ADIFEMU 120 mg Capsules

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Adifemu, 120 mg, Gastro-Resistant Hard Capsules
3. Adifemu, 240 mg, Gastro-Resistant Hard Capsules
   1. You Should Carefully Read the Contents of This Leaflet Before Taking the Medication, as it Contains Important Information for the Patient.
   2. Table of Contents of the Leaflet
4. What is Adifemu and What is it Used for
   1. What is Adifemu
   2. What is Adifemu Used for
   3. Adifemu is Used to Treat Relapsing-Remitting Multiple Sclerosis (MS) in Patients Aged 13 Years and Older.
   4. How Adifemu Works
5. Important Information Before Taking Adifemu
   1. When Not to Take Adifemu
   2. Warnings and Precautions
   3. Children and Adolescents
   4. Adifemu and Other Medications
   5. Adifemu and Alcohol
   6. Pregnancy and Breastfeeding
   7. Driving and Operating Machinery
   8. Adifemu Contains Sodium
6. How to Take Adifemu
   1. Initial Dose
   2. 120 mg Twice a Day.
   3. Usual Dose
   4. 240 mg Twice a Day.
   5. Taking a Higher Dose of Adifemu than Recommended
   6. Missing a Dose of Adifemu
7. Possible Side Effects
   1. Severe Side Effects
   2. Severe Allergic Reactions
   3. Very Common Side Effects
   4. Common Side Effects
   5. Uncommon Side Effects
   6. Children (Aged 13 and Above) and Adolescents
   7. Reporting Side Effects
8. How to Store Adifemu
9. Contents of the Pack and Other Information
   1. What Adifemu Contains
   2. What Adifemu Looks Like and Contents of the Pack
   3. Marketing Authorization Holder and Manufacturer
   4. This Medication is Authorized for Marketing in the Member States of the European Economic Area Under the Following Names:
   5. Date of Last Revision of the Leaflet:

Package Leaflet: Information for the Patient

Adifemu, 120 mg, Gastro-Resistant Hard Capsules

Adifemu, 240 mg, Gastro-Resistant Hard Capsules

Dimethyl Fumarate

You Should Carefully Read the Contents of This Leaflet Before Taking the Medication, as it Contains Important Information for the Patient.

• You Should Keep This Leaflet, so You Can Read it Again if You Need to.
• If You Have Any Further Questions, Please Ask Your Doctor or Pharmacist.
• This Medication Has Been Prescribed Specifically for You. Do Not Pass it on to Others. The Medication May Harm Them, Even if Their Symptoms are the Same as Yours.
• If You Experience Any Side Effects, Including Those Not Mentioned in This Leaflet, Please Inform Your Doctor or Pharmacist. See Section 4.

Table of Contents of the Leaflet

• 1. What is Adifemu and What is it Used for
• 2. Important Information Before Taking Adifemu
• 3. How to Take Adifemu
• 4. Possible Side Effects
• 5. How to Store Adifemu
• 6. Contents of the Pack and Other Information

1. What is Adifemu and What is it Used for

What is Adifemu

Adifemu is a Medication Containing Dimethyl Fumarate as the Active Substance.

What is Adifemu Used for

Adifemu 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 (Called Relapses). Symptoms Vary Among Patients, but Typically Include Difficulty Walking and Balance, as Well as Vision Problems (Such as Blurred or Double Vision). These Symptoms May Completely Disappear After a Relapse, but Some Problems May Persist.

How Adifemu Works

Adifemu Appears to Prevent the Immune System from Causing Damage to the Brain and Spinal Cord, Which May Also Help Slow Down the Progression of the Disease in the Future.

2. Important Information Before Taking Adifemu

When Not to Take Adifemu

• If You are Allergic to Dimethyl Fumarateor Any of the Other Ingredients of This Medication (Listed in Section 6).
• If You Suspect or Have Been Diagnosed with a Rare Brain Infection Called Progressive Multifocal Leukoencephalopathy (PML)

Progressive Multifocal Leukoencephalopathy (PML)

Warnings and Precautions

Adifemu May Affect Your White Blood Cell Countand the Function of Your Kidneysand Liver. Before Starting Treatment with Adifemu, Your Doctor Will Check Your White Blood Cell Count and Ensure Your Kidneys and Liver are Functioning Properly. These Tests Will be Performed Periodically During Treatment. If Your White Blood Cell Count Decreases During Treatment, Your Doctor May Consider Additional Tests or Discontinue Treatment.
Before Taking Adifemu, You Should Discuss with Your Doctor if You Have:

• Severe Kidney Disease
• Severe Liver Disease
• Stomach or Intestinal Disease
• Severe Infection(Such as Pneumonia).

While Taking Adifemu, You May Experience Shingles. In Some Cases, Severe Complications Have Occurred. If You Suspect You Have Symptoms of Shingles, You Must Inform Your Doctor Immediately.
If Your Multiple Sclerosis Worsens (Such as Weakness or Vision Problems) or You Experience Any New Symptoms, You Should Contact Your Doctor Immediately, as These May be Symptoms of a Rare Brain Infection Called Progressive Multifocal Leukoencephalopathy (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 Serious Kidney Damage (Fanconi Syndrome) Has Been Reported. If You Notice You are Producing More Urine, Feeling Thirstier, and Drinking More Than Usual, Your Muscles Feel Weaker, You Have a Fracture or Simply Feel Pain, You Should See Your Doctor as Soon as Possible to Investigate These Symptoms.

Children and Adolescents

The Above Warnings and Precautions Also Apply to Children. Adifemu Can be Used in Children and Adolescents Aged 13 Years and Older. Data on Children Under 10 Years of Age are Not Available.

Adifemu and Other Medications

You Must Inform Your Doctor or PharmacistAbout All Medications You are Currently Taking or Have Recently Taken, as Well as Any Medications You Plan to Take, Especially:

• Medications Containing Fumaric Acid Esters(Fumarates) Used to Treat Psoriasis;
• Medications Affecting the Immune System, Including Other Medications Used to Treat Multiple Sclerosis, Such as Fingolimod, Natalizumab, Teriflunomide, Alemtuzumab, Ocrelizumab, or Cladribine, and Some Medications Commonly Used to Treat Cancer(Rituximab or Mitoxantrone);
• Medications Affecting the Kidneys, Including Certain Antibiotics(Used to Treat Infections), Diuretics(Diuretics), Certain Types of Pain Relievers(Such as Ibuprofen and Other Similar Anti-Inflammatory Medications and Over-the-Counter Medications), and Medications Containing Lithium
• The Use of Certain Vaccines (Vaccines Containing Live Microorganisms) During Treatment with Adifemu May Cause Infection, So it Should be Avoided. Your Doctor Will Advise Whether to Administer Vaccines of Another Type (Vaccines Containing Inactivated Microorganisms).

Adifemu and Alcohol

You Should Avoid Consuming High-Percentage Alcoholic Beverages (More than 30% Alcohol by Volume) in Quantities Greater than 50 ml Within an Hour of Taking Adifemu, Due to the Risk of Interaction Between Alcohol and This Medication. This May Lead to the Onset of Gastritis (Inflammation of the Gastric Mucosa), Especially in Individuals Prone to this Disease.

Pregnancy and Breastfeeding

If You are Pregnant or Breastfeeding, Think You May be Pregnant, or Plan to Have a Child, You Should Consult Your Doctor or Pharmacist Before Taking this Medication.
Pregnancy
Adifemu Should Not be Taken During Pregnancy, Unless You Have Discussed it with Your Doctor.
Breastfeeding
It is Not Known Whether the Active Substance of Adifemu Passes into Human Milk. Adifemu Should Not be Taken During Breastfeeding. Your Doctor Will Help You Decide Whether to Stop Breastfeeding or Discontinue Adifemu. The Decision Will be Made Based on the Assessment of the Benefits of Breastfeeding for the Child Compared to the Benefits of Treatment for the Patient.

Driving and Operating Machinery

The Effect of Adifemu on the Ability to Drive and Operate Machinery is Not Known. It is Not Expected that Adifemu Will Affect the Ability to Drive and Operate Machinery.

Adifemu Contains Sodium

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

3. How to Take Adifemu

This Medication Should Always be Taken as Directed by Your Doctor. If You Have Any Questions, You Should Consult Your Doctor.

Initial Dose

120 mg Twice a Day.

This Initial Dose Should be Taken for the First 7 Days, and Then the Usual Dose Should be Taken.

Usual Dose

240 mg Twice a Day.

Adifemu Should be Taken Orally.
Each Capsule Should be Swallowed Whole, with a Glass of Water. The Capsules Should Not be Divided, Crushed, Dissolved, Sucked, or Chewed, as This May Increase Certain Side Effects.
Adifemu Should be Taken with Food– This Will Help Alleviate the Very Common Side Effects (Listed in Section 4).

Taking a Higher Dose of Adifemu than Recommended

If You Have Taken More Capsules than Recommended, You Should Inform Your Doctor Immediately. Side Effects Similar to Those Described Below in Section 4 May Occur.

Missing a Dose of Adifemu

You Should Not Take a Double Doseto Make Up for a Missed Dose.
A Missed Dose Can be Taken Later, Provided a 4-Hour Interval is Maintained Before the Next Dose. In Any Other Case, the Next Dose Should be Taken at the Usual Time.
If You Have Any Further Questions About Taking this Medication, You Should Consult Your Doctor or Pharmacist.

4. Possible Side Effects

Like All Medications, Adifemu Can Cause Side Effects, Although Not Everybody Gets Them.

Severe Side Effects

Adifemu 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 Your Doctor Should Monitor Your White Blood Cell Count Throughout the Treatment Period, and You Should Pay Attention to the Symptoms Described Below, Which May Indicate PML. The Risk of Developing PML May be Higher if You Have Previously Taken Medications that Affect the Immune System.

• Symptoms of PML May Resemble Those of a Relapse of Multiple Sclerosis. These Include Weakness or Increased Weakness on One Side of the Body, Coordination Problems, Vision Problems, Changes in Thinking or Memory, Confusion (Disorientation) or Personality Changes, Speech and Communication Difficulties Lasting More than a Few Days. For this Reason, if You Experience a Worsening of Your Multiple Sclerosis Symptoms or the Onset of Any New Symptoms While Taking Adifemu, You Should Contact Your Doctor as Soon as Possible. You Should Also Discuss Your Treatment with Your Partner or Caregivers and Inform Them About Your Medication. You May Not be Aware of Certain Symptoms.

Severe Allergic Reactions

The Frequency of Severe Allergic Reactions Cannot be Determined from the Available Data (Unknown).
A Very Common Side Effect is Sudden (Paroxysmal) Redness of the Face or Body. If This 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).
→ You Should Discontinue Adifemu and Contact Your Doctor Immediately

Very Common Side Effects

These Symptoms May Occur More Often than 1 in 10 People:

• Redness of the Skin on the Face or a Feeling of Increased Body Temperature, Heat, Burning of the Skin, or Itching of the Skin (Paroxysmal Redness)
• Diarrhea (Diarrhea)
• Nausea (Nausea)
• Stomach Pain or Cramps
• Taking Adifemu with FoodWill Help Alleviate the Above Side Effects. During Treatment with Adifemu, the Presence of Ketone Bodies (Substances Normally Produced in the Body) in the Urine is Very Common.

You Should Ask Your DoctorHow to Deal with These Side Effects. Your Doctor May Reduce the Dose of Adifemu. You Should Not Reduce the Dose Yourself, Unless Your Doctor Advises You to Do So.

Common Side Effects

These May Occur in 1 in 10 People, but No More Often:

• Gastroenteritis (Gastroenteritis)
• Vomiting
• Indigestion
• Gastritis (Gastritis)
• 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)
• Hair Loss (Alopecia)

Side Effects that May be Visible in Blood or Urine Test Results

• Low White Blood Cell Count (Lymphopenia, Leukopenia). A Decreased White Blood Cell Count May Mean that the Body is Less Able to Fight Infection. In Case of Severe Infection (Such as Pneumonia), You Should Contact Your Doctor Immediately;
• Protein (Albumin) in the Urine;
• Increased Activity of Liver Enzymes (ALT, AST) in the Blood.

Uncommon Side Effects

These May Occur in 1 in 100 People, but No More Often:

• Allergic Reactions (Hypersensitivity)
• Decreased Platelet Count

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

• Hepatitis and Increased Liver Enzyme Activity (ALT or ASTTogether with Bilirubin)
• Shingles, with Symptoms Such as Blisters on the Skin, Burning, Itching, or Pain of the Skin, Usually on One Side of the Upper Body or Face, and Other Symptoms, Such as Fever and Weakness in the Early Stages of Infection, and Then Numbness, Itching, or Red Spots, and Severe Pain
• Rhinitis (Rhinitis)

Children (Aged 13 and Above) and Adolescents

The Above Side Effects Also Apply to Children and Adolescents.
Certain Side Effects Have Been Reported More Frequently in Children and Adolescents than in Adults, Such as Headache, Abdominal Pain or Stomach Cramps, Vomiting, Sore Throat, Cough, and Painful Menstruation.

Reporting Side Effects

If You Experience Any Side Effects, Including Those Not Mentioned in This Leaflet, You Should Inform Your Doctor or Pharmacist, or Nurse.
Side 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
Side Effects Can Also be Reported to the Marketing Authorization Holder.
Reporting Side Effects Will Help Gather More Information on the Safety of the Medication.

5. How to Store Adifemu

The Medication Should be Stored in a Place that is Inaccessible to Children.
Do Not Use this Medication After the Expiration Date Stated on the Blister Pack and Carton After: "EXP". The Expiration Date Refers to the Last Day of the Month.
There are No Special Precautions for Storing the Medication.
Medications Should Not be Disposed of in Sewers or Household Waste. You Should Ask Your Pharmacist How to Dispose of Medications that are No Longer Needed. This Will Help Protect the Environment.

6. Contents of the Pack and Other Information

What Adifemu Contains

The Active Substance of Adifemu is Dimethyl Fumarate.
Adifemu, 120 mg: Each Capsule Contains 120 mg of Dimethyl Fumarate.
Adifemu, 240 mg: Each Capsule Contains 240 mg of Dimethyl Fumarate.
Other Ingredientsare:
Enteric-Coated Pellets: Microcrystalline Cellulose, Sodium Carboxymethylcellulose, Talc, Silicon Dioxide, Magnesium Stearate, Triethyl Citrate, Methacrylic Acid and Methyl Methacrylate Copolymer (1:1), Methacrylic Acid and Ethyl Acrylate Copolymer (1:1), 30% Dispersion.
Capsule Shell: Gelatin, Titanium Dioxide (E171), Brilliant Blue FCF (E133), Yellow Iron Oxide (E172), Black Iron Oxide (E172).
Capsule Print (Black Ink): Shellac (20% Esterified), Propylene Glycol (E1520), Black Iron Oxide (E172).

What Adifemu Looks Like and Contents of the Pack

Adifemu 120 mg are Hard Gastro-Resistant Capsules with a Light Green Opaque Cap and a White Opaque Body, 21.4 ± 0.4 mm in Length, 7.4 ± 0.4 mm in Width, with "120" Printed on the Body in Black Ink, Containing Enteric-Coated Pellets.
Adifemu 240 mg are Hard Gastro-Resistant Capsules with a Light Green Opaque Cap and a Light Green Opaque Body, 21.4 ± 0.4 mm in Length, 7.4 ± 0.4 mm in Width, with "240" Printed on the Body in Black Ink, Containing Enteric-Coated Pellets.
Pack Sizes:
Adifemu, 120 mg, Gastro-Resistant Hard Capsules are Available in Packs Containing 14, 28, 56, 84, 98 Capsules.
Adifemu, 240 mg, Gastro-Resistant Hard Capsules are Available in Packs Containing 14, 28, 56, 84, 98 or 168 Capsules.
Not All Pack Sizes May be Marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder
Vipharm S.A.
ul. A. i F. Radziwiłłów 9
05-850 Ożarów Mazowiecki
tel.: +48 22 679 51 35
e-mail: [email protected]
Manufacturer
Pharmathen International S.A.
Industrial Park Sapes
Block No 5
69300 Rodopi
Greece
Pharmathen S.A.
Dervenakion 6
15351 Pallini, Attiki
Greece

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

Germany
Adifemu 120 mg
Adifemu 240 mg
Czech Republic
Adifemu
Poland
Adifemu
Hungary
Adifemu 120 mg Gastro-Resistant Hard Capsules
Adifemu 240 mg Gastro-Resistant Hard Capsules
Slovakia
Adifemu 120 mg
Adifemu 240 mg

Date of Last Revision of the Leaflet: