TEMOZOLOMIDE 5 mg Kapsułki Twarde

Treść ulotki

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

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

