TEMOZOLOMIDE 5 mg Капсулы

Содержание инструкции

1. Temozolomide SUN 5 mg hard capsules, 20 mg hard capsules, 100 mg hard capsules, 140 mg hard capsules, 180 mg hard capsules
   1. What is Temozolomide SUN and what is it used for
   2. What you need to know before you take Temozolomide SUN
   3. How to take Temozolomide SUN
   4. Possible side effects
   5. How to store Temozolomide SUN
   6. Package contents and other information

Temozolomide SUN 5 mg hard capsules, 20 mg hard capsules, 100 mg hard capsules, 140 mg hard capsules, 180 mg hard capsules

Temozolomide SUN 250 mg hard capsules
temozolomide

Read this leaflet carefully before you start taking this medicine because 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 their symptoms are the same as yours, as it could 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 SUN is and what it is used for
• 2. What you need to know before you take Temozolomide SUN
• 3. How to take Temozolomide SUN
• 4. Possible side effects
• 5. How to store Temozolomide SUN
• 6. Contents of the pack and other information

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

Temozolomide SUN contains a medicine called temozolomide. This medicine is an antitumor agent.
Temozolomide SUN is used for the treatment of specific forms of brain tumor:

• in adults with newly diagnosed glioblastoma multiforme. Temozolomide SUN 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 SUN is used in these tumors that manifest relapse or progression after standard therapy.

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

Do not take Temozolomide SUN

• if you are allergic to temozolomide or to any of the other ingredients of this medicine (listed in section 6).
• if you have had an allergic reaction to dacarbazine (a cancer medicine sometimes called DTIC). The signs of an allergic reaction include itching, shortness of breath or wheezing, swelling of the face, lips, tongue or throat.
• if the number of certain types of blood cells is severely reduced (myelosuppression), such as white blood cells or platelets. These blood cells are important for

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

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

• because you must be kept under strict medical supervision, to detect the possible development of a severe lung infection called Pneumocystis jiroveciiPneumonia (PCP). If you are a newly diagnosed patient (glioblastoma multiforme), you may be given Temozolomide SUN for 42 days in combination with radiotherapy. In this case, your doctor will also prescribe you a medicine to help prevent this type of pneumonia (PCP).
• if you have ever had or currently have an ongoing hepatitis B infection. This is because Temozolomide SUN 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 verify 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, interrupt, suspend or change the treatment. You may also need other treatments. In some cases, it may be necessary to stop giving Temozolomide SUN. Samples of your blood will be analyzed frequently during treatment to check for side effects of Temozolomide SUN on your blood cells.
• because you may be at low risk of developing other blood cell changes, including leukemia.
• if you experience nausea (feeling sick to the stomach) and/or vomiting, which are very common side effects of Temozolomide SUN (see section 4), your doctor may prescribe you a medicine (anti-emetic) to help prevent vomiting. If you vomit frequently before or during treatment, ask your doctor for the best time to take Temozolomide SUN until the vomiting is under control. If you vomit after taking a dose, do not take a second dose on the same day.
• if you develop a fever or symptoms of an infection, contact your doctor immediately.
• if you are over 70 years of age, you may be more prone to infections, bruising or bleeding.
• if you have liver or kidney problems, your dose of Temozolomide SUN 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 SUN.

Other medicines and Temozolomide SUN
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 a pregnancy, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking this medicine. This
is because you should not be treated with Temozolomide SUN during pregnancy unless it is
clearly indicated by your doctor.
Effective contraceptive precautions must be taken by women of childbearing potential during treatment with Temozolomide SUN and for at least 6 months after completion of
treatment.
While you are being treated with Temozolomide SUN, you must stop breastfeeding.

Male fertility
Temozolomide SUN may cause permanent infertility. Male patients 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 SUN may make you feel tired or sleepy. If this happens, do not drive vehicles or
use any tools or machinery or ride a bicycle until you see the effects of this medicine on
you (see section 4).

Temozolomide SUN contains lactose
Temozolomide SUN contains lactose (a type of sugar). If your doctor has diagnosed you with
an intolerance to certain sugars, contact him before taking this medicine.

3. How to take Temozolomide SUN

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, ask your doctor or pharmacist.
Dosage and duration of treatment
Your doctor will calculate your dose of Temozolomide SUN. The dose will depend on your height and weight, and
on whether the tumor is recurrent and you have already undergone chemotherapy in the past.
You may be prescribed other medicines (antiemetics) to take before and/or after taking
Temozolomide SUN, to prevent or control nausea and vomiting.

Patients with newly diagnosed glioblastoma multiforme
If you are a newly diagnosed patient, treatment will occur in two phases:

• first, treatment combined with radiotherapy (concomitant phase)
• followed by treatment with Temozolomide SUN alone (monotherapy).

During the concomitant phase, your doctor will start Temozolomide SUN at a dose of 75 mg/m (standard dose). You will take this dose every day, for a period of 42 to 49 days, in combination with
radiotherapy. The dose of Temozolomide SUN may be delayed or interrupted, depending on your blood tests and how you tolerate the medicine during the concomitant phase.
Once radiotherapy is finished, you should not have any treatment for 4 weeks. This will allow
your body some time to recover.
Then you will start the monotherapy phase.
During the monotherapy phase, the dose and method of taking Temozolomide SUN may
vary. Your doctor will calculate the exact dose. There may be up to 6 treatment periods (cycles).
Each one lasts 28 days. The first dose will start at 150 mg/m . You will take the new dose of
Temozolomide SUN once a day for the first 5 days (“days of taking”) of each cycle.
This will be followed by 23 days without Temozolomide SUN. This completes the 28 days of the
treatment cycle.
After day 28, you will start the next cycle. You will again take Temozolomide SUN once a
day for 5 days, followed by 23 days without taking the medicine. The dose of Temozolomide SUN
may be adjusted, delayed or interrupted depending on blood tests and how you tolerate the
medicine during each treatment cycle.

Patients with recurrent or worsening tumors (malignant glioma, such as glioblastoma multiforme or

anaplastic astrocytoma) treated only with Temozolomide SUN
A treatment cycle with Temozolomide SUN lasts 28 days.
You will take Temozolomide SUN once a day for the first 5 days. The daily dose
depends on whether you have had chemotherapy before.
If you have never been treated with chemotherapy, the first dose of Temozolomide SUN will be
200 mg/m once a day for the first 5 days. If you have already undergone
chemotherapy in the past, the first dose of Temozolomide SUN will be 150 mg/m once a day for the first
5 days. For the next 23 days you will not receive Temozolomide SUN. This completes the 28
day treatment cycle.
After the 28th day, you will start the next cycle. You will again take Temozolomide SUN once a
day for 5 days, followed by 23 days without taking the medicine.
Before each new treatment cycle, your doctor will perform a blood test to check
if the dose of Temozolomide SUN needs to be adjusted. Depending on the results of the blood test, your
doctor may adjust the dose for the next cycle.
How to take Temozolomide SUN
Take your prescribed dose of Temozolomide SUN once a day, preferably at the same
time each day.
Take the capsules on an empty stomach; for example, at least one hour before breakfast. Swallow
the capsule(s) whole with a glass of water. The capsules must not be opened, crushed, or
chewed. If a capsule is damaged, avoid contact of the powder with skin, eyes or the
nasal mucosa. If some powder accidentally comes into contact with your eyes or nose,
rinse the affected area with water.

Depending on the dose you are prescribed, you may need to take more than one capsule at a time. To make
a dose, you may need to take capsules from different strengths. The marking on the capsules is
different for each strength (see the table below).

You must make sure you fully understand the following:

• how many capsules you need to take for your daily dose. Ask your doctor or pharmacist to write it down for you (including the markings)
• what your days of taking are. Check the dose with your doctor each time you start a new cycle, as it may be different from the previous cycle.

Take Temozolomide SUN exactly as your doctor has explained to you. If you
have any doubts, it is very important that you consult your doctor or pharmacist. An error in the way this medicine is taken could have very serious consequences for your health.

If you take more Temozolomide SUN than you should
If you accidentally take more Temozolomide SUN capsules than you have been told, contact
your doctor, pharmacist or nurse immediately.

If you forget to take Temozolomide SUN
Take the forgotten dose as soon as possible during the same day. If a whole day has passed,
ask your doctor. Do not take a double dose to make up for a missed dose, unless your doctor tells you to do so.
If you have any further questions about using this medicine, ask your doctor, pharmacist or
nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Immediatelyinform your treating physician if you notice any of the following side effects:

• a severe allergic (hypersensitivity) reaction (urticaria, shortness of breath or other difficulty breathing)
• uncontrolled bleeding
• convulsions
• fever
• chills
• severe headache that does not go away.

Treatment with Temozolomide SUN may cause a reduction in certain types of blood cells.
This may cause you to bruise and bleed more easily, anemia (a reduction in red blood cells), fever, and a
reduction in resistance to infections. The reduction in red blood cells is usually short-lived. In some cases,
it may be prolonged and may lead to a very serious form of anemia (aplastic anemia). Your doctor will
subject you to regular blood tests to highlight any changes, and will decide on the need for specific
treatments. In some cases, the dose of Temozolomide SUN will have to be reduced or treatment will have to
be discontinued.
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, wound infections
• decrease in the number of blood cells (neutropenia, lymphopenia, thrombocytopenia)
• allergic reaction
• increased blood sugar
• memory loss, depression, anxiety, confusion, inability to fall asleep or stay asleep
• coordination disorders and balance problems
• difficulty concentrating, altered mental status or attention, memory loss
• dizziness, sensory disturbances, tingling sensation, tremor, altered taste
• partial loss of vision, abnormal vision, double vision, dryness or pain in the eyes
• deafness, ringing in the ears, earache
• 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 retaining 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 resulted in death
• new or reactivated infections from cytomegalovirus
• infections caused by reactivated hepatitis B virus
• secondary tumors including leukemia
• decrease 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 potassium levels in the blood
• 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 causing 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, urticaria (hives), increased sweating, change in skin color
• difficulty urinating
• vaginal bleeding, vaginal irritation, absent or heavy menstrual cycles, breast pain, sexual impotence
• chills, facial swelling, discoloration of the tongue, thirst, dental disorders.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform
your doctor, pharmacist or nurse. You can also report side effects directly
through the national reporting system detailed in Annex V.
Reporting side effects can help provide more information on the safety of
this medicine.

5. How to store Temozolomide SUN

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 take 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.
Do not store at a temperature above 25°C.
Inform your pharmacist if you notice any change 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. Package contents and other information

What Temozolomide SUN contains

• The active ingredient is temozolomide. Temozolomide SUN 5 mg hard capsules:Each hard capsule contains 5 mg of temozolomide. Temozolomide SUN 20 mg hard capsules:Each hard capsule contains 20 mg of temozolomide. Temozolomide SUN 100 mg hard capsules:Each hard capsule contains 100 mg of temozolomide. Temozolomide SUN 140 mg hard capsules:Each hard capsule contains 140 mg of temozolomide. Temozolomide SUN 180 mg hard capsules:Each hard capsule contains 180 mg of temozolomide. Temozolomide SUN 250 mg hard capsules:Each hard capsule contains 250 mg of temozolomide.
• The excipients are: capsule content:lactose, sodium starch glycolate (type B), tartaric acid, stearic acid (see section 2 "Temozolomide SUN contains lactose") capsule shell:gelatin, titanium dioxide (E171), sodium lauryl sulfate ink:Temozolomide SUN 5 mg hard capsules:lacquer, propylene glycol, yellow iron oxide (E172), Blue No. 1/E133 brilliant blue FCF aluminium lake. Temozolomide SUN 20 mg hard capsules:lacquer, propylene glycol, yellow iron oxide (E172). Temozolomide SUN 100 mg hard capsules:lacquer, propylene glycol, yellow iron oxide (E172), red iron oxide (E172), titanium dioxide (E171). Temozolomide SUN 140 mg hard capsules:lacquer, propylene glycol, titanium dioxide (E171), Blue No. 1/E133 brilliant blue FCF aluminium lake. Temozolomide SUN 180 mg hard capsules:lacquer, propylene glycol, red iron oxide (E172). Temozolomide SUN 250 mg hard capsules:lacquer, propylene glycol, black iron oxide (E172).

Description of the appearance of Temozolomide SUN and contents of the pack
Hard capsules 5 mg
Temozolomide SUN 5 mg hard gelatin capsules have an opaque white body and cap and are
printed with green ink. ‘890’ is imprinted on the cap. ‘5 mg’ and two lines are imprinted on the body.
Hard capsules 20 mg
Temozolomide SUN 20 mg hard gelatin capsules have an opaque white body and cap and
are printed with yellow ink. ‘891’ is imprinted on the cap. ‘20 mg’ and two lines are imprinted on the body.
Hard capsules 100 mg
Temozolomide SUN 100 mg hard gelatin capsules have an opaque white body and cap and
are printed with pink ink. ‘892’ is imprinted on the cap. ‘100 mg’ and two lines are imprinted on the body.
Hard capsules 140 mg
Temozolomide SUN 140 mg hard gelatin capsules have an opaque white body and cap and
are printed with blue ink. ‘929’ is imprinted on the cap. ‘140 mg’ and two lines are imprinted on the body.
Hard capsules 180 mg
Temozolomide SUN 180 mg hard gelatin capsules have an opaque white body and cap and
are printed with red ink. ‘930’ is imprinted on the cap. ‘180 mg’ and two lines are imprinted on the body.
Hard capsules 250 mg
Temozolomide SUN 250 mg hard gelatin capsules have an opaque white body and cap and
are printed with black ink. ‘893’ is imprinted on the cap. ‘250 mg’ and two lines are imprinted on the body.
The hard capsules are available in blisters containing 5 capsules. For packs of 20 capsules,
4 blisters of 5 capsules will be included in the carton.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands
For further information on this medicine, contact the local representative of the Marketing
Authorisation Holder:

België/Belgique/Belgien/България/Česká republika/
Danmark/Eesti/Ελλάδα/Hrvatska/Ireland/Ísland/
Κύπρος/Latvija/Lietuva/Luxembourg/Luxemburg/Magyarország/
Malta/Nederland/Norge/Österreich/Portugal/
Slovenija/Slovenská republika/Suomi/Finland/Sverige
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
Nederland/Pays-Bas/Niederlande/Нидерландия/Nizozemsko/
Nederlandene/Holland/Ολλανδία/NizozemskaThe Netherlands/Holland/
Ολλανδία/Nīderlande/Nyderlandai/Pays-Bas/Niederlande/Hollandia/
L-Olanda/Nederland/Nederland/Niederlande/Países Baixos/
Nizozemska/Holandsko/Alankomaat/Nederländerna/Nederländerna
Tel./тел./tlf./τηλ./Sími/τηλ./Tlf./Puh./
+31 (0)23 568 5501

Deutschland
Sun Pharmaceuticals Germany GmbH
Hemmelrather Weg 201
51377 Leverkusen
Deutschland
tel. +49 214 403 990

España
Sun Pharma Laboratorios, S.L.
Rambla de Catalunya 53-55
08007 Barcelona
España
tel. +34 93 342 78 90

France
Sun Pharma France
11-15, Quai de Dion Bouton
92800 Puteaux
France
Tel. +33 1 41 44 44 50

Italia
Sun Pharma Italia Srl
Viale Giulio Richard, 1
20143 Milano
Italia
tel. +39 02 33 49 07 93

Polska
Ranbaxy (Poland) Sp. Z o. o.
ul. Kubickiego 11
02-954 Warszawa
Polska
Tel. +48 22 642 07 75

România
Terapia S.A.
Str. Fabricii nr 124
Cluj-Napoca, Judeţul Cluj
România
Tel. +40 (264) 501 500

United Kingdom (Northern Ireland)
Ranbaxy UK Ltd
a Sun Pharma Company
Millington Road 11
Hyde Park, Hayes 3
5 Floor
UB3 4AZ HAYES
United Kingdom
Tel. +44 (0) 208 848 8688

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