Dimforda

Package Leaflet: Information for the Patient

Dimforda, 120 mg, Gastro-Resistant Hard Capsules

Dimforda, 240 mg, Gastro-Resistant Hard Capsules

Dimethyl Fumarate

Before Taking Dimforda, Read This Leaflet Carefully, as It Contains Important Information for You.

• You should keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Dimforda and What is it Used For

What is Dimforda

Dimforda is a medicine that contains the active substance dimethyl fumarate.

What is Dimforda Used For

Dimforda is Used to Treat Relapsing-Remitting Multiple Sclerosis in Patients Aged 13 Years and Older.

Multiple sclerosis is a long-term disease that affects the central nervous system (the brain and spinal cord). The relapsing-remitting form of multiple sclerosis is characterized by recurring episodes of symptoms (relapses) that can include problems with walking and balance, and vision problems (such as blurred or double vision). These symptoms can completely disappear after a relapse, but some problems may remain.

How Dimforda Works

Dimforda seems to prevent 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 Dimforda

When Not to Take Dimforda

• If You are Allergic to Dimethyl Fumarateor any of the other ingredients of this medicine (listed in section 6).
• If You Have a Suspected or Confirmed Rare Brain Infection Called Progressive Multifocal Leukoencephalopathy (PML).

Warnings and Precautions

Dimforda may Affect Your White Blood Cell Countand Kidneyand LiverFunction. Before Starting Treatment with Dimforda, Your Doctor Will Check Your White Blood Cell Count and Kidney and Liver Function. These Tests Will be Performed Periodically During Treatment. If Your White Blood Cell Count Decreases During Treatment, Your Doctor May Consider Additional Tests or Stop Treatment.

• Severe Kidney Disease
• Severe Liver Disease
• Stomachor IntestineDisease
• Severe Infection(e.g., Pneumonia).

During Treatment with Dimforda, Shingles (Herpes Zoster) May Occur. In Some Cases, Serious Complications Have Occurred. If You Suspect Any Symptoms of Shingles, You Must Inform Your Doctor Immediately. If Your Multiple Sclerosis Worsens (e.g., You Experience Weakness or Vision Problems) or You Develop 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 Cause Severe Disability or Death.

Children and Adolescents

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

Dimforda and Other Medicines

Tell Your Doctor or PharmacistAbout All Medicines You are Taking, Have Recently Taken, or Might Take, Especially:

• Medicines Containing Fumaric Acid EstersUsed to Treat Psoriasis
• Medicines that Affect the Immune System, Including Chemotherapy, Immunosuppressants, or Other Medicines Used to Treat Multiple Sclerosis
• Medicines that Affect Kidney Function, Including Certain Antibiotics(Used to Treat Infections), Diuretics(Diuretics), Certain Pain Relievers(Such as Ibuprofen and Similar Anti-Inflammatory Medicines and Over-the-Counter Medicines), and Medicines Containing Lithium
• Using Certain Vaccines ( Live Vaccines) During Treatment with Dimforda May Cause Infection, So This Should be Avoided. Your Doctor Will Advise Whether to Give Vaccines of Another Type ( Killed Vaccines).

Dimforda and Alcohol

Avoid Consuming High-Percentage Alcoholic Beverages (More than 30% Alcohol by Volume, e.g., Spirits) in Excess of 50 ml Within 1 Hour of Taking Dimforda, Due to the Risk of Interaction Between Alcohol and This Medicine, Which May Lead to Gastritis (Inflammation of the Stomach Lining), Especially in People Prone to this Disease.

Pregnancy and Breastfeeding

If You are Pregnant or Breastfeeding, Think You May be Pregnant, or Plan to Have a Child, Consult Your Doctor or Pharmacist Before Taking this Medicine.
Pregnancy
There is Limited Data on the Use of this Medicine in Pregnant Women. Dimforda Should Not be Taken During Pregnancy Unless You Have Discussed this with Your Doctor and the Use of Dimforda is Necessary.
Breastfeeding
It is Not Known Whether the Active Substance of Dimforda Passes into Human Milk. Your Doctor Will Advise Whether to Stop Breastfeeding or Stop Taking Dimforda. The Decision Will be Made Based on the Assessment of the Benefits of Breastfeeding for the Baby Compared to the Benefits of Treatment for You.

Driving and Using Machines

You Should Not Expect Dimforda to Affect Your Ability to Drive or Use Machines.

