Copemytri

Patient Information Leaflet

Copemyltri 40 mg/ml injection solution in pre-filled syringe

glatiramer acetate
Please read all of this leaflet carefully before you start using this medicine, as 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 give it to other people, even if they have the same symptoms as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, speak to your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Copemyltri is and what it is used for
2. What you need to know before using Copemyltri
3. How to use Copemyltri
4. Possible side effects
5. How to store Copemyltri
6. Contents of the pack and other information

1. What Copemyltri is and what it is used for

Copemyltri is a medicine administered three times a week that modifies the way your body's immune system works (it is classified as an immunomodulator). It is believed that the symptoms of multiple sclerosis (MS) are caused by a defect in the body's immune system. This leads to episodes of inflammation in the brain and spinal cord.
Copemyltri is used to reduce the number of times you experience MS attacks (relapses). Benefit has not been demonstrated in cases where you have a form of MS that does not present, or rarely presents, relapses. Copemyltri may have no effect on the duration of an MS attack or on the intensity of pain during an attack.

2. What you need to know before using Copemyltri

Do not use Copemyltri

• 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 Copemyltri

• if you have any kidney or heart problems, as you may need regular tests and check-ups.

Children
Copemyltri must not be used in children under 18 years of age.
Elderly
Copemyltri has not been specifically studied in the elderly. Please consult your doctor.
Other medicines and Copemyltri
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, think you may be pregnant, planning to become pregnant, or breastfeeding, please consult your doctor or pharmacist for advice and evaluation regarding treatment with Copemyltri during pregnancy and/or breastfeeding.
Driving and using machines
The influence of Copemyltri on the ability to drive vehicles and use machines is unknown.

3. How to use Copemyltri

Use this medicine exactly as instructed by your doctor. If you have any doubts,
consult your doctor or pharmacist.
The dose for adults is one pre-filled syringe (40 mg of glatiramer acetate), administered under the
skin (subcutaneous route) 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 inject Copemyltri 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 materials must be disposed of properly.
• Do not mix or co-administer the contents of Copemyltri 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 Copemyltri, you will be given complete instructions and supervised by
a doctor or nurse. They will stay with you while you administer the injection yourself
and for 30 minutes afterwards, to ensure that you do not experience any problems.
Instructions for use
Read these instructions carefully before using Copemyltri.
Before the injection, make sure you have everything you need:

• A blister pack containing one pre-filled syringe of Copemyltri
• A container for the disposal of used needles and syringes.
• For each injection, take only one blister pack 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 pack containing the syringe 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 the Copemyltri injection device to administer the injection, refer
to the instructions for use provided with the Copemyltri injection device.
Choose the injection site using the diagrams in Figure 1.
There are seven possible injection areas on your body: arms, thighs, hips, and abdomen (stomach).
Each injection area contains several injection sites. Choose a different injection site each day.
This will reduce 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 in areas that are tender, discolored, or where you feel lumps or nodules.
It is recommended to keep a record of your planned rotation of injection sites, noting them in a diary.
Some body sites may be difficult to inject by yourself (such as the back of the upper arm). If you wish to use these sites, you may need assistance.

Figure 1
How to administer the injection

• Remove the syringe from its protective blister by peeling off the paper label.
• Remove the needle cap.
• Gently pinch the skin with the thumb and index finger of your free hand (Figure 2).
• Insert the needle into the skin as shown in Figure 3.
• 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; place it carefully into a puncture-proof container as advised by your doctor or nurse.

Figure 2 Figure 3
If you think that the effect of Copemyltri is too strong or too weak, consult your
doctor.
If you use more Copemyltri than you should
Inform your doctor immediately.
If you forget to use Copemyltri
Take it as soon as you remember or are able to, then skip the next scheduled day.
Do not take a double dose to make up for a missed dose. If possible, resume your regular dosing schedule the following week.
If you stop using Copemyltri
Do not stop using Copemyltri without consulting your doctor.
If you have any doubts about how to use 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 an allergic reaction to this medicine, but this is not common.
Stop using Copemyltri and contact your doctor or go immediately 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 (difficulty breathing)
• seizures (fits)
• fainting.

Other reactions following injection (immediate post-injection reaction)
Some people may experience one or more of the following symptoms within minutes after
injection of glatiramer acetate. These usually do not cause problems 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).

In general, the side effects reported by patients using glatiramer acetate 40 mg/ml three times
a week have also been reported by patients using glatiramer acetate 20 mg/ml (see the list below).
The following side effects have been reported with glatiramer acetate:
Very common (may affect more than 1 in 10 people):

• infections, influenza
• anxiety, depression
• headache
• nausea
• skin rashes
• joint or back pain
• feeling weak, injection site reactions 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 infections, 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 stiffness, 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, 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, inflammation of the skin and underlying soft tissues, boils, Herpes Zoster, kidney inflammation

• skin tumor

• increased white blood cell count, decreased white blood cell count, enlarged spleen, decreased platelet count, changes in the shape of white blood cells

• enlarged thyroid, overactive thyroid

• low tolerance to alcohol, 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, 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 (unconscious state), blind spot vision

• cataract, corneal eye injury, dry eye, eye bleeding, drooping of the upper eyelid, pupil dilation, optic nerve weakness 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, esophageal ulcer, gum inflammation, rectal bleeding, enlarged salivary glands

• gallstones, enlarged liver

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

• swelling, inflammation and joint pain (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 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 destruction at the injection site, mucosal problems

• disorders following vaccination.

Reporting of side effects
If you experience any side effects, 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.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa”.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Copemyltri

Keep this medicine out of the sight and reach of children.
Store in a refrigerator (2°C - 8°C).
Pre-filled syringes of Copemyltri may be kept outside the refrigerator at a temperature between 15°C and 22°C for up to one month. This may only be done once. After one month, any unused pre-filled syringes of Copemyltri that remain 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 Copemyltri 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.
• The excipients are mannitol and water for injections.

Description of the appearance of Copemyltri and contents of the pack
Copemyltri injection solution in a pre-filled syringe is a sterile, clear solution, colourless to slightly yellowish/brownish, free from visible particles.
Discard the syringe if it contains particles and start again. Use a new syringe.
Pack contents:
3 pre-filled syringes,
12 pre-filled syringes,
36 (3x12) 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, S.L.
C/ Castelló no1, Pol. Las Salinas, Sant Boi de Llobregat
Barcelona 08830, Spain
Synthon BV
Microweg 22
Nijmegen 6545 CM, Netherlands

This medicinal product is authorised in the European Economic Area Member States under the following names:
Belgium: Glatiramyl 40 mg/ml, solution for injection in a pre-filled syringe
Denmark: Copemyl
Finland: Glatimyl 40 mg/ml injection solution, solution, pre-filled syringe
France: Glatiramer Mylan 40 mg/ml, solution injectable en seringue préremplie
Germany: CLIFT 40 mg/ml Injektionslösung in einer Fertigspritze
Greece: Glatiramer / Mylan 40 mg/ml solution for injection, pre-filled syringe
Ireland: Brabio 40 mg/ml solution for injection, pre-filled syringe
Italy: COPEMYLTRI
Norway: Copemyl 40 mg/ml injeksjonsvæske, oppløsning i ferdigfylt sprøyte
Netherlands: Glatirameeracetaat Mylan 40 mg/ml, oplossing voor injectie in een voorgevulde spuit
Spain: Glatiramero Mylan 40 mg/ml solución inyectable en jeringa precargada
Sweden: Glatimyl 40 mg/ml injektionsvätska, lösning, förfylld spruta