Prospecto: Information for the User

Glatiramero Viatris 40 mg/ml Injectable Solution in Pre-filled Syringe

glatiramero, acetate

Read this prospectus carefully before starting to use this medication because it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to you and should not be given to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an adverse effect that does not appear in this prospectus. See section 4.

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

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

3.How to use Glatiramero Viatris

4.Possible adverse effects

5.Storage of Glatiramero Viatris

6.Contents of the package and additional information

Glatiramero is a medicationused for the treatment of recurrent forms of multiple sclerosis (MS).It modifies the way the immune system of your body functions and is classified as an immunomodulator agent. It is believed that the symptoms of multiple sclerosis (MS) are produced by a defect in the immune system of the body. This produces areas of inflammation in the brain and spinal cord.

Glatiramero is used to reduce the number of times you experience MS attacks (relapses). It has not been shown to be effective if you have a form of MS that does not have relapses or almost no relapses. Glatiramero may have no effect on the duration of an MS attack, or how poorly you feel during an attack.

Do not use Glatiramero Viatris

• If you areallergic to glatiramer acetate or to any of the other componentsof this medication (listed in section 6).

Warnings and precautions

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

• If you haveany kidney or heart problems, as you may need to have regular tests or examinations.
• If you have or have had any problems with libido (including those caused by alcohol consumption).

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

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

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

Children

Glatiramero cannot be used in children under 18 years old.

Older patients

Glatiramero has not been specifically studied in older people. Consult your doctor about this.

Other medications and Glatiramero Viatris

Inform your doctor or pharmacistif you are using, have used recently, or may need to use any other medication.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor for guidance on using acetate of glatiramero during pregnancy.

Glatiramero can be used during pregnancy under the guidance of your doctor.

Limited human data showed no negative effects of acetate of glatiramero on newborns/breastfed infants. Acetate of glatiramero can be used during breastfeeding.

Driving and operating machinery

Glatiramero does not affect your ability to drive or operate machinery.

Follow exactly the administration instructions indicated by your doctor for this medication. In case of doubt, consult your doctor or pharmacist again.

The recommended dose in adults is a pre-filled syringe (40 mg of glatiramer acetate), administered under the skin (subcutaneously) three times a week, with a separation of at least 48 hours between injections, for example, Monday, Wednesday, and Friday. It is recommended to administer the medication on the same days each week.

It is very important that the glatiramer injection is performed correctly:

• Only in the tissue under the skin (subcutaneous tissue) (see "Usage Instructions" below).
• At the dose indicated by your doctor. Administer only the prescribed dose by your doctor.
• Never use the same syringe more than once. Any unused or excess product must be discarded.
• Do not mix or co-administer the contents of the pre-filled syringes of glatiramer 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 30 minutes, only to ensure that you have no problems.

Usage Instructions

Read these instructions carefully before using Glatiramer Viatris.

Before the injection, make sure you have everything you need:

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

Wash your hands thoroughly with water and soap.

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

Choose a place for the injectionwithin the areafollowing the diagrams.

There are seven possible injection areas on your body:

.

Area1: abdominal area (around the navel) Avoid the area 5cm around the navel.

Areas 2 and 3: Thighs (above the knees)

Areas 4, 5, 6, and 7: Upper back of the upper arms, end of the upper hips (below the waistline).

Within each injection area, there are several places where you can apply the injection. 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 in any area that is painful or discolored, or where you notice knots or firm lumps. It is recommended to have a schedule with the planned injection sites and note it in a diary. There are some areas 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:

• Take the syringe out of the blister pack, peeling off therear label of the blister.
• Remove the needle cap,do notuse your mouth or teeth to do it.
• 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 medication by pushing the plunger firmly until the syringe is empty.
• Remove the syringe and needle.
• Dispose of the syringe in a safe disposal container. Do not throw used syringes in the trash, carefully place them in a puncture-proof container as recommended by your doctor or nurse.

Figure 1Figure 2

If you think the effect of glatiramer is too strong or too weak, inform your doctor.

If you use more Glatiramer 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 medication and the amount ingested.

If you forget to use Glatiramer Viatris

Administer it as soon as you remember or have the opportunity to administer it, and avoid using it the next day. Do not administer a double dose to compensate for the missed doses. If possible, you should return to your usual administration schedule the following week.

If you interrupt treatment with Glatiramer Viatris

Do not stop using glatiramer without consulting your doctor.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience 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 no allergic reactions have occurred after previous administrations.

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

• Generalized hives (red spots or rashes),
• inflammation of the eyelids, face, lips, mouth, throat, or tongue
• sudden shortness of breath, difficulty breathing, or wheezing ("whistling" when breathing)
• seizures (crisis)
• difficulty swallowing or speaking
• syncope (fainting), feeling of dizziness or fainting
• collapse

Other reactions after injection (reaction immediately after injection)

Some people may experience one or more of the following symptoms minutes after the injection of glatiramero acetate. These usually do not pose a problem and disappear within 30 minutes.

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

• 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 occur rarely with Glatiramero Viatris.

Contact your doctor immediately if you experience symptoms such as:

• nausea,
• loss of appetite,
• dark urine and pale stools,
• yellowing of the skin or white part of the eye,
• easier bleeding than normal.

In general, the side effects reported by patients using glatiramero acetate 40 mg/ml three times a week were also reported by patients using glatiramero acetate 20 mg/ml (see the next list).

The following side effects have been described with glatiramero acetate:

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

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

Common(may affect up to 1 in 10 people)

• respiratory tract inflammation, stomach flu, fever, ear inflammation, nasal congestion, dental abscesses, vaginal candidiasis
• benign skin growths (benign skin neoplasms), tissue growth
• swollen lymph nodes
• allergic reactions
• loss of appetite, weight gain
• nervousness
• alteration of taste, increased muscle tone, migraine, speech problems, fainting, tremors
• double vision, eye problems
• ear problems
• cough, hay fever
• anal or rectal problems, constipation, tooth decay, indigestion, difficulty swallowing, incontinence, vomiting.
• abnormal liver function test results
• cardinal signs, excessive sweating, itching, skin changes, urticaria
• neck pain
• urgency to urinate, frequent urination, inability to empty the bladder properly
• common cold, facial swelling, subcutaneous tissue loss at the injection site, local reaction, peripheral edema due to fluid accumulation, fever.

Rare(may affect up to 1 in 100 people)

• abscesses, inflammation of the skin and subcutaneous tissue, furuncles, herpes, kidney inflammation
• skin cancer
• increased white blood cell count, decreased white blood cell count, enlarged spleen
• decreased platelet count, change in white blood cell shape
• enlarged thyroid gland or hyperthyroidism
• low tolerance to alcohol, gout, increased blood fat levels, increased sodium levels in the blood, decreased ferritin levels in the blood.
• strange dreams, confusion, euphoric state, seeing, hearing, smelling, touching, or feeling things that are not there (hallucinations), aggression, abnormal happiness, personality disorders, suicide attempt
• numbness of the hands and pain (carpal tunnel syndrome), mental disorders, seizures, writing and reading difficulties, muscle disorders, movement problems, muscle spasms, nerve inflammation, abnormal nerve-muscle connection that causes abnormal muscle function, rapid and involuntary eye movements, paralysis, foot drop (peroneal nerve paralysis), unconsciousness (stupor), blind spots
• cataracts, eye injuries in the cornea, dry eyes, eye bleeding, eyelid drooping, pupil dilation, optic nerve degeneration that causes visual problems.
• rapid heartbeats, slow heartbeats, episodes of rapid heartbeats
• varicose veins
• periodic breathing pauses, nasal bleeding, abnormal breathing (hyperventilation), sensation of throat constriction, lung problems, inability to breathe due to throat constriction (sensation of asphyxia)
• inflammation of the small intestine, colon polyps, intestinal inflammation, belching, esophageal ulcer, gum inflammation, rectal bleeding, salivary gland enlargement
• bile stones, liver enlargement
• skin and soft tissue swelling, skin rash due to contact, red, painful skin bumps, skin bumps
• swelling, inflammation, and pain of the joints (arthritis or osteoarthritis), inflammation and pain of the fluid-filled sacs that cover the joints (present in some joints), side pain, muscle mass decrease
• blood in the urine, kidney stones, urinary system problems, abnormal urine

• breast swelling, difficulty achieving an erection, pelvic organ prolapse (pelvic organ prolapse), persistent erections, prostate changes, abnormal Pap test results (abnormal cervical smear), testicular changes, vaginal bleeding, vaginal disorder
• abscess, hangover, low body temperature (hypothermia), non-specific inflammation, tissue destruction at the injection site, mucous membrane problems
• post-vaccination changes.

Reporting of side effects

If you experience any type of side effect,consult your doctor or pharmacist, even if it is a side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use: https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Store in refrigerator (between2°Cand8°C).

Pre-filled syringes of Glatiramero Viatris can be stored for up to one month outside the refrigerator, between15ºCand25ºC. This can only be done once. If after one month, pre-filled syringes of Glatiramero Viatris have not been used and are still in their original packaging, they must be returned to the refrigerator.

Do not freeze.

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

Do not use this medication after the expiration date that appears on the label and on the cardboard box after “CAD”. The first two digits indicate the month and the last four digits indicate the year. The expiration date is the last day of the month indicated.

Dispose of any syringe that contains particles.

Medicines should not be thrown away through drains or in the trash. Ask your pharmacist how to dispose of the packaging and unused medicines. This will help protect the environment.

Composition ofGlatiramero Viatris

• The active ingredient is glatiramer acetate. 1 ml of the injection solution (the content of 1 pre-filled syringe) contains 40 mg of glatiramer acetate.
• The other components are mannitol (E421) and water for injections.

Appearance of the product and contents of the pack

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

If the solution contains particles, discard it and start again. Use a new syringe.

3 pre-filled syringes

12 pre-filled syringes

36 (3x12) pre-filled syringes

Only some pack sizes may be marketed.

Marketing Authorization Holder

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer

Synthon Hispania S.L.

Polígono Les Salines,C/Castelló 1

08830 Sant Boi de Llobregat (Barcelona)

Spain

Or

Synthon BV

Microweg 22

6545 CMNijmegen

Netherlands

You can request more information about this medicine by contacting 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 and in the United Kingdom (Northern Ireland)with the following names:

Germany:CLIFT 40 mg/ml Injection Solution in a Pre-filled Syringe

Belgium:Glatiramyl 40 mg/ml, solution for injection in a pre-filled syringe

Cyprus:Glatiramer/Mylan 40mg/mL?usableliquidinapre-filledsyringe

Denmark:Copemyl

Spain:Glatiramero Viatris 40 mg/ml injection solution in a pre-filled syringe

Finland:Glatimyl 40 mg/ml injection solution, ready-to-use syringe

France:GLATIRAMER VIATRIS40 mg/ml, injection solution in a pre-filled syringe

Greece:Glatiramer / Mylan 40 mg/ml solution for injection, pre-filled syringe

Ireland:Brabio 40 mg/ml solution for injection, pre-filled syringe

Italy:COPEMYLPLUS

Norway:Copemyl 40 mg/ml injection solution, ready-to-use syringe

Netherlands:Glatirameeracetaat Viatris 40 mg/ml, solution for injection in a pre-filled syringe

Portugal:Acetato de glatirâmero Mylan

United Kingdom (Northern Ireland):Brabio 40 mg/ml solution for injection, pre-filled syringe

Sweden:Glatimyl 40 mg/ml injection solution, ready-to-use syringe

The reusable autoinjector is authorized in the member states of the European Economic Area with the following names:

Myject

Last review date of this leaflet:November 2024

More detailed and up-to-date information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/