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 get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Pack

• 1. What is Dimforda and What is it Used For
• 2. Before You Take 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 difficulties with vision (such as blurred or double vision). These symptoms can completely disappear after a relapse, but some problems may remain.

How Dimforda Works

Dimforda is thought to work by stopping 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. Before You Take Dimforda

When Not to Take Dimforda

• If You are Allergic to Dimethyl Fumarate or Any of the Other Ingredients of This Medicine(listed in section 6)
• If You Have a Suspected or Confirmed Infection of the Brain Called Progressive Multifocal Leukoencephalopathy (PML)

Warnings and Precautions

Dimforda may Affect Your White Blood Cell Countand the Function of Your Kidneysand Liver. Before Starting Treatment with Dimforda, Your Doctor Will Check Your White Blood Cell Count and Kidney and Liver Function. These Tests Will be Repeated 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
• Stomach or Intestinal Disease
• Severe Infection(such as pneumonia)

During Treatment with Dimforda, You May Develop Shingles. In Some Cases, Serious Complications Have Occurred. If You Suspect You Have Any Symptoms of Shingles, You Must Inform Your Doctor Immediately. If Your Multiple Sclerosis Gets Worse (for example, you get weakness or vision problems) or You Get New Symptoms, You Should Contact Your Doctor Immediately, as These Could 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 Must Not be Given to Children Under 10 Years of Age, as There is No Data Available for This Age Group.

Dimforda with Other Medicines

Tell Your Doctor or Pharmacist About All Medicines You are Taking Now or Have Recently Taken, including those You Plan to 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 the Kidneys, Including Certain Antibiotics(used to treat infections), Diuretics(water pills), Certain Pain Relievers(such as ibuprofen and similar anti-inflammatory medicines and over-the-counter medicines) and Medicines Containing Lithium
• the Use of Certain Vaccines ( live vaccines) During Treatment with Dimforda May Cause Infection, so This Should be Avoided. Your Doctor Will Advise Whether to Give Other Types of Vaccines ( killed vaccines).

Dimforda with Alcohol

You Should Avoid Drinking High-Percentage Alcoholic Beverages (over 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 Breast-Feeding

If You are Pregnant or Breast-Feeding, Think You May be Pregnant or are Planning to Have a Baby, Ask Your Doctor or Pharmacist for Advice Before Taking This Medicine.
Pregnancy
There is Limited Information 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.
Breast-Feeding
It is Not Known Whether the Active Substance of Dimforda Passes into Human Milk. Your Doctor Will Advise Whether to Stop Breast-Feeding or Stop Dimforda Treatment. The Decision Will be Based on the Assessment of the Benefit of Breast-Feeding to the Baby Compared to the Benefit of Treatment with Dimforda for the Mother.

Driving and Using Machines

Dimforda is Not Expected 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, i.e., it is Essentially Sodium-Free.

3. How to Take Dimforda

Always Take This Medicine Exactly as Your 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 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 the Risk of 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 similar to those described below in section 4 may occur.

Missing a Dose of Dimforda

Do Not Take a Double Doseto Make Up for a Forgotten Dose.
You Can Take the Missed Dose if the Next Dose is Not Due Within 4 Hours. Otherwise, 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 Product, Ask Your Doctor or Pharmacist.

4. Possible Side Effects

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

Serious 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.

What to Do if You Experience Any of the Following Symptoms

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 a Feeling of Increased Body Temperature, Heat, Burning of the Skin, or Itching of the Skin ( flushing)
• Diarrhea ( diarrhea)
• Nausea ( nausea)
• Abdominal Pain or Cramps → Taking Dimforda with Foodwill help alleviate the above side effects.

During Treatment with Dimforda, Urine Tests Often Show Increased Production of Ketone Bodies (substances normally produced in the body).
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 Affect Laboratory 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. If You Have a Severe Infection (such as pneumonia), You Should 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, followed by numbness, itching, or red spots with severe pain
• Rhinitis ( rhinitis)

Children (13 Years and Older) 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, such as Headache, Abdominal Pain or Cramps, Vomiting, Sore Throat, Cough, and Painful Menstruation.

Reporting Side Effects

If You Get Any Side Effects, Talk to Your Doctor or Pharmacist. This Includes Any Possible Side Effects Not Listed in This Leaflet. Side Effects Can be Reported to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje 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.
By Reporting Side Effects, You Can Help Provide 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 Which is Stated on the Blister and Carton After EXP. The Expiry Date Refers to the Last Day of the Month.
There are No Special Storage Conditions 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. These Measures 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 croscarmellose (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 solution of shellac 45% (E904), propylene glycol (E1520), concentrated ammonia solution (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 opaque body and a light green opaque cap, containing white to off-white mini-tablets, available in packs of 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 opaque body and a light green opaque cap, containing white to off-white mini-tablets, available in packs of 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 Medicinal Product 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: