DIMETHYL 240 mg Capsules

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Dimethyl Fumarate Aurovitas, 120 mg, Gastro-Resistant Hard Capsules
3. Dimethyl Fumarate Aurovitas, 240 mg, Gastro-Resistant Hard Capsules
   1. Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.
   2. Package Leaflet Contents:
4. What is Dimethyl Fumarate Aurovitas and What is it Used for
   1. What is Dimethyl Fumarate Aurovitas
   2. What is Dimethyl Fumarate Aurovitas Used for
   3. Dimethyl Fumarate Aurovitas is Used to Treat Relapsing-Remitting Multiple Sclerosis (MS) in Patients Aged 13 Years and Older.
   4. How Dimethyl Fumarate Aurovitas Works
5. Important Information Before Taking Dimethyl Fumarate Aurovitas
   1. When Not to Take Dimethyl Fumarate Aurovitas:
   2. Warnings and Precautions
   3. Children and Adolescents
   4. Dimethyl Fumarate Aurovitas and Other Medications
   5. Dimethyl Fumarate Aurovitas and Alcohol
   6. Pregnancy and Breastfeeding
   7. Driving and Using Machines
   8. Dimethyl Fumarate Aurovitas Contains Sodium
6. How to Take Dimethyl Fumarate Aurovitas
   1. Initial Dose: 120 mg Twice a Day.
   2. Recommended Dose: 240 mg Twice a Day.
   3. Taking a Higher Dose of Dimethyl Fumarate Aurovitas than Recommended
   4. Missing a Dose of Dimethyl Fumarate Aurovitas
7. Possible Undesirable Effects
   1. Severe Undesirable Effects
   2. Severe Allergic Reactions
   3. Stop Taking Dimethyl Fumarate Aurovitas and Immediately Contact a Doctor
   4. Other Undesirable Effects
   5. Children (Aged 13 and Above) and Adolescents
   6. Reporting Undesirable Effects
8. How to Store Dimethyl Fumarate Aurovitas
9. Package Contents and Other Information
   1. What Dimethyl Fumarate Aurovitas Contains
   2. What Dimethyl Fumarate Aurovitas Looks Like and Contents of the Package
   3. Package Sizes:
   4. Marketing Authorization Holder and Manufacturer/Importer
   5. Marketing Authorization Holder:
   6. Manufacturer/Importer:
   7. This Medication is Authorized for Marketing in the Member States of the European Economic Area Under the Following Names:
   8. Date of Last Revision of the Package Leaflet: 02/2025

Package Leaflet: Information for the User

Dimethyl Fumarate Aurovitas, 120 mg, Gastro-Resistant Hard Capsules

Dimethyl Fumarate Aurovitas, 240 mg, Gastro-Resistant Hard Capsules

Dimethyl Fumarate

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this Package Leaflet, as You May Need to Read it Again.
• In Case of Any Doubts, Consult a Doctor or Pharmacist.
• This Medication has been Prescribed Specifically for You. Do Not Pass it on to Others. The Medication may Harm Another Person, even if their Symptoms are the Same.
• If the Patient Experiences any Undesirable Effects, Including those Not Mentioned in this Package Leaflet, they Should Inform their Doctor or Pharmacist. See Section 4.

Package Leaflet Contents:

• 1. What is Dimethyl Fumarate Aurovitas and What is it Used for
• 2. Important Information Before Taking Dimethyl Fumarate Aurovitas
• 3. How to Take Dimethyl Fumarate Aurovitas
• 4. Possible Undesirable Effects
• 5. How to Store Dimethyl Fumarate Aurovitas
• 6. Package Contents and Other Information

1. What is Dimethyl Fumarate Aurovitas and What is it Used for

What is Dimethyl Fumarate Aurovitas

Dimethyl Fumarate Aurovitas is a Medication Containing the Active Substance Dimethyl Fumarate.

