Remurel

Package leaflet: Information for the patient

Remurel, 40 mg/ml, solution for injection in a pre-filled syringe
Glatirameri acetas
Please read all of this leaflet carefully before using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents

1. What Remurel is and what it is 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 Remurel is and what it is used for

Remurel is a medicinal product used in the treatment of relapsing-remitting multiple sclerosis (MS). This medicine affects the way the patient's immune system works and belongs to a group of medicines known as immunomodulators. It is believed that MS symptoms are caused by abnormal functioning of the body's immune system, leading to inflammatory lesions in the brain and spinal cord.
Remurel is used to reduce the frequency of relapses in multiple sclerosis (disease attacks). The beneficial effect of this medicine has not been demonstrated in other forms of multiple sclerosis where relapses are absent or very infrequent.
Remurel may not affect the duration of a multiple sclerosis relapse or the severity of symptoms during a relapse.

2. Important information before using Remurel

When not to use Remurel

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

Warnings and precautions
Before starting treatment with Remurel, discuss the following with your doctor or pharmacist:

• if the patient has kidney or heart diseases, regular examinations or follow-up visits may be necessary;
• if the patient has or has had any liver diseases (including those caused by alcohol consumption). Remurel may cause severe allergic reactions, some of which may be life-threatening. These reactions may occur shortly after administration, several months, or even several years after starting treatment, even if no allergic reactions occurred after previous doses.

Subjective and objective symptoms of allergic reactions may overlap with injection site reactions. Your doctor will inform you about the symptoms of an allergic reaction.

Children and adolescents
Remurel must not be used in children and adolescents under 18 years of age.

Elderly patients
Studies on the use of Remurel in elderly patients have not been conducted. Please consult your doctor.

Remurel with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should contact her doctor for advice and consideration of using Remurel during pregnancy.

Remurel may be used during pregnancy after consultation with a doctor.

Limited human data have not shown a negative effect of glatiramer acetate on breastfed newborns and (or) infants. Remurel may be used during breastfeeding.

Driving and using machines
Remurel has no influence on the ability to drive or operate machinery.

3. How to use Remurel

This medicine should always be used exactly as directed by your doctor. If in doubt, consult your
doctor or pharmacist.
The recommended dose for adults is one pre-filled syringe (40 mg of glatiramer acetate), administered
by subcutaneous injection (under the skin) three times a week, with at least 48 hours between doses,
for example on Monday, Wednesday, and Friday. It is recommended to use the medicine on the
same days each week.
It is very important to use Remurel correctly:

• Remurel must only be given by subcutaneous injection (see "Instructions for use" below).
• Use the medicine exactly as prescribed by your doctor. Only use the dose prescribed by your doctor.
• Never use the same pre-filled syringe more than once. Any unused product or waste material must be discarded.
• The contents of Remurel pre-filled syringes must not be mixed or administered together with any other products.
• If the solution contains visible particles, it must not be used. Use a new pre-filled syringe instead.

Your doctor or nurse will provide you with detailed instructions and supervise your first
self-injection of Remurel. Your doctor or nurse will stay with you while you perform the injection
yourself and for the following half hour to ensure that no adverse reactions occur.
Instructions for use
Before using Remurel, carefully read these instructions.
Before injecting the medicine, make sure you have all the necessary items ready:

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

Wash your hands thoroughly with soap and water.
If you wish to use an injection device for administering the injections, an auto-injector called Autoxon is available and may be used with Remurel. The Autoxon auto-injector is designed for use with Remurel and has not been tested for use with other medicines. Please read the instructions for use provided with the Autoxon auto-injector.
Select an injection site from the areas indicated in the diagrams.
There are seven areas on the body where injections can be given:
Area 1. Abdominal area around the navel. Avoid injecting within 5 cm of the navel.
Areas 2 and 3: Thighs (above the knees),

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

Within each area, there are several possible injection sites. Choose a different site for each subsequent injection to reduce the likelihood of irritation or pain at the injection site. Rotate injection areas and change injection sites within each area. Do not inject the medicine into the same spot every time.
Note: Do not inject the medicine into areas that are painful or have discoloured skin, or where lumps or thickened areas can be felt.
Consider developing a rotational schedule for selecting injection sites and record it in a diary. Some body areas are difficult to reach when injecting yourself (e.g. the back of the upper arm). If you wish to use these areas, you may need help from another person.
How to inject:

• Remove the syringe from its protective tray by peeling off the foil.
• Remove the needle cap. Do not remove the cap with your mouth or teeth.
• Gently pinch a fold of skin between the thumb and index finger of your free hand (Figure 1).
• Insert the needle into the skin as shown in Figure 2.
• Inject the medicine by steadily pressing down the plunger until the syringe is empty.
• Withdraw the syringe and needle straight upwards. Dispose of the syringe in a special container. Do not throw used syringes into household waste. Carefully place them in a special sharps container, as recommended by your doctor or nurse.

Figure 1. Figure 2.
If you feel that the effect of Remurel is too strong or too weak, consult your doctor.
Use of more than the recommended dose of Remurel
Contact your doctor immediately.
Missed dose of Remurel
Use the missed dose as soon as you remember or when you are able to administer the medicine. Then skip the next scheduled dose. Do not use a double dose to make up for a missed dose. If possible, return to your regular dosing schedule the following week.
Stopping Remurel treatment
Do not stop using Remurel without consulting your doctor.
If you have any further questions about the use of this medicine, consult 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 reactions)
Severe allergic reactions to this medicine may occur shortly after administration. This is an uncommon
adverse effect. These reactions may occur several months or years after starting treatment with Remurel,
even if no allergic reactions occurred after previous doses.
You must stop using Remurel and contact your doctor immediately or go to the emergency department
of your nearest hospital if you notice any signs of these adverse effects:

• 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, dizziness or feeling faint;
• collapse.

Other injection-related reactions (immediate post-injection reaction)
In some people, one or more of the following symptoms may occur within minutes after injection of Remurel.
These usually do not lead to complications and resolve spontaneously within half an hour.
However, if these symptoms persist for longer than 30 minutes, you should contact your doctor immediately
or go to the emergency department of your nearest hospital:

• skin redness (with a sensation of warmth) on the chest or face (vasodilation);
• shallow breathing (shortness of breath);
• chest pain;
• palpitations and rapid heartbeat (palpitations, tachycardia).

Liver disorders
During treatment with Remurel, liver disorders or worsening of pre-existing liver conditions, including
liver failure, may rarely occur. You should contact your doctor immediately if any of the following
symptoms occur:

• nausea;
• loss of appetite;
• dark urine and pale stools;
• yellowing of the skin or the white part of the eye (jaundice);
• increased tendency to bleed.

In general, adverse effects reported by patients treated with glatiramer acetate
at a dose of 40 mg/ml three times a week have also been observed in patients treated with
glatiramer acetate at a dose of 20 mg/ml (see list below).
The following adverse effects have been reported after administration of glatiramer acetate:
Very common: (may affect more than 1 in 10 people):

• infection, influenza;
• 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, rhinitis, dental abscess, vaginal candidiasis;
• benign skin neoplasm (benign skin tumor), tissue overgrowth (neoplasm);
• enlarged lymph nodes;
• allergic reactions;
• loss of appetite, weight gain;
• nervousness;
• taste disturbances, increased muscle tone, migraine, speech disorders, fainting, tremor;
• double vision, eye disorders;
• ear disorders;
• cough, allergic rhinitis;
• anal or rectal disorders, constipation, dental caries, indigestion, difficulty swallowing, fecal incontinence, vomiting;
• abnormal liver function test results;
• bruising, excessive sweating, itching, skin disorders, urticaria;
• neck pain;
• sudden urge to urinate, frequent urination, inability to adequately empty the bladder;
• 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 soft tissue infection, boils, shingles, kidney inflammation;

• skin cancer;

• increased white blood cell count, decreased white blood cell count, splenomegaly, decreased platelet count, changes in white blood cell morphology;

• thyroid enlargement, hyperthyroidism;

• reduced alcohol tolerance, gout, increased blood lipid levels, increased blood sodium levels, decreased plasma ferritin levels;

• unusual dreams, confusion, euphoric mood, hallucinations (seeing, hearing, smelling, tasting or feeling something that does not exist), hostility, abnormally elevated mood, personality disorders, suicide attempts;

• numbness and pain in the hands (carpal tunnel syndrome), psychiatric disorders, seizures (convulsions), problems with writing and reading, muscle disorders, movement disorders, muscle spasms, nerve inflammation, neuromuscular junction disorders leading to
  muscle function impairment, nystagmus (involuntary rapid eye movements), paralysis, foot drop (peroneal nerve palsy), unconscious state (stupor), visual loss;

