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COPAXONE 20MG/ML SOLUTION FOR INJECTION PREFILLED SYRINGE

Active substance(s): GLATIRAMER ACETATE / GLATIRAMER ACETATE / GLATIRAMER ACETATE

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Copaxone / UK Side A
(Kfar Saba / Baxter / Runcorn)
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3-xxxx-172
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PExxxx

Package leaflet: Information for the user
®

20 mg/ml
solution for injection, pre-filled syringe
glatiramer acetate
Read all of this 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 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 signs of illness are the same as
yours.
• If you get any of the side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Copaxone 20 mg/ml is and what it is used for
2. What you need to know 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. Contents of the pack and other information

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.
If you wish to use the COPAXONE injection device to make your injection,
please refer to the instructions for use provided together with the
COPAXONE injection device.
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.

1. 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.

2. What you need to know before you use Copaxone 20 mg/ml
Do not use Copaxone 20 mg/ml
• if you are allergic to glatiramer acetate or any of the other ingredients of
this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before using Copaxone 20 mg/ml
• 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.
Other medicines and Copaxone 20 mg/ml
Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are
planning to have a baby, ask your doctor for advice and consideration
regarding Copaxone treatment during pregnancy and/or lactation.
Driving and using machines
Copaxone 20 mg/ml is not known to influence the ability to drive or
operate machinery.

3. How to use Copaxone 20 mg/ml
Always use this medicine 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.

Teva Pharmaceuticals Europe B.V
Effective Date: TBD

How to inject:
• Remove the syringe from its protective blister by peeling back the blister
lid.
• 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
Use it as soon as you remember but do not use a double dose to make up
for forgotten individual doses. Use the next dose 24 hours later.
If you stop using Copaxone 20 mg/ml
Do not stop using Copaxone 20 mg/ml without consulting your doctor.
If you have any further questions on the use of this medicine, ask your
doctor or pharmacist.

REG0208721
Valid For 7 Days from 07-Apr-2017

Version 0.3

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Copaxone 20 mg

Side B

280x380 mm Folded: 140x127 mm

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not
everybody gets them.
Allergic reactions (hypersensitivity)
You may rarely develop a serious allergic reaction to this medicine.
Stop using Copaxone 20 mg/ml and contact your doctor immediately or
go to the casualty department at your nearest hospital, 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 reaction)
It’s uncommon but 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, contact
your doctor immediately or go to the casualty department at your nearest
hospital:
• flushing (reddening) of the chest or face (vasodilatation)
• shortness of breath (dyspnoea)
• chest pain
• pounding and rapid heartbeat (palpitations, tachycardia)
The following side effects have been reported with Copaxone:
Very common (may affect more than 1 in 10 people)
• infection, flu
• anxiety, depression
• headache
• feeling sick
• skin rash
• pain in the joints or back
• feeling weak, skin reactions at the injection site including reddening of
skin, pain, formation of wheals, itching, tissue swelling, inflammation and
hypersensitivity (these injection site reactions are not unusual and
normally decrease over time), non-specific pain
Common (may affect up to 1 in 10 people)
• inflammation of the respiratory tract, gastric flu, cold sore, inflammation
of the ears, runny nose, tooth abscess, vaginal thrush
• non-malignant skin growth (non-malignant neoplasm of skin), tissue
growth (neoplasm)
• lymph node swelling
• allergic reactions
• loss of appetite, weight gain
• nervousness
• altered taste, increased tightness of muscle tone, migraine, speech
disorder, fainting, tremor
• double vision, eye disorder
• ear disorder
• cough, hay fever
• disorder of anus or rectum, constipation, tooth decay, indigestion,
difficulty in swallowing, bowel incontinence, vomiting
• abnormal liver function test
• bruising, excessive sweating, itching, skin disorder, nettle rash
• neck pain
• urge to empty your bladder, frequent urination, inability to empty your
bladder appropriately
• chill, face swelling, wasting of tissue under the skin at injection site, local
reaction, peripheral swelling due to build-up of fluid, fever
Uncommon (may affect up to 1 in 100 people)
• abscess, inflammation of skin and the soft tissue underneath, boils,
shingles, inflammation of kidney
• skin cancer
• increased white blood cell count, reduced white blood cell count, spleen
enlargement, low blood platelet count, change in form of white blood cells
• enlarged thyroid, overactive thyroid
• low alcohol tolerance, gout, increase in blood fat levels, increase in blood
sodium, decrease in serum ferritin
• abnormal dreams, confusion, euphoric mood, seeing, hearing, smelling,
tasting or feeling something that is not there (hallucinations), aggression,
abnormal elevated mood, personality disorder, suicide attempt
• hand numbness and pain (carpal tunnel syndrome), mental disorder, fits
(convulsion), problems with handwriting and reading, muscle disorders,
problems with movement, muscle spasm, nerve inflammation, abnormal
nerve-muscle link leading to abnormal muscle function, involuntary rapid
movement of the eyeballs, paralysis, foot drop (peroneal nerve palsy),
unconscious state (stupor), visual blind spots
• cataract, eye lesion in the cornea, dry eye, eye bleeding, droopy upper
eyelid, pupil widening, wasting of the optic nerve leading to visual
problems
• extra heart beats, slow heart beats, episodic fast heart beats
• varicose vein
• periodic stops in breathing, nose bleeding, abnormally fast or deep
breathing (hyperventilation), tight feeling in the throat, lung disorder,
inability to breath due to throat tightness (choking sensation)
• bowel inflammation, polyps in the colon, intestine inflammation, burping,
ulcer in the gullet, inflammation of the gums, rectal bleeding, enlarged
salivary glands
• gallstones, liver enlargement
• swelling of the skin and soft tissues, skin contact rash, painful red skin
lumps, skin lumps
• swelling, inflammation and pain of joints (arthritis or osteoarthritis),
inflammmation and pain of fluid-sacs lining the joint (exist in some of the
joints), flank pain, decrease in the mass of muscles
• blood in the urine, kidney stones, urinary tract disorder, urine abnormality
• abortion