What is Dimethyl Fumarate Aurovitas Used for

Dimethyl Fumarate Aurovitas is Used to Treat Relapsing-Remitting Multiple Sclerosis (MS) 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 Exacerbations of Neurological Symptoms. Symptoms Vary Among Patients but Typically Include Walking Difficulties, Balance Problems, and Vision Disturbances (e.g., Blurred or Double Vision). These Symptoms may Completely Resolve after an Exacerbation, but Some Problems may Persist.

How Dimethyl Fumarate Aurovitas Works

Dimethyl Fumarate Aurovitas Appears to Work by Inhibiting the Immune System from Causing Damage to the Brain and Spinal Cord. This may also Help Slow Down the Progression of Multiple Sclerosis in the Future.

2. Important Information Before Taking Dimethyl Fumarate Aurovitas

When Not to Take Dimethyl Fumarate Aurovitas:

• If the Patient is Allergic to Dimethyl Fumarateor any of the Other Ingredients of this Medication (Listed in Section 6).
• If the Patient is Suspected or Confirmed to have a Rare Brain Infection Called Progressive Multifocal Leukoencephalopathy (PML).

Warnings and Precautions

Before Starting Treatment with Dimethyl Fumarate Aurovitas, Discuss it with a Doctor or Pharmacist.
Dimethyl Fumarate Aurovitas may Affect White Blood Cell Count, Kidney Function, and Liver Function. Before Starting Treatment with Dimethyl Fumarate Aurovitas, the Doctor will Check the Patient's White Blood Cell Count and Ensure that 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 Additional Tests or Discontinue Treatment.
Before Starting Treatment with Dimethyl Fumarate Aurovitas, Discuss it with a Doctorif the Patient has:

• Severe Kidney Disease
• Severe Liver Disease
• Stomach or Intestinal Disease
• Severe Infection(e.g., Pneumonia)

During Treatment with Dimethyl Fumarate Aurovitas, Shingles may Occur. In Some Cases, Severe Complications have Occurred. If the Patient Suspects any Symptoms of Shingles, such as Blisters, Burning, Itching, or Pain on the Skin, Typically on one Side of the Upper Body or Face, and Other Symptoms like Fever and Weakness, they Should Immediately Inform their Doctor.
If Multiple Sclerosis Worsens (e.g., the Patient Experiences Weakness or Vision Disturbances) or New Symptoms Appear, the Patient Should Immediately Contact their Doctor, as these may be Symptoms of a Rare Brain Infection Called PML. PML is a Serious Disease that can Lead to Severe Disability or Death.
During Treatment with a Medication Containing Dimethyl Fumarate in Combination with Other Fumaric Acid Esters Used to Treat Psoriasis (a Skin Disease), Rare but Severe Kidney Damage Called Fanconi Syndrome has been Reported. If the Patient Notices that they are Producing More Urine, Feeling Thirsty, and Drinking More than Usual, their Muscles seem Weaker, they Experience a Fracture, or Simply Feel Pain, they Should Consult their Doctor as Soon as Possibleto Investigate these Symptoms.

Children and Adolescents

This Medication Should Not be Given to Children Under 10 Years of Age, as there is No Data Available for this Age Group.

Dimethyl Fumarate Aurovitas and Other Medications

Tell the Doctor or Pharmacistabout all Medications the Patient is Currently Taking or has Recently Taken, and any Medications they Plan to Take, Especially:

• Medications Containing Fumaric Acid Esters(Fumarates) Used to Treat Psoriasis
• Medications that Affect the Immune System, Including Chemotherapy, Immunosuppressive Medications, or Other Medications Used to Treat Multiple Sclerosis
• Medications that Affect the Kidneys, such as Certain Antibiotics(Used to Treat Infections), Diuretics, Certain Types of Pain Relievers(e.g., Ibuprofen and Similar Anti-Inflammatory Medications, Including those Available Over-the-Counter), and Medications Containing Lithium
• Certain Vaccines(Live Vaccines) Should be Avoided During Treatment with Dimethyl Fumarate Aurovitas, as they may Cause Infection. The Doctor will Advise on Whether to Use a Different Type of Vaccine (Inactivated Vaccines).

