Copaxone 20 mg/ml solution for injection in pre-filled syringe
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: Information for the user
Copaxone 20 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, as 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 adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Leaflet contents:
- What Copaxone is and what it is used for
- What you need to know before using Copaxone
- How to use Copaxone
- Possible side effects
- How to store Copaxone
- 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) are believed to result from a defect 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 with no relapses or very few relapses. Copaxone may not have any effect on the duration of an MS attack, or on the severity of symptoms during an attack.
It is used to treat patients who are able to walk without assistance.
Copaxone may also be used in patients who have experienced symptoms for the first time, indicating a high risk of developing MS. Your doctor will rule out any other possible causes of these symptoms before treating you.
2. What you need to know before using Copaxone
Do not use Copaxone
- if you are allergic to glatiramer acetate or to any of the other ingredients 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 after 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 to use Copaxone if you have any kidney or heart problems, as you may need periodic tests or examinations.
Consult your doctor or pharmacist before starting to use Copaxone if you have or have had liver problems (including those due to alcohol consumption).
Children
Copaxone must not be used in children under 12 years of age.
Elderly patients
Copaxone has not been specifically studied in elderly patients. Please consult your doctor.
Using Copaxone with other medicines
Tell 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 on the advice of your doctor.
Limited data in humans 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 any influence on the ability to drive or operate machinery.
3. How to use Copaxone
Follow exactly the administration instructions for this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.
The recommended daily dose in adults and adolescents aged 12 years and older is one pre-filled syringe (20 mg glatiramer acetate), administered under the skin (subcutaneously).
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 prescribed by your doctor. Use 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 instead.
The first time you use Copaxone, you will be given complete instructions and supervised by a doctor or nurse. They will be 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 discarding used needles and syringes.
- For each injection, remove only one blister pack with a pre-filled syringe from the outer 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 injection so that it can warm to room temperature.
Wash your hands thoroughly with soap and water.
If you wish to use an injection device for self-injection, 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 consult the instructions for use provided with the CSYNC injection device.
Choose an injection site within the areas shown 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, multiple injection sites are possible. Choose a different site each day to reduce the likelihood 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 injection site.
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 schedule of planned injection sites and record them in a diary. Some areas of 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 its 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, creating a skin 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 medication 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 sharps container. Do not throw used syringes into the trash; carefully place them in 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 immediately at telephone number 915620420, stating the medication and the amount ingested.
If you forget to use Copaxone
Take it as soon as you remember, but do not take a double dose to make up for missed doses. Take the next dose 24 hours after the last one.
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 (immediate reaction after injection)
Although uncommon, some people may experience one or more of the following symptoms within minutes after a Copaxone injection. These symptoms usually do not cause concern and resolve within 30 minutes.
However, if any of the following symptoms last longer than 30 minutes, contact your doctor immediately, or go to the nearest hospital emergency department:
- flushing (redness) 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 rarely occur 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
The following adverse effects have been reported with Copaxone:
Very common: may affect more than 1 in 10 people
- infections, flu
- anxiety, depression
- headache
- nausea
- skin rash
- joint or back pain
- feeling weak, skin reactions at the 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, runny nose, dental abscesses, vaginal candidiasis
- non-malignant skin growths (benign skin neoplasms), tissue growth (neoplasm)
- swollen lymph nodes
- allergic reactions
- loss of appetite, weight gain
- 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, tooth decay, indigestion, difficulty swallowing, intestinal incontinence, vomiting
- abnormal liver function test results
- bruising, excessive sweating, itching, skin disorders, urticaria
- neck pain
- urgency to empty the bladder, frequent urination, inability to adequately empty the bladder
- chills, facial swelling, loss of tissue under the skin at the 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, change in white blood cell shape
- enlarged thyroid or overactive thyroid (hyperthyroidism)
- low alcohol tolerance, gout, increased blood fat levels, increased blood sodium, decreased blood ferritin
- strange dreams, confusion, euphoric state, seeing, hearing, smelling, touching, or feeling things that are not there (hallucinations), aggression, abnormally happy state, personality disorders, suicide attempt
- numbness of the hands and pain (carpal tunnel syndrome), mental disorders, seizures (fits), problems with writing and reading, muscular disorders, movement problems, 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 visual spots
- cataracts, corneal eye lesions, dry eyes, eye bleeding, drooping eyelid, pupil dilation, optic nerve wear causing visual problems
- extra heartbeats, slow heartbeats, episodes of rapid heartbeats
- 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, burping, throat ulcer, gum inflammation, rectal bleeding, enlarged salivary glands
- gallstones, enlarged liver
- swelling of the skin and soft tissues, contact skin rash, painful red skin lumps, skin nodules
- swelling, inflammation, and joint pain (arthritis or osteoarthritis), inflammation and pain in the fluid-filled sacs covering joints (bursitis), 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 the injection site, mucous membrane problems
- adverse 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 can 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 prefilled syringe for injectable solution may be stored outside the refrigerator at temperatures between 15 °C and 25 °C for up to one month. This may only be done once. If, after this one-month period, the prefilled 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 prefilled 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 containers and medicines at the SIGRE Point in your pharmacy. If you are unsure, 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 injection solution (the content of 1 pre-filled syringe) contains 20 mg of glatiramer acetate, equivalent to 18 mg of glatiramer.
- The other components are mannitol and water for injections.
Appearance of the product and contents of the pack
Copaxone 20 mg/ml solution for injection in pre-filled syringe is a sterile, clear solution free from visible particles.
Each pre-filled syringe is individually packed in a PVC blister.
Copaxone is available in packs containing 7, 28 or 30 pre-filled syringes of 1 ml injection solution, or in a multi-pack containing 90 pre-filled syringes consisting of 3 packs, each containing 30 pre-filled syringes of 1 ml injection 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 20 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 about this medicinal product is available from the local representative of the Marketing Authorization Holder:
Teva Pharma, S.L.U.
C/ Anabel Segura, 11, Edificio Albatros B, 1st floor
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 of 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 outer packaging. You may also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/65983/P_65983.html
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