CopemyL

Package leaflet: Information for the patient

Copemyl 20 mg/ml injection solution 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.
• 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 Copemyl is and what it is used for
2. What you need to know before using Copemyl
3. How to use Copemyl
4. Possible side effects
5. How to store Copemyl
6. Contents of the pack and other information

1. What Copemyl is and what it is used for

Copemyl 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. It is believed that MS symptoms are caused by a defect in the body's immune system, which leads to episodes of inflammation in the brain and spinal cord.
Copemyl 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 that does not present relapses or only rarely relapses. Copemyl may not affect the duration of an MS attack or the severity of symptoms during an attack.
It is used to treat patients who are able to walk without assistance.
Copemyl may also be used in patients who have experienced symptoms for the first time 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 need to know before using Copemyl

Do not use Copemyl

• if you are allergic to glatiramer acetate or to any of the other components of this medicine (listed in section 6). Warnings and precautions Talk to your doctor or pharmacist before using Copemyl
• if you have any kidney or heart problems, as you may need regular tests and monitoring.

Children
Copemyl must not be used in children under 12 years of age.
Elderly
Copemyl has not been specifically studied in the elderly. Consult your doctor for advice.
Other medicines and Copemyl
Tell 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, planning to become pregnant, or are breastfeeding, consult your doctor for advice and evaluation regarding treatment with Copemyl during pregnancy and/or breastfeeding.
Driving and using machines
The influence of Copemyl on the ability to drive vehicles and use machinery is unknown.

3. How to use Copemyl

Use this medicine exactly as instructed 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 Copemyl correctly:

• Only into the tissue beneath the skin (subcutaneous tissue) (see “Instructions for use” below).
• At the dose prescribed by your doctor. Take only the dose prescribed by your doctor.
• Never use the same syringe more than once. Unused product or waste material must be discarded.
• Do not mix or administer the contents of Copemyl 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 Copemyl, you will be given complete instructions and supervised by a
doctor or healthcare professional. They will be with you while you administer the injection
yourself and for 30 minutes afterwards, to ensure you do not experience any problems.
Instructions for use
Read these instructions carefully before using Copemyl.
Before the injection, make sure you have everything you need:

• A blister pack containing one pre-filled syringe of Copemyl
• A container for the safe disposal of used needles and syringes.
• For each injection, take only one blister pack containing 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 pack containing the syringe and leave it at room temperature for at least 20 minutes before the injection to allow it to warm up.

Wash your hands thoroughly with water and soap.
If you wish to use an injection device to administer the injection, the MyJect device may
be used with Copemyl. The MyJect device is approved only for use with Copemyl and
has not been tested with other products. Refer to the instructions for use provided with
the MyJect 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
sites within the same area. Do not use the same site every time.
Note: do not administer the injection into an area that is painful, discolored, or where you feel hard lumps or nodules. It is recommended to keep a record of your planned injection site rotation and note it in a diary. Some body sites (such as the back of the arm) may be difficult to inject by yourself. If you wish to use these sites, you may need assistance.
How to administer the injection

• Remove the syringe from its protective blister pack 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 disposal container. Do not place the syringe in household waste; instead, place it carefully in a puncture-proof container as recommended by your doctor or healthcare professional.

Figure 1 Figure 2
If you think the effect of Copemyl is too strong or too weak, consult your
doctor.
If you use more than one syringe of Copemyl per day
Inform your doctor immediately.
If you forget to use Copemyl
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 previous one.
If you stop using Copemyl
Do not stop using Copemyl 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 an allergic reaction to this medicine.
Stop using Copemyl and contact your doctor immediately or go to the nearest hospital Emergency Department if you notice any of the following side effects:

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

Other reactions following injection (immediate post-injection reaction)
This is not common, but some people may experience one or more of the following symptoms within minutes after receiving Copemyl 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 (vasodilatation)
• shortness of breath (dyspnoea)
• chest pain
• pounding and rapid heartbeat (palpitations, tachycardia).

The following side effects have been reported with Copemyl:

Very common (may affect more than 1 in 10 people):

• infections, flu
• anxiety, depression
• headache
• nausea
• skin rashes
• joint or back pain
• feeling weak, skin reactions at the injection site, including redness of the skin, pain, formation of lumps (wheals), 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 inflammations, stomach flu, 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 rigidity, migraine, speech disorder, fainting, tremor
• double vision, eye disorders
• ear disorders
• cough, hay fever
• disorders of the anus or rectum, constipation, dental caries, indigestion, difficulty swallowing, faecal 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 adequately empty the bladder
• 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, inflammation of the skin and underlying soft tissues, boils, Herpes Zoster, kidney inflammation
• skin tumour
• 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, 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, attempted suicide
• 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 spot vision
• cataract, corneal eye injury, dry eye, eye bleeding, drooping of the upper eyelid, pupil dilation, optic nerve weakening 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 tightening, lung problems, inability to breathe due to throat narrowing (sensation of suffocation)
• intestinal inflammation, colon polyps, intestinal inflammation, belching, oesophageal ulcer, gum inflammation, rectal bleeding, enlarged salivary glands
• gallstones, liver enlargement
• swelling of the skin and soft tissues, contact dermatitis, red and painful skin nodules, skin nodules
• swelling, inflammation and pain in the joints (arthritis or osteoarthritis), inflammation and pain of the fluid-filled cushion lining the joints (present in some joints), flank pain, decreased muscle mass
• blood in urine, kidney stones, urinary tract disorders, urine abnormalities
• abortion
• swollen breast, difficulty achieving an erection, downward displacement or protrusion of pelvic organs (pelvic 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 problems
• post-vaccination disorders.

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 Copemyl

Keep this medicine out of the sight and reach of children.
Store in a refrigerator (2°C - 8°C).
Pre-filled syringes of Copemyl 20 mg/ml may be kept outside the refrigerator at a temperature between 15°C and 25°C for one month. This may be done only once. After one month, unused pre-filled syringes of Copemyl 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.
Do not use this medicine after the expiry date stated on the label and on the carton (Exp.). The expiry date refers to the last day of that month.
Discard any syringe containing particles.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Copemyl 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.
• The excipients are mannitol and water for injections.

Description of the appearance of Copemyl and contents of the pack
Copemyl injectable solution in pre-filled syringe is a sterile, clear, colourless to slightly yellowish/brownish solution, free from visible particles.
Discard the syringe if particles are present and start again. Use a new syringe.
7 pre-filled syringes,
28 pre-filled syringes,
30 pre-filled syringes,
90 (3x30) pre-filled syringes.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Mylan S.p.A.
Via Vittor Pisani, 20
20124 Milan (Italy)

Manufacturer
Synthon Hispania SL
C/ Castellò n.1, Pol. Las Salinas,
Sant Boi de Llobregat, 08830 Barcelona
Spain
Synthon BV
Microweg 22, Nijmegen
6545 CM
The Netherlands

This medicinal product is authorised in the European Economic Area Member States under the following names:
Belgium: Glatiramyl 20 mg/ml, oplossing voor injectie in een voorgevulde spuit
France: Glatiramer Mylan 20 mg/ml, solution injectable en seringue préremplie
Germany: Clift 20 mg/ml Injektionslösung in einer Fertigspritze
Italy: Copemyl
Portugal: Acetato de glatirâmero Mylan
The Netherlands: Glatirameeracetaat Mylan 20 mg/ml, oplossing voor injectie in voorgevulde spuit
Spain: Glatiramero Mylan 20 mg/ml solución inyectable