Remurel

Leaflet attached to the packaging: patient information

Remurel, 20 mg/ml, solution for injection in a pre-filled syringe

Glatiramer acetate

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Remurel and what is it used for

Remurel is used to treat relapsing-remitting multiple sclerosis. This medicine affects the way the patient's immune system works and is classified as an immunomodulatory drug. It is believed that the symptoms of multiple sclerosis are caused by the abnormal functioning of the body's immune system, leading to the formation of inflammatory lesions in the brain and spinal cord.

Remurel is used to reduce the frequency of multiple sclerosis relapses (disease exacerbations). No beneficial effect of the medicine has been demonstrated in other forms of multiple sclerosis where relapses do not occur or occur very rarely.

Remurel may not affect the duration of a relapse or the severity of symptoms during a relapse.

Remurel is used in patients who are able to walk without assistance.

Remurel may also be used in patients who have experienced their first symptoms that suggest a high risk of developing multiple sclerosis. Before starting treatment, the doctor will rule out any other causes that may have triggered these symptoms.

2. Important information before using Remurel

When not to use Remurel:

• if the patient is allergic to glatiramer acetate or any of the other ingredientsof this medicine (listed in section 6).

Warnings and precautions

Before starting treatment with Remurel, discuss it with your doctor or pharmacist.

• if the patient has kidney or heart disease, regular check-ups or tests may be necessary.
• if the patient has or has had any liver problems(including those related to alcohol consumption). Remurel may cause severe allergic reactions, some of which can be life-threatening. These reactions can occur shortly after administration, several months, or even several years after starting treatment, even if no allergic reactions have occurred after previous administration. The objective and subjective symptoms of allergic reactions may overlap with injection site reactions. The doctor will inform the patient about the symptoms of an allergic reaction.

Children

Remurel should not be used in children under 12 years of age.

Elderly patients

No studies have been conducted on the use of Remurel in elderly patients.

Before using the medicine, consult your doctor.

Remurel and other medicines

Tell your doctor or pharmacistabout all medicines the patient is taking, has recently taken, or plans to take.

Pregnancy and breastfeeding

If the patient is pregnant, thinks she may be pregnant, or plans to have a baby, she should consult her doctor before using Remurel. Remurel can be used during pregnancy after consulting a doctor.

Limited data in humans have not shown a negative effect of glatiramer acetate on breastfed newborns or infants. Remurel can be used during breastfeeding.

Driving and using machines

There is no data on the effect of Remurel on the ability to drive and use machines.

3. How to use Remurel

This medicine should always be used exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.

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

It is very important to administer Remurel correctly:

• The medicine should only be administered subcutaneously (see "Instructions for use" below).
• The medicine should be used at the dose prescribed by the doctor. Only the dose prescribed by the doctor should be used.
• Never use the same pre-filled syringe more than once. Unused product or waste should be disposed of.
• Remurel should not be mixed or administered with other medicines.
• If the solution contains visible particles, it should not be used. A new pre-filled syringe should be used.

The doctor or nurse will provide the patient with detailed instructions and will supervise the first self-administration of Remurel. The doctor or nurse will stay with the patient during and for 30 minutes after the injection to ensure that no adverse reactions occur.

Instructions for use

Read these instructions carefully before using Remurel.

Before injecting the medicine, make sure you have all the necessary items:

• One blister pack containing one pre-filled syringe of Remurel.
• A container for used needles and syringes.
• For each injection, remove only one blister pack with one pre-filled syringe from the packaging. Store the remaining syringes in the box.
• If the syringes have been stored in the refrigerator, remove the blister pack from the refrigerator and let it sit at room temperature for at least 20 minutes before injecting the medicine to allow the solution to warm up to room temperature.

Wash your hands thoroughly with soap and water.

If the patient wants to use a special device (auto-injector) to administer Remurel, an auto-injector called Autoxon is available. The Autoxon auto-injector is designed for use with Remurel and has not been tested for use with other medicines.

Read the instructions for use provided with the auto-injector.

Choose an injection site according to the diagrams. There are seven areas on the body where injections can be administered:

Area 1. Abdomen around the navel. Avoid injecting within a 5 cm radius of the navel,

Areas 2 and 3: Thighs (above the knees),

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

Each area has several injection sites. Change the injection site every day to reduce the risk of irritation or pain at the injection site. Rotate the areas and injection sites within each area.

Do not inject the medicine into the same site every time.

Note:do not inject the medicine into a painful or discolored area, or into an area with lumps or nodules. Consider creating a rotation schedule for choosing injection sites and recording it in a diary. There are certain areas on the body where it is difficult to self-administer injections (e.g., the back of the arm). If the patient wants to use these areas for injections, they may need assistance from another person.

How to inject the medicine:

• Remove the syringe from the protective cap by tearing off the foil.
• Remove the needle shield, do notremove the shield with your mouth or teeth.
• Gently grasp the 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 pushing the plunger down at a steady pace until the syringe is empty.
• Remove the syringe and needle in an upward motion.
• Dispose of the syringe in a special container. Used syringes should not be thrown away in household trash. They should be carefully placed in a special container for sharp objects, following the doctor's or nurse's instructions.

Figure 1.

Figure 2.

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

Using a higher dose of Remurel than recommended

Contact your doctor immediately.

Missing a dose of Remurel

Administer the dose as soon as possible, but do not take a double dose to make up for the missed dose. The next dose should be administered 24 hours later.

Stopping treatment with Remurel

Do not stop using Remurel without consulting your doctor.

If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Remurel can cause side effects, although not everybody gets them.

Allergic reactions (hypersensitivity, anaphylactic reactions)

A severe allergic reaction to the administration of Remurel may occur shortly after injection.

This is an uncommon side effect. These reactions can occur several months or years after starting treatment with Remurel, even if no allergic reactions have occurred after previous administration.

Stop using Remurel and contact your doctor immediately or

go to the emergency department of the nearest hospitalif you suddenly experience any of the following symptoms:

• 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 (convulsions),
• difficulty swallowing or speaking,
• fainting, feeling dizzy, or fainting,
• falling.

Other injection site reactions (immediate post-injection reaction)

In rare cases, within a few minutes of injecting Remurel, one or more of the following symptoms may occur in some individuals. They usually do not cause any complications and resolve on their own within 30 minutes.

However, if the following symptoms last longer than 30 minutes, contact your doctor immediately or

go to the emergency department of the nearest hospital:

• redness of the skin (with a feeling of heat) on the chest or face (vasodilation)
• shallow breathing (shortness of breath)
• chest pain
• rapid heartbeat and rapid pulse (tachycardia).

Liver problems

Rarely, liver problems or worsening of existing liver problems, including liver failure (in some cases requiring a liver transplant), may occur during treatment with Remurel.

Contact your doctor immediately if you experience any symptoms such as:

• nausea
• loss of appetite
• dark urine and pale stools
• yellowing of the skin or the white part of the eyes
• easy bruising

Reported side effects of Remurel:

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

• infection, flu
• anxiety, depression
• headache
• nausea
• skin rash
• joint or back pain
• weakness, injection site reactions, including: redness, pain, blistering, itching, swelling, inflammation, and hypersensitivity (these injection site reactions are common and usually decrease over time), non-specific pain.

Common(may affect up to 1 in 10 people):

• respiratory tract infection, gastroenteritis, herpes, ear infection, runny nose, tooth abscess, vaginal thrush
• benign skin growth (non-cancerous skin tumor), growth (tumor)
• enlarged lymph nodes
• allergic reactions
• loss of appetite, weight gain
• nervousness
• taste disorders, increased muscle tone, migraines, speech disorders, fainting, tremors
• double vision, eye disorders
• ear disorders
• cough, hay fever
• anal and rectal disorders, constipation, tooth decay, indigestion, difficulty swallowing, fecal incontinence, vomiting
• abnormal liver function test results
• bruising, excessive sweating, itching, skin disorders, hives
• neck pain
• urinary urgency, frequent urination, inability to empty the bladder properly
• chills, facial swelling, atrophy of subcutaneous tissue at the injection site, local reaction, peripheral edema due to fluid accumulation, fever.

Uncommon (may affect up to 1 in 100 people):

• abscess, skin and subcutaneous tissue infections, furuncles, shingles, kidney inflammation
• skin cancer
• increased white blood cell count, decreased white blood cell count, splenomegaly, decreased platelet count, changes in the appearance of white blood cells
• thyroid enlargement, hyperthyroidism
• decreased alcohol tolerance, gout, increased blood lipid levels, increased sodium levels in the blood, decreased ferritin levels in the serum
• unusual dreams, confusion, euphoric mood, hallucinations (seeing, hearing, smelling, tasting, or feeling things that do not exist), hostility, excessively elevated mood, personality disorders, suicidal attempts
• carpal tunnel syndrome (numbness and pain in the hands), psychiatric disorders, seizures (convulsions), writing and reading disorders, muscle disorders, movement disorders, muscle spasms, nerve inflammation, disorders of the nerve-muscle connection leading to muscle dysfunction, involuntary rapid eye movements, paralysis, foot drop (peroneal nerve palsy), loss of consciousness (stupor), loss of parts of the visual field
• cataract, corneal damage, dry eye, nosebleeds, eyelid ptosis, pupil dilation, optic nerve atrophy leading to vision disorders
• vaccination-related disorders

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products

Al. Jerozolimskie 181C

02-222 Warsaw

Tel: +48 22 49 21 301

Fax: +48 22 49 21 309

Website: https://smz.ezdrowie.gov.pl

Side effects can also be reported to the marketing authorization holder.

Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Remurel

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

Store in a refrigerator (2°C – 8°C).

Remurel pre-filled syringes can be stored at room temperature (15°C to 25°C) for a single period of up to 1 month. After 1 month, if the pre-filled syringes have not been used and are still in their original packaging, they must be returned to the refrigerator.

Do not freeze.

Pre-filled syringes should be stored in the outer packaging to protect them from light.

Do not use this medicine after the expiry date stated on the label and carton after: EXP (abbreviation used to describe the expiry date). The first two digits indicate the month, and the last four digits indicate the year. The expiry date indicates the last day of the specified month.

If the solution contains visible particles, the syringe should be discarded.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Remurel contains

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

What Remurel looks like and contents of the pack

Remurel solution for injection in pre-filled syringes is a sterile, clear, colorless or slightly yellowish to brownish solution.

If the solution contains visible particles, it should be discarded and a new pre-filled syringe should be used.

7 pre-filled syringes

28 pre-filled syringes

30 pre-filled syringes

90 (3x30) pre-filled syringes

Marketing authorization holder and manufacturer

Marketing authorization holder

Zentiva k.s.

U kabelovny 130

Dolní Měcholupy

102 37 Prague 10

Czech Republic

Manufacturer/Importer

Synthon Hispania SL

C/ Castelló no1, Pol. Las Salinas, Sant Boi de Llobregat

08830 Barcelona

Spain

Synthon BV

Microweg 22

6545 CM Nijmegen

Netherlands

To obtain more detailed information on the medicine and its names in the Member States of the European Economic Area, contact:

Zentiva Polska Sp. z o.o.

ul. Bonifraterska 17

00-203 Warsaw

tel: +48 22 375 92 00

[Zentiva (logo)]

The multi-dose auto-injector is called Autoxon.

Date of last revision of the leaflet:November 2024