240 mg of dimethyl fumarate.
The other components are microcrystalline cellulose (E460), sodium croscarmellose (E468), povidone
K30 (E1201), talc (E553b), magnesium stearate (E1505), methacrylic acid–methyl methacrylate
copolymer (1:1) (E1205), sodium lauryl sulfate (E470a), triethyl citrate (E1505), methacrylic acid–ethyl
acrylate copolymer (1:1) dispersion 30% (E1205), polysorbate 80 (E433), gelatin, titanium dioxide
(E171), Brilliant Blue FCF (E133), yellow iron oxide (E172), shellac, potassium hydroxide and
black iron oxide (E172).

Description of the appearance of Dimetilfumarato Dr. Reddy’s and the contents of the pack
Dimetilfumarato Dr. Reddy’s 120 mg gastro-resistant hard capsules (size 1, approximately 19.3 mm) are green and white in colour, with the imprint "RDY" on the cap and "429" on the body.
Each blister contains 14 or 56 capsules.
Each unit-dose divisible blister contains 14 x 1 capsules.

Dimetilfumarato Dr. Reddy’s 240 mg gastro-resistant hard capsules (size 0, approximately 21.4 mm) are green in colour, with the imprint "RDY" on the cap and "430" on the body.
Each blister contains 14, 56, 112, 168 or 196 capsules.
Each unit-dose divisible blister contains 56 x 1 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Dr. Reddy’s S.r.l.
Piazza Santa Maria Beltrade, 1
Milan (MI)
Italy

Manufacturer
betapharm Arzneimitteln GmbH, Kobelweg 95, Augsburg, 86156, Germany
Pharmadox Healthcare Ltd., KW20A Kordin Industrial Park, Paola PLA 3000, Malta
Rual Laboratories S.R.L., Splaiul Unirii nr. 313, Building H, 1st floor, sector 3, Bucharest, 030138, Romania
Laboratori Fundacio Dau, Calle Lletra C De La Zona Franca 12-14, Poligono Industrial De La Zona Franca De Barcelona, Barcelona, 08040, Spain

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Austria Dimethylfumarat Reddy 120 mg magensaftresistente Hartkapseln
Dimethylfumarat Reddy 240 mg magensaftresistente Hartkapseln
Germany Dimethylfumarat beta 120 mg magensaftresistente Hartkapseln
Dimethylfumarat beta 240 mg magensaftresistente Hartkapseln
Italy Dimetilfumarato Dr. Reddy’s
Netherlands Dimethylfumaraat Reddy 120 mg harde maagsapresistente capsules
Dimethylfumaraat Reddy 240 mg harde maagsapresistente capsules
Poland Dimethyl fumarate Reddy
Portugal Dimethyl fumarate Reddy 120 mg cápsulas gastrorresistentes
Dimethyl fumarate Reddy 240 mg cápsulas gastrorresistentes
Czech Republic Dimethyl fumarate Reddy
Romania Dimetil fumarat Dr. Reddy’s 120 mg capsule gastrorezistente
Dimetil fumarat Dr. Reddy’s 240 mg capsule gastrorezistente
Slovakia Dimethyl fumarate Reddy 120 mg tvrdé gastrorezistentné kapsuly
Dimethyl fumarate Reddy 240 mg tvrdé gastrorezistentné kapsuly
Spain Fumarato de Dimetilo Dr. Reddys 120 mg cápsulas duras gastrorresistentes EFG
Fumarato de Dimetilo Dr. Reddys 240 mg cápsulas duras gastrorresistentes EFG
Sweden Dimethyl fumarate Reddy