Noroplex

Package Leaflet: Information for the Patient

Noroplex, 120 mg, Gastro-Resistant Capsules, Hard

Noroplex, 240 mg, Gastro-Resistant Capsules, Hard

Dimethyl Fumarate

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

• Keep this Package Leaflet, You May Need to Read it Again.
• In Case of Any Doubts, Consult a Doctor or Pharmacist.
• This Medicine has been Prescribed to You by Your Doctor. 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 Package Leaflet, Inform Your Doctor or Pharmacist. See Section 4.

Table of Contents of the Package Leaflet

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

1. What is Noroplex and What is it Used for

What is Noroplex

Noroplex is a Medicine that Contains the Active Substance Dimethyl Fumarate.

What is Noroplex Used for

Noroplex 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 Repeated Episodes of Neurological Symptoms (Called Relapses). Symptoms Vary from Person to Person, but Usually Include Problems with 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 Does Noroplex Work

Noroplex Appears to Prevent the Immune System from Causing Damage to the Brain and Spinal Cord, which may also Help to Slow Down the Progression of the Disease in the Future.

2. Important Information Before Taking Noroplex

When Not to Take Noroplex

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

Warnings and Precautions

Noroplex may Unfavorably Affect White Blood Cell Countand Kidneyand LiverFunction. Before Starting Treatment with Noroplex, Your Doctor will Check Your White Blood Cell Count and Ensure that 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 Noroplex, Consult Your Doctorif You have:

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

During Treatment with Noroplex, Shingles may Occur. In Some Cases, Severe Complications have Occurred. If You Suspect any Symptoms of Shingles, Inform Your Doctor Immediately. If Your Multiple Sclerosis Worsens (Such as Weakness or Vision Problems) or New Symptoms Appear, 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.

Children and Adolescents

The Above Warnings and Precautions also Apply to Children. Noroplex can be Used in Children and Adolescents Aged 13 Years and Older. Data on Children Under 10 Years of Age are not Available.

Noroplex and Other Medicines

Tell Your Doctor or Pharmacistabout all Medicines You are Currently Taking or Have Recently Taken, as well as any Medicines You Plan to Take, Especially:

• Medicines Containing Fumaric Acid Esters(Fumarates) Used to Treat Psoriasis
• Medicines that Affect the Immune System, Including Other Medicines Used to Treat Multiple Sclerosis, Such as Fingolimod, Natalizumab, Teriflunomide, Alemtuzumab, Ocrelizumab, or Cladribine, as well as Some Medicines Commonly Used to Treat Cancer (Rituximab or Mitoxantrone)
• Medicines that Affect Kidney Function, Including Certain Antibiotics(Used to Treat Infections), Diuretics, Certain Pain Relievers(Such as Ibuprofen and Similar Anti-Inflammatory Medicines, as well as Over-the-Counter Medicines), and Medicines Containing Lithium
• Using Certain Types of Vaccines (Live Vaccines) During Treatment with Noroplex may Cause Infection, so they should be Avoided. Your Doctor will Advise if Other Types of Vaccines (Inactivated Vaccines) can be Given.

Taking Noroplex with Alcohol

Avoid Consuming High-Percentage Alcoholic Beverages (More than 30% Alcohol by Volume) in Excess of 50 ml Within 1 Hour of Taking Noroplex, 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 are Planning to have a Child, Consult Your Doctor or Pharmacist Before Taking this Medicine.
Pregnancy
Noroplex should not be Taken During Pregnancy, Unless You have Discussed it with Your Doctor.
Breastfeeding
It is not Known if the Active Substance of Noroplex Passes into Breast Milk. Noroplex should not be Taken During Breastfeeding. Your Doctor will Help You Decide whether to Stop Breastfeeding or Stop Taking Noroplex. The Decision will be Based on the Assessment of the Benefits of Breastfeeding for the Baby Compared to the Benefits of Treatment for You.

Driving and Using Machines

The Effect of Noroplex on the Ability to Drive and Use Machines is not Known. It is not Expected that this Medicine will Affect the Ability to Drive and Use Machines.

3. How to Take Noroplex

Always Take this Medicine Exactly as Your Doctor has Told You. If You are not Sure, Consult 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.

Usual Dose

240 mg Twice a Day

Noroplex should be Taken Orally.
Each Capsule should be Swallowed Whole, with a Glass of Water. Capsules should not be Divided, Crushed, Dissolved, Sucked, or Chewed, as this may Increase the Risk of Certain Side Effects.
Noroplex should be Taken with Food– this will Help to Reduce the Very Common Side Effects (Listed in Section 4).

Taking More Noroplex 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 Noroplex

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.
If You have any Further Questions on the Use of this Medicine, Consult Your Doctor or Pharmacist.

4. Possible Side Effects

Like all Medicines, Noroplex can Cause Side Effects, although not Everybody gets them.

Serious Side Effects

Noroplex may Lower the Number of Lymphocytes (a Type of White Blood Cell). A Low White Blood Cell Count may 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 will 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 be Similar to those of a Relapse of Multiple Sclerosis. They Include:

• Weakness or Increased Weakness on One Side of the Body
• Coordination Problems
• Vision Problems
• Thinking or Memory Problems
• Confusion (Disorientation) or Personality Changes
• Speech and Communication Difficulties that Last for More than a Few Days

If You Experience any of these Symptoms, Tell 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.

