Glatiramer ViatriS 40 mg/ml solution for injection in pre-filled syringe

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Glatiramero Viatris 40 mg/ml solution for injection in pre-filled syringe

glatiramer acetate

Read the entire leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet as 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 and must not be given to other people, even if they have the same symptoms as you, since it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

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

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

Glatiramero is a medicine used for the treatment of relapsing forms of multiple sclerosis (MS). It modifies the way your body's immune system functions and is classified as an immunomodulating agent. It is believed that the symptoms of multiple sclerosis (MS) are caused by a defect in the body's immune system. This leads to 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 help if you have a form of MS with no relapses or very few relapses. Glatiramero may not have any effect on the duration of an MS attack, or on how severe your symptoms are during an attack.

2. What you need to know before using Glatiramero Viatris

Do not use Glatiramero Viatris

• If you are allergic to glatiramer acetate or to any of the other ingredients of 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 periodic tests or examinations.
• If you have or have had any problems with libido (including those due to alcohol consumption).

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

These reactions may occur shortly after administration, even months or years after starting treatment, and even if no allergic reactions occurred after previous administrations.

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

Children

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

Elderly patients

Glatiramero has not been specifically studied in elderly individuals. Please consult your doctor about this.

Other medicines and Glatiramero Viatris

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take 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 acetate during pregnancy.

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

Limited data in humans have not shown negative effects of glatiramer acetate on newborns/breastfed infants. Glatiramer acetate may be used during breastfeeding.

Driving and using machines

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

3. How to use Glatiramero Viatris

Follow exactly the administration instructions given by your doctor for this medicine. If in doubt, consult your doctor or pharmacist again.

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

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

• Only into the tissue beneath 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 must be discarded.
• Do not mix or co-administer the contents of pre-filled glatiramer syringes with any other product.
• Do not use if the solution contains particles. Use a new syringe.

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

Instructions for use

Read these instructions carefully before using Glatiramero Viatris.

Before the injection, ensure you have everything you need:

• A blister containing the pre-filled glatiramer syringe.
• A container for disposing of used needles and syringes.
• For each injection, take out only one blister with one pre-filled syringe from the package. Keep the rest of the syringes in the box.
• If your syringe was stored in the refrigerator, remove the blister containing the syringe at least 20 minutes before injecting the medicine, so it can warm to room temperature.

Wash your hands thoroughly with soap and water.

If you wish to use an injection device for self-injection, you may use the injection device designed for pre-filled syringes with Glatiramero Viatris. The pre-filled syringe injection device is only approved for use with Glatiramero Viatris and has not been tested with other products. Refer to the instructions for use provided with the pre-filled syringe injection device.

Choose an injection site within the areas shown in the diagrams.

There are seven possible injection zones on your body:

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

Areas 2 and 3: Thighs (above the knees)

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

Within each injection area, there are several possible injection sites. Choose a different site each day. This will reduce the likelihood of irritation or pain at the injection site. Rotate injection sites within each area. Do not use the same injection site repeatedly.

Warning: Do not inject into any area that is painful, discolored, or where you notice firm lumps or nodules. It is recommended to keep a record of planned injection sites and note them in a diary. Some areas of your body (such as the back of your arm) may be difficult for self-injection. If you wish to use these, you may need assistance.

How to inject:

• Remove the syringe from the protective blister by peeling back the backing foil.
• Remove the needle cap, do not use your mouth or teeth to do this.
• Gently pinch the skin to form a skin fold between your thumb and index finger (Figure 1).
• Insert the needle into the skin as shown in Figure 2.
• Inject the medicine by firmly pushing the plunger to the end until the syringe is empty.
• Remove the syringe and needle.
• Dispose of the syringe in a safe sharps container. Do not throw used syringes into the household trash; place them carefully in a puncture-resistant 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, inform your doctor.

If you use more Glatiramero Viatris than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20, stating the medicine and the amount ingested.

If you forget to use Glatiramero Viatris

Take it as soon as you remember or are able to administer it, and avoid using it the following day. Do not administer a double dose to make up for a missed dose. If possible, you should return to your usual administration schedule the following week.

If you stop using Glatiramero Viatris

Do not stop using glatiramer without consulting your doctor.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse 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 an uncommon adverse effect. These reactions may occur months or years after starting treatment with Glatiramero Viatris, even if no allergic reactions occurred after previous administrations.

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

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

Other reactions after injection (immediate reaction after injection)

Some people may experience one or more of the following symptoms within minutes after injection of glatiramer acetate. These symptoms usually do not cause concern and 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),
• difficulty breathing (dyspnea),
• chest pain,
• rapid and strong heartbeat (palpitations, tachycardia).

Liver problems

Liver problems or worsening of existing liver problems, including liver failure (in some cases leading to liver transplantation), may rarely occur with Glatiramero Viatris.

Contact your doctor immediately if you experience symptoms such as:

• nausea,
• loss of appetite,
• dark-colored urine and pale stools,
• yellowing of the skin or the whites of the eyes,
• unusual bleeding.

In general, the adverse effects reported by patients using glatiramer acetate 40 mg/ml three times a week were also reported by patients using glatiramer acetate 20 mg/ml (refer to the list below).

The following adverse effects have been reported with glatiramer acetate:

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

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

Common (may affect up to 1 in 10 people)

• respiratory tract inflammation, stomach flu, hot flushes, ear infection, runny nose, dental abscesses, vaginal candidiasis
• non-malignant skin growths (benign skin neoplasms), tissue growth (neoplasia)
• swollen 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
• ear problems
• cough, hay fever
• anal or rectal problems, constipation, tooth decay, indigestion, difficulty swallowing, intestinal incontinence, vomiting
• abnormal liver function test results
• bruising, excessive sweating, itching, skin disorders, urticaria
• neck pain
• urgency to empty the bladder, frequent urination, inability to adequately empty the bladder
• cold symptoms, facial swelling, loss of subcutaneous tissue at the injection site, local reaction, peripheral swelling due to fluid accumulation, fever.

Uncommon (may affect up to 1 in 100 people)

• abscesses, skin and underlying soft tissue inflammation, boils, herpes, kidney inflammation
• skin cancer
• increased white blood cell count, decreased white blood cell count, enlarged spleen
• decreased platelet count, changes in white blood cell shape
• enlarged thyroid or overactive thyroid (hyperthyroidism)
• low alcohol tolerance, gout, increased blood lipid levels, increased blood sodium, decreased blood ferritin
• strange dreams, confusion, euphoric state, seeing, hearing, smelling, touching, or feeling things that are not there (hallucinations), aggression, abnormally elevated mood, personality disorders, suicide attempt
• numbness and pain in the hands (carpal tunnel syndrome), mental disorders, seizures, problems with writing and reading, muscle disorders, movement problems, muscle spasms, nerve inflammation, abnormal nerve-muscle connection causing abnormal muscle function, rapid and involuntary eye movements, paralysis, foot drop (peroneal nerve paralysis), unconscious state (stupor), blind spots in vision
• cataracts, corneal eye lesions, dry eyes, eye bleeding, drooping upper eyelid, pupil dilation, optic nerve damage causing visual problems
• extra heartbeats, slow heart rate, episodes of rapid heartbeat
• varicose veins
• periodic breathing pauses, nosebleeds, abnormally fast or deep breathing (hyperventilation), sensation of throat tightness, lung problems, inability to breathe due to throat constriction (suffocation sensation)
• inflammation of the small intestine, colon polyps, intestinal inflammation, belching, esophageal ulcer, gum inflammation, rectal bleeding, enlarged salivary glands
• gallstones, enlarged liver
• swelling of skin and soft tissues, contact skin rash, painful red skin nodules, skin lumps
• joint swelling, inflammation, and pain (arthritis or osteoarthritis), inflammation and pain in fluid-filled sacs covering joints (bursitis), flank pain, decreased muscle mass
• blood in urine, kidney stones, urinary system problems, urine abnormalities
• breast swelling, erection difficulty, pelvic organ prolapse, prolonged erections, prostate disorders, abnormal Pap test results (abnormal cervical smear), testicular disorders, vaginal bleeding, vaginal disorders
• cyst, hangover, abnormally low body temperature (hypothermia), non-specific inflammation, tissue destruction at injection site, mucous membrane problems
• adverse events following vaccination.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if they are not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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).

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

Do not freeze.

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

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

Discard any syringe containing particles.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Glatiramer Viatris

• The active substance 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

Glatiramer Viatris is a sterile, clear, colourless or slightly yellowish/brownish 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 certain pack sizes may be marketed.

Marketing Authorisation 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 CM Nijmegen
The Netherlands

For further information about this medicine, contact the local representative of the Marketing Authorisation Holder:

Viatris Pharmaceuticals, S.L.U.
C/ General Aranaz, 86
28027 - Madrid
Spain

This medicine is authorised in the member states of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Germany: CLIFT 40 mg/ml Injektionslösung in einer Fertigspritze
Belgium: Glatiramyl 40 mg/ml, oplossing voor injectie in een voorgevulde spuit
Cyprus: Glatiramer/Mylan 40 mg/mL ενέσιμο διάλυμα σε προγεμισμένη σύριγγα
Denmark: Copemyl
Spain: Glatiramero Viatris 40 mg/ml solución inyectable en jeringa precargada
Finland: Glatimyl 40 mg/ml injektioneste, liuos, esitäytetty ruisku
France: GLATIRAMER VIATRIS 40 mg/ml, solution injectable en seringue préremplie
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 injeksjonsvæske, oppløsning i ferdigfylt sprøyte
Netherlands: Glatirameeracetaat Viatris 40 mg/ml, oplossing voor injectie in een voorgevulde spuit
Portugal: Acetato de glatirâmero Mylan
United Kingdom (Northern Ireland): Brabio 40 mg/ml solution for injection, pre-filled syringe
Sweden: Glatimyl 40 mg/ml injektionsvätska, lösning, förfylld spruta

The reusable auto-injector is authorised in the European Economic Area member states under the following name:

Myject

Date of the most recent revision of this leaflet: November 2024

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