Copaxone

Package Leaflet: Information for the User

Copaxone, 40 mg/ml, Solution for Injection in a Prefilled Syringe

Glatiramer Acetate

Read All of This Leaflet Carefully Before Using This Medicine Because It Contains Important Information for You.

• 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, Tell 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 Copaxone and What is It Used For
• 2. Important Information Before You Use Copaxone
• 3. How to Use Copaxone
• 4. Possible Side Effects
• 5. How to Store Copaxone
• 6. Contents of the Pack and Other Information

1. What is Copaxone and What is It Used For

Copaxone is a Medicine Used to Treat Relapsing Forms of Multiple Sclerosis (MS).
It Modifies the Way the Immune System Works and is Classified as an Immunomodulatory Drug.
Multiple Sclerosis is Thought to be Caused by Disruption of the Immune System, Leading to Inflammation in the Brain and Spinal Cord.
Copaxone is Indicated to Reduce the Frequency of Relapses in Multiple Sclerosis. It Has Not Been Shown to Be Effective in Other Forms of Multiple Sclerosis Where Relapses Do Not Occur or Occur Very Rarely. Copaxone May Not Have an Effect on the Duration of a Relapse or the Severity of Symptoms During a Relapse.

2. Important Information Before You Use Copaxone

When Not to Use Copaxone:

• If You Are Allergic to Glatiramer Acetate or Any of the Other Ingredients of This Medicine (Listed in Section 6).

Warnings and Precautions

Copaxone May Cause Severe Allergic Reactions, Some of Which Can Be Life-Threatening.
These Reactions Can Occur Shortly After Injection, Several Months, or Even Several Years After Starting Treatment, Even if No Allergic Reactions Have Occurred After Previous Injections.
The Symptoms of Allergic Reactions Can Overlap with Injection-Related Reactions. Your Doctor Will Inform You About the Symptoms of an Allergic Reaction.
Before Starting Copaxone, Discuss with Your Doctor or Pharmacist If You Have Kidney or Heart Disease, as Your Doctor May Prescribe Regular Laboratory Tests and Follow-Up Visits.
Before Starting Copaxone, Discuss with Your Doctor or Pharmacist If You Have or Have Had Any Liver Disease (Including Those Caused by Alcohol Consumption).

Children

Copaxone Should Not Be Used in Children Under 18 Years of Age.

Elderly

The Use of Copaxone in the Elderly Has Not Been Studied. Consult Your Doctor Before Using This Medicine.

Copaxone and Other Medicines

Tell Your Doctor or Pharmacist About All Medicines You Are Taking or Have Recently Taken, as Well as Any Medicines You Plan to Take.

Pregnancy and Breast-Feeding

If You Are Pregnant, Think You May Be Pregnant, or Plan to Become Pregnant, Ask Your Doctor for Advice Before Taking This Medicine.
Copaxone Can Be Used During Pregnancy After Consulting Your Doctor.
Limited Data in Humans Do Not Indicate Any Adverse Effects of Copaxone on Breast-Fed Infants. Copaxone Can Be Used During Breast-Feeding.

Driving and Using Machines

There is No Known Effect of Copaxone on the Ability to Drive or Use Machines.

3. How to Use Copaxone

Always Use This Medicine Exactly as Your Doctor Has Told You.
If You Are Not Sure, Check with Your Doctor or Pharmacist.
The Usual Dose for Adults is One Prefilled Syringe (40 mg Glatiramer Acetate) Given by Subcutaneous Injection Three Times a Week, at Least 48 Hours Apart, for Example on Monday, Wednesday, and Friday. It is Recommended to Inject Copaxone on the Same Days Each Week.
It is Very Important to Use Copaxone Correctly:

• The Medicine Should Only Be Injected Subcutaneously (See "Instructions for Use" Below).
• Use the Dose Prescribed by Your Doctor. Only Use the Prescribed Dose.
• Never Use the Same Prefilled Syringe More Than Once. Dispose of Any Unused Product or Waste.
• Do Not Mix or Administer Copaxone with Other Medicines.
• If the Solution Contains Visible Particles, Discard It and Use a New Prefilled Syringe.

When You First Start Using Copaxone, Your Doctor or Nurse Will Give You Full Instructions and Supervise Your First Injection. Your Doctor or Nurse Will Stay with You for 30 Minutes After the Injection to Check for Any Reactions.