Dimforda Contains Sodium

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

3. How to Take Dimforda

This Medicine Should Always be Taken Exactly as Your Doctor Has Told You. If You are Not Sure, Ask 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.

Dimforda Should be Taken Orally.
Each Capsule Should be Swallowed Whole, with a Glass of Water. Do Not Divide, Crush, Dissolve, Suck, or Chew the Capsules, as This May Increase Certain Side Effects.
Dimforda Should be Taken with Food– This May Help Reduce the Very Common Side Effects (Listed in Section 4).

Taking More Dimforda Than Prescribed

If You Have Taken More Capsules Than Prescribed, Tell Your Doctor Immediately. Side Effects May Occur that are Similar to Those Described Below in Section 4.

Missing a Dose of Dimforda

Do Not Take a Double Doseto Make Up for a Forgotten Dose.
A Forgotten Dose Can be Taken if There is a 4-Hour Interval Before the Next Dose. Otherwise, Do Not Take the Forgotten Dose, but Take the Next Dose at the Usual Time.
If You Have Any Further Questions on the Use of this Product, Ask Your Doctor or Pharmacist.

4. Possible Side Effects

Like All Medicines, Dimforda Can Cause Side Effects, Although Not Everybody Gets Them.

Severe Side Effects

Dimforda 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 a Rare Brain Infection Called Progressive Multifocal Leukoencephalopathy (PML). PML Can Cause 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 Treatment, and You Should be Aware of the Symptoms Described Below, Which May Indicate PML. The Risk of PML May be Higher if You Have Previously Taken Medicines that Affect the Immune System.

Symptoms of PML May Resemble Those of a Relapse of Multiple Sclerosis.

They Include Weakness or Increased Weakness on One Side of the Body, Coordination Problems, Vision Problems, Speech or Thinking Problems, Confusion (Disorientation) or Personality Changes, Speech or Communication Problems that Last for More than a Few Days. Therefore, if You Experience Worsening of Multiple Sclerosis Symptoms or New Symptoms While Taking Dimforda, You Should Contact Your Doctor Immediately. You Should Also Discuss Your Treatment with Your Partner or Caregivers and Inform Them About Your Treatment. There May be Symptoms that You are Not Aware of.

If You Experience Any of the Following Symptoms, Contact Your Doctor Immediately.

Severe Allergic Reactions

The Frequency of Severe Allergic Reactions Cannot be Estimated from the Available Data (Frequency Not Known).
A Very Common Side Effect is Sudden (Acute) Redness of the Face or Body. If the Redness is Accompanied by a Red Rash or Hives and Any 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) May Indicate a Severe Allergic Reaction (Anaphylaxis). →

Stop Taking Dimforda and Contact Your Doctor Immediately.

Other Side Effects

Very Common:May Affect More than 1 in 10 People:

• Redness of the Skin of the Face or Feeling of Increased Body Temperature, Heat, Burning of the Skin, or Itching of the Skin ( Flushing)
• Diarrhea ( Diarrhea)
• Nausea ( Nausea)
• Stomach Pain or Cramps → Taking Dimforda with FoodWill Help Reduce the Above Side Effects.

During Treatment with Dimforda, Increased Production of Ketone Bodies (Substances Normally Produced in the Body) is Very Commonly Found in Urine Tests.
Ask Your DoctorHow to Deal with Side Effects. Your Doctor May Reduce the Dose of Dimforda. Do Not Reduce the Dose Yourself Unless Your Doctor Advises You to Do So.
Common:May Affect Up to 1 in 10 People:

• Gastrointestinal Inflammation ( 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 Cause Abnormal Blood or Urine Test Results

• Low White Blood Cell Count ( Lymphopenia, Leukopenia) in the Blood. A Low White Blood Cell Count May Mean that the Body is Less Able to Fight Infection. In Case of Severe Infection (e.g., Pneumonia), Contact Your Doctor Immediately
• Protein ( Albumin) in the Urine
• Increased Liver Enzyme Activity ( ALAT, AspAT) in the Blood

Uncommon:May Affect Up to 1 in 100 People:

• Allergic Reactions ( Hypersensitivity)
• Decreased Platelet Count

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

• Hepatitis and Increased Liver Enzyme Activity ( ALAT or AspATTogether 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 with Severe Pain
• Rhinitis ( Rhinitis)

Children (Aged 13 and Over) and Adolescents

The Above Side Effects Also Apply to Children and Adolescents.
Some Side Effects Have Been Reported More Frequently in Children and Adolescents than in Adults, e.g., 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 Listed in this Leaflet, Please Inform Your Doctor or Pharmacist. Side Effects Can be Reported Directly to the Department of Drug Safety Monitoring of the 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.
Side Effects Can Also be Reported to the Marketing Authorization Holder.
Reporting Side Effects Will Help to Gather More Information on the Safety of this Medicine.

