Copaxone

Package leaflet: Information for the user

Copaxone 20 mg/ml solution for injection in pre-filled syringe

glatiramer acetate
Please 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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 used to treat relapsing forms of multiple sclerosis (MS).
It modifies the way your body's immune system works and is classified as an immunomodulating agent.
The symptoms of MS are believed to be caused by a malfunction of the body's immune system, which produces episodes 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 help if you have a form of MS with few or no relapses. Copaxone may not have any effect on the duration of an MS attack or on the intensity of pain 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 a first episode of symptoms indicating a high risk of developing MS. Before you take this medicine, your doctor will rule out any other possible causes that might explain these symptoms.

2. What you should 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
Talk to your doctor or pharmacist before using Copaxone if you have any kidney or heart problems, as you may need regular tests and check-ups.
Ask your doctor or pharmacist before using Copaxone if you have or have had liver problems (including those caused by alcohol consumption).
Children
Copaxone must not be used in children under 12 years of age.
Elderly
Copaxone has not been specifically studied in the elderly. Please consult your doctor for advice.
Other medicines and Copaxone
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, consult your doctor for advice and evaluation regarding treatment with Copaxone during pregnancy.
Copaxone may be used during pregnancy on the advice of a doctor.
Limited human data have not shown negative effects of Copaxone on infants who are breastfed. Copaxone may be used during breastfeeding.
Driving and using machines
The influence of Copaxone on the ability to drive vehicles and operate machinery is unknown.

3. How to use Copaxone

Use this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.

The recommended daily dose in adults and adolescents aged 12 years and older is one pre-filled syringe (20 mg of glatiramer acetate), administered under the skin (subcutaneous route).

It is very important to inject Copaxone 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. Unused product or any waste must be disposed of properly.
• Do not mix or administer the contents of Copaxone pre-filled syringes with any other product.
• Do not use the solution if it contains particles. Use a new syringe.

The first time you use Copaxone, complete instructions will be provided and you will be supervised by a doctor or healthcare professional. They will stay with you while you give yourself the injection and for 30 minutes afterwards to ensure you do not experience any problems.

Instructions for use
Read these instructions carefully before using Copaxone.
Before the injection, make sure you have everything you need:

• A blister pack containing one pre-filled syringe of Copaxone
• A container for the disposal of used needles and syringes.
• For each injection, take only one blister pack with one pre-filled syringe from the package. Store all remaining syringes in the box.
• If the syringe has been stored in the refrigerator, remove the blister containing the syringe and leave it out for at least 20 minutes before injection to allow it to warm to room temperature.

Wash your hands thoroughly with soap and water.
If you wish to use an injection device to administer the injection, the CSYNC device may be used with Copaxone. The CSYNC device is approved only for use with COPAXONE and has not been tested with other products. Refer to the instructions for use provided with the CSYNC injection device.

Choose the injection site within the designated areas, using the diagrams.
There are seven possible injection areas on your body:

Area 1: Abdominal area (abdomen) around the navel. Leave at least 5 cm between the navel and the injection site.

Area 2 and 3: Thighs (above the knees)

Area 4, 5, 6 and 7: Back of the arms and upper hips (below the waist)

Each injection area contains several injection sites. Choose a different injection site each day. This reduces the likelihood of irritation or pain at the injection site. Rotate injection areas and also rotate injection sites within each area. Do not use the same site every time.

Note: Do not administer the injection into tender, discolored areas or into spots where you feel hardened lumps or nodules.

It is recommended to keep a record of your scheduled injection site rotation and note it in a diary. Some body sites may be difficult to inject by yourself (such as the back of the arm). If you wish to use these sites, you may need assistance.

How to give yourself the injection:

• Remove the syringe from its protective blister by peeling off the blister packaging.
• Remove the cap from the needle, do not remove the cap with your mouth or teeth.
• Gently pinch the skin with the thumb and index finger of your free hand (Figure 1).
• Insert the needle into the skin as shown in Figure 2.
• Inject the medicine by steadily pushing the plunger down until the syringe is empty.
• Remove the syringe and needle straight out.
• Dispose of the syringe in a safe sharps container. Do not throw the syringe into household waste, but place it carefully into a puncture-resistant container as advised by your doctor or nurse.

Figure 1 Figure 2

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

If you use more Copaxone than you should
Inform your doctor immediately.

If you forget to use Copaxone
Take it as soon as you remember, but do not take a double dose to make up for the missed dose. Take the next dose 24 hours after the missed dose.

If you stop using Copaxone
Do not stop using Copaxone without consulting your doctor.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Allergic reactions (hypersensitivity)
Rarely, you may develop a severe allergic reaction to this medicine.
Stop using Copaxone and contact your doctor immediately or go to the nearest hospital Emergency Department
if you experience any of the following side effects:

• skin rash (red spots or hives)
• swelling of the eyelids, face or lips
• sudden shortness of breath
• seizures (fits)
• fainting

Other injection-site reactions (immediate post-injection reaction)
This is not common, but some people may experience one or more of the following symptoms within minutes
after a Copaxone injection. These symptoms usually do not cause problems and generally 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)
• shortness of breath (dyspnea)
• chest pain
• pounding and rapid heartbeat (palpitations, tachycardia)

Liver problems
Liver problems or worsening of pre-existing liver conditions, including liver failure (requiring liver transplantation in some cases), have been rarely reported with Copaxone. Contact your doctor immediately if you develop symptoms such as:

• nausea
• loss of appetite
• dark-colored urine and pale stools
• yellowing of the skin or whites of the eyes (jaundice)
• unusual bleeding

The following side effects have been reported with Copaxone:
Very common: may affect more than 1 in 10 people

• infections, flu
• anxiety, depression
• headache
• feeling unwell (nausea)
• skin rashes
• joint or back pain
• feeling weak, injection site reactions including redness of the skin, pain, formation of lumps, itching, swelling of tissues, inflammation and hypersensitivity (these injection site reactions are not unusual and usually decrease over time), non-specific pain

Common: may affect up to 1 in 10 people

• respiratory tract inflammation, gastroenteritis, herpes, ear inflammation, runny nose, dental abscess, vaginal candidiasis
• non-malignant skin growth (non-malignant skin neoplasm), tissue growth (neoplasm)
• swollen lymph nodes
• allergic reactions
• loss of appetite, weight gain
• nervousness
• altered taste, increased muscle tone, migraine, speech problems, fainting, tremor
• double vision, eye problems
• ear problems
• cough, hay fever
• anal or rectal disorders, constipation, dental caries, indigestion, difficulty swallowing, fecal incontinence, vomiting
• abnormal liver function tests
• bruising, excessive sweating, itching, skin changes, hives
• neck pain
• urgent need to empty the bladder, frequent need to urinate, inability to empty the bladder adequately
• chills, facial swelling, loss of tissue under the skin at the injection site, local reactions, peripheral swelling due to fluid accumulation, fever

Uncommon: may affect up to 1 in 100 people

• abscess, skin and underlying soft tissue infections, boils, shingles, kidney inflammation

• skin tumor

• increased white blood cell count, decreased white blood cell count, enlarged spleen, decreased platelet count, changes in white blood cell morphology

• enlarged thyroid, overactive thyroid

• low alcohol tolerance, gout, increased blood lipid levels, increased blood sodium levels, decreased serum ferritin

• abnormal dreams, confusion, euphoric mood, seeing, hearing, smelling, tasting or sensing things that are not there (hallucinations), aggression, unusually elevated mood, personality disorders, suicide attempt

• numbness and pain in the hand (carpal tunnel syndrome), mental disorders, seizures
  (fits), difficulty in writing and reading, muscular disorders, difficulty in movement, involuntary muscle contractions, nerve inflammation, abnormal neuromuscular transmission leading to abnormal muscle function, rapid involuntary eye movements, paralysis, foot drop (peroneal nerve paralysis), stupor, blind spots in vision

• cataract, corneal eye injury, dry eyes, eye bleeding, drooping of the upper eyelid, pupil dilation, optic nerve damage leading to vision problems

• extrasystoles, slow heartbeats, episodic 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)

• intestinal inflammation, colon polyps, inflammation of the small intestine, belching, esophageal ulcer, gum inflammation, rectal bleeding, enlarged salivary glands

• gallstones, enlarged liver

• swelling of the skin and soft tissues, contact dermatitis, painful and red skin thickenings, skin thickenings

• swelling, inflammation and joint pain (arthritis or osteoarthritis), inflammation and pain of the fluid-filled cushion lining the joints (present in some joints), hip pain, decreased muscle mass

• blood in urine, kidney stones, urinary tract disorders, abnormal urine findings

