Dimethil fumarate Polpharma

Package Leaflet: Information for the Patient

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

Dimethyl Fumarate Polpharma, 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 Others, even if their Symptoms are the Same.
• If the Patient Experiences any Adverse Reactions, including those not Listed in this Package Leaflet, Inform a Doctor or Pharmacist. See Section 4.

Package Leaflet Contents

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

1. What is Dimethyl Fumarate Polpharma and what is it Used for

What is Dimethyl Fumarate Polpharma

Dimethyl Fumarate Polpharma is a Medication Containing Dimethyl Fumarate.

What is Dimethyl Fumarate Polpharma Used for

Dimethyl Fumarate Polpharma 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 from Person to Person, but Typically Include Difficulty Walking and Balance, as well as Vision Impairment (e.g., Blurred or Double Vision). These Symptoms may Completely Disappear after a Relapse, but some Problems may Persist.

How Dimethyl Fumarate Polpharma Works

Dimethyl Fumarate Polpharma Appears to Inhibit the Immune System from Causing Damage to the Brain and Spinal Cord, which may also Help Slow the Progression of the Disease in the Future.

2. Important Information Before Taking Dimethyl Fumarate Polpharma

When Not to Take Dimethyl Fumarate Polpharma

• 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

Dimethyl Fumarate Polpharma may Adversely Affect White Blood Cell Countand Kidney and Liver Function. Before Starting Treatment with Dimethyl Fumarate Polpharma, 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 Taking Dimethyl Fumarate Polpharma, Discuss with the Doctorif the Patient has:

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

During Treatment with Dimethyl Fumarate Polpharma, Shingles may Occur. In some Cases, Severe Complications have Occurred. If the Patient Suspects any Symptoms of Shingles, Inform the Doctor Immediately. If the Patient Experiences a Relapse of Multiple Sclerosis (e.g., Weakness or Vision Impairment) or New Symptoms, they should Contact the Doctor Immediately, 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.

Children and Adolescents

Do Not Give this Medication to Children Under 10 Years of Age, as there is Limited Data Available for this Age Group.

Dimethyl Fumarate Polpharma and Other Medications

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

• Medications Containing Fumaric Acid Esters(Fumarates) Used to Treat Psoriasis;
• Medications that Affect the Immune System, including Chemotherapy, Immunosuppressants, or other Medications Used to Treat Multiple Sclerosis;
• Medications that Affect Kidney Function, including certain Antibiotics (Used to Treat Infections), Diuretics, certain Pain Relievers (such as Ibuprofen and similar Anti-Inflammatory Medications), and Medications Containing Lithium;
• Taking certain Vaccines (Live Vaccines) During Treatment with Dimethyl Fumarate Polpharma may Cause Infection, so this should be Avoided. The Doctor will Advise on whether to Give other Types of Vaccines (Inactivated Vaccines).

Dimethyl Fumarate Polpharma and Alcohol

Avoid Consuming High-Percentage Alcoholic Beverages (over 30% Alcohol by Volume) in Excess of 50 ml within 1 Hour of Taking Dimethyl Fumarate Polpharma, due to the Risk of Interaction between Alcohol and this Medication, which may Lead to Stomach Upset (Gastritis), especially in People Prone to this Condition.

Pregnancy and Breastfeeding

If the Patient is Pregnant or Breastfeeding, or 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 Polpharma should Not be Taken During Pregnancy, unless the Patient has Discussed it with their Doctor and the Benefits of Treatment Outweigh the Risks.

Breastfeeding

It is Not Known if the Active Substance of Dimethyl Fumarate Polpharma Passes into Breast Milk. The Doctor will Advise the Patient whether to Stop Breastfeeding or Discontinue Dimethyl Fumarate Polpharma. The Decision will be Based on the Assessment of the Benefits of Breastfeeding to the Baby Compared to the Benefits of Treatment for the Patient.

Driving and Operating Machines

Dimethyl Fumarate Polpharma is Not Expected to Affect the Ability to Drive or Operate Machines.

Dimethyl Fumarate Polpharma Contains Sodium

The Medication Contains Less than 1 mmol (23 mg) of Sodium per Capsule, which means it is Considered "Sodium-Free".

3. How to Take Dimethyl Fumarate Polpharma

Always Take this Medication Exactly as Prescribed by the Doctor. If in Doubt, Consult the 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.

Dimethyl Fumarate Polpharma 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 the Risk of Certain Adverse Reactions.

Take Dimethyl Fumarate Polpharma with Foodto Help Reduce the Risk of Adverse Reactions (listed in Section 4).

Taking More than the Recommended Dose of Dimethyl Fumarate Polpharma

If More than the Recommended Number of Capsules is Taken, Tell the Doctor Immediately. Adverse Reactions Similar to those Described in Section 4 may Occur.

Missing a Dose of Dimethyl Fumarate Polpharma

Do Not Take a Double Doseto Make up for a Missed Dose.

A Missed Dose can be Taken Later, Provided that a 4-Hour Interval is Maintained before the Next Dose. If it is Too Late, Do Not Take the Missed Dose, but Take the Next Dose at the Usual Time.

In Case of Further Doubts about Taking this Medication, Consult the Doctor or Pharmacist.

4. Possible Adverse Reactions

Like all Medications, Dimethyl Fumarate Polpharma can Cause Adverse Reactions, although not Everybody gets them.

