20 mg/ml Solution for Injection, Pre-filled Syringe
Glatiramer acetate
Read all of this leaflet carefully before you start using this medicine.
- 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
- 1. What Copaxone 20 mg/ml is and what it is used for
- 2. Before you use Copaxone 20 mg/ml
- 3. How to use Copaxone 20 mg/ml
- 4. Possible side effects
- 5. How to store Copaxone 20 mg/ml
- 6. Further information
WHAT COPAXONE 20 mg/ml IS AND WHAT IT IS USED FOR
Copaxone 20 mg/ml is a medicinal product which modifies the way in which your body’s immune system works (it is classed as an immunomodulating agent). The symptoms of multiple sclerosis (MS) are thought to be caused by a defect in the body’s immune system. This produces patches of inflammation in the brain and spinal cord.
Copaxone 20 mg/ml is used to reduce the number of times you suffer attacks of MS (relapses). It has not been demonstrated to help if you have any form of MS which does not have relapses, or hardly any relapses. Copaxone 20 mg/ml may not have any effect on the length of time an MS attack lasts, or how badly you suffer during an attack.
It is used to treat patients who are able to walk without help.
Copaxone may also be used in patients who have experienced symptoms for the first time which indicate a high risk of developing MS. Your doctor will rule out any other reasons which could explain these symptoms before you are treated.
BEFORE YOU USE COPAXONE 20 mg/ml
DO NOT use Copaxone 20 mg/ml
- if you are allergic (hypersensitive) to the active ingredient glatiramer acetate, or any of the other ingredients of Copaxone 20 mg/ml;
- if you are pregnant.
Take special care with Copaxone 20 mg/ml
Ask your doctor for advice if you have any kidney or heart problems as you may need to have regular tests and check-ups.
Children: Copaxone is not to be used in children below the age of 12 years.
Elderly: Copaxone has not been specifically studied in the elderly. Please ask your doctor for advice.
Using other medicines
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
Do not take Copaxone 20 mg/ml if you are pregnant. Tell your doctor if you become pregnant while you are taking this medicine or if you plan to become pregnant.
You should use effective birth-control (e.g. the ‘pill’ or condoms) to avoid pregnancy during the treatment with Copaxone.
If you are breast-feeding talk to your doctor before using Copaxone.
Driving and using machines
Copaxone 20 mg/ml is not known to influence the ability to drive or operate machinery.
HOW TO USE COPAXONE 20 mg/ml
Always use Copaxone 20 mg/ml exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
The daily dose in adults and adolescents aged 12 years and over is one pre-filled syringe (20 mg of glatiramer acetate), administered under the skin (subcutaneously).
It is very important to inject Copaxone 20 mg/ml properly:
- Into the tissue under the skin (subcutaneous tissue) only (see "Instructions for Use" below).
- At the dose instructed by your doctor. Take only the dose prescribed by your doctor.
- Never use the same syringe more than once. Any unused product or waste must be discarded.
- Do not mix or co-administer the content of Copaxone 20 mg/ml pre-filled syringes with any product.
- If the solution contains particles, do not use it. Use a new syringe.
The first time you use Copaxone 20 mg/ml you will be given full instructions and will be supervised by a doctor or nurse. They will be with you while you give yourself the injection and for half an hour afterwards, just to make sure you do not have any problems.
Instructions for Use
Read these instructions carefully before using Copaxone 20 mg/ml.
Before the injection, make sure you have everything you need:
- One blister with one Copaxone 20 mg/ml pre-filled syringe
- Disposal unit for used needles and syringes.
For each injection, take only one blister with one pre-filled syringe from the package. Keep all remaining syringes in the box.
- If your syringe has been stored in the refrigerator, take the blister containing the syringe out at least 20 minutes before you will inject the medicine so that it warms up to room temperature.
Wash your hands thoroughly with soap and water.
Choose the injection site, using the diagrams in Figure 1.
