GLATIRAMERO VIATRIS 20 mg/ml INJECTABLE SOLUTION IN PRE-FILLED SYRINGE

Introduction

Package Leaflet: Information for the User

Glatiramero Viatris 20mg/ml solution for injection in 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 side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Glatiramero Viatris and what is it used for

Glatiramero Viatris is a medicine used to treat the relapsing forms of multiple sclerosis (MS). It modifies the way your body's immune system works and is classified as an immunomodulatory agent. It is believed that MS symptoms are caused by a defect in the body's immune system. This produces areas of inflammation in the brain and spinal cord.

Glatiramer is used to reduce the number of times you have MS attacks (relapses). It has not been shown to help if you have a form of MS that does not have relapses or has very few relapses. Glatiramero Viatris may not have any effect on the duration of an MS attack or how bad it is during an attack.

It is used to treat patients who are able to walk unaided.

Glatiramer 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 reason that explains these symptoms before treating you.

2. What you need to know before you use Glatiramero Viatris

Do not use Glatiramero Viatris

• If you are allergic to glatiramer acetate or any of the other ingredientsof this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Glatiramero Viatris:

• If you have any kidney or heart problems, as you may need to have regular tests or check-ups.
• If you have or have had any problems with your libido (including those due to alcohol consumption).

Glatiramero Viatris can cause severe allergic reactions, some of which can be life-threatening.

These reactions can occur shortly after administration, even months or years after starting treatment, and even if you have not had allergic reactions after previous administrations.

The signs and symptoms of allergic reactions can overlap with post-injection reactions. Your doctor will inform you about the signs of an allergic reaction.

Children

Glatiramer must not be used in children under 12 years of age.

Elderly patients

The pharmacokinetics of glatiramer have not been specifically studied in elderly people. Consult your doctor about this.

Other medicines and Glatiramero Viatris

Tell your doctor or pharmacistif you are using, have recently used, or might use any other medicines.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor for advice on treatment with glatiramer during pregnancy.

Glatiramer may be used during pregnancy following your doctor's recommendations.

Limited human data do not show negative effects of glatiramer acetate on newborns/infants. Glatiramer may be used during breastfeeding.

Driving and using machines

Glatiramer does not affect your ability to drive or use machines.

3. How to use Glatiramero Viatris

Follow exactly the administration instructions given by your doctor for this medicine. If you are unsure, consult your doctor or pharmacist again.

The recommended daily dose in adults and adolescents from 12 years of age is one pre-filled syringe (20 mg of glatiramer acetate), administered subcutaneously.

It is very important that the injection of Glatiramero Viatris is performed correctly:

• Only into the tissue under the skin (subcutaneous tissue) (see "Instructions for use" below).
• At the dose indicated by your doctor. Administer only the dose prescribed by your doctor.
• Never use the same syringe more than once. Any unused or leftover product should be discarded.
• Do not mix or co-administer the contents of glatiramer pre-filled syringes with any other product.
• If the solution contains particles, do not use it. Use a new syringe.

The first time you use glatiramer, you will be given complete instructions and will be supervised by a doctor or nurse. They will be with you during the injection and for the next half hour, just to make sure you do not have any problems.

Instructions for use

Read these instructions carefully before using glatiramer.

Before injection, make sure you have everything you need:

• A blister pack containing the pre-filled syringe of glatiramer.
• A container for disposing of used needles and syringes.
• For each injection, take only one blister pack containing a pre-filled syringe from the packaging. Keep the rest of the syringes in the box.
• If your syringe was in the refrigerator, remove the blister pack containing the syringe at least 20 minutes before you are going to inject the medicine, so it will warm up to room temperature.

Wash your hands thoroughly with soap and water.

If you want to use an injection device to inject yourself, you can use the injection device for pre-filled syringes with glatiramer. The injection device for pre-filled syringes is only approved for use with Glatiramero Viatris and has not been tested with other products. Consult the instructions for use provided with the injection device for pre-filled syringes.

Choose an injection site within the areas following the diagrams.

There are seven possible injection areas on your body:

Area 1: abdominal area around the navel. Avoid the area 5 cm around the navel.

Areas 2 and 3: Thighs (above the knees)

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

Within each injection area, there are several places where the injection can be applied. Choose a different place for the injection each day. This will reduce the possibility of irritation or pain at the injection site. Change the injection site within each area. Do not always use the same injection site.

Warning:do not inject into any area that is painful or discolored, or where you notice lumps or firm nodules. It is recommended to have a scheme with planned injection sites and write it down in a diary. There are some places on your body that may be difficult for self-injection (such as the back of your arm). If you want to use them, you may need help.

How to inject:

• Remove the syringe from the protective blister by peeling off the rear label of the blister.
• Remove the needle cap; do not use your mouth or teeth to do so.
• Gently pinch the skin, making a fold between your thumb and index finger (Figure 1).
• Insert the needle into the skin, as shown in Figure 2.
• Inject the medicine by pushing the plunger firmly to the end, leaving the syringe empty.
• Remove the syringe and needle.
• Dispose of the syringe in a secure container for disposable products. Do not throw away used syringes in the trash; carefully place them in a puncture-proof container as recommended by your doctor or nurse.

Figure 1 Figure 2

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

If you use more Glatiramero Viatris than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to use Glatiramero Viatris

Administer it as soon as you remember, but do not administer a double dose to make up for forgotten doses. Administer the next dose 24 hours later.

If you stop using Glatiramero Viatris

Do not stop using glatiramer without consulting your doctor.

If you have any other questions about the use of this medicine, ask 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, anaphylactic reaction)

You may develop a severe allergic reaction to this medicine shortly after administration. This is a rare side effect. These reactions can occur months or years after starting treatment with Glatiramero Viatris, even if you have not had allergic reactions after previous administrations.

If you notice any of the following side effects, stop using glatiramer and call your doctor immediately or go to the emergency department of the nearest hospital:

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

Post-injection reactions (reaction immediately after injection)

It is rare, but some people may have one or more of the following symptoms minutes after the injection of glatiramer. These usually do not pose any problem and disappear within half an hour.

However, if the following symptoms last more than 30 minutes, contact your doctor immediately or go to the emergency department of the nearest hospital:

• flushing (redness) of the chest or face (vasodilation),
• difficulty breathing (dyspnea),
• chest pain,
• rapid and strong heartbeats (palpitations, tachycardia).

Liver problems

Liver problems or worsening of liver problems, including liver failure (which in some cases led to liver transplantation), can rarely occur with glatiramer.

Contact your doctor immediately if you have symptoms such as:

• nausea,
• loss of appetite,
• dark-colored urine and pale stools,
• yellowing of the skin or the white part of the eye,
• bleeding more easily than usual.

The following side effects have been reported with glatiramer:

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

• infections, flu
• anxiety, depression
• headache
• nausea
• skin rash
• joint or back pain
• feeling weak, skin reactions at the injection site including redness of the skin, pain, blistering, itching, swelling of the tissues, inflammation, and hypersensitivity (these reactions at the injection site are not abnormal and usually disappear over time), nonspecific pain.

Common(may affect up to 1 in 10 people)

• respiratory tract inflammation, stomach flu, fever, ear inflammation, runny nose, dental abscesses, vaginal candidiasis
• non-cancerous skin growths (benign skin neoplasms), tissue growth (neoplasia)
• swelling of the lymph nodes
• allergic reactions
• loss of appetite, weight gain
• nervousness
• altered sense of taste, increased muscle tone, migraine, speech problems, fainting, tremor
• double vision, eye problems
• hearing problems
• cough, hay fever
• anal or rectal problems, constipation, tooth decay, indigestion, difficulty swallowing, intestinal incontinence, vomiting.
• abnormal liver function test results
• bruises, excessive sweating, itching, skin changes, hives
• neck pain
• need to urinate urgently, frequent urination, inability to empty the bladder properly
• cold, swelling of the face, loss of tissue under the skin at the injection site, local reaction, peripheral swelling due to fluid accumulation, fever.