• cataract, corneal damage, dry eye sensation, eye hemorrhage, ptosis (drooping eyelid), pupil dilation, optic nerve atrophy leading to visual disturbances;

• extrasystoles, decreased heart rate, paroxysmal tachycardia;

• varicose veins;

• apnea (periodic breathing cessation), nosebleeds, abnormally rapid or deep breathing (hyperventilation), throat tightness, lung disorders, inability to breathe due to throat pressure (sensation of choking);

• colitis, colon polyps, belching, esophageal ulceration, gingivitis, rectal bleeding, salivary gland enlargement;

• gallstones, hepatomegaly;

• skin and soft tissue swelling, contact dermatitis, painful nodular erythema (red nodules on the skin), skin nodules;

• joint swelling, inflammation and pain (arthritis or osteoarthritis), bursitis (inflammation of the fluid-filled sac lining certain joints), flank pain, decreased muscle mass;

• hematuria, kidney stones, urinary tract disorders, abnormal urine;

• breast swelling, erection disorders, pelvic organ prolapse, prolonged penile erection (priapism), prostate disorders, abnormal cervical cytology, testicular disorders, vaginal bleeding, vaginal disorders;

• cyst, "hangover" symptoms, decreased body temperature (hypothermia), non-specific inflammation, tissue necrosis at the injection site, mucosal disorders;

• post-vaccination disorders.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, you should inform your doctor, pharmacist, or nurse. Adverse effects can also be reported directly to the Department of Monitoring of Adverse Drug Reactions at 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
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to gather more information on the safety of this medicine.

5. How to store Remurel

Keep this medicine out of the sight and reach of children.
Store in a refrigerator (2°C – 8°C).
Remurel pre-filled syringes may be stored once outside the refrigerator
at a temperature between 15°C and 25°C for up to 1 month. After this 1-month period, if any
Remurel pre-filled syringes have not been used and are still in their
original packaging, they must be returned to the refrigerator.
Do not freeze.
Keep pre-filled syringes in the outer carton to protect from light.
Do not use this medicine after the expiry date stated on the label and carton after: EXP. The first two digits indicate the month, and the last four digits indicate the year.
The expiry date refers to the last day of the stated month.
If the solution contains visible particles, discard the syringe.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required.
These measures 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 injection solution (the contents of one pre-filled syringe) contains 40 mg of glatiramer acetate.
• The other ingredients are mannitol and water for injections.

What Remurel looks like and contents of the pack
Remurel injection solution in pre-filled syringes is a sterile, clear, colourless or slightly yellowish/brownish solution.
If the solution contains visible particles, it should be discarded and a new pre-filled syringe used.
Pack sizes:
3 pre-filled syringes
12 pre-filled syringes
36 pre-filled syringes
Not all pack sizes may be marketed.

Marketing Authorisation 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
The Netherlands

This medicinal product is authorised in the member states of the European Economic Area under the following names:
Bulgaria: Ремурел 40 mg/ml инжекционен разтвор в предварително напълнена спринцовка
Czech Republic: Remurel
Croatia: Remurel 40 mg/ml otopina za injekciju, u napunjenoj štrcaljki
Estonia: Remurel
Iceland: Remurel
Latvia: Remurel 40 mg/ml šķīdums injekcijām pilnšļircē
Lithuania: Remurel 40 mg/ml injekcinis tirpalas užpildytame švirkšte
Netherlands: Glatirameeracetaat Zentiva 40 mg/ml, oplossing voor injectie in een voorgevulde spuit
Poland: Remurel
Romania: Remurel 40 mg/ml soluţie injectabilă în seringă preumplută
Slovenia: Remurel 40 mg/ml raztopina za injiciranje v napolnjeni injekcijski brizgi
Slovakia: Remurel 40 mg/ml
Hungary: Remurel 40 mg/ml oldatos injekció előretöltött fecskendőben

The reusable auto-injector is authorised in the member states of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
Autoxon – Bulgaria, Croatia, Estonia, Iceland, Lithuania, Latvia, Poland, Czech Republic, Romania, Slovenia, Slovakia, Hungary
Sensigo – Netherlands

For further information about this medicine, contact the local representative of the Marketing Authorisation Holder:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
tel: + 48 22 375 92 00
[Zentiva (logo)]