• breast swelling, difficulty achieving erection, downward displacement of pelvic organs (pelvic organ prolapse), prolonged erection, prostate disorders, abnormal Pap test (abnormal cervical smear), testicular disorders, vaginal bleeding, vaginal disorders

• cysts, hangover-like effects, low body temperature (hypothermia), non-specific inflammation, tissue damage at injection site, mucosal membrane disorders

• disorders following vaccination

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store 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 (Exp.). The expiry date refers to the last day of that month.
Store in a refrigerator (2°C - 8°C).
Copaxone pre-filled syringes may be kept outside the refrigerator for up to one month at a temperature between 15°C and 25°C. This may be done only once. After one month, unused Copaxone pre-filled syringes that have not been used and are still in their original packaging must be returned to the refrigerator.
Do not freeze.
Keep pre-filled syringes in the outer packaging to protect the medicine from light.
Discard any syringe containing particles.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Copaxone contains

• The active substance is glatiramer acetate. 1 ml of injection solution (the content of one pre-filled syringe) contains 20 mg of glatiramer acetate, equivalent to 18 mg of glatiramer.
• The other components are mannitol and water for injections.

Description of the appearance of Copaxone and contents of the pack
Copaxone injectable solution in pre-filled syringe is a 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 with 1 ml of injection solution, or in a multiple pack containing 90 pre-filled syringes comprising 3 packs, each containing 30 pre-filled syringes with 1 ml of injection solution.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Teva GmbH
Graf-Arco-Str. 3,
89079 Ulm, Germany

Manufacturer
Teva Pharmaceuticals Europe B.V.
Swensweg 5
2031 GA Haarlem (The Netherlands)
or
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-Str. 3
89079 Ulm - Germany

This medicinal product is authorized in the European Economic Area Member States under the
name COPAXONE 20 mg/ml:
Austria, Belgium, Croatia, Czech Republic, Cyprus, Denmark, Estonia, Finland, France, Germany,
Greece, Hungary, Ireland, Iceland, Italy, Latvia, Lithuania, Luxembourg, Norway, Poland,
Portugal, Romania, Spain, Sweden, Slovakia, Slovenia, The Netherlands, United Kingdom (Northern Ireland).

Detailed and up-to-date information on this product is available at the following address:
www.tevaitalia.it/iniziative/yourteva-app/copaxone.pdf

Package leaflet: Information for the user

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

glatiramer acetate
Please 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to other people, even if their symptoms are the same as yours, as it may be harmful to them.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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 is Copaxone and what is it used for

Copaxone is a medicine used to treat relapsing forms of multiple sclerosis (MS).
It modifies the way your body's immune system works and is classified as an immunomodulating agent.
The symptoms of MS are believed to be caused by a dysfunction of the body's immune system, which 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 beneficial if you have an MS form with few or no relapses. Copaxone may not affect the duration of an MS attack or how ill you feel during an attack.

2. What you should 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
Talk to your doctor or pharmacist before using Copaxone if you have any kidney or heart problems, as you may need regular tests and monitoring.
Ask your doctor or pharmacist before using 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
Copaxone has not been specifically studied in the elderly. Please consult your doctor for advice.
Other medicines and Copaxone
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, consult your doctor for advice and evaluation regarding treatment with Copaxone during pregnancy.
Copaxone may be used during pregnancy on the advice of a doctor.
Limited human data have not shown negative effects of Copaxone on infants breastfed by treated mothers. Copaxone may be used during breastfeeding.
Driving and using machines
The influence of Copaxone on the ability to drive vehicles and use machinery is unknown.

3. How to use Copaxone

Use this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The recommended dose for adults is one pre-filled syringe (40 mg of glatiramer acetate), administered under the skin (subcutaneous route) three times a week, at least 48 hours apart, for example on Monday, Wednesday, and Friday. It is recommended to administer the medicine on the same days each week.
It is very important to inject Copaxone 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 product or waste must be disposed of properly.
• Do not mix or administer the contents of Copaxone pre-filled syringes with any other product.
• Do not use the solution if it contains particles. Use a new syringe.