Uncommon(may affect up to 1 in 100 people)

• abscesses, inflammation of the skin and soft tissue, boils, herpes, kidney inflammation
• skin cancer
• increased white blood cell count, decreased white blood cell count, spleen enlargement
• decreased platelet count, change in the shape of white blood cells
• thyroid enlargement or hyperthyroidism
• low alcohol tolerance, gout, increased blood fat levels, increased sodium in the blood, decreased ferritin in the blood.
• strange dreams, confusion, euphoric state, seeing, hearing, smelling, touching, or feeling things that are not there (hallucinations), aggression, abnormally happy state, personality disorders, attempted suicide
• numbness of the hands and pain (carpal tunnel syndrome), mental disorders, seizures (crisis), problems with writing and reading, muscle disorders, movement problems, muscle spasms, nerve inflammation, abnormal nerve-muscle connection that produces abnormal muscle function, rapid and involuntary movement of the eyeballs, paralysis, foot drop (peroneal nerve paralysis), state of unconsciousness (stupor), blind spots
• cataracts, corneal eye injuries, dry eye, eye bleeding, drooping eyelid, pupil dilation, optic nerve wear that causes vision problems.
• rapid heartbeats, slow heartbeats, episodes of rapid heartbeats
• varicose veins
• periodic breathing stops, nosebleeds, abnormally rapid or deep breathing (hyperventilation), feeling of throat constriction, lung problems, inability to breathe due to throat constriction (feeling of suffocation)
• inflammation of the small intestine, colon polyps, intestinal inflammation, belching, esophageal ulcers, gum inflammation, rectal bleeding, salivary gland enlargement
• gallstones, liver enlargement
• skin and soft tissue swelling, skin rash due to contact, painful red lumps on the skin, lumps on the skin
• swelling, inflammation, and pain of the joints (arthritis or osteoarthritis), inflammation and pain of the fluid-filled sacs that cover the joints (existing in some joints), side pain, decreased muscle mass
• blood in the urine, kidney stones, urinary system problems, urine abnormalities
• breast swelling, difficulty getting an erection, prolapse of the pelvic organs, prolonged erections, prostate problems, abnormal Pap test results (abnormal cervical smear), testicular problems, vaginal bleeding, vaginal disorders.
• cysts, hangover, lower than normal body temperature (hypothermia), non-specific inflammation, tissue destruction at the injection site, problems with mucous membranes
• post-vaccination reactions

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is a side effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Glatiramero Viatris

Keep this medicine out of the sight and reach of children.

Store in a refrigerator (between 2°C and 8°C).

Glatiramero Viatris pre-filled syringes can be stored for up to one month outside of the refrigerator, between 15°C and 25°C. This can only be done once. If after one month the Glatiramero Viatris pre-filled syringes have not been used and are still in their original packaging, they must be stored in the refrigerator again.

Do not freeze.

Keep the pre-filled syringes in the outer packaging to protect them from light.

Do not use this medicine after the expiry date which is stated on the label and on the carton after CAD or EXP. The first two digits indicate the month and the last four digits indicate the year. The expiry date is the last day of the month indicated.

Discard any syringe that contains particles.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition ofGlatiramero Viatris

• The active substance is glatiramer acetate. 1 ml of the solution for injection (the contents of one pre-filled syringe) contains 20 mg of glatiramer acetate.
• The other ingredients are mannitol (E 421) and water for injections.

Appearance and Package Contents of the Product

Glatiramero Viatris is a sterile, clear, colorless or slightly yellowish/brown solution.

If the solution contains particles, discard it 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 Authorization Holder

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer

Synthon Hispania S.L.

Castelló 1

Polígono Les Salines

08830 Sant Boi de Llobregat (Barcelona)

Spain

Or

Synthon BV

Microweg 22

6545 CM Nijmegen

Netherlands

For further information on this medicine, please contact the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Germany: CLIFT 20 mg/ml Injektionslösung in einer Fertigspritze

Belgium: Glatiramyl 20 mg/ml, oplossing voor injectie in een voorgevulde spuit

Spain: Glatiramero Viatris 20 mg/ml solución inyectable en jeringa precargada

France: GLATIRAMER MYLAN 20 mg/ml, solution injectable en seringue préremplie

Italy: COPEMYL

Netherlands: Glatirameeracetaat Mylan 20 mg/ml, oplossing voor injectie in voorgevulde spuit

Portugal: Acetato de glatirâmero Mylan

The reusable autoinjector isauthorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

MyJect

Date of last revision of this leaflet:November 2024.

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/