TEMOZOLOMIDE 5 mg Hard Capsules

Зміст інструкції

1. Temozolomide Accord 5 mg hard capsules, 20 mg hard capsules, 100 mg hard capsules, 140 mg hard capsules, 180 mg hard capsules, 250 mg hard capsules
   1. What is Temozolomide Accord and what is it used for
   2. What you need to know before you take Temozolomide Accord
   3. How to take Temozolomide Accord
   4. Possible side effects
   5. How to store Temozolomide Accord
   6. Contents of the pack and other information
2. Temozolomide Accord 20 mg hard capsules: gelatin, titanium dioxide (E 171), iron oxide
3. Temozolomide Accord 140 mg hard capsules: gelatin, titanium dioxide (E 171), carmine

Temozolomide Accord 5 mg hard capsules, 20 mg hard capsules, 100 mg hard capsules, 140 mg hard capsules, 180 mg hard capsules, 250 mg hard capsules

temozolomide

Read this leaflet carefully before you start using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

• 1. What Temozolomide Accord is and what it is used for
• 2. What you need to know before you take Temozolomide Accord
• 3. How to take Temozolomide Accord
• 4. Possible side effects
• 5. How to store Temozolomide Accord
• 6. Contents of the pack and other information

1. What is Temozolomide Accord and what is it used for

Temozolomide is an antineoplastic medicine.
Temozolomide Accord capsules are used for the treatment of specific forms of brain tumor:

• in adults with newly diagnosed glioblastoma multiforme. Temozolomide is initially used in association with radiotherapy (concomitant treatment phase) and subsequently alone (monotherapy treatment phase).
• In children aged 3 years and over and in adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma. Temozolomide is used in these tumors that manifest relapse or progression after standard therapy.

2. What you need to know before you take Temozolomide Accord

Do not take Temozolomide Accord

• if you are allergic to temozolomide or to any of the other ingredients of Temozolomide Accord (listed in section 6).
• if you have had an allergic reaction to another anti-cancer medicine called dacarbazine. Signs of an allergic reaction include itching, shortness of breath or wheezing, swelling of the face, lips, tongue or throat.
• if the number of your blood cells is reduced (myelosuppression), such as the number of white blood cells and platelets. These blood cells are important for fighting

infections and for proper blood clotting. Your doctor will have blood tests done
to make sure that the number of these cells is sufficient to start treatment.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Temozolomide Accord

• because you must be carefully monitored for the development of a severe form of chest infection called Pneumocystis jiroveciipneumonia (PCP). If you are a newly diagnosed patient (glioblastoma multiforme) you may be given Temozolomide Accord for 42 days in combination with radiotherapy. In this case, your doctor will also prescribe medicines to help prevent this type of pneumonia (PCP).
• if you have ever had or currently have an infection with hepatitis B. This is because Temozolomide Accord may cause a reactivation of hepatitis B, which in some cases can be fatal. Before starting treatment, patients will be carefully checked by the doctor to see if there are signs of this infection.
• if you have a low number of red blood cells (anemia), white blood cells and platelets, or blood clotting problems before starting treatment, or if you develop them during treatment. The doctor may decide to reduce the dose. In severe cases, the doctor may stop, suspend or change the treatment. You may also need other treatments. In some cases, it may be necessary to stop giving temozolomide. In addition, blood samples will be analyzed frequently during treatment to check for adverse effects of Temozolomide Accord on your blood cells.
• because you may be at low risk of developing other blood cell changes, including leukemia.
• if you have nausea (feeling sick to the stomach) and/or vomiting, which are very common side effects of temozolomide (see section 4), your doctor may prescribe you a medicine to help prevent vomiting. If you vomit frequently before or during treatment, ask your doctor for the best time to take temozolomide until the vomiting is under control. If you vomit after taking a dose, do not take a second one on the same day.
• if you develop a fever or symptoms of an infection, contact your doctor immediately.
• if you are over 70 years old, you may be more prone to infections, bruising or bleeding.
• if you have liver or kidney problems, your dose of temozolomide may need to be adjusted.

Children and adolescents
Do not give this medicine to children under 3 years of age because it has not been studied. There are
limited data in patients over 3 years of age who have taken Temozolomide Accord.

Other medicines and Temozolomide Accord
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, ask your doctor
or pharmacist for advice before taking this medicine. This is because you should not be treated with
Temozolomide Accord during pregnancy unless clearly indicated by your doctor.
Effective contraceptive precautions must be taken by women of childbearing potential during treatment with Temozolomide Accord and for at least 6 months after completion
of treatment.
You must stop breastfeeding if you are being treated with Temozolomide Accord.

Male fertility
Temozolomide Accord may cause permanent infertility. Men must use effective
contraception and not try to father a child for at least 3 months after stopping
treatment. It is recommended to inquire about sperm preservation before starting
treatment.

Driving and using machines
Temozolomide can cause tiredness or drowsiness. If this happens, do not drive or use tools or
machines or ride a bicycle until you see how this medicine affects you (see
section 4).

Temozolomide Accord contains lactose
This medicine contains lactose (a type of sugar). If you have been told by your doctor that you
are intolerant to some sugars, contact them before taking this medicine.

Temozolomide Accord contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, that is to say essentially ‘sodium free’.

3. How to take Temozolomide Accord

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, ask your doctor or pharmacist.
How to open the sachet
Fold and tear the sachet along the fold line with the notch located at the corner of the
sachet.
Temozolomide must only be prescribed by a specialist with experience in the treatment of brain
tumors.
Dosage and duration of treatment
The doctor will determine your dose of temozolomide. It depends on your size (height and weight) and, if
you have a recurrent tumor, on any previous chemotherapy treatment you have had. Other medicines (anti-emetics) may be
prescribed to be taken before and/or after taking temozolomide to
prevent or control nausea and vomiting.
Take the prescribed dose of Temozolomide Accord once a day. Take the medicine on
an empty stomach; for example, at least one hour before breakfast. Swallow the capsule(s) whole with
a glass of water. Do not open, crush or chew the capsules.
If a capsule is damaged, avoid contact of the powder contained in it with the skin, with the
eyes or nose. Avoid inhaling the powder. If accidentally some powder comes into
contact with your eyes or nose, rinse the affected area with water.

If you are taking Temozolomide Accord in combination with radiotherapy (patients
newly diagnosed):
While radiotherapy is in progress, the doctor will start temozolomide at a dose of 75 mg/m² and the daily dosage
you will take depends on your height and weight. You will take this dose every day for
42 days (up to 49 days) in association with radiotherapy. Based on the number of your blood
cells and how you tolerate temozolomide, the dose may be delayed or interrupted.
Once the radiotherapy is completed, you will stop treatment for 4 weeks. This will give
your body a chance to recover.
Then, you will start monotherapy.
During the monotherapy phase, the dose and how to take Temodal will be different. The doctor
will establish your correct dose. There may be up to 6 periods of treatment cycles each lasting
at least 28 days. You will take your new dose of temozolomide capsules initially at
150 mg/m² once a day for the first 5 days (“therapy days”) of each cycle, then followed by
23 days without temozolomide; thus reaching the 28 days of the treatment cycle.
After Day 28, you will start the next cycle in which you will still take this medicine once
a day for five days followed by 23 days without temozolomide. The dose of temozolomide may
be adjusted, delayed or interrupted based on your blood count and how you tolerate the
drug during each treatment cycle.

If you are taking Temozolomide Accord capsules alone (without radiotherapy):
A treatment cycle with Temozolomide Accord lasts 28 days. You will take the capsules once a day for the first five days (“therapy days”) followed by 23 days without temozolomide, thus reaching
28 days of the treatment cycle.
After day 28, you will begin the next cycle, in which you will take this medicine again once
a day for five days followed by 23 days without temozolomide. Before each new cycle,
you will have blood tests to check if the dose of temozolomide needs to be
modified.
If you have not been previously treated with chemotherapy, your first dose of temozolomide will be
200 mg/m² once a day for the first five days (“therapy days”) followed by 23 days without
temozolomide. If you have been previously treated with chemotherapy, your first dose of
temozolomide will be 150 mg/m² once a day for the first five days (“therapy days”)
followed by 23 days without temozolomide.
Based on the results of the blood tests, the doctor may modify your dose for the next
cycle.
Whenever you start a new treatment cycle, make sure you fully understand how many
capsules of each dosage you need to take each day and for how many days you will take this dosage.

All patients
Temozolomide is available in capsules of different dosages (indicated on the outer label in mg).
Each dosage is highlighted by capsules of a different color. Depending on the dose of temozolomide
that your doctor prescribes, you may need to take several capsules during each day of the treatment
cycle.