Instructions for Use

Read These Instructions Carefully Before Using Copaxone.
Before Injecting, Make Sure You Have All the Necessary Items:

• One Copaxone Prefilled Syringe Blister Pack
• A Sharps Container for Used Needles and Syringes.
• Only Remove One Blister Pack from the Outer Packaging at a Time. Store All Other Syringes in the Outer Packaging.
• If the Syringes Have Been Stored in the Refrigerator, Remove the Blister Pack from the Refrigerator and Let It Reach Room Temperature for at Least 20 Minutes Before Injecting to Allow the Solution to Warm Up to Room Temperature.

Wash Your Hands Thoroughly with Soap and Water.
If You Wish to Use an Auto-Injector, You Can Use the CSYNC Device for Injecting Copaxone. This Auto-Injector is Approved for Use with Copaxone and Has Not Been Tested with Other Products. Read the Instructions for Use Provided with the CSYNC Auto-Injector.
Choose an Injection Site, Using the Diagrams Provided.
There Are Seven Areas of the Body Where You Can Give the Injections:

• Area 1:The Abdomen Around the Navel. Avoid Injecting Within 5 cm of the Navel,

• Areas 2 and 3:The Thighs (Above the Knees),

• Areas 4, 5, 6, and 7:The Back of the Arms and the Top of the Hips (Below the Waist),

In Each Injection Area, There Are Several Injection Sites. Each Time You Inject, Choose a Different Site to Reduce the Risk of Irritation or Pain at the Injection Site. Rotate the Injection Areas and Sites Within That Area.
Do Not Inject in the Same Site Each Time.
Warning:Do Not Inject in a Sensitive Area or Where the Skin is Discolored, Has Lumps, or Is Indurated. It is Recommended to Develop a Rotation Plan for Injection Sites and Record It in a Diary. There Are Certain Areas of the Body Where It May Be Difficult to Inject Yourself (e.g., the Back of the Arm). In Such Cases, Assistance May Be Needed.
How to Inject:

• Remove the Syringe from the Blister Pack by Peeling Off the Foil.
• Remove the Needle Cover, Do NotRemove the Cover with Your Mouth or Teeth.
• Gently Hold a Fold of Skin Between Your Thumb and Index Finger of Your Free Hand (Figure 1).
• Insert the Needle into the Skin as Shown in Figure 2.
• Inject the Medicine by Pressing the Plunger Down Slowly Until the Syringe is Empty.
• Withdraw the Syringe and Needle Straight Up.
• Dispose of the Syringe in a Sharps Container. Do Not Throw Away Used Syringes in the Household Trash. Place Them in a Sharps Container as Instructed by Your Doctor or Nurse.

Figure 1 Figure 2

If You Feel That the Effect of Copaxone is Too Strong or Too Weak, Talk to Your Doctor.

Overdose

Tell Your Doctor Immediately.

Missed Dose

Give the Dose as Soon as You Remember or Are Able to, and Then Skip the Next Day's Dose. Do Not Take a Double Dose to Make Up for a Forgotten Dose. Try to Get Back to Your Regular Schedule the Following Week.

Stopping Copaxone

Do Not Stop Using Copaxone Without Consulting Your Doctor First.
If You Have Any Further Questions on the Use of This Product, Ask Your Doctor or Pharmacist.

4. Possible Side Effects

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

Allergic Reactions (Hypersensitivity, Anaphylactic Reaction)

A Severe Allergic Reaction Can Occur Shortly After Injection. This is an Uncommon Side Effect. These Reactions Can Occur Several Months or Years After Starting Treatment with Copaxone, Even if No Allergic Reactions Have Occurred After Previous Injections.

You Must Stop Using Copaxone and Contact Your Doctor Immediately or

Go to the Emergency Department of Your Nearest HospitalIf You Suddenly Experience Any of the Following Symptoms:

• Widespread Rash (Red Spots or Hives)
• Swelling of the Eyelids, Face, Lips, Mouth, Throat, or Tongue
• Sudden Difficulty Breathing, Breathing Difficulties, or Wheezing
• Seizures (Convulsions)
• Difficulty Swallowing or Speaking
• Fainting, Feeling Dizzy, or Fainting
• Falling.

Other Injection-Related Reactions

Within a Few Minutes of Injecting Copaxone, Reactions with at Least One of the Following Symptoms Can Occur. They Usually Do Not Cause Any Problems and Disappear Within Half an Hour.
However, If the Following Symptoms Last Longer Than 30 Minutes, Tell Your Doctor Immediately or
Go to the Emergency Department of Your Nearest Hospital:

• Flushing (Redness of the Skin with a Feeling of Heat) on the Chest or Face (Vasodilation)
• Shortness of Breath (Dyspnea)
• Chest Pain
• Strong and Fast Heartbeat (Palpitations, Tachycardia).

Liver Disorders

Rarely, Liver Disorders or Worsening of Existing Liver Disorders, Including Liver Failure (in Some Cases Requiring Liver Transplantation), Can Occur During Treatment with Copaxone. Contact Your Doctor Immediately If You Experience Symptoms Such as:

• Nausea
• Loss of Appetite
• Dark Urine and Pale Stools
• Yellowing of the Skin or the White Part of the Eyes
• Increased Tendency to Bleed.

Other Side Effects Reported by Patients Using Copaxone 40 mg/ml Injected Three Times a Week Were Also Reported by Patients Using Copaxone 20 mg/ml

(See Below List).

Very Common: May Affect More Than 1 in 10 People

• Infection, Flu
• Anxiety, Depression
• Headache
• Nausea
• Skin Rash
• Joint or Back Pain
• Weakness, Injection Site Reactions, Including Redness, Pain, Swelling, Itching, or Induration (These Injection Site Reactions Are Common and Usually Decrease Over Time), Non-Specific Pain.

Common: May Affect Up to 1 in 10 People

• Respiratory Tract Infection, Gastroenteritis, Herpes, Ear Infection, Nasal Congestion, Tooth Abscess, Gum Infection
• Benign Skin Growth (Non-Cancerous Skin Tumor), Tissue Growth (Tumor)
• Lymph Node Enlargement
• Allergic Reactions
• Loss of Appetite, Weight Gain
• Nervousness
• Taste Disturbances, Increased Muscle Tone, Migraine, Speech Disorders, Fainting, Tremor
• Double Vision, Eye Disorders
• Hearing Disorders
• Cough, Hay Fever
• Anal or Rectal Disorders, Constipation, Tooth Decay, Indigestion, Difficulty Swallowing, Faecal Incontinence, Vomiting
• Abnormal Liver Function Tests
• Bruising, Excessive Sweating, Itching, Skin Disorder, Hives
• Neck Pain
• Urinary Urgency, Frequent Urination, Inability to Empty the Bladder Properly
• Chills, Facial Swelling, Subcutaneous Tissue Atrophy at the Injection Site, Local Reaction, Peripheral Oedema Due to Fluid Accumulation, Fever

Uncommon: May Affect Up to 1 in 100 People

• Abscess, Skin and Subcutaneous Tissue Infection, Furuncle, Herpes Zoster, Nephritis
• Skin Cancer
• Increased White Blood Cell Count, Decreased White Blood Cell Count, Splenomegaly, Decreased Platelet Count, Abnormal White Blood Cell Appearance
• Thyroid Enlargement, Hyperthyroidism
• Decreased Alcohol Tolerance, Gout, Increased Blood Lipid Levels, Increased Sodium Levels in the Blood, Decreased Ferritin Levels in the Blood
• Strange Dreams, Confusion, Euphoric Mood; Seeing, Hearing, Smelling, or Tasting Something That Does Not Exist (Hallucinations), Hostility, Excessive Good Mood, Personality Disorders, Suicidal Behaviour
• Carpal Tunnel Syndrome, Psychiatric Disorders, Seizures (Convulsions), Agraphia, Dysarthria, Muscle Disorders, Movement Disorders, Muscle Spasms, Neuritis, Neuromuscular Junction Disorders Leading to Muscle Dysfunction, Involuntary Rapid Eye Movements, Paralysis, Foot Drop (Peroneal Nerve Palsy), Loss of Consciousness (Stupor), Blind Spots
• Cataract, Corneal Damage, Dry Eye, Eye Haemorrhage, Ptosis, Pupillary Dilation, Optic Nerve Atrophy Leading to Vision Disorders
• Extra Heartbeats, Slow Heart Rate, Occasionally Fast Heart Rate
• Varicose Veins
• Periodic Breathing Pause, Nosebleeds, Abnormal Breathing (Hyperventilation), Feeling of Throat Constriction, Pulmonary Disorders, Inability to Breathe Due to Throat Constriction (Choking)
• Enteritis, Colon Polyp, Belching, Oesophageal Ulcer, Gingivitis, Rectal Bleeding, Salivary Gland Enlargement
• Gallstones, Liver Enlargement
• Skin and Subcutaneous Tissue Swelling, Contact Dermatitis, Painful Red Nodules on the Skin, Skin Nodules
• Swelling, Arthritis, or Arthralgia (Joint or Bone and Joint Inflammation), Synovitis (Inflammation of the Fluid-Filled Sac That Surrounds Joints), Hip Pain, Muscle Atrophy
• Hematuria, Kidney Stones, Urinary Disorders, Abnormal Urine
• Breast Swelling, Erectile Dysfunction, Pelvic Organ Prolapse, Prolonged Erection, Prostate Disorders, Abnormal Pap Smear (Abnormal Cervical Smear), Testicular Disorders, Vaginal Bleeding, Vaginal Disorders
• Cyst, "Morning After" Symptoms, Hypothermia, Unspecified Inflammation, Tissue Necrosis at the Injection Site, Mucosal Disorders
• Vaccination-Related Reactions.

Reporting of Side Effects

If You Experience Any Side Effects, Including Any Not Listed in This Leaflet, Tell 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, 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 Authorisation Holder.
By Reporting Side Effects, You Can Help Provide More Information on the Safety of This Medicine.

5. How to Store Copaxone

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 Outer Packaging and on the Label After “Expiry Date:” or “EXP:”. The Expiry Date Refers to the Last Day of the Month.
Store in a Refrigerator (2°C - 8°C).
Copaxone Prefilled Syringes Can Be Stored at Room Temperature (15°C - 25°C) for a Single Period of Up to 1 Month. After 1 Month, If the Prefilled Syringes Have Not Been Used and Are Still in the Original Packaging, They Must Be Returned to the Refrigerator.
Do Not Freeze.
Store the Prefilled Syringes in the Original Packaging (Cardboard Box) to Protect Them from Light.
Discard Any Prefilled Syringes Containing Particulate Matter.
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 Copaxone Contains

• The Active Substance is Glatiramer Acetate. 1 ml of the Solution for Injection (Equivalent to the Contents of One Prefilled Syringe) Contains 40 mg Glatiramer Acetate, Which Corresponds to 36 mg Glatiramer.
• The Other Ingredients Are Mannitol and Water for Injections.

What Copaxone Looks Like and Contents of the Pack

Copaxone Solution for Injection in a Prefilled Syringe is a Sterile, Clear Solution Without Visible Particles.
Each Prefilled Syringe is Packaged Individually in a PVC Blister Pack.
Copaxone is Available in Packs Containing 3, 12, or 36 Prefilled Syringes, Each Containing 1 ml of the Solution for Injection, or a Multipack Containing 3 Cardboard Boxes, Each of 12 Prefilled Syringes Containing 1 ml of the Solution for Injection.
Not All Pack Sizes May Be Marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Teva GmbH
Graf-Arco-Str. 3,
89079 Ulm
Germany

Manufacturer/Importer

Actavis Group PTC ehf.
Dalshraun 1
220, Hafnarfjörður
Iceland
Merckle GmbH
Graf-Arco-Str. 3
89079 Ulm
Germany

This Medicinal Product is Authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) Under the Following Names:

Copaxone 40 mg/ml:

Austria, Belgium, Croatia, Czech Republic, Cyprus, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Iceland, Italy, Latvia, Lithuania, Luxembourg, Malta, Norway, Portugal, Romania, Spain, Sweden, Slovakia, Slovenia, Netherlands, United Kingdom (Northern Ireland).

Copaxone:

Poland
For Further Information on This Medicinal Product, Contact the Marketing Authorisation Holder:
Teva Pharmaceuticals Polska Sp. z o.o.
ul. Emilii Plater 53
00-113 Warsaw
tel.: (22) 345 93 00

Date of Last Revision of the Leaflet: October 2024