Dimethyl Fumarate Aurovitas and Alcohol

Avoid Consuming High-Percentage Alcoholic Beverages (More than 30% Alcohol by Volume) (More than 50 mL) Within an Hour of Taking Dimethyl Fumarate Aurovitas, Due to the Risk of Interaction Between Alcohol and this Medication. This may Lead to Gastritis (Inflammation of the Stomach Lining), Especially in Individuals Prone to this Condition.

Pregnancy and Breastfeeding

If the Patient is Pregnant or Breastfeeding, Thinks they may be Pregnant, or Plans to Have a Child, they Should Consult a Doctor or Pharmacist Before Taking this Medication.
Pregnancy
There is Limited Data on the Use of this Medication in Pregnant Women. Dimethyl Fumarate Aurovitas Should Not be Taken During Pregnancy, Unless the Patient has Discussed it with their Doctor and the Use of the Medication is Necessary.
Breastfeeding
It is Not Known if the Active Substance of Dimethyl Fumarate Aurovitas Passes into Human Milk. The Doctor will Advise the Patient on Whether to Stop Breastfeeding or Stop Taking Dimethyl Fumarate Aurovitas. The Decision will be Based on the Assessment of the Benefits of Breastfeeding for the Baby Compared to the Benefits of Treatment for the Patient.

Driving and Using Machines

It is Not Expected that Dimethyl Fumarate Aurovitas will Affect the Ability to Drive or Use Machines.

Dimethyl Fumarate Aurovitas Contains Sodium

This Medication Contains Less than 1 mmol (23 mg) of Sodium per Capsule, Which Means that Dimethyl Fumarate Aurovitas is Considered "Sodium-Free".

3. How to Take Dimethyl Fumarate Aurovitas

Always Take this Medication Exactly as the Doctor has Told you. If you are Not Sure, Check with your Doctor.

Initial Dose: 120 mg Twice a Day.

This Initial Dose Should be Taken for the First 7 Days, and then the Recommended Dose Should be Taken.

Recommended Dose: 240 mg Twice a Day.

Dimethyl Fumarate Aurovitas Should be Taken Orally.
Swallow Each Capsule Whole, with a Glass of Water. Do Not Divide, Crush, Dissolve, Suck, or Chew the Capsules, as this may Increase Certain Undesirable Effects.
Take Dimethyl Fumarate Aurovitas with Food– this will Help Reduce Very Common Undesirable Effects (Listed in Section 4).

Taking a Higher Dose of Dimethyl Fumarate Aurovitas than Recommended

If More Capsules of Dimethyl Fumarate Aurovitas are Taken than Recommended, Immediately Contact a Doctor. Undesirable Effects Similar to those Described Below in Section 4 may Occur.

Missing a Dose of Dimethyl Fumarate Aurovitas

Do Not Take a Double Doseto Make up for a Missed Dose.
A Missed Dose can be Taken if at Least a 4-Hour Interval is Maintained Between Doses. If it is Too Late, Do Not Take the Missed Dose, but Take the Next Dose at the Usual Time.
If you have any Further Questions on the Use of this Medication, Consult a Doctor or Pharmacist.

4. Possible Undesirable Effects

Like all Medications, Dimethyl Fumarate Aurovitas can Cause Undesirable Effects, although Not Everybody gets them.

Severe Undesirable Effects

Dimethyl Fumarate Aurovitas may Decrease the Number of Lymphocytes (a Type of White Blood Cell). A Low White Blood Cell Count can 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 After 1 to 5 Years of Treatment, so the Doctor will Monitor the Patient's White Blood Cell Count Throughout the Treatment Period, and the Patient Should be Aware of the Symptoms Described Below, which may Indicate PML. The Risk of PML may be Higher if the Patient has Previously Taken Medications that Affect the Immune System.