• Make sure you fully understand how many capsules of each dosage you need to take. Ask your doctor or pharmacist to write down the number for each dosage (including the color) that you need to take for each day of treatment.
• Make sure you know exactly what the days of taking the therapy are.
• Make sure to review the dose with your healthcare provider whenever you need to start a new cycle, as sometimes the dose or combination of capsules you need to take may be different from the previous cycle.
• When you take the medicine at home, if you are confused or unsure about how to take your dose, before starting the therapy cycle, call to be re-instructed on how to proceed. Errors in taking this medicine could cause serious harm to your health.

If you take more Temozolomide Accord than you should
In the event of accidental taking of a number of capsules greater than prescribed, contact
your doctor, pharmacist or nurse immediately.

If you forget to take Temozolomide Accord
Take the dose you forgot as soon as possible during the same day. If an entire
day has passed, contact your doctor. Do not take a double dose to make up for the missed dose, unless you are told to do so by your doctor.
If you have any doubts about the use of this medicine, ask your doctor, pharmacist or
nurse.

4. Possible side effects

Like all medicines, Temozolomide Accord can cause side effects, although not everyone gets them.
Patients receiving temozolomide in combination with radiotherapy may experience side effects different
from those reported by patients receiving temozolomide alone.
Contact your doctor immediately if you experience any of the following:

• a severe allergic reaction (hypersensitivity) (hives, wheezing or other breathing difficulty),
• uncontrolled bleeding,
• seizures (convulsions),
• fever,
• chills,
• severe headache that does not go away.

Treatment with temozolomide may cause a decrease in certain types of blood cells. This may
lead to increased bruising or bleeding, anemia (reduced number of red blood cells), fever and/or a
reduced resistance to infections. The decrease in the number of blood cells is usually temporary, in some
cases, it may be prolonged and may lead to a very serious form of anemia
(aplastic anemia). Your doctor will regularly monitor your blood and decide if
specific therapy is necessary. In some cases the dose of temozolomide will be reduced or treatment
stopped.
Other side effects that have been reported are listed below:

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

• loss of appetite, difficulty speaking, headache
• vomiting, nausea, diarrhea, constipation
• skin rash, hair loss
• fatigue

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

• infections, mouth infections
• reduction in the number of blood cells (neutropenia, lymphopenia, thrombocytopenia)
• allergic reaction
• increased blood sugar
• memory loss, depression, anxiety, confusion, difficulty falling asleep or staying asleep
• coordination problems and balance problems
• difficulty concentrating, altered mental status or attention, memory loss
• dizziness, sensory disturbance, tingling, tremor, altered taste
• partial vision loss, abnormal vision, double vision, dry or painful eyes
• hearing loss, ringing in the ears, ear pain
• blood clots in the lung or legs, high blood pressure
• pneumonia, shortness of breath, bronchitis, cough, inflammation of the nasal cavities
• stomach or abdominal pain, stomach disorders/heartburn, difficulty swallowing
• dry skin, itching
• muscle damage, muscle weakness, muscle pain and cramps
• joint pain, back pain
• frequent urination, difficulty holding urine
• fever, flu-like symptoms, pain, feeling unwell, cold or flu
• fluid retention, swollen legs
• increased liver enzymes
• weight loss, weight gain
• radiation injury

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

• brain infections (herpes meningoencephalitis) including cases that have been fatal
• wound infections
• new or reactivated cytomegalovirus infections
• infections caused by reactivated hepatitis B virus
• secondary tumors including leukemia
• reduction in the number of blood cells (pancytopenia, anemia, leucopenia)
• red spots under the skin
• diabetes insipidus (symptoms include increased urine output and feeling thirsty), low blood potassium levels
• mood changes, hallucination
• partial paralysis, change in the perception of smells
• hearing disorders, middle ear infection
• palpitations (when you can feel your heartbeat), hot flashes
• stomach swelling, difficulty controlling bowel movements, hemorrhoids, dry mouth
• hepatitis and liver damage (including liver failure leading to death), cholestasis, increased bilirubin
• blisters on the body or in the mouth, skin peeling, painful red rash, severe rash with swelling of the skin (including palms of the hands and soles of the feet)
• increased sensitivity of the skin to sunlight, hives (nettle rash), increased sweating, change in skin color
• difficulty urinating
• vaginal bleeding, vaginal irritation, absent or heavy menstrual periods, breast pain, sexual impotence
• chills, facial swelling, discoloration of the tongue, thirst, dental disorders
• dry eyes

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not
listed in this leaflet. You can also report side effects directly through the national reporting system
indicated in Annex V. By reporting side effects you can help provide more information on the safety
of this medicine.

5. How to store Temozolomide Accord

Keep this medicine out of the sight and reach of children, preferably in a locked cabinet. Accidental ingestion may be fatal to children.
Do not use this medicine after the expiry date which is stated on the label and the carton. The expiry date refers to the last day of that month.
Bottle
Do not store above 25°C.
Store in the original bottle.
Keep the bottle tightly closed to protect the medicine from moisture.
Sachet
Do not store above 25 °C.
To protect the medicine from moisture, store in the original packaging.
Inform your pharmacist if you notice signs of deterioration in the appearance of the capsules.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Temozolomide Accord contains

• The active substance is temozolomide. Temozolomide Accord 5 mg hard capsules: Each capsule contains 5 mg of temozolomide. Temozolomide Accord 20 mg hard capsules: Each capsule contains 20 mg of temozolomide. Temozolomide Accord 100 mg hard capsules: Each capsule contains 100 mg of temozolomide. Temozolomide Accord 140 mg hard capsules: Each capsule contains 140 mg of temozolomide. Temozolomide Accord 180 mg hard capsules: Each capsule contains 180 mg of temozolomide. Temozolomide Accord 250 mg hard capsules: Each capsule contains 250 mg of temozolomide.
• The other ingredients are: Capsule content: anhydrous lactose, anhydrous colloidal silicon dioxide, sodium starch glycolate type A, tartaric acid, stearic acid, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172) and indigo carmine (E132).

Capsule shell:

Temozolomide Accord 5 mg hard capsules:gelatin, titanium dioxide (E 171), yellow iron oxide (E 172), indigo carmine (E 132), water.

Temozolomide Accord 20 mg hard capsules: gelatin, titanium dioxide (E 171), iron oxide

yellow (E 172), water

Temozolomide Accord 100 mg hard capsules:gelatin, titanium dioxide (E 171), iron oxide
red (E 172), water

Temozolomide Accord 140 mg hard capsules: gelatin, titanium dioxide (E 171), carmine

indigo (E 132), water

Temozolomide Accord 180 mg hard capsules:gelatin, titanium dioxide (E 171), iron oxide
yellow (E 172), iron oxide red (E172), water

Temozolomide Accord 250 mg hard capsules:gelatin, titanium dioxide (E 171), water
Printing ink:
Shellac, propylene glycol, iron oxide black (E 172), potassium hydroxide.

Description of the appearance of Temozolomide Accord and contents of the pack
Temozolomide Accord 5 mg hard capsules have a white body, a green head, with ‘TMZ’ printed
on the head and ‘5’ on the body with black ink.
Temozolomide Accord 20 mg hard capsules have a white body, a yellow head, with ‘TMZ’ printed
on the head and ‘20’ on the body with black ink.
Temozolomide Accord 100 mg hard capsules have a white body, a pink head, with ‘TMZ’ printed
on the head and ‘100’ on the body with black ink.
Temozolomide Accord 140 mg hard capsules have a white body, a blue head, with ‘TMZ’ printed
on the head and ‘140’ on the body with black ink.
Temozolomide Accord 180 mg hard capsules have a white body, a brown head, with ‘TMZ’ printed
on the head and ‘180’ on the body with black ink.
Temozolomide Accord 250 mg hard capsules have a white body, a white head with ‘TMZ’ printed
on the head and ‘250’ on the body with black ink.
The hard capsules are available in amber glass bottles containing 5 or 20 capsules.
Each pack contains 1 bottle.
The hard capsules are available in blisters containing 1 capsule.
Each pack contains 5 or 20 blisters.
Not all pack sizes may be marketed

Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder
Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona, s/n,
Edifici Est 6ª planta,
08039 Barcelona,
Spain

Manufacturer
Accord Healthcare Polska Sp.z o.o.,
ul. Lutomierska 50,95-200 Pabianice, Poland
Accord Healthcare B.V.,
Winthontlaan 200,
3526 KV Utrecht,
Netherlands

Other sources of information
More detailed information on this medicinal product is available on the website of the European
Medicines Agency http://www.ema.europa.eu .