Package Insert: Information for the User

Copaxone 40 mg/ml Pre-filled Injectable Suspension

Glatiramer Acetate

Read this entire package insert carefully before starting to use this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you alone, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert.See section 4.

6. Contents of the pack and additional information

Copaxone is a medication, indicated for the treatment of recurrent forms of multiple sclerosis (MS). It modifies the way the body's immune system functions and is classified as an immunomodulator. MS symptoms are produced by a defect in the body's immune system. This produces 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 effective if you have a form of MS that does not have relapses, or almost no relapses. Copaxone may have no effect on the duration of an MS attack, or how poorly you tolerate an attack.

Do not use Copaxone

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

Warnings and precautions

Copaxone may cause severe 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 have occurred after previous administrations.

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

Consult your doctor or pharmacist before starting to use Copaxone if you have any kidney or heart problems, as you may need to have regular tests or examinations.

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

Children

Copaxone cannot be used in children under 18 years old.

Older patients

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

Using Copaxone with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or intend to become pregnant, consult your doctor about using Copaxone during pregnancy.

Copaxone can be used during pregnancy under the guidance of your doctor.

Limited human data showed no negative effects of Copaxone on newborns/breastfeeding infants. Copaxone can be used during breastfeeding.

Driving and operating machinery

The effect of Copaxone on the ability to drive or operate machinery is unknown.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

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

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

• Only in the tissue under the skin (subcutaneous use) (see "Usage Instructions")
• At the dose indicated by your doctor. Administer only the prescribed dose by your doctor.
• Never use the same syringe more than once. Any unused or excess product must be discarded.
• Do not mix or co-administer the contents of the pre-filled syringes of Copaxone with any other product.
• If the solution contains particles, do not use it. Use a new syringe.

The first time you use Copaxone, you will be given complete instructions and will be supervised by a doctor or nurse. They will be with you during the injection and for another 30 minutes afterwards, just to make sure you have no problems.

Usage Instructions

Read these instructions carefully before using Copaxone.

Before the injection, make sure you have everything you need:

• A blister pack with a pre-filled syringe of Copaxone injectable solution.
• A container for disposing of used needles and syringes.
• For each injection, take only one blister pack with a pre-filled syringe, from the package. Keep the rest of the syringes in the box.
• If your syringe was in the refrigerator, take the blister pack containing the syringe out at least 20 minutes before you are going to inject the medication, so it will warm up to room temperature.

Wash your hands thoroughly with soap and water.

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

Choose a place for the injection within the areas, following the diagrams.

There are seven possible injection areas on your body:

Area 1: Abdominal area (around the navel) below the belly button. Avoid placing the injection 5 cm to 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 possible injection sites. Choose a different site for each injection. This will reduce the likelihood of irritation or pain at the injection site. Change the injection areas and also change the site within each area.Do not always use the same injection site.

Warning: Do not inject in any area that is painful, discolored, or has firm nodules or lumps.

It is recommended to have a schedule of planned injection sites and to note it in a diary. There are some areas on your body that may be difficult for self-injection (such as the back of your arm). If you want to use them, you may need help.

How to inject:

• Remove the syringe from the blister pack by peeling off the blister cover.
• Remove the needle cap,do not removethe protective cap with your mouth or teeth.
• Gently pinch the skin, making a 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 medication by pushing the plunger firmly until the syringe is empty.
• Remove the syringe and needle.
• Dispose of the syringe in a safe disposal container. Do not throw used syringes in the trash, carefully place them in a puncture-proof container as recommended by your doctor or nurse.

Figure 1 Figure 2

If you think the effect of Copaxone is too strong or too weak, tell your doctor.

If you use more Copaxone than you should

Immediately consult your doctor, pharmacist, or call the Toxicological Information Service, phone 915620420, indicating the medication and the amount ingested.

If you forget to use Copaxone

Administer it as soon as you remember or can administer it and omit it the next day. Do not administer a double dose to compensate for the missed doses. If possible, return to your regular administration schedule the following week.

If you interrupt treatment with Copaxone

Do not stop using Copaxone without consulting your doctor

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Allergic reactions (hypersensitivity, anaphylactic reaction)

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

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

• Generalized hives (red spots or rashes)
• Inflammation of the eyelids, face, lips, mouth, throat, or tongue
• Sudden shortness of breath, difficulty breathing, or wheezing ("whistling" when breathing)
• Seizures (convulsions)
• Difficulty swallowing or speaking
• Syncope (fainting), dizziness, or feeling of fainting
• Collapsing

Other reactions after injection (reaction immediately after injection)

Some people may experience one or more of the following symptoms within minutes of receiving a Copaxone injection. These usually do not pose a problem and resolve within 30 minutes.

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

• Redness (flushing) of the chest or face (vasodilation)
• Difficulty breathing (dyspnea)
• Chest pain
• Fast and strong heartbeats (palpitations, tachycardia)

Liver problems (liver disease)

Liver problems or worsening of liver problems, including liver failure (which in some cases led to liver transplantation), can occur rarely 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 white part of the eye
• Bleeding more easily than normal

In general, the following side effects reported by patients receiving Copaxone 40 mg/ml three times a week also occurred in patients treated with Copaxone 20 mg/ml (see the following list).

