Dimethyl fumarate Aurobindo

Package leaflet: Information for the user

Dimethylfumarate Aurobindo 120 mg gastro-resistant hard capsules, 240 mg gastro-resistant hard capsules

Generic 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 yours, 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

1. What Dimethylfumarate Aurobindo is and what it is used for
2. What you need to know before taking Dimethylfumarate Aurobindo
3. How to take Dimethylfumarate Aurobindo
4. Possible side effects
5. How to store Dimethylfumarate Aurobindo
6. Contents of the pack and other information

1. What Dimetilfumarato Aurobindo is and what it is used for

What Dimetilfumarato Aurobindo is
Dimetilfumarato Aurobindo is a medicine containing the active substance dimethyl fumarate.
What Dimetilfumarato Aurobindo is used for
Dimetilfumarato Aurobindo 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 characterised by repeated attacks (relapses) of neurological symptoms. Symptoms vary from patient to patient but generally include walking difficulties, a sensation 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 Aurobindo works
Dimetilfumarato Aurobindo 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 Dimetilfumarato Aurobindo

Do not take Dimetilfumarato Aurobindo

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

Warnings and precautions
Talk to your doctor or pharmacist before taking Dimetilfumarato Aurobindo.
Dimetilfumarato Aurobindo may affect the number of white blood cells in your blood, your kidneys, and your liver. Before starting Dimetilfumarato Aurobindo, 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 periodic 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 Dimetilfumarato Aurobindo 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 Dimetilfumarato Aurobindo. In some cases, severe complications may arise. Contact 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 signs of a rare brain infection called PML. PML is a serious condition that may 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 increased urination, increased thirst and fluid intake, muscle weakness, or experience bone fractures or bone 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 Aurobindo
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 chemotherapeutic agents, immunosuppressants, or other medicines used for the treatment of 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 medicines containing lithium;
• taking Dimetilfumarato Aurobindo 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.

Dimetilfumarato Aurobindo and alcohol
Consumption of alcoholic beverages with high alcohol content (more than 30% alcohol by volume, e.g. spirits) exceeding a small amount (more than 50 mL) should be avoided within one hour of taking Dimetilfumarato Aurobindo, 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 Dimetilfumarato Aurobindo during pregnancy unless you have discussed this with your doctor and the medicine is clearly necessary for you.
Breastfeeding
It is not known whether the active substance of Dimetilfumarato Aurobindo passes into breast milk. Your doctor will advise you whether you should discontinue breastfeeding or the treatment with Dimetilfumarato Aurobindo. This involves weighing the benefit of breastfeeding for your child against the benefit of therapy for you.
Driving and using machines
Dimetilfumarato Aurobindo is not expected to affect your ability to drive or operate machinery.
Dimetilfumarato Aurobindo contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per capsule, i.e. essentially "sodium-free".

3. How to take Dimetilfumarato Aurobindo

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
Starting dose: 120 mg twice daily.
Take this starting dose for the first 7 days, then proceed to the regular dose.
Regular dose: 240 mg twice daily.
Dimetilfumarato Aurobindo 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 certain side effects.
Take Dimetilfumarato Aurobindo with food – this may help reduce some of the more common side effects (listed in section 4).
If you take more Dimetilfumarato Aurobindo than you should
If you have taken too many capsules, contact your doctor immediately . You may experience side effects similar to those described below in section 4.
If you forget to take Dimetilfumarato Aurobindo
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 will pass between doses. Otherwise, wait until your next scheduled dose.
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 everyone will experience them.

Serious side effects

Dimethyl fumarate Aurobindo 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; therefore, your doctor must continue to monitor your white blood cell counts throughout the duration of treatment. Be vigilant in observing 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, or memory; confusion or personality changes; or difficulty 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 Dimethyl fumarate Aurobindo, it is very important to contact your doctor as soon as possible. Also, inform your partner or caregiver about your treatment, as symptoms may arise that you might not notice yourself.

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

Serious allergic reactions

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

Flushing (reddening 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 serious allergic reaction ( anaphylaxis ).

➢ Stop taking Dimethyl fumarate Aurobindo and call a doctor immediately.

Other side effects

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

• flushing (reddening of the face or body, sensation of warmth, intense heat, burning, or itching);
• loose stools ( diarrhea );
• feeling unwell ( 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 Aurobindo.

Talk to 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.

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 illness;
• 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 appear in blood or urine tests

• low levels of white blood cells ( lymphopenia, leukopenia ) in the blood. A reduced number of white blood cells may indicate that you are not able 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.

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

• inflammation of the liver and increased liver enzyme levels ( ALT or AST in combination with bilirubin ).

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

• 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 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, 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. Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Dimetilfumarato Aurobindo

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.
This medicine requires no special storage conditions.
Do not dispose of medicines via wastewater or household waste. Return unused medicines to your pharmacist. This will help protect the environment.

6. Package contents and other information

What Dimetilfumarato Aurobindo contains

• The active substance is dimethyl fumarate hydrochloride. Each gastro-resistant hard capsule contains 120 mg of dimethyl fumarate. Each gastro-resistant hard capsule contains 240 mg of dimethyl fumarate.
• The other components are: Capsule contents: Silicified microcrystalline cellulose (Grade - 90), sodium croscarmellose, anhydrous colloidal silica, magnesium stearate, methacrylic acid - methyl methacrylate copolymer (1:1), methacrylic acid - ethyl acrylate copolymer (1:1) 30% dispersion, triethyl citrate, talc.

Capsule shell:
Cap and body:
FD&C Blue 2 (E132) (only for 240 mg), yellow iron oxide (E172) (only for 240 mg), titanium
dioxide (E171), gelatin, purified water, sodium lauryl sulfate.
Printing ink:
Shellac (E904), black iron oxide (E172), potassium hydroxide (E525).

Description of the appearance of Dimetilfumarato Aurobindo and contents of the pack
Gastro-resistant hard capsules.
Dimetilfumarato Aurobindo 120 mg gastro-resistant hard capsules
Hard gelatin capsules, size ‘0’, with white cap and white body, printed "DMT 120" on the body in black ink. Each capsule contains three enteric-coated tablets, round, biconvex, white to off-white in colour.
Dimetilfumarato Aurobindo 240 mg gastro-resistant hard capsules
Hard gelatin capsules, size ‘0’, with green cap and green body, printed "DMT 240" on the body in black ink. Each capsule contains six enteric-coated tablets, round, biconvex, white to off-white in colour.
Dimetilfumarato Aurobindo gastro-resistant hard capsules are available in blister packs.
Packs:
Blister packs: 14, 28, 56, 168 and 196 gastro-resistant hard capsules.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Aurobindo Pharma (Italia) Srl
Via San Giuseppe, 102 - 21047 Saronno (VA), Italy

Manufacturer
APL Swift Services (Malta) Ltd
HF26, Hal Far Industrial Estate, Hal Far, Birzebbugia, BBG3000, Malta
Generis Farmacêutica SA
Rua João de Deus, n. 19, Venda Nova, 2700-487 Amadora, Portugal

This medicinal product is authorized in the European Economic Area Member States under the following names:
Germany: Dimethylfumarat Puren Pharma 120 mg/240 mg magensaftresistente Hartkapseln
Italy: Dimetilfumarato Aurobindo
Portugal: Fumarato de dimetilo Generis Phar