The first time you use Copaxone, you will be given complete instructions and monitored by a doctor or healthcare professional. They will be with you while you give yourself the injection and for 30 minutes afterwards to ensure you do not experience any problems.
Instructions for use
Read these instructions carefully before using Copaxone.
Before the injection, check that you have everything you need:

• A blister containing one pre-filled syringe of Copaxone.
• A container for the disposal of used needles and syringes.
• For each injection, take only one blister with a pre-filled syringe from the package. Store all remaining syringes in the box.
• If the syringe has been stored in the refrigerator, remove the blister containing the syringe and leave it out for at least 20 minutes before injection to allow it to warm to room temperature.

Wash your hands thoroughly with soap and water.
If you wish to use an injection device for the injection, the CSYNC device may be used with Copaxone. The CSYNC device is approved only for use with COPAXONE and has not been tested with other products. Refer to the instructions for use provided with the CSYNC injection device.
Choose the injection site within the designated areas, using the diagrams.
There are seven possible injection areas on your body:
Area 1: Abdominal area (abdomen) around the navel. Leave at least 5 cm between the navel and the injection site.

Area 2 and 3: Thighs (above the knees).

Area 4, 5, 6 and 7: Back of the arms and upper hips (below the waist).

Each injection area contains several injection sites. Choose a different injection site for each injection. This reduces the likelihood of irritation or pain at the injection site. Rotate injection areas and also rotate injection sites within each area. Do not use the same site every time.
Note: Do not administer the injection in an area that is tender or discolored, or at sites where you feel hardened lumps or nodules.
It is recommended to keep a record of your planned rotation of injection sites and to note it in a diary. There are some areas of the body where it may be difficult to self-inject (such as the back of the arm). If you wish to use these sites, you may need assistance.
How to give yourself the injection:

• Remove the syringe from its protective blister by peeling off the blister packaging.
• Remove the needle cap, do not remove the cap with your mouth or teeth.
• Gently pinch the skin with the thumb and index finger of your free hand (Figure 1).
• Insert the needle into the skin as shown in Figure 2.
• Inject the medicine by steadily pushing the plunger down until the syringe is empty.
• Remove the syringe and needle straight out.
• Dispose of the syringe in a safe disposal container. Do not throw the syringe into household waste, but place it carefully in a puncture-proof container as advised by your doctor or nurse.

Figure 1 Figure 2

If you think that the effect of Copaxone is too strong or too weak, consult your doctor.
If you use more Copaxone than you should
Inform your doctor immediately.
If you forget to use Copaxone
Use it as soon as you remember or are able to, then skip the next scheduled dose. Do not take a double dose to make up for the missed dose. 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 questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Allergic reactions (hypersensitivity)
You may develop a severe allergic reaction to this medicine, although this is not common.
Stop using Copaxone and contact your doctor immediately or go to the nearest hospital Emergency Department
if you experience any of the following side effects:

• rash (red spots or hives)
• swelling of the eyelids, face or lips
• sudden shortness of breath
• seizures (fits)
• fainting

Other injection-related reactions (immediate post-injection reaction)
Some people may experience one or more of the following symptoms within minutes after injection
of Copaxone. These are usually not serious and generally 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 (redness) of the chest or face (vasodilation)
• shortness of breath (dyspnea)
• chest pain
• pounding and rapid heartbeat (palpitations, tachycardia)

Liver problems
Liver problems or worsening of pre-existing liver conditions, including liver failure (requiring liver
transplantation in some cases), may rarely occur with Copaxone. Contact your doctor immediately
if you develop any of the following symptoms:

• nausea
• loss of appetite
• dark-colored urine and pale stools
• yellowing of the skin or whites of the eyes
• unusual bleeding or bruising

In general, the side effects reported by patients using Copaxone 40 mg/ml three times a week
have also been reported by patients using Copaxone 20 mg/ml (see the list below).

Very common: may affect more than 1 in 10 people

• infections, influenza
• anxiety, depression
• headache
• feeling unwell (nausea)
• skin rashes
• joint or back pain
• feeling weak, injection site reactions including redness of the skin, pain, formation of lumps (nodules), itching, swelling of tissues, inflammation and hypersensitivity (these injection site reactions are not unusual and usually decrease over time), non-specific pain

