Copaxone

Package Leaflet: Information for the User

Copaxone, 20 mg/ml, Solution for Injection in a Prefilled Syringe

Glatiramer Acetate

Read the package leaflet carefully before using the medicine, as it contains important information for you.

• Keep this package 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 any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Copaxone and what is it used for
• 2. Important information before using 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 patient's immune system works and is classified as an immunomodulatory drug.
It is thought that the symptoms of multiple sclerosis are caused by a disturbance in the body's immune system.
This leads to the formation of inflammatory lesions in the brain and spinal cord.
Copaxone is indicated to reduce the frequency of multiple sclerosis relapses (exacerbations).
No effect of the drug has been demonstrated 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 multiple sclerosis relapse or the severity of symptoms during that relapse.
Copaxone is used in patients who are able to walk unaided.
Copaxone may also be used in patients who have experienced their first symptoms, which suggest a high risk of developing multiple sclerosis.
Before starting treatment, the doctor will rule out any other causes that may have triggered these symptoms.

2. Important information before using 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 objective and subjective symptoms of allergic reactions may overlap with injection site 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 order regular laboratory tests and check-ups.
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 12 years of age.

Elderly

The use of Copaxone in the elderly has not been studied. Consult your doctor before using the medicine.

Copaxone and other medicines

Tell your doctor or pharmacist about all the medicines you are taking or have recently taken, as well as any medicines you plan to take.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or plan to become pregnant, ask your doctor for advice and consider using Copaxone during pregnancy.
Copaxone can be used during pregnancy after consulting a doctor.
Limited human data do not indicate any adverse effects of Copaxone on breastfed infants or (and) toddlers.
Copaxone can be used during breastfeeding.

Driving and using machines

No studies have been conducted on the effects of Copaxone on the ability to drive or operate machinery.

3. How to use Copaxone

Always use this medicine exactly as your doctor has told you.
If you are unsure, ask your doctor or pharmacist.
The usual daily dose for adults and adolescents over 12 years of age is one prefilled syringe (20 mg glatiramer acetate), administered subcutaneously.
It is very important to administer Copaxone correctly:

• The medicine should only be administered subcutaneously (see "Instructions for use" below).
• The medicine should be used at the dose prescribed by your doctor. Only use the dose prescribed by your doctor.
• Never use the same prefilled syringe more than once. Dispose of unused product or waste.
• Copaxone should not be mixed or administered with other medicines.
• If the solution contains visible particles, it should be discarded and a new prefilled syringe used.

When you receive Copaxone for the first time, your doctor or nurse will give you full instructions and will supervise your condition.
Your doctor or nurse will stay with you for a while after you have administered the injection yourself and for another half hour to make sure you do not experience any problems.

Instructions for use

Read these instructions carefully before using Copaxone.
Before injecting the medicine, make sure you have all the necessary items:

• one Copaxone blister pack, prefilled syringe
• a container for used needles and syringes.
• Only remove one blister pack with one prefilled syringe from the packaging at a time.
  Store all other syringes in the packaging.
• If the syringes have been stored in the refrigerator, remove the blister pack with the syringe from the refrigerator and let it sit at 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 want to use an injector, you can use the CSYNC device for Copaxone injections.
This injector is an approved device for use with Copaxone and has not been tested with other products.
Read the instructions for use that come with the CSYNC injector.
Choose an injection site using the diagrams.
There are seven areas of the body where injections can be administered:

• Area 1:Abdomen around the navel.
  Avoid injecting within a 5 cm radius of the navel,

• Areas 2 and 3:Thighs (above the knees),

• Areas 4, 5, 6, and 7:Back of the arms and upper hips (below the waist),

In each injection area, there are several injection sites.
Choose a different injection site every day to reduce the risk of irritation or pain at the injection site.
Rotate the injection areas and sites within that area.
Do not inject the medicine in the same place every time.
Warning:do not inject the medicine in a painful area or where the skin is discolored, has lumps, or has a rash.
It is recommended to develop a rotation plan for injecting the medicine and write it down in a diary.
There are certain areas of the body where it is difficult to administer injections yourself (e.g., the back of the arm).
In such cases, assistance is needed.
How to inject the medicine:

• Remove the syringe from the blister pack by tearing off the protective foil.
• Remove the needle shield, do notremove the shield with your mouth or teeth.
• Gently grasp the skin fold 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 special container.
  Used syringes should not be thrown away in the trash.
  They should be carefully placed in a special container, following the instructions of your doctor or nurse.

Figure 1 Figure 2

If you feel that the effect of Copaxone is too strong or too weak, consult your doctor.

Using more than the recommended dose of Copaxone

Inform your doctor immediately.

Missing a dose of Copaxone

Take the dose as soon as you remember, but do not take a double dose to make up for the missed dose.
Take the next dose 24 hours later.

Stopping Copaxone treatment

Do not stop using Copaxone without consulting your doctor first.
If you have any further questions about using this medicine, 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 may 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 the nearest hospital, if you suddenly experience the following symptoms:

• widespread rash (red spots or hives)
• swelling of the eyelids, face, lips, mouth, throat, or tongue
• sudden shortness of breath, difficulty breathing, or wheezing
• seizures (convulsions)
• difficulty swallowing or speaking
• fainting, feeling dizzy, or fainting
• falling.

Other injection site reactions (immediate post-injection reaction)

Uncommonly, within a few minutes of injecting Copaxone, reactions may occur with at least one of the following symptoms.
They usually do not cause any problems and go away within half an hour.
However, if the following symptoms last longer than 30 minutes, you must
contact your doctor immediately or go to the emergency department of the nearest hospital:

• flushing (redness of the skin with a feeling of heat) on the chest or face (vasodilation)
• shortness of breath (dyspnea)
• chest pain
• rapid or strong heartbeat (palpitations, tachycardia).

Liver disorders

Rarely, liver disorders or worsening of existing liver disorders, including liver failure (in some cases leading to liver transplantation), may occur during treatment with Copaxone.
Inform 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.

The following side effects have been reported with Copaxone:

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 of the skin, pain, blistering, itching, swelling of the tissues, inflammation, and hypersensitivity (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, rhinitis, dental abscess, thrush
• benign skin growth (benign skin tumor), growth of tissue (tumor)
• enlarged lymph nodes
• allergic reactions
• loss of appetite, weight gain
• nervousness
• taste disorders, increased muscle tone, migraine, speech disorders, fainting, tremors
• double vision, eye disorders
• hearing disorders
• cough, hay fever
• anal or rectal disorders, constipation, tooth decay, indigestion, difficulty swallowing, fecal incontinence, vomiting
• abnormal liver function tests
• bruises, excessive sweating, itching, skin disorders, hives
• neck pain
• urinary urgency, frequent urination, inability to empty the bladder properly
• chills, facial swelling, atrophy of subcutaneous tissue at the injection site, local reaction, peripheral edema due to fluid accumulation, fever

Uncommon: may affect up to 1 in 100 people

• abscess, skin and subcutaneous tissue infection, furuncles, shingles, kidney infection
• skin cancer
• increased white blood cell count, decreased white blood cell count, splenomegaly, decreased platelet count, changes in the appearance of white blood cells
• thyroid enlargement, hyperthyroidism
• decreased alcohol tolerance, gout, increased blood lipid levels, increased sodium levels in the blood, decreased ferritin levels in the blood serum
• strange dreams, confusion, euphoric mood; seeing, hearing, smelling, or tasting something that does not exist (hallucinations), hostility, overly good mood, personality disorders, suicidal behavior
• numbness and pain in the hands (carpal tunnel syndrome), mental disorders, seizures (convulsions), inability to write and read, muscle disorders, movement disorders, muscle spasms, nerve inflammation, disorders of the nerve-muscle connection leading to muscle dysfunction, rapid involuntary eye movements, paralysis, foot drop (peroneal nerve palsy), loss of consciousness (stupor), blurred vision
• cataract, corneal damage, feeling of dry eye, eye bleeding, eyelid drooping, pupil dilation, optic nerve atrophy leading to vision disorders
• extra heartbeats, slow heart rate, occasional rapid heartbeat
• varicose veins
• periodic breathing cessation, nosebleeds, unnatural rapid or deep breathing (hyperventilation), feeling of throat constriction, lung disorders, inability to breathe due to throat constriction (feeling of choking)
• enteritis, colon polyp, belching, esophageal ulcer, gum inflammation, rectal bleeding, salivary gland enlargement
• gallstones, liver enlargement
• skin and soft tissue swelling, contact dermatitis, painful red nodules on the skin, skin nodules
• swelling, inflammation, and pain in the joints (arthritis or osteoarthritis), inflammation, and pain in the fluid-filled sac surrounding the joint (bursitis), side pain, muscle atrophy
• hematuria, kidney stones, urinary disorders, abnormal urine
• breast swelling, erectile dysfunction, pelvic organ prolapse, prolonged erection, prostate disorders, abnormal Pap smear, testicular disorders, vaginal bleeding, vaginal disorders
• cyst, "next-day" symptoms, decreased body temperature (hypothermia), unspecified inflammation, tissue necrosis at the injection site, mucous membrane disorders
• vaccination-related disorders.

Reporting 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,
Jerozolimskie Avenue 181C, 02-222 Warsaw, Poland, 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 Copaxone

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the outer packaging and on the immediate packaging after "Expiry Date:" or "EXP:". The expiry date refers to the last day of the month stated.
Store in a refrigerator (2°C - 8°C).
Copaxone prefilled syringes can be stored at room temperature (15°C to 25°C) for up to 1 month.
After 1 month, if the prefilled syringes have not been used and are still in their original packaging, they must be returned to the refrigerator.
Do not freeze.
Store the prefilled syringes in their original packaging to protect them from light.
Any syringes containing solid particles should be discarded.
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 (corresponding to the contents of one prefilled syringe) contains 20 mg glatiramer acetate, which corresponds to 18 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 separately in a PVC blister pack.
Copaxone is available in packs containing 7, 28, or 30 prefilled syringes, each containing 1 ml of the solution for injection, or in a multipack containing 3 cardboard boxes, each containing 30 prefilled syringes, each containing 1 ml of the solution for injection.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization 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 medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the name

Copaxone 20 mg/ml:

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

Copaxone:

Poland
To obtain more detailed information on this medicine, please contact the representative of the marketing authorization holder:
Teva Pharmaceuticals Polska Sp. z o.o.
Emilii Plater 53
00-113 Warsaw
phone: (22) 345 93 00

Date of last revision of the package leaflet: October 2024