Very common; may affect more than 1 in 10 people

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

Common: may affect up to 1 in 10 people

• Respiratory tract inflammation, gastrointestinal disease, fever, ear inflammation, nasal discharge, dental abscesses, vaginal candidiasis
• Benign skin growths (benign skin neoplasms), tissue growth (neoplasia)
• Lymph node swelling
• Allergic reactions
• Loss of appetite, weight gain
• Nervousness
• Alteration of taste, increased muscle tone, migraine, speech problems, dizziness, tremors
• Double vision, eye problems
• Ear problems
• Cough, hay fever
• Anal or rectal problems, constipation, tooth decay, indigestion, difficulty swallowing, incontinence, vomiting
• Abnormal liver function test results
• Cardinal signs, excessive sweating, itching, skin changes, urticaria
• Neck pain
• Urgent need to urinate, frequent urination, inability to empty the bladder properly
• Chills, facial swelling, tissue loss under the skin at the injection site, local reaction, peripheral edema due to fluid accumulation, fever.

Rare: may affect up to 1 in 100 people

• Abscesses, inflammation of the skin and subcutaneous tissue, furuncles, herpes, kidney inflammation
• Skin cancer
• Increased white blood cell count, decreased white blood cell count, spleen enlargement, decreased platelet count, change in white blood cell shape
• Thyroid enlargement, hyperthyroidism
• Low tolerance to alcohol, gout, increased blood lipid levels, increased sodium levels in the blood, decreased ferritin levels in the blood
• Strange dreams, confusion, euphoric state, seeing, hearing, smelling, touching, or feeling things that are not there (hallucinations), aggression, abnormal happiness, personality disorders, suicidal attempts
• Hand numbness and pain (carpal tunnel syndrome), mental disorders, seizures, speech and writing difficulties, muscle disorders, movement problems, muscle spasms, nerve inflammation, abnormal nerve-muscle connection resulting in abnormal muscle function, rapid and involuntary eye movements, paralysis, foot drop (peroneal nerve paralysis), unconsciousness (stupor), blind spots
• Cataracts, eye injuries in the cornea, dry eyes, eye bleeding, eyelid drooping, pupil dilation, optic nerve degeneration resulting in visual problems
• Fast heartbeats, slow heartbeats, episodes of rapid heartbeats
• Varicose veins
• Periodic respiratory arrest, nasal bleeding, abnormal breathing (hyperventilation), sensation of throat constriction, lung problems, inability to breathe due to throat constriction (sensation of asphyxia)
• Small intestine inflammation, colon polyps, intestinal inflammation, belching, throat ulcers, gum inflammation, rectal bleeding, salivary gland enlargement
• Bile stones, liver enlargement
• Skin and soft tissue swelling, skin rash due to contact, painful, red skin nodules, skin nodules
• Joint and tissue inflammation (arthritis or osteoarthritis), inflammation and pain of the fluid-filled sacs that cover the joints (present in some joints), side pain, muscle mass decrease
• Blood in the urine, kidney stones, urinary system problems, abnormal urine
• Breast swelling, difficulty achieving an erection, pelvic organ prolapse, persistent erections, prostate changes, abnormal Pap smear results (abnormal cervical smear), testicular changes, vaginal bleeding, vaginal disorders
• Cysts, hangover, low body temperature (hypothermia), non-specific inflammation, tissue destruction at the injection site, mucous membrane problems
• Alterations after vaccination

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this prospectus. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the label and the box (CAD or EXP).The expiration date is the last day of the month indicated.

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

Copaxone injectable solution in pre-filled syringecanbe stored for up to one month outside the refrigerator between 15 °C and 25 °C.Only do this once.If after this one-month period the pre-filled syringes of Copaxone have not been used and are still in their original packaging,theymust be stored in the refrigerator again.

Do not freeze.

The pre-filled syringesmustbe stored in their original packaging, protected from light.

Dispose of any syringe that contains particles.

Medicines should not be thrown away through the drains or in the trash.Deposit the containers and medicines that you do not need in the SIGRE pointof the pharmacy.In case of doubt, ask your pharmacist how to dispose of the containers and medicines that you do not need.This way, you will help protect the environment.

Composition ofCopaxone

• The active ingredient is glatiramer acetate. 1 ml of the injection solution (the content 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 injection.

Appearance of the product and contents of the package

Copaxone injectable solution in pre-filled syringe is a sterile, clear solution without visible particles.

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

Copaxone is available in packages containing 3, 12 or 36 pre-filled syringes of 1 ml injectable solution or a multi-pack of 36 pre-filled syringes composed of 3 packs, each containing 12 pre-filled syringes of 1 ml injectable solution.

Only some package 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,

220Hafnarfjörður

Islandia

or

Merckle GmBH

Graf Arco Strasse 3

Ulm - D-89079

Germany

This medicine is authorized in the member states of the European Economic Area with the name of 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.

For more information about this medicine, please contact 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)

Last review date of this leaflet:September 2024

For detailed and updated information about this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.

You can access detailed and updated information about this medicine by scanning the QR code included in the packaging with your smartphone. 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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