Common: may affect up to 1 in 10 people

• respiratory tract inflammation, gastroenteritis, herpes, ear infection, runny nose, dental abscess, vaginal candidiasis
• non-malignant skin growth (non-malignant skin neoplasia), tissue growth (neoplasia)
• swollen lymph nodes
• allergic reactions
• loss of appetite, weight gain
• nervousness
• altered taste, increased muscle tone, migraine, speech problems, fainting, tremor
• double vision, eye problems
• ear problems
• cough, hay fever
• anal or rectal disorders, constipation, dental caries, indigestion, difficulty swallowing, fecal incontinence, vomiting
• abnormal liver function tests
• bruising, excessive sweating, itching, skin changes, urticaria
• neck pain
• urgent need to empty the bladder, frequent need to urinate, inability to empty the bladder adequately
• chills, facial swelling, loss of tissue under the skin at the injection site, local reactions, peripheral swelling due to fluid accumulation, fever

Uncommon: may affect up to 1 in 100 people

• abscess, skin and underlying soft tissue infections, boils, shingles, kidney inflammation
• skin tumor
• 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 lipid levels, increased blood sodium, decreased serum ferritin
• abnormal dreams, confusion, euphoric mood, seeing, hearing, smelling, tasting or sensing things that are not there (hallucinations), aggression, abnormally elevated mood, personality disorders, suicide attempt
• numbness and pain in the hand (carpal tunnel syndrome), mental disorders, seizures, difficulty in writing and reading, muscular disorders, movement difficulties, involuntary muscle contractions, nerve inflammation, abnormal neuromuscular transmission leading to abnormal muscle function, rapid involuntary eye movements, paralysis, foot drop (peroneal nerve paralysis), stupor, blind spots in vision
• cataract, corneal eye injury, dry eyes, eye bleeding, drooping of the upper eyelid, pupil dilation, optic nerve damage leading to vision problems
• extrasystoles, slow heart rate, episodic 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 (sensation of suffocation)
• intestinal inflammation, colon polyps, inflammation of the small intestine, belching, esophageal ulcer, gum inflammation, rectal bleeding, enlarged salivary glands
• gallstones, enlarged liver
• swelling and inflammation of skin and soft tissues, contact dermatitis, painful and red skin thickenings, skin thickenings
• swelling, inflammation and joint pain (arthritis or osteoarthritis), inflammation and pain of the fluid-filled sacs lining the joints (bursitis), flank pain, decreased muscle mass
• blood in urine, kidney stones, urinary tract disorders, abnormal urine findings
• breast enlargement, difficulty achieving an erection, downward displacement or protrusion of pelvic organs (pelvic organ prolapse), prolonged erection, prostate disorders, abnormal Pap test (abnormal cervical smear), testicular disorders, vaginal bleeding, vaginal disorders
• cysts, hangover-like effects, low body temperature (hypothermia), non-specific inflammation, tissue damage at injection site, mucous membrane disorders
• disorders following vaccination

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store 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 the carton (Exp.). The expiry date refers to the last day of that month.
Store in the refrigerator (2°C - 8°C).
Copaxone pre-filled syringes may be kept outside the refrigerator for up to one month at a temperature between 15°C and 25°C. This may only be done once. After one month, unused Copaxone pre-filled syringes that are still in their original packaging must be returned to the refrigerator.
Do not freeze.
Keep pre-filled syringes in the outer packaging to protect the medicine from light.
Discard any syringe containing particles.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Copaxone contains

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

Description of the appearance of Copaxone and package contents
Copaxone injectable solution in pre-filled syringe is a clear solution free from visible particles.
Each pre-filled syringe is individually packaged in a PVC blister.
Copaxone is available in packages containing 3, 12 or 36 pre-filled syringes of 1 ml injection solution, or in a multiple pack containing 36 pre-filled syringes comprising 3 packs, each containing 12 pre-filled syringes of 1 ml injection solution.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Teva GmbH
Graf-Arco-Str. 3,
89079 Ulm, Germany

Manufacturer
Teva Pharmaceuticals Europe B.V.
Swensweg 5
2031 GA Haarlem (Netherlands)
or
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-Str. 3
89079 Ulm - Germany

This medicinal product is authorized in the Member States of the European Economic Area under the name COPAXONE 40 mg/ml:
Austria, Belgium, Croatia, Czech Republic, Cyprus, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Iceland, Italy, Latvia, Lithuania, Luxembourg, Norway, Poland, Portugal, Romania, Spain, Sweden, Slovakia, Slovenia, Netherlands, United Kingdom (Northern Ireland).

Detailed and updated information on this product is available at the following address:
www.tevaitalia.it/iniziative/yourteva-app/copaxone.pdf