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 (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)
• Dizziness or Loss of Consciousness (Hypotension) may Indicate a Severe Allergic Reaction (Anaphylaxis).

Stop Taking Noroplex and Tell Your Doctor Immediately.

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

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

Taking Noroplex with Food will Help to Reduce these Side Effects

During Treatment with Dimethyl Fumarate, an Increased Production of Ketone Bodies (Substances Normally Produced by the Body) is Very Commonly Found in Urine Tests.
Ask Your Doctor how to Deal with Side Effects. Your Doctor may Reduce the Dose of Noroplex. Do not Reduce the Dose Yourself, Unless Your Doctor Advises You to do so.
Common Side Effects(may Affect up to 1 in 10 People)

• Gastroenteritis (Inflammation of the Stomach and Intestines)
• Vomiting
• Indigestion
• Gastritis (Inflammation of the Stomach)
• 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). A Low White Blood Cell Count may Mean that the Body is Less Able to Fight Infection. In Case of Severe Infection (Such as Pneumonia), Tell Your Doctor Immediately.
• Protein (Albumin) in Urine
• Increased Liver Enzyme Levels (ALT, AST) in Blood Uncommon Side Effects(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 (ALT or AST Together 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 Part of the Body or Face, as well as Other Symptoms, such as: Fever and Weakness in the Early Stages of Infection, and then Numbness, Itching, or Red Spots, and Severe Pain
• Common Cold (Rhinitis)

Children (Aged 13 and Above) 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 Stomach Cramps, Vomiting, Sore Throat, Cough, and Painful Menstruation.

Reporting Side Effects

If You Experience any Side Effects, including those not Listed in this Package Leaflet, Tell Your Doctor or Pharmacist. Side Effects can be Reported Directly to the National Medicines Agency, [insert contact information], or 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 Noroplex

Keep this Medicine out of the Sight and Reach of Children.
Do not Use this Medicine after the Expiry Date Stated on the Blister, Bottle Label, and Carton after “EXP”. The Expiry Date Refers to the Last Day of the Month Stated.
This Medicine does not Require any Special Storage Conditions.
Store in the Original Package to Protect from Light.
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 to Protect the Environment.

6. Contents of the Package and Other Information

What Noroplex Contains

• The Active Substance is Dimethyl Fumarate.

Noroplex, 120 mg, Gastro-Resistant Capsules, Hard
Each Capsule Contains 120 mg of Dimethyl Fumarate.
Noroplex, 240 mg, Gastro-Resistant Capsules, Hard
Each Capsule Contains 240 mg of Dimethyl Fumarate.

• Other Ingredients are: Microcrystalline Cellulose, Crospovidone, Talc, Povidone, Colloidal Silica, Anhydrous, Magnesium Stearate, Triethyl Citrate, Methacrylic Acid, and Ethyl Acrylate Copolymer (1:1), Hypromellose, Titanium Dioxide (E 171), Triacetin Capsule Shell: Gelatin, Titanium Dioxide (E 171), Brilliant Blue FCF (E 133), Iron Oxide Yellow (E 172) Ink: Shellac, Potassium Hydroxide, Propylene Glycol (E 1520), Iron Oxide Black (E 172), Ammonium Hydroxide

What Noroplex Looks Like and Contents of the Package

Noroplex, 120 mg, Gastro-Resistant Capsules, Hard (Gastro-Resistant Capsules)
A Hard Gelatin Capsule, 21.4 mm in Size, Consisting of a White Body with Black Printing “DMF 120” and a Green Cap, Containing White to Off-White Mini-Tablets.
Noroplex is Available in OPA/Aluminum/PVC/Aluminum Blisters or Single-Dose OPA/Aluminum/PVC/Aluminum Blisters Packaged in a Carton Containing 14 Gastro-Resistant Capsules, Hard.
Noroplex, 240 mg, Gastro-Resistant Capsules, Hard (Gastro-Resistant Capsules)
A Hard Gelatin Capsule, 23.2 mm in Size, Consisting of a Green Body with Black Printing “DMF 240” and a Green Cap, Containing White to Off-White Mini-Tablets.
Noroplex is Available in OPA/Aluminum/PVC/Aluminum Blisters or Single-Dose OPA/Aluminum/PVC/Aluminum Blisters Packaged in a Carton Containing 56 Gastro-Resistant Capsules, Hard.

Marketing Authorization Holder

+pharma Arzneimittel GmbH
Hafnerstrasse 211
8054 Graz
Austria

Importer

Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park
Paola PLA 3000
Malta
Adalvo Limited
Malta Life Sciences Park
Building 1, Level 4, Sir Temi Zammit Buildings
San Gwann, SGN 3000
Malta
KeVaRo GROUP Ltd
9 Tzaritza Elenora Str. Office 23
Sofia 1618
Bulgaria

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

Iceland
Noroplex 120 mg Magasýruþolin Hörð Hylki
Noroplex 240 mg Magasýruþolin Hörð Hylki
Poland/Czech Republic
Noroplex
For Further Information on this Medicine, Contact the Marketing Authorization Holder:
+pharma Polska Sp. z o.o.
ul. Podgórska 34
31-536 Kraków, Poland
tel. +48 12 262 32 36

Date of Last Revision of the Package Leaflet: