Copaxone 40 mg/ml solution for injection in pre-filled syringe

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Copaxone 40 mg/ml solution for injection in pre-filled syringe

glatiramer acetate

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet; you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Copaxone is and what it is used for

2. What you need to know 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 Copaxone is and what it is used for

Copaxone is a medicine indicated for the treatment of relapsing forms of multiple sclerosis (MS). It modifies the way your body's immune system functions and is classified as an immunomodulatory agent. The symptoms of multiple sclerosis (MS) arise due to a dysfunction in the body's immune system. This leads to areas of inflammation in the brain and spinal cord.

Copaxone is used to reduce the number of times you experience MS attacks (relapses). It has not been shown to be beneficial if you have a form of MS that does not involve relapses, or has very few relapses. Copaxone may not have any effect on the duration of an MS attack or on the severity of symptoms you experience during an attack.

2. What you need to know before starting Copaxone

Do not use Copaxone

• if you are allergic to glatiramer acetate or to any of the other components of this medicine (listed in section 6).

Warnings and precautions

Copaxone may cause serious allergic reactions, some of which may be potentially life-threatening.

These reactions may occur shortly after administration, even months or years after starting treatment, and even if no allergic reactions occurred following previous administrations.

The signs and symptoms of allergic reactions may overlap with injection-related reactions. Your doctor will inform you about the signs of an allergic reaction.

Consult your doctor or pharmacist before starting Copaxone if you have any kidney or heart problems, as you may require periodic blood tests or examinations.

Consult your doctor or pharmacist before starting Copaxone if you have or have had liver problems (including those due to alcohol consumption).

Children

Copaxone must not be used in children under 18 years of age.

Elderly patients

Copaxone has not been specifically studied in elderly patients. Please consult your doctor.

Use of Copaxone with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor about treatment with Copaxone during pregnancy.

Copaxone may be used during pregnancy if recommended by your doctor.

Limited human data have not shown negative effects of Copaxone on newborns/breastfed infants. Copaxone may be used during breastfeeding.

Driving and using machines

It is unknown whether Copaxone has an influence on the ability to drive or operate machinery.

3. How to use Copaxone

Follow exactly the administration instructions for this medicine given by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended dose for adults is one pre-filled syringe (40 mg glatiramer acetate), administered under the skin (subcutaneously) three times a week, injected with an interval of at least 48 hours between doses, for example, on Monday, Wednesday, and Friday. It is recommended to administer the medicine on the same days each week.

It is very important that the Copaxone injection is performed correctly:

• Only into the tissue beneath the skin (subcutaneous use) (see “Instructions for use”)
• At the dose indicated by your doctor. Administer only the dose prescribed by your doctor.
• Never use the same syringe more than once. Any unused or leftover product must be discarded.
• Do not mix or co-administer the contents of Copaxone pre-filled syringes with any other product.
• Do not use if the solution contains particles. Use a new syringe.

The first time you use Copaxone, you will be given complete instructions and supervised by a doctor or nurse. They will stay with you during the injection and for an additional half hour afterward, just to make sure you do not experience any problems.

Instructions for use

Read these instructions carefully before using Copaxone.

Before injection, ensure you have everything you need:

• A blister pack containing one pre-filled syringe of Copaxone injectable solution.
• A container for disposal of used needles and syringes.
• For each injection, remove only one blister pack with a pre-filled syringe from the carton. Keep the remaining syringes in the box.
• If your syringe has been stored in the refrigerator, remove the blister pack containing the syringe at least 20 minutes before you plan to inject the medicine, so it can warm to room temperature.

Wash your hands thoroughly with soap and water.

If you wish to use an injection device, the CSYNC device may be used with Copaxone. The CSYNC device is authorized only for use with COPAXONE and has not been tested with other products. Please refer to the instructions for use provided with the CSYNC injection device.

Choose an injection site within the areas indicated in the diagrams.

There are seven possible injection zones on your body:

Area 1: Abdominal area (abdomen) around the navel. Avoid injecting within 5 cm on either side of the navel.

Areas 2 and 3: Thighs (above your knees)

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

Within each injection area, there are multiple injection sites. Choose a different site for each injection. This will reduce the possibility of irritation or pain at the injection site. Rotate injection areas and also change the injection site within each area. Do not always use the same site for injection.

Warning: do not inject into any area that is painful, discolored, or where you feel firm lumps or nodules.

It is recommended to keep a record of planned injection sites and note them in a diary. Some sites on your body may be difficult for self-injection (such as the back of your arm). If you wish to use these sites, you may need assistance.

How to inject:

• Remove the syringe from the protective blister by peeling back the blister packaging.
• Remove the needle cap. Do not remove the protective cap with your mouth or teeth.
• Gently pinch the skin to form a fold between the thumb and index finger of your free hand (Figure 1).
• Gently insert the needle into the skin as shown in Figure 2.
• Inject the medicine by firmly pushing the plunger to the end until the syringe is empty.
• Remove the syringe and needle.
• Dispose of the syringe in a safe container for sharps. Do not throw used syringes into the household trash; carefully deposit them into a puncture-proof container as recommended by your doctor or nurse.

Figure 1 Figure 2

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

If you use more Copaxone than you should

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service at telephone number 915620420, indicating the medicine and the amount ingested.

If you forget to use Copaxone

Take it as soon as you remember or are able to administer it, and skip the next scheduled dose. Do not administer a double dose to make up for missed doses. If possible, resume your regular dosing schedule the following week.

If you stop using Copaxone

Do not stop using Copaxone without consulting your doctor.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Allergic reactions (hypersensitivity, anaphylactic reaction)

You may develop a severe allergic reaction to this medicine shortly after administration. This is an uncommon adverse effect. These reactions may occur months or years after starting treatment with Copaxone, even if no allergic reactions occurred after previous administrations.

If you notice any of the following sudden adverse effects, stop using Copaxone and contact your doctor immediately, or go to the nearest hospital emergency department:

• Widespread rash (red spots or hives)
• Swelling of the eyelids, face, lips, mouth, throat, or tongue
• Sudden shortness of breath, difficulty breathing, or wheezing ("whistling" when breathing)
• Seizures (fits)
• Difficulty swallowing or speaking
• Fainting (syncope), dizziness, or feeling faint
• Collapse

Other injection-related reactions (reactions occurring immediately after injection)

Some people may experience one or more of the following symptoms within minutes after injection of Copaxone. These usually are not serious and resolve within 30 minutes.

However, if the following symptoms last longer than 30 minutes, contact your doctor immediately, or go to the nearest hospital emergency department:

• Flushing of the chest or face (vasodilation)
• Difficulty breathing (dyspnea)
• Chest pain
• Rapid and strong heartbeat (palpitations, tachycardia)

Liver problems

Liver problems or worsening of existing liver problems, including liver failure (in some cases leading to liver transplantation), may occur rarely with Copaxone. Contact your doctor immediately if you experience symptoms such as:

• Nausea
• Loss of appetite
• Dark-colored urine and pale stools
• Yellowing of the skin or whites of the eyes (jaundice)
• Bleeding more easily than normal

In general, the following adverse effects reported by patients receiving Copaxone 40 mg/mL three times weekly were also reported in patients treated with Copaxone 20 mg/mL (see the list below).

Very common: may affect more than 1 in 10 people

• Infections, flu
• Anxiety, depression
• Headache
• Nausea
• Skin rash
• Joint or back pain
• Feeling of weakness, skin reactions at injection site including redness, pain, blistering, itching, tissue swelling, inflammation, and hypersensitivity (these injection site reactions are not unusual and usually resolve over time), non-specific pain.

Common: may affect up to 1 in 10 people

• Respiratory tract inflammation, gastric illness, hot flushes, ear inflammation, nasal discharge, dental abscesses, vaginal candidiasis
• Non-malignant skin growths (benign skin neoplasms), tissue growth (neoplasia)
• Swollen lymph nodes
• Allergic reactions
• Loss of appetite, weight gain
• Restlessness
• Altered sense of taste, increased muscle tone, migraine, speech problems, fainting, tremor
• Double vision, eye problems
• Ear problems
• Cough, hay fever
• Anal or rectal problems, constipation, dental caries, indigestion, difficulty swallowing, intestinal incontinence, vomiting
• Abnormal liver function test results
• Bruising, excessive sweating, itching, skin disorders, urticaria
• Neck pain
• Urgency to empty bladder, frequent urination, inability to adequately empty bladder
• Chills, facial swelling, loss of tissue under the skin at injection site, local reaction, peripheral swelling due to fluid accumulation, fever.

Uncommon: may affect up to 1 in 100 people

• Abscesses, skin and underlying soft tissue inflammation, boils, herpes, kidney inflammation
• Skin cancer
• Increased white blood cell count, decreased white blood cell count, enlarged spleen, decreased platelet count, changes in white blood cell shape
• Enlarged thyroid, overactive thyroid
• Low alcohol tolerance, gout, increased blood fat levels, increased blood sodium levels, decreased blood ferritin levels
• Strange dreams, confusion, euphoric state, seeing, hearing, smelling, touching, or feeling things that are not there (hallucinations), aggression, abnormally elevated mood, personality disorders, suicide attempt
• Numbness and pain in hands (carpal tunnel syndrome), mental disorders, seizures (fits), problems with writing and reading, muscular disorders, movement disorders, muscle spasms, nerve inflammation, abnormal nerve-muscle connection causing abnormal muscle function, rapid involuntary eye movements, paralysis, foot drop (peroneal nerve paralysis), unconscious state (stupor), blind spots in vision
• Cataracts, corneal eye lesions, dry eyes, eye bleeding, drooping eyelid, pupil dilation, optic nerve damage causing visual problems
• Extra heartbeats, slow heart rate, episodes of rapid heartbeat
• Varicose veins
• Periodic breathing pauses, nosebleeds, abnormally fast or deep breathing (hyperventilation), sensation of throat tightness, lung problems, inability to breathe due to throat narrowing (suffocation sensation)
• Inflammation of the small intestine, colon polyps, intestinal inflammation, belching, throat ulcer, gum inflammation, rectal bleeding, enlarged salivary glands
• Gallstones, enlarged liver
• Swelling of skin and soft tissues, contact skin rash, painful red skin lumps, skin nodules
• Swelling, inflammation, and joint pain (arthritis or arthrosis), inflammation and pain in fluid-filled sacs covering joints (present in some joints), side pain, decreased muscle mass
• Blood in urine, kidney stones, urinary system problems, urine abnormalities
• Breast swelling, erection difficulty, pelvic organ prolapse, prolonged erections, prostate disorders, abnormal Pap test results (abnormal cervical smear), testicular disorders, vaginal bleeding, vaginal disorders
• Cyst, hangover, abnormally low body temperature (hypothermia), non-specific inflammation, tissue destruction at injection site, mucous membrane problems
• Reactions following vaccination

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Copaxone

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the label and carton (CAD or EXP). The expiry date refers to the last day of the month indicated.

Store in a refrigerator (between 2 °C and 8 °C).

Copaxone pre-filled syringe for injectable solution may be stored for up to one month outside the refrigerator at temperatures between 15 °C and 25 °C. This may only be done once. If after this one-month period the pre-filled syringes of Copaxone have not been used and are still in their original packaging, they must be returned to refrigerated storage.

Do not freeze.

The pre-filled syringes must be kept in their original packaging, protected from light.

Discard any syringe containing particles.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE Point in your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Copaxone

• The active substance is glatiramer acetate. 1 ml of the injectable solution (the contents of 1 pre-filled syringe) contains 40 mg of glatiramer acetate, equivalent to 36 mg of glatiramer.
• The other components are mannitol and water for injections.

Appearance of the product and contents of the pack

Copaxone 40 mg/ml solution for injection in a pre-filled syringe is a sterile, clear solution without visible particles.

Each pre-filled syringe is individually packed in a PVC blister pack.

Copaxone is available in packs containing 3, 12 or 36 pre-filled syringes of 1 ml injectable solution, or in a multipack of 36 pre-filled syringes consisting of 3 packs, each containing 12 pre-filled syringes of 1 ml injectable solution.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva GmbH

Graf Arco Strasse 3

89079 Ulm

Germany

Manufacturer

Norton Healthcare Limited T/A IVAX Pharmaceuticals UK (Teva Runcorn)

Aston Lane North, Whitehouse Vale Industrial Estate

Runcorn, Cheshire, WA7 3FA

United Kingdom

or

Actavis Group PTC ehf.

Dalshraun 1,

220 Hafnarfjörður

Iceland

or

Merckle GmbH

Graf Arco Strasse 3

Ulm - D-89079

Germany

This medicinal product is authorized in the European Economic Area member states under the name COPAXONE 40 mg/ml:

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

Further information on this medicinal product can be obtained by contacting the local representative of the Marketing Authorization Holder:

Teva Pharma, S.L.U.

C/ Anabel Segura, 11, Edificio Albatros B, 1ª planta

28108, Alcobendas, Madrid (Spain)

Date of the most recent review of this leaflet: October 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http*://www.aemps.gob.es/.*

You can access detailed and up-to-date information about this medicinal product by scanning with your mobile phone (smartphone) the QR code included in the packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/79515/P_79515.html

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