There are seven possible areas on your body for injection: arms, thighs, hips and stomach (belly). Within each injection area there are several injection sites. Choose a different site for the injection every day. This will reduce the likeliness of any irritation or pain at the site of the injection. Rotate the injection sites within an area. Do not use the same site each time.
Please note: do not inject in any area that is painful or discoloured or where you feel firm knots or lumps.
You should consider having a planned schedule for rotating injection sites and making a note of it in a diary.
There are some sites on your body that may be difficult for self-injection (like the back of your arm). If you want to use these, you may require assistance.
Area 1 is the stomach. Avoid the 5 centimetres immediately surrounding the navel.
Area 2 is the right thigh. This area is 5 centimetres above the knee and 5 centimetres below the groin.
Area 3 is the left thigh. This area is 5 centimetres above the knee and 5 centimetres below the groin.
Area 4 is the left arm. This area is the fleshy part of the upper back arm.
Area 5 is the right arm. This area is the fleshy part of the upper back arm.
Area 6 is the left hip. This is the fleshy area of the upper hip, above the buttock and below the waist.
Area 7 is the right hip. This is the fleshy area of the upper hip, above the buttock and below the waist.
It may help to think of each injection area being divided into at least 8 sections; a left and right side and then 4 or more horizontal sections. Within each of these sections you can inject into a different place each time.
How to inject:
- Remove the syringe from its protective blister by peeling back the paper label.
- Remove the shield from the needle.
- Gently pinch up the skin with the thumb and forefinger of the free hand (Figure 2).
- Push the needle into the skin as shown in Figure 3.
- Inject the medicine by steadily pushing the plunger all the way down until the syringe is empty.
- Pull the syringe and needle straight out.
- Discard the syringe in a safe disposal container. Do not put used syringes into the household waste but dispose of them carefully in a puncture-proof container as recommended by your doctor or nurse.
If you have the impression that the effect of Copaxone 20 mg/ml is too strong or too weak, talk to your doctor.
If you use more than one syringe of Copaxone 20 mg/ml a day then you should
talk to your doctor immediately.
If you forget to use Copaxone 20 mg/ml
take it as soon as you remember but do not take a double dose to make up for forgotten individual doses. Take the next dose 24 hours later.
If you stop taking Copaxone 20 mg/ml
Do not stop taking Copaxone 20 mg/ml without consulting your doctor.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible Side Effects
Like all medicines, Copaxone 20 mg/ml can cause side effects, although not everybody gets them.
Allergic reactions (hypersensitivity)
You may rarely develop a serious allergic reaction to this medicine.
Stop taking Copaxone 20 mg/ml and contact your doctor immediately or go to the nearest hospital casualty department, if you notice any sign of these side effects:
- rash (red spots or nettle rash),
- swelling of the eyelids, face or lips,
- sudden shortness of breath,
- convulsions (fits),
- fainting.
Other reactions following injection (Immediate Post-Injection)
Some people may get one or more of the following symptoms within minutes after injecting Copaxone 20 mg/ml. They normally do not cause any problems and usually disappear within half an hour.
However, if the following symptoms last longer than 30 minutes, tell your doctor immediately or go to the casualty department at your nearest hospital:
- flushing of the chest or face,
- a feeling of tightness in the chest,
- shortness of breath,
- rapid and pounding heartbeat (palpitations).
The following side effects have been reported with Copaxone:
Very common (more than 1 in 10 patients):
- Skin reactions at the injection site. They included: reddening of skin, pain, formation of wheals, itching, tissue swelling, inflammation and hypersensitivity at the injection site. These injection site reactions are not unusual and normally decrease over time.
Further very common side effects included:
- nausea
- feeling weak, chest pain, non-specific pain
- infections, flu
- pain in the joints or back
- headache
- anxiety, depression
- skin rash
Common (less than 1 in 10, but more than 1 in 100 patients):
- swollen lymph nodes
- rapid heart beats, rapid and throbbing heartbeat (palpitations)
- ear problems
- eye problems, double vision
- problems with your bottom, constipation, tooth fillings, indigestion, difficulty swallowing, bowel incontinence, vomiting
- chills, local reactions, accumulation of fluid, swollen ankles, swollen face, high temperature, loss of tissue under the skin at injection site
- allergic reactions
- infection of the respiratory track, stomach, ear, runny nose, cold sores, tooth abscess, vaginal thrush
- abnormal liver function test
- weight gain, loss of appetite
- pain in your neck
- skin growths, tissue growth
- altered taste, abnormal tension of arteries or muscles, migraine, problems with speech, fainting, tremor
- nervousness
- inability to empty your bladder, need to empty your bladder quickly, frequent urination
- cough, hayfever
- bruising, excessive sweating, itching, nettle rash and other skin problems
Uncommon (less than 1 in 100, but more than 1 in 1000 patients):
- change in number or form of white cells, less platelets, big spleen
- extra heart beats, slow or fast heart beats
- enlarged or overactive thyroid
- cataract, scratch on the eyeball, dry eye, a bleed on the eye, droopy eyelid, widening of the pupil, abnormal vision or loss of vision
- bowel inflammation, polyps in the colon, burping, ulcer in the gullet, inflammation of the gums, rectal bleed, enlarged salivary glands
- cyst, hangover, body temperature lower than normal (hypothermia), non-specific inflammation, destruction of tissues at the injection site, problems with mucous membranes
- abscess, boils, infection of skin or kidney, shingles
- tiredness after vaccination
- gallstones, enlarged liver
- low alcohol tolerance, gout, too much fat (lipids) in the blood, changes in the blood (increased sodium, decreased ferritin)
- swollen joints (arthritis or osteoarthritis), decrease in the mass of muscles
- skin cancer
- hand numbness and pain, mental disorders, fits (convulsion), writing and reading disabilities, muscle spasm, impaired muscle tone, nerve inflammation, muscle weakness, paralysis, eye flickers, foot drop, unconscious state (stupor), visual blind spots
- abortion
- strange dreams, confusion, abnormally happy or active, seeing or hearing things that are not there, aggressiveness, personality change, suicide attempt
- blood in the urine or other problem in the urinary system, kidney stones
- swollen breasts, sustained erections, difficulties getting an erection, prolapse, problems with the vagina, prostate or testes, vaginal bleed, abnormal smear test
- problems with the lungs, tight feeling in the throat, inability to breath, abnormally fast or deep breathing (hyperventilation), nose bleeds
- swelling of the capillaries, skin contact rash, skin lumps, painful red skin lumps
- varicose veins
Rare (between 1 and 10 in every 10,000 patients) and very rare (less than 1 in every 10,000 patients)
- Severe allergic reaction
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
HOW TO STORE COPAXONE 20 mg/ml
Keep out of the reach and sight of children.
Store in a refrigerator (2°C - 8°C).
Copaxone 20 mg/ml pre-filled syringes can be kept for up to one month outside the refrigerator at room temperature. You can do this only once. After one month any Copaxone 20 mg/ml prefilled syringes that have not been used and are still in their original packaging must be returned to the refrigerator.
Do not freeze.
Keep the syringes in the outer carton in order to protect from light.
Do not use Copaxone 20 mg/ml after the expiry date which is stated on the package (EXP). The expiry date refers to the last day of that month.
Dispose of any syringes that contain particles.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Further Information
What Copaxone 20 mg/ml contains
- The active substance is glatiramer acetate. The 1 ml solution for injection (the contents of one pre-filled syringe) contains 20 mg glatiramer acetate.
- The other ingredients are mannitol and water for injections.
What Copaxone 20 mg/ml looks like and contents of the pack
Copaxone 20 mg/ml is a sterile, clear solution, free of visible particles.
Packs containing 7 or 28 pre-filled syringes, each with 1 ml of Copaxone.
Not all pack sizes may be marketed."
If the solution contains particles, throw it away and start again. Use a new syringe.
Marketing Authorisation Holder and Manufacturer
The marketing authorisation holder of this medicine is
The manufacturer of this medicine is
This leaflet was last approved in
February 2009.
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