Copaxone

Package leaflet: Information for the user

Copaxone, 40 mg/ml, solution for injection in pre-filled syringe
Glatirameri acetas
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 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 symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Copaxone is and what it is used for
2. What you need to know before you use 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 the patient's immune system works and belongs to a group of medicines called immunomodulators.
Relapsing-remitting multiple sclerosis is thought to be caused by a malfunction of the body's immune system, leading to inflammatory lesions in the brain and spinal cord.
Copaxone is indicated to reduce the frequency of relapses in multiple sclerosis. The effectiveness of Copaxone has not been established in other forms of multiple sclerosis that are not relapsing or have very infrequent relapses. Copaxone may not affect the duration or severity of individual multiple sclerosis relapses.

2. Important information before using Copaxone

When not to use Copaxone:

• if the patient is allergic to glatiramer acetate or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Copaxone may cause severe allergic reactions, some of which may be life-threatening.
These reactions may occur shortly after administration, several months, or even several years after starting treatment, even if no allergic reactions occurred after previous doses.
The signs and symptoms of allergic reactions may overlap with injection-related reactions. The doctor will inform the patient about the symptoms of an allergic reaction.
Before starting Copaxone, discuss with the doctor or pharmacist if the patient has kidney or heart disease; the doctor may recommend regular laboratory tests and follow-up visits.
Before starting Copaxone, discuss with the doctor or pharmacist if the patient has or has had any liver diseases (including those caused by alcohol consumption).

Children
Copaxone must not be used in children under 18 years of age.

Elderly patients
The effect of Copaxone has not been studied in elderly patients. Consult a doctor before use.

Copaxone with other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.

Pregnancy and breastfeeding
If the patient is pregnant, suspects she may be pregnant, or is planning to become pregnant, she should consult the doctor and consider the use of Copaxone during pregnancy.
Copaxone may be used during pregnancy after consultation with a doctor.
Limited human data have not shown any negative effects of Copaxone on breastfed newborns and/or infants. Copaxone may be used during breastfeeding.

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

3. How to use Copaxone

This medicine should always be used exactly as directed by your doctor. If in doubt, consult your doctor or pharmacist.

The usual dose for adults is one pre-filled syringe (40 mg glatiramer acetate), administered as a subcutaneous injection three times a week, with at least 48 hours between doses, 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 use Copaxone correctly:

• Copaxone must only be given by subcutaneous injection (see "Instructions for use" below).
• Use the dose prescribed by your doctor. Only use the dose prescribed by your doctor.
• Never use the same pre-filled syringe more than once. Unused product or waste must be discarded.
• Copaxone must not be mixed or administered together with other medicines.
• If the solution contains visible particles or precipitate, it should be discarded and a new pre-filled syringe used.

When a patient receives Copaxone for the first time, the doctor or nurse will provide full instructions and supervise the patient. The doctor or nurse will remain with the patient during and for at least 30 minutes after the patient self-administers the injection to ensure no adverse reactions occur.

Instructions for use

Before using Copaxone, carefully read these instructions. Before injecting the medicine, ensure all necessary items are ready:

• One blister pack of Copaxone pre-filled syringe

• A sharps container for used needles and syringes

• Remove only one blister containing one pre-filled syringe from the packaging at a time. Store all other syringes in their packaging.

• If syringes have been stored in the refrigerator, allow the blister with the syringe to reach room temperature for at least 20 minutes before injection so that the solution warms to room temperature.

Wash hands thoroughly with soap and water.

If the patient wishes to use an injection device, the CSYNC injection device specifically designed for Copaxone may be used. This device is approved for use with Copaxone and has not been tested with other products. Read the user instructions provided with the CSYNC injection device.

Choose an injection site using the diagrams below.

There are seven body areas where injections can be given:

• Area 1: Abdominal area around the navel. Avoid injecting within 5 cm of the navel.

• Areas 2 and 3: Thighs (above the knees)

• Areas 4, 5, 6, and 7: Upper arms and upper buttocks (below the waist)

Each injection area contains multiple injection sites. Always select a different site each time, as this reduces the risk of irritation or pain at the injection site. Rotate both the injection areas and the specific sites within each area. Do not inject the medicine into the same site every time.