Teva Pharmaceuticals Europe B.V
Effective Date: TBD

• breast swelling, difficulties getting an erection, fall down or slip out of the
place of pelvic organs (pelvic prolapse), sustained erections, disorders of
prostate, abnormal PAP smear test (Smear Cervix Abnormal), testes
disorder, vaginal bleeding, vaginal disorder
• cyst, hangover, low body temperature (hypothermia), non-specific
inflammation, destruction of tissue at the injection site, problems with
mucous membranes
• disorders after vaccination
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet. You can also report side
effects directly via Yellow Card Scheme, Tel: Freephone 0808 100 3352,
Website: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the
safety of this medicine.

5. How to store Copaxone 20 mg/ml
Keep this medicine out of sight and the reach 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 between 15°C and 25°C. 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 pre-filled syringes in the outer carton in order to protect from
light.
Do not use this medicine after the expiry date which is stated on the label
and carton (EXP). The expiry date refers to the last day of that month.
Dispose of any syringes that contain particles.
Do not throw away any medicine via wastewater or household waste. Ask
your pharmacist how to throw away medicines you no longer use. These
measures will help protect the environment.

6. Contents of the pack and other information
What Copaxone 20 mg/ml contains
• The active substance is glatiramer acetate. 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 solution for injection in pre-filled syringe is a sterile,
clear solution, free of visible particles.
If the solution contains particles, throw it away and start again. Use a new
syringe.
Copaxone is available in packs containing 7, 28 or 30 pre-filled syringes of
1 ml solution for injection or in a multipack comprising 3 cartons, each
containing 30 pre-filled syringes of 1 ml of solution for injection.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Teva Pharmaceuticals Ltd.
Ridings Point, Whistler Drive
Castleford, West Yorkshire
WF10 5HX
UK
Tel: +44 (0)207 540 7117
Fax: +44 (0)207 540 7349
Manufacturer:
Norton Healthcare Limited T/A IVAX Pharmaceuticals UK (Teva Runcorn)
Aston Lane North, Whitehouse Vale Industrial Estate
Runcorn, Cheshire, WA7 3FA
United Kingdom
This medicinal product is authorised in the Member States of the EEA
under the name COPAXONE 20 mg/ml in:
Austria, Belgium, Croatia, Czech Republic, Cyprus, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary,
Ireland, Iceland, Italy, Latvia, Lithuania, Luxembourg, Malta, Norway,
Poland, Portugal, Romania, Spain, Sweden,
Slovakia, Slovenia, The Netherlands, United Kingdom
This leaflet was last revised in 02/2017

REG0208721
Valid For 7 Days from 07-Apr-2017

Version 0.3

Approved
Page 2 of 3

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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