5. How to Store Dimforda

Keep this Medicine Out of the Sight and Reach of Children.
Do Not Use this Medicine After the Expiry Date Stated on the Blister Pack and Carton After: EXP.
The Expiry Date Refers to the Last Day of the Month Stated.
There are No Special Storage Instructions for this Medicine.
Medicines Should Not be Disposed of via Wastewater or Household Waste. Ask Your Pharmacist How to Dispose of Medicines No Longer Required. This Will Help Protect the Environment.

6. Contents of the Pack and Other Information

What Dimforda Contains

• Active Substanceis Dimethyl Fumarate. Dimforda 120 mg: Each Capsule Contains 120 mg of Dimethyl Fumarate. Dimforda 240 mg: Each Capsule Contains 240 mg of Dimethyl Fumarate.
• Other Ingredientsare: Microcrystalline Cellulose (E460i), Sodium Carboxymethylcellulose (E468), Talc (E553b), Siliconized Microcrystalline Cellulose, Colloidal Anhydrous Silica (E551), Magnesium Stearate (E470b), Triethyl Citrate (E1505), Methacrylic Acid and Methyl Methacrylate Copolymer (1:1) (E1207), Methacrylic Acid and Ethyl Acrylate Copolymer (1:1), 30% Dispersion (E1207), Sodium Lauryl Sulfate, Polysorbate 80, Gelatin, Titanium Dioxide (E171), Brilliant Blue FCF (E133), Yellow Iron Oxide (E172), Black Iron Oxide (E172), Ethanol Shellac Solution 45% (E904), Propylene Glycol (E1520), Concentrated Ammonium Hydroxide (E527).

What Dimforda Looks Like and Contents of the Pack

Dimforda 120 mg Gastro-Resistant Hard Capsules are Hard Gelatin Capsules with a Diameter of 7.6 mm and a Total Length of 21.7 mm, with the Imprint "120 mg", Consisting of a White Non-Transparent Body and a Light Green Non-Transparent Cap, Containing White to Off-White Mini-Tablets, Available in Packs Containing 14 Capsules.
Dimforda 240 mg Gastro-Resistant Hard Capsules are Hard Gelatin Capsules with a Diameter of 7.6 mm and a Total Length of 21.7 mm, with the Imprint "240 mg", Consisting of a Light Green Non-Transparent Body and a Light Green Non-Transparent Cap, Containing White to Off-White Mini-Tablets, Available in Packs Containing 56 Capsules.
Not All Pack Sizes May be Marketed.

Marketing Authorization Holder

Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland
Phone: +48 17 865 51 00

Importer

Bausch Health Poland Sp. z o.o.
Przemysłowa 2
35-959 Rzeszów
Bausch Health Poland Sp. z o.o.
Kosztowska 21
41-409 Mysłowice

This Medicine is Authorized in the Member States of the European Economic Area Under the Following Names:

Bulgaria
Димфорда 120 mg твърди стомашно-устойчиви капсули
Димфорда 240 mg твърди стомашно-устойчиви капсули
Czech Republic
Dimforda
Denmark
Dimforda
Finland
Dimforda
Greece
Dimforda
Spain
Dimforda
Lithuania
Dimforda 120 mg skrandyje neirios kietosios kapsulės
Dimforda 240 mg skrandyje neirios kietosios kapsulės
Latvia
Dimforda 120 mg zarnās šķīstošā kapsula, cietā
Dimforda 240 mg zarnās šķīstošā kapsula, cietā
Norway
Dimforda
Poland
Dimforda
Slovakia
Dimforda
Slovenia
Dimforda 120 mg trde gastrorezistentne kapsule
Dimforda 240 mg trde gastrorezistentne kapsule
Sweden
Dimforda
Hungary
Dimforda 120 mg gyomornedv-ellenálló kemény kapszula
Dimforda 240 mg gyomornedv-ellenálló kemény kapszula
Italy
Dimforda

Date of Last Revision of the Leaflet: