DIMETILFUMARATO 120 mg Enteric-Coated Hard Capsule

Зміст інструкції

1. Dimetilfumarato Dr. Reddy’s 120 mg hard gastro-resistant capsules, 240 mg hard gastro-resistant capsules
   1. What is Dimetilfumarato Dr. Reddy’s and what is it used for
   2. What you need to know before taking Dimetilfumarato Dr. Reddy’s
   3. How to take Dimetilfumarato Dr. Reddy’s
   4. Possible side effects
   5. How to store Dimetilfumarato Dr. Reddy’s
   6. Package contents and other information

Dimetilfumarato Dr. Reddy’s 120 mg hard gastro-resistant capsules, 240 mg hard gastro-resistant capsules

dimetilfumarato

Generic medicine

Read this leaflet carefully before 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What Dimetilfumarato Dr. Reddy’s is and what it is used for
• 2. What you need to know before you take Dimetilfumarato Dr. Reddy’s
• 3. How to take Dimetilfumarato Dr. Reddy’s
• 4. Possible side effects
• 5. How to store Dimetilfumarato Dr. Reddy’s
• 6. Contents of the pack and other information

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

What is Dimetilfumarato Dr. Reddy’s
Dimetilfumarato Dr. Reddy’s is a medicine that contains the active ingredient dimethyl fumarate.

What is Dimetilfumarato Dr. Reddy’s used for
Dimetilfumarato Dr. Reddy’s is used to treat relapsing-remitting multiple sclerosis (RRMS) in patients aged 13 years and older.
Multiple sclerosis is a chronic disease that affects the central nervous system (CNS), i.e. the
brain and spinal cord. Relapsing-remitting multiple sclerosis is characterized by repeated attacks
(relapses) of symptoms that affect the nervous system. The symptoms vary from patient to patient,
but generally include difficulty walking, a feeling of imbalance and visual disturbances
(e.g. blurred or double vision). These symptoms may disappear completely when the relapse
resolves, but some problems may remain.

How does Dimetilfumarato Dr. Reddy’s work
It appears that Dimetilfumarato Dr. Reddy’s works by preventing the body's defense system from
damaging the brain and spinal cord. This may also help to delay future worsening
of MS.

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

Do not take Dimetilfumarato Dr. Reddy’s

• if you are allergic to dimethyl fumarateor 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 the diagnosis of PML has been confirmed.

Warnings and precautions
Dimetilfumarato Dr. Reddy’s can affect the number of white blood cells in the blood, the kidneysand the

liver. Before starting to take 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 perform the tests periodically during treatment. If the number of your white blood cells decreases during treatment, your doctor may consider further tests or discontinuation of therapy.

Consult your doctorbefore taking Dimetilfumarato Dr. Reddy’s if you have:

• a serious disease of the kidneys
• a serious disease of the liver
• a disease of the stomachor intestine
• a serious infection(such as pneumonia)

Cases of herpes zoster infection (shingles) can occur with dimethyl fumarate treatment. In some cases, serious complications have occurred. Tell your doctorimmediately if you suspect you have any symptoms of herpes zoster infection.

• Symptoms of herpes zoster infection include pain, burning, tingling, itching, blisters, and fever.

If you believe that your MS is worsening (for example, if you experience weakness or changes in vision) or if you notice new symptoms, consult your doctor immediately as these may be symptoms of a rare brain infection called progressive multifocal leukoencephalopathy (PML).
PML is a serious condition that can lead to severe disability or death.
With a medicine containing dimethyl fumarate in combination with other fumaric acid esters, used for the treatment of psoriasis (a skin disease), a rare but serious kidney disorder called Fanconi syndrome has been observed. If you notice that you are urinating more frequently, if you are more thirsty and drink more than usual, if your muscles are weaker, or in case of fracture or just pain, contact your doctor as soon as possible so that further investigations can be carried out.

Children and adolescents
Do not give this medicine to children under 10 years of age because data are not available in this age group.

Other medicines and Dimetilfumarato Dr. Reddy’s
Tell your doctor or pharmacistif you are taking, have recently taken or might take any other medicines, especially:

• medicines that contain fumaric acid esters(fumarates) used for the treatment of psoriasis;
• medicinesthataffecttheimmunesystem,including chemotherapy, immunosuppressants or other medicines used for the treatment of MS;
• medicines that affect the kidneys, includingsome antibiotics(used to treat infections), diuretics, certain types of painkillers(such as ibuprofen and other similar anti-inflammatory drugs and over-the-counter medicines) and medicines that contain lithium;
• taking Dimetilfumarato Dr. Reddy’s with certain types of vaccines (live vaccines) could cause you to become infected and should therefore be avoided. Your doctor will tell you if other types of vaccines (non-live vaccines) should be given.

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

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning to become pregnant or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
There is limited information on the effects of this medicine on the unborn child if used during pregnancy. Do not use dimethyl fumarate if you are pregnant unless you have discussed this with your doctor and this medicine is clearly necessary for you.
Breastfeeding
It is not known whether dimethyl fumarate passes into breast milk. Your doctor will advise you whether to stop breastfeeding or treatment with dimethyl fumarate. This involves assessing the benefit of breastfeeding for your baby versus the benefit of therapy for you.

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

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 following exactly the instructions of your doctor. If you have any doubts, ask your
doctor.

Initial dose: 120 mg twice a day.
Take this initial dose for the first 7 days, and then take the regular dose.

Regular dose: 240 mg twice a day.
Dimetilfumarato Dr. Reddy’s is for oral use.

Swallow each capsule whole,with a little water. You must not split, crush, dissolve,
suck or chew the capsule, because this could increase some undesirable effects.

TakeDimetilfumarato Dr. Reddy’s with food– this may help to reduce some more
common undesirable effects (listed in paragraph 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
undesirable effects similar to those described below in paragraph 4.

If you forget to take Dimetilfumarato Dr. Reddy’s
If you forget or miss a dose, do not take a double dose. You can take the missed dose if at least
4 hours have passed between doses. Otherwise, wait until the next scheduled dose.
If you have any questions about using 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.
li manifestino.

Serious side effects
Dimethyl fumarate can reduce the 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 cause severe disability
or death. PML has been reported after 1 - 5 years of treatment, so the doctor must
continue to monitor white blood cell counts throughout the duration of treatment. Be careful to observe
carefully any potential symptom of PML, as described below. The risk of PML may be
higher if you have previously taken medicines that compromise the function of the immune
system.
The symptoms of PML can be similar to those of an SM relapse. Symptoms may
include the onset or worsening of weakness on one side of the body; clumsiness;
changes in vision, thinking, or memory; or confusion or changes in personality or
difficulty with speech and communication lasting more than a few days.
Therefore, if you think your MS is getting worse or if you notice any new symptoms during therapy
with dimethyl fumarate, it is very important that you see your doctor as soon as possible. Also inform your
partner or caregiver about your treatment. Symptoms may develop that you may not
be aware of.
→ If you experience any of these symptoms, call your doctor immediately
Serious allergic reactions
The frequency of serious allergic reactions cannot be defined based on available data (not
known).
Facial or body flushing is a very common side effect. However, if
flushing is accompanied by a red or urticaria rash and you have any of these symptoms:

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

this may be a serious allergic reaction ( anaphylaxis)
→ Stop taking Dimetilfumarato Dr. Reddy’s and call a doctor immediately
Other side effects
Very common(may affect more than 1 in 10 people)

• facial or body flushing, sensation of warmth, heat, burning or itching (flushing)
• soft stools (diarrhea)
• feeling of impending vomiting (nausea)
• stomach pain or stomach cramps

→Taking the medicine with foodmay help reduce the above side effects
mentioned
The presence of substances called ketones, which are produced naturally by the body, is very
commonly revealed in urine tests during the intake of dimethyl fumarate.

Talk to your doctorfor information on how to manage these side effects. The 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 lining of the intestine (gastroenteritis)
• feeling unwell ( vomiting)
• indigestion (dyspepsia)
• inflammation of the stomach (gastritis)
• gastrointestinal illness
• burning sensation
• hot flush, feeling of heat
• itching
• 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 ( lymphocytopenia, leucopenia) in the blood. A decrease in the number of white blood cells in the blood may indicate that you are unable to fight off an infection adequately. If you have a serious infection (such as pneumonia), see your doctor immediately
• 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 platelets in the blood

Not known(frequency cannot be estimated based on available data)

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

Children (13 years of age and over) 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
compared to adults, such as headache, stomach pain or cramps, vomiting, sore throat,
cough and painful periods.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system reported at the address 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 which is stated on the blister and the package after
“Exp.”.
The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in 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 ingredientis 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 ingredientsare 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 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 and bear the inscription "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 capsule.
Dimetilfumarato Dr. Reddy’s 240 mg gastro-resistant hard capsules (size 0, approximately 21.4 mm) are
green in colour and bear the inscription "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 capsule.
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
Milano (MI)
20123
Italy

Manufacturer
betapharm Arzneimitteln GmbH, Kobelweg 95, Augusta, 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 with the
following denominations
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