Symptoms of PML may Resemble a Relapse of Multiple Sclerosis. These Include Sudden Weakness or Worsening of Weakness on one Side of the Body, Coordination Problems, Vision Disturbances, Difficulty Thinking or Remembering, Confusion (Disorientation), or Personality Changes, Speech and Communication Difficulties Lasting More than a Few Days. Therefore, if the Patient Experiences a Worsening of Multiple Sclerosis Symptoms or the Appearance of New Symptoms while Taking Dimethyl Fumarate Aurovitas, they Should Immediately Contact their Doctor. They Should also Discuss their Treatment with their Partner or Caregivers and Inform them about their Medication. There may be Symptoms that the Patient is Not Aware of.

• If any of these Symptoms Occur, Immediately Contact a Doctor

Severe Allergic Reactions

The Frequency of Severe Allergic Reactions Cannot be Estimated from the Available Data (Frequency Not Known).
A Very Common Undesirable Effect is Sudden Redness of the Face or Body. If Sudden Redness is Accompanied by a Red Rash or Hives andany 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)

it may Indicate a Severe Allergic Reaction (Anaphylaxis).

Stop Taking Dimethyl Fumarate Aurovitas and Immediately Contact a Doctor

Other Undesirable Effects

Very Common(May Affect More than 1 in 10 People)

• Sudden Redness of the Face or a Feeling of Increased Body Temperature, Heat, Burning, or Itching of the Skin
• Diarrhea
• Nausea
• Stomach Pain or Cramps
• Taking the Medication with Foodwill Help Reduce the Above Undesirable Effects

During Treatment with Dimethyl Fumarate Aurovitas, Substances Called Ketone Bodies are Very Commonly Detected in Urine Tests, which are Naturally Produced in the Body.
Discuss with a Doctorhow to Manage Undesirable Effects. The Doctor may Reduce the Dose of the Medication. Do Not Reduce the Dose of the Medication Unless the Doctor Advises it.
Common(May Affect Up to 1 in 10 People)

• Gastroenteritis (Gastrointestinal Inflammation)
• Vomiting
• Indigestion
• Gastritis (Inflammation of the Stomach Lining)
• Gastrointestinal Disorders
• Burning Sensation of the Skin
• Hot Flashes, Feeling of Heat
• Itching of the Skin (Pruritus)
• Rash
• Pink or Red Spots on the Skin (Erythema)
• Excessive Hair Loss (Alopecia)

Undesirable Effects that may Appear in Blood or Urine Test Results

• Low White Blood Cell Count (Lymphopenia, Leukopenia). A Decreased White Blood Cell Count may Indicate that the Body is Less Able to Fight Infection. In Case of Severe Infection (such as Pneumonia), Immediately Contact a Doctor.
• Protein (Albumin) in the Urine
• Increased Liver Enzyme Activity (ALT, AST) in the Blood

Uncommon(May Affect Up to 1 in 100 People)

• Allergic Reactions (Hypersensitivity)
• Decreased Platelet Count

Rare(May Affect Up to 1 in 1,000 People)

• Hepatitis and Increased Liver Enzyme Activity (ALT or AST in Combination with Bilirubin)

Frequency Not Known(Cannot be Estimated from the Available Data)

• Shingles, with Symptoms such as Blisters, Burning, Itching, or Pain on the Skin, Typically on one Side of the Upper Body or Face, and Other Symptoms like Fever and Weakness, Followed by Numbness, Itching, or Red Spots with Severe Pain
• Rhinitis (Inflammation of the Nasal Mucosa)

Children (Aged 13 and Above) and Adolescents

The Above Undesirable Effects also Apply to Children and Adolescents.
Certain Undesirable Effects have been Reported More Frequently in Children and Adolescents than in Adults, such as Headache, Stomach Pain or Cramps, Nausea (Vomiting), Sore Throat, Cough, and Painful Menstruation.

Reporting Undesirable Effects

If any Undesirable Effects Occur, Including those Not Mentioned in this Package Leaflet, Inform a Doctor or Pharmacist. Undesirable Effects can be Reported Directly to the Department of Adverse Reaction Monitoring 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
Undesirable Effects can also be Reported to the Marketing Authorization Holder.
Reporting Undesirable Effects will Help to Gather More Information on the Safety of this Medication.