Severe Adverse Reactions

Dimethyl Fumarate Polpharma may Reduce the Number of Lymphocytes, a Type of White Blood Cell. A Low White Blood Cell Count can Increase the Risk of Infections, including the Rare Brain Infection called PML. PML can Lead to Severe Disability or Death. PML has been Reported after 1 to 5 Years of Treatment, so the Doctor should Monitor the Patient's White Blood Cell Count Throughout Treatment, 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. They Include:

• Weakness or Increased Weakness on one Side of the Body
• Coordination Problems
• Vision Impairment
• Thinking or Memory Problems
• Confusion (Disorientation) or Personality Changes
• Speech or Communication Difficulties Lasting more than a few Days

If the Patient Experiences any of these Symptoms while Taking Dimethyl Fumarate Polpharma, Inform the Doctor Immediately. Also, Discuss the Treatment with the Partner or Caregivers and Inform them about the Treatment. The Patient may not be Aware of the Symptoms.

If any of these Symptoms Occur, Contact the Doctor Immediately

Severe Allergic Reactions

The Frequency of Severe Allergic Reactions cannot be Determined from the Available Data (Frequency Unknown).

A Very Common Adverse Reaction is Sudden (Acute) 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);
• Dizziness or Loss of Consciousness (Hypotension), this may Indicate a Severe Allergic Reaction (Anaphylaxis).

Stop Taking Dimethyl Fumarate Polpharma and Contact the Doctor Immediately

Other Adverse Reactions

Very Common(may Affect more than 1 in 10 People)

• Redness of the Skin on the Face or Body, or a Feeling of Increased Body Temperature, Heat, Burning, or Itching of the Skin (Flush);
• Diarrhea
• Nausea
• Stomach Pain or Cramps

Taking the Medication with Food will Help Reduce these Adverse Reactions.

During Treatment with Dimethyl Fumarate Polpharma, the Urine Test may Frequently Show Increased Ketone Body Production (Substances Normally Produced in the Body).

Ask the Doctorabout how to Manage Adverse Reactions. The Doctor may Reduce the Dose of the Medication. Do Not Reduce the Dose Yourself, unless the Doctor Advises you to do so.

Common(may Affect up to 1 in 10 People)

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

Adverse Reactions that may Cause Abnormal Blood or Urine Test Results

• Low White Blood Cell Count (Lymphopenia, Leukopenia). A Low White Blood Cell Count may Indicate that the Body is Less Able to Fight Infection. In Case of Severe Infection (e.g., Pneumonia), Contact the Doctor Immediately;
• 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

Frequency Unknown(Cannot be Determined from the Available Data)

• Hepatitis and Increased Liver Enzyme Activity (ALT or AST) with Bilirubin
• Shingles, with Symptoms such as Blisters on the Skin, Burning, Itching, or Pain on 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, followed by Numbness, Itching, or Red Spots and Severe Pain
• Common Cold (Rhinitis)

Children (Aged 13 and Older) and Adolescents

The Adverse Reactions Listed above also Apply to Children and Adolescents.

Certain Adverse Reactions 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 Adverse Reactions

If any Adverse Reactions Occur, including those not Listed in this Package Leaflet, Inform the Doctor, Pharmacist, or Nurse. Adverse Reactions can be Reported Directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products

Al. Jerozolimskie 181C

02-222 Warsaw

Phone: +48 22 49 21 301

Fax: +48 22 49 21 309

Website: https://smz.ezdrowie.gov.pl

Adverse Reactions can also be Reported to the Marketing Authorization Holder.

Reporting Adverse Reactions will Help Gather more Information on the Safety of this Medication.

5. How to Store Dimethyl Fumarate Polpharma

Store the Medication out of Sight and Reach of Children.

Do Not Use this Medication after the Expiration Date Stated on the Carton and Blister. The Expiration Date refers to the Last Day of the Month.

The Label on the Packaging with the Abbreviation EXP Indicates the Expiration Date, and the Label with the Abbreviation Lot/LOT Indicates the Batch Number.

Do Not Store above 30°C.

Medications should Not be Disposed of via Wastewater or Household Waste. Ask the 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 Polpharma Contains

• The Active Substance of the Medication is Dimethyl Fumarate. Dimethyl Fumarate Polpharma 120 mg: each Capsule Contains 120 mg of Dimethyl Fumarate. Dimethyl Fumarate Polpharma 240 mg: each Capsule Contains 240 mg of Dimethyl Fumarate.
• Other Ingredients are: Capsule Filling: Sodium Carboxymethylcellulose, Colloidal Silica, Sodium Stearyl Fumarate, Methacrylic Acid and Methyl Methacrylate Copolymer (1:1), Talc, Triethyl Citrate, Methacrylic Acid and Ethyl Acrylate Copolymer (1:1), Glycerol Monostearate 40-55, Polysorbate 80; Capsule: Gelatin, Titanium Dioxide (E171), Yellow Iron Oxide (E172), Brilliant Blue FCF (E133); Ink for Printing: Shellac, Propylene Glycol (E1520), Black Iron Oxide (E172), Concentrated Ammonium Hydroxide (28%).

What Dimethyl Fumarate Polpharma Looks Like and What the Package Contains

Dimethyl Fumarate Polpharma 120 mg Hard Gelatin Capsules, 19.4 mm in Length and 8.53 mm in Width, White Body, Light Green Cap, with Printing on the Body "120 mg". Available in Aluminum/PVC/PVDC Blisters in Packs of 14 or 56 Capsules.

Dimethyl Fumarate Polpharma 240 mg Hard Gelatin Capsules, 23.3 mm in Length and 8.53 mm in Width, Light Green, with Printing on the Body "240 mg". Available in Aluminum/PVC/PVDC Blisters in Packs of 56 or 168 Capsules.

Not all Pack Sizes may be Marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Polpharma S.A.

Pelplińska 19, 83-200 Starogard Gdański

Phone: +48 22 364 61 01

Manufacturer

Polpharma S.A.

Production Plant in Nowa Dęba

Metalowca 2, 39-460 Nowa Dęba

Date of Last Revision of the Package Leaflet: