GLATIRAMER ACETATE TEVA

Package leaflet: Information for the patient

Glatiramer acetate Teva, 40 mg/ml, solution for injection in pre-filled syringe
Glatirameri acetas
Read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are similar.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

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

1. What Glatiramer acetate Teva is and what it is used for

Glatiramer acetate Teva is a medicine indicated for the treatment of relapsing forms of multiple sclerosis
administered three times a week. Glatiramer acetate Teva is not indicated for use in patients with primary or secondary progressive forms of multiple sclerosis.
It modifies the way the patient's immune system functions and belongs to a group of medicines called immunomodulators. It is believed that symptoms of multiple sclerosis are caused by a malfunction of the body's immune system, leading to inflammatory lesions in the brain and spinal cord.
Glatiramer acetate Teva is indicated to reduce the frequency of relapses in multiple sclerosis. The effect of the medicine has not been demonstrated in other forms of multiple sclerosis where relapses are absent or very rare. Glatiramer acetate Teva may not affect the duration of a multiple sclerosis relapse or the severity of symptoms during such a relapse.

2. Important information before using Glatiramer acetate Teva

When not to use Glatiramer acetate Teva:

• 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 Glatiramer acetate Teva, discuss this with your doctor or
pharmacist:

• if the patient has kidney or heart disease, as the doctor may recommend regular laboratory tests and follow-up visits.
• if the patient has or has had any liver problems (including those caused by alcohol consumption).

Children and adolescents
Glatiramer acetate Teva must not be used in children and adolescents under 18 years of age.
Elderly patients
The effect of Glatiramer acetate Teva has not been studied in elderly patients. Consult your doctor.
Glatiramer acetate Teva and 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, suspects she may be pregnant, or is planning to become pregnant,
she should consult her doctor before using this medicine.
Limited human data have not shown any negative effects of Glatiramer acetate Teva on breastfed newborns and (or) infants. Glatiramer acetate Teva may be used during breastfeeding.
Driving and operating machinery
The influence of Glatiramer acetate Teva on the ability to drive or operate machinery is unknown.

3. How to use Glatiramer acetate Teva

This medicine should always be used exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.

The usual dose for adults is one pre-filled syringe (40 mg glatiramer acetate), administered by subcutaneous injection three times a week, with at least 48 hours between injections. It is recommended to administer the medicine on the same days each week.

When a patient receives Glatiramer acetate Teva for the first time, the doctor or nurse will provide full instructions and supervise the patient. The doctor or nurse will remain with the patient during the first self-administration of the injection and for a further half hour to ensure that no adverse reactions occur.

Instructions for use

Before using Glatiramer acetate Teva, carefully read these instructions. Before injecting the medicine, ensure that all necessary items are prepared:

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

Wash hands thoroughly with soap and water.

If the patient wishes to use an injection device, the special CSYNC injection device for Glatiramer acetate Teva may be used. This injection device is approved for use with Glatiramer acetate Teva and has not been tested with other products. Read the instructions for use provided with the CSYNC injection device.

Select an injection site using the diagrams.

There are seven body areas where injections can be administered:

• 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 buttocks (below the waist)

Each injection area contains multiple injection sites. A different site should be selected daily to reduce the risk of irritation or pain at the injection site. Rotate 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, discolored, or have palpable lumps or nodules.

It is recommended to develop a rotational schedule for selecting injection sites and record it in a diary. Some body areas (e.g., the back of the arm) may be difficult to inject into without assistance. In such cases, help from another person is needed.

How to inject the medicine:

• Remove the syringe from the protective blister by tearing off the foil seal.
• Remove the needle cap, do not remove it with mouth or teeth.
• Gently pinch a fold of skin between the thumb and index finger of the free hand (Figure 1).
• Insert the needle into the skin as shown in Figure 2.
• Inject the medicine by pressing the plunger down steadily until the syringe is empty.
• Remove the syringe and needle straight upward.
• Dispose of the syringe in a designated sharps container.

Figure 1 Figure 2

It is very important to administer Glatiramer acetate Teva correctly:

• Administer only by subcutaneous injection.
• Use only the dose prescribed by the doctor. Always follow the doctor's prescribed dose.
• A single pre-filled syringe must never be used more than once. Unused product or waste must be disposed of properly.
• Glatiramer acetate Teva pre-filled syringes must not be mixed or administered simultaneously with other medicines.
• Do not use the solution if visible particles or precipitates are present. Use a new syringe.

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

Overdose of Glatiramer acetate Teva

Inform your doctor immediately.

Missed dose of Glatiramer acetate Teva

Take the missed dose as soon as you remember or as soon as you are able to, and skip the next scheduled dose. Do not take a double dose to make up for a missed dose. Resume the regular dosing schedule the following week, if possible.

Stopping treatment with Glatiramer acetate Teva

Do not stop using Glatiramer acetate Teva without consulting your doctor.

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.

Allergic reactions (hypersensitivity)
A severe allergic reaction to the administration of the medicine may rarely occur (may affect up to 1 in 1,000 patients).

You must stop using Glatiramer acetate Teva and contact your doctor immediately or go to the nearest hospital emergency department if any of the following symptoms occur:

• rash (red spots or hives)
• swelling of the eyelids, face, or lips
• sudden shortness of breath
• seizures (convulsions)
• fainting.

Other reactions after administration of the medicine (immediate post-injection reaction)
In some patients, within a few minutes after injection of Glatiramer acetate Teva, reactions may occur not infrequently (up to 1 in 100 patients), with at least one of the following symptoms. These usually do not cause problems and resolve within half an hour.
However, if the following symptoms persist for longer than 30 minutes, you should immediately contact your doctor or go to the nearest hospital emergency department:

• flushing (skin redness with a sensation of warmth) in the chest or facial area (vasodilation)
• shortness of breath
• chest pain
• palpitations and rapid heartbeat (strong heartbeat, tachycardia).