5. How to Store Dimethyl Fumarate Aurovitas

Keep the Medication Out of Sight and Reach of Children.
Do Not Use this Medication After the Expiration Date Stated on the Blister and Carton: EXP.
The Expiration Date Refers to the Last Day of the Month.
There are No Special Storage Instructions for this Medication.
Medications Should Not be Disposed of via Wastewater or Household Waste. Ask a Pharmacist how to Dispose of Medications that are No Longer Needed. This will Help Protect the Environment.

6. Package Contents and Other Information

What Dimethyl Fumarate Aurovitas Contains

• The Active Substance of Dimethyl Fumarate Aurovitas is Dimethyl Fumarate. Each Capsule Contains 120 mg of Dimethyl Fumarate. Each Capsule Contains 240 mg of Dimethyl Fumarate.
• Other Ingredients are:Capsule Contents:Microcrystalline Cellulose, Silicon Dioxide, Croscarmellose Sodium, Colloidal Anhydrous Silica, Magnesium Stearate, Methacrylic Acid and Methyl Methacrylate Copolymer (1:1), Methacrylic Acid and Ethyl Acrylate Copolymer (1:1), 30% Dispersion (0.7% Sodium Lauryl Sulfate and 2.3% Polysorbate 80), Triethyl Citrate, and Talc.

Capsule Shell:
Cap and Body:
Brilliant Blue FCF (E 132) (Only for 240 mg Dose), Yellow Iron Oxide (E 172) (Only for 240 mg Dose), Titanium Dioxide (E 171), Gelatin, Purified Water, and Sodium Lauryl Sulfate.
Black Ink for Printing:Shellac (E 904), Black Iron Oxide (E 172), and Potassium Hydroxide (E 525).

• 525).

What Dimethyl Fumarate Aurovitas Looks Like and Contents of the Package

Gastro-Resistant Hard Capsules
Dimethyl Fumarate Aurovitas, 120 mg, Gastro-Resistant Hard Capsules
Hard Gelatin Capsules, Size "0", with a White Cap and White Body, with "DMT 120" Printed on the Body in Black Ink. Each Capsule Contains Three White or Almost White, Round, Biconvex, Enteric-Coated Tablets.
Dimethyl Fumarate Aurovitas, 240 mg, Gastro-Resistant Hard Capsules
Hard Gelatin Capsules, Size "0", with a Green Cap and Green Body, with "DMT 240" Printed on the Body in Black Ink. Each Capsule Contains Six White or Almost White, Round, Biconvex, Enteric-Coated Tablets.

Package Sizes:

Blisters:14, 28, 56, 60, 98, 100, 112, 120, 168, and 196 Gastro-Resistant Hard Capsules.
Not All Package Sizes may be Marketed.

Marketing Authorization Holder and Manufacturer/Importer

Marketing Authorization Holder:

Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 27
01-909 Warsaw
e-mail: [email protected]

Manufacturer/Importer:

APL Swift Services (Malta) Ltd.
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
Generis Farmacêutica, S.A.
Rua João de Deus n° 19, Venda Nova
2700-487 Amadora
Portugal
Arrow Génériques
26 Avenue Tony Garnier
69007 Lyon
France

This Medication is Authorized for Marketing in the Member States of the European Economic Area Under the Following Names:

Belgium:
Dimethyl Fumarate AB 120 mg/240 mg Hard Gastro-Resistant Capsules / Gélules Gastro-Résistantes / Magensaftresistente Hartkapseln
France:
Dimethyl Fumarate Arrow 120 mg/240 mg Gélule Gastro-Résistante
Germany:
Dimethylfumarat PUREN 120 mg/240 mg Magensaftresistente Hartkapseln
Netherlands:
Dimethylfumaraat Aurobindo 120mg/240mg, Hard Gastro-Resistant Capsules
Poland:
Dimethyl Fumarate Aurovitas
Portugal:
Fumarato de Dimetilo Aurobindo
Spain:
Fumarato de Dimetilo Aurovitas 240 mg Cápsulas Duras Gastrorresistentes EFG

Date of Last Revision of the Package Leaflet: 02/2025