Note: Do not inject the medicine into areas that are painful, discolored, or have palpable lumps or thickened skin. It is recommended to develop a rotating schedule for selecting injection sites and record it in a diary. Some body areas (e.g., the back of the upper arm) may be difficult to inject by oneself. In such cases, assistance is needed.

How to inject the medicine:

• Remove the syringe from the protective blister by tearing open the foil seal.
• Remove the needle cap. Do not remove the cap with mouth or teeth.
• Gently pinch a skin fold between the thumb and index finger of the free hand (Figure 1).
• Insert the needle into the skin as shown in Figure 2.
• Inject the medicine by pressing the plunger down steadily until the syringe is completely empty.
• Remove the syringe and needle straight upward.
• Dispose of the syringe in a special sharps container. Used syringes must not be thrown into household waste. They should be carefully placed in a special sharps container as instructed by your doctor or nurse.

Figure 1 Figure 2

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

Overdose of Copaxone

Inform your doctor immediately.

Missed dose of Copaxone

Take the missed dose as soon as you remember or as soon as you are able to, and skip the next scheduled dose. Do not use a double dose to make up for a missed dose. Resume your regular dosing schedule the following week, if possible.

Stopping Copaxone treatment

Do not stop using Copaxone without first consulting your doctor.

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
Allergic reactions (hypersensitivity, anaphylactic reaction)
A severe allergic reaction may occur shortly after administration of the medicine. This is an uncommon
adverse reaction. These reactions may occur several months or years after starting treatment
with Copaxone, even if no allergic reactions occurred after previous administrations.
You must stop using Copaxone immediately and contact your doctor or go to the emergency department of the nearest hospital
if any of the following symptoms occur suddenly:

• widespread rash (red spots or hives)
• swelling of the eyelids, face, lips, mouth, throat or tongue
• sudden shortness of breath, difficulty breathing or wheezing
• convulsions (seizures)
• difficulty swallowing or speaking
• fainting, dizziness or feeling faint
• collapse.

Other reactions after administration (immediate post-injection reaction)
Within minutes of injecting Copaxone, reactions may occur with at least one of the following
symptoms. These usually do not cause problems and resolve within half an hour.
However, if the following symptoms persist for longer than 30 minutes, you must immediately inform your doctor or go to the emergency department of the nearest hospital:

• flushing (skin redness with a feeling of warmth) in the chest or face area (vasodilation)
• shortness of breath (dyspnea)
• chest pain
• rapid and strong heartbeat (palpitations, tachycardia).

Liver disorders
During treatment with Copaxone, liver disorders or worsening of pre-existing liver conditions may rarely occur, including liver failure (in some cases requiring liver transplantation). You should contact your doctor immediately if any of the following symptoms occur:

• nausea
• loss of appetite
• dark urine and pale stools
• yellowing of the skin or whites of the eyes
• increased tendency to bleed.

Generally, adverse reactions reported by patients using Copaxone 40 mg/ml administered three times weekly were also reported in patients using Copaxone 20 mg/ml (see list below).
Very common: may affect more than 1 in 10 people

• infection, influenza
• anxiety, depression
• headache
• nausea
• skin rash
• joint or back pain
• fatigue, injection site reactions including redness, pain, blistering, itching, swelling, inflammation and hypersensitivity (these injection site reactions are common and usually decrease over time), non-specific pain.

Common: may affect 1 in 10 people

• respiratory tract infection, influenza, herpes, ear infection, rhinitis, dental abscess, vaginal fungal infection
• benign skin proliferation (benign skin neoplasm), tissue proliferation (neoplasm)
• enlarged lymph nodes
• allergic reactions
• loss of appetite, weight gain
• nervousness
• taste disturbances, increased muscle tone, migraine, speech disorders, fainting, tremor
• double vision, eye disorders
• ear disorders
• 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 disorder, urticaria
• neck pain
• sudden urge to urinate, frequent urination, inability to properly empty the bladder
• chills, facial swelling, atrophy of subcutaneous tissue at injection site, local reaction, peripheral edema due to fluid accumulation, fever

Uncommon: may affect up to 1 in 100 people

• abscess, skin and soft tissue infection, boils, shingles, kidney infection

• skin cancer

• increased white blood cell count, decreased white blood cell count, enlarged spleen, decreased platelet count, change in appearance of white blood cells

• enlarged thyroid, hyperthyroidism

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

• strange dreams, confusion, euphoric mood; seeing, hearing, smelling, tasting or feeling something that does not exist (hallucinations), hostility, overly good mood, personality disorders, suicidal behaviour

• numbness and pain in hands (carpal tunnel syndrome), psychiatric disorders, seizures (convulsions), inability to write or read, muscle disorders, movement disorders, muscle spasms, nerve inflammation, neuromuscular junction disorders leading to muscle dysfunction, involuntary rapid eye movements, paralysis, foot drop (peroneal nerve palsy), unconscious state (stupor), visual scotoma

• cataract, corneal damage, dry eye sensation, eye hemorrhage, eyelid drooping, pupil dilation, optic nerve atrophy leading to visual disturbances

• extra heartbeats, slowed heart rate, occasional rapid heartbeat

• varicose veins

• periodic breathing cessation, nosebleeds, abnormally rapid or deep breathing (hyperventilation), throat tightness, lung disorders, inability to breathe due to throat constriction (sensation of choking)

• intestinal inflammation, colon polyp, belching, esophageal ulcer, gingivitis, rectal bleeding, salivary gland enlargement

• gallstones, enlarged liver

• swelling and inflammation of skin and soft tissues, contact dermatitis, painful red skin nodules, skin nodules

• swelling, inflammation and pain in joints (arthritis or osteoarthritis), inflammation and pain in the fluid-filled sac lining the joint (occurring in certain joints), flank pain, muscle atrophy

• hematuria, kidney stones, urinary system disorders, abnormal urine

• breast swelling, erectile dysfunction, lowering or displacement of pelvic organs (pelvic organ prolapse), prolonged penile erection, prostate disorders, abnormal cytology smear (abnormal cervical cytology), testicular disorders, vaginal bleeding, vaginal disorders

• cyst, "hangover-like" symptoms, decreased body temperature (hypothermia), unspecified inflammation, tissue necrosis at injection site, mucous membrane disorders

• post-vaccination disorders.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, you should inform your doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, PL-02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions helps to provide more information on the safety of the 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 outer packaging and on the immediate packaging after "Expiry date (EXP):" or "EXP:". The expiry date refers to the last day of the stated month.
Store in a refrigerator (2°C - 8°C).
Copaxone pre-filled syringes may be stored once at room temperature between 15°C and 25°C for up to 1 month. After 1 month, if the pre-filled syringes have not been used and are still in their original packaging, they must be returned to the refrigerator.
Do not freeze.
Keep the pre-filled syringes in their original packaging (cardboard box) to protect from light.
Discard any syringes containing solid particles.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Following this advice helps protect the environment.

6. Contents of the pack and other information

What Copaxone contains

• The active substance is glatiramer acetate. 1 ml of injection solution (corresponding to 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.

What Copaxone looks like and contents of the pack
Copaxone, solution for injection in a pre-filled syringe, is a sterile, clear solution without visible particles.
Each pre-filled syringe is individually packed in a PVC blister.
Copaxone is available in packs containing 3, 12 or 36 pre-filled syringes containing 1 ml of solution for injection, or in a multipack containing 3 cartons, each containing 12 pre-filled syringes with 1 ml of solution for injection.
Not all pack sizes may be marketed.

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

Manufacturer/Importer
Actavis Group PTC ehf.
Dalshraun 1
220, Hafnarfjörður
Iceland
Merckle GmbH
Graf-Arco-Str. 3
89079 Ulm
Germany

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

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Teva Pharmaceuticals Polska Sp. z o.o.
ul. Emilii Plater 53
00-113 Warsaw
tel.: (22) 345 93 00