Liver disorders
During treatment with Glatiramer acetate Teva, liver disorders or worsening of pre-existing liver disease may rarely occur, including liver failure in some cases leading to liver transplantation. You should contact your doctor immediately if any of the following symptoms occur:

• nausea
• loss of appetite
• dark-colored urine and pale stools
• yellowing of the skin or the whites of the eyes
• increased tendency to bleed.

Generally reported adverse reactions in patients using glatiramer acetate
40 mg/ml administered three times a week were also reported in patients using
glatiramer acetate 20 mg/ml (see list below).
Very common: may affect more than 1 in 10 patients

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

Common: may affect less than 1 in 10 patients

• respiratory tract infection, influenza, herpes, ear infection, rhinitis, peritonsillar abscess, vaginal fungal infection
• benign skin neoplasm (benign skin tumor), tissue proliferation (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, sinusitis
• anal or rectal disorders, constipation, dental caries, indigestion, difficulty swallowing, fecal incontinence, vomiting
• abnormal liver function test results
• bruising, excessive sweating, itching, skin disorder, urticaria
• neck pain
• sudden urge to urinate, frequent urination, inability to adequately empty the bladder
• chills, facial swelling, subcutaneous tissue atrophy at the injection site, local reaction, peripheral edema due to fluid accumulation, fever

Uncommon: may affect less than 1 in 100 patients

• 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, change in appearance of white blood cells

• enlarged thyroid, hyperthyroidism

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

• strange dreams, confusion, euphoric mood; seeing, hearing, smelling, tasting, or feeling something that does not exist (hallucinations), hostility, overly good mood, personality disorders, suicidal behavior

• numbness and pain in hands (carpal tunnel syndrome), psychiatric disorders, seizures (convulsions), inability to write or read, muscle disorders, movement disorders, muscle spasms, nerve inflammation, neuromuscular junction disorders leading to muscle dysfunction, involuntary rapid eye movements, paralysis, foot drop (peroneal nerve palsy), unconscious state (stupor), visual scotoma

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

• additional heartbeats, slowed heart rate, occasional rapid heartbeat

• varicose veins

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

• intestinal inflammation, colon polyp, belching, esophageal ulcer, gingivitis, rectal bleeding, enlarged salivary glands

• gallstones, liver enlargement

• swelling of skin and soft tissues, contact dermatitis, painful red skin nodules, skin nodules

• swelling, inflammation, and joint pain (arthritis or osteoarthritis), inflammation and pain in the fluid-filled sac lining the joint (occurring in certain joints), flank pain, muscle atrophy

• hematuria, kidney stones, urinary system disorders, abnormal urine

• breast swelling, erectile dysfunction, pelvic organ prolapse, priapism, prostate disorders, abnormal cytology smear (abnormal cervical smear), testicular disorders, vaginal bleeding, vaginal disorders

• cyst, alcohol abuse symptoms, decreased body temperature (hypothermia), unspecified inflammation, necrosis of tissue at injection site, mucosal disorders

• post-vaccination disorders.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, PL-02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Glatiramer acetate Teva

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the outer packaging and on the immediate packaging following: "Expiry date (EXP):" or "EXP:". The expiry date refers to the last day of the stated month.
Store in a refrigerator (2°C - 8°C).
Glatiramer acetate Teva pre-filled syringes may be stored once at a temperature between 15°C and 25°C for up to 1 month. After this 1-month period, 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 kept in the original packaging to protect from light.
Dispose of all syringes containing solid particles.
Used syringes should be discarded carefully, using a special puncture-resistant container, as recommended by your doctor or nurse.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Following this advice helps protect the environment.

6. Contents of the pack and other information

What Glatiramer acetate Teva contains

• The active substance is glatiramer acetate. 1 ml of injection solution (the content of one pre-filled syringe) contains 40 mg of glatiramer acetate.
• Other ingredients are: mannitol and water for injections.

What Glatiramer acetate Teva looks like and contents of the pack
Glatiramer acetate Teva, solution for injection in a pre-filled syringe, is a clear, colourless solution.
Glatiramer acetate Teva is available in packs of 3 or 12 pre-filled syringes, each containing 1 ml of solution for injection, or in a multi-pack containing 3 cartons, each with 12 pre-filled syringes containing 1 ml of solution for injection.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Teva GmbH
Graf-Arco-Str. 3
89079 Ulm
Germany

Manufacturers/Importers:
Teva Pharmaceuticals Europe B.V.
Swensweg 5
2031 GA Haarlem
The Netherlands
Merckle GmbH
Ludwig-Merckle-Strasse 3
89143 Blaubeuren
Germany
Actavis Group PTC ehf.
Dalshraun 1
220, Hafnarfjörður
Iceland

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Germany: Glatirameracetat AbZ 40 mg/ml Injektionslösung in einer Fertigspritze
Austria: Copaxobene 40 mg/ml Injektionslösung in einer Fertigspritze
Belgium: Glataxon 40 mg/ml solution injectable en seringue préremplie / oplossing voor injectie in een voor gevulde spuit / Injektionslösung in einer Fertigspritze
Luxembourg: Glaxaton 40 mg/ml solution injectable en seringue préremplie
Poland: Glatiramer acetate Teva
Portugal: Acetato de Glatirâmero Mepha
Slovakia: Glatirameracetát Teva 40 mg/ml injekčný roztok naplnený v injekčnej striekačke

For further information, please contact the local representative of the Marketing Authorisation Holder:
Teva Pharmaceuticals Polska Sp. z o.o.
ul. Emilii Plater 53
00-113 Warsaw
tel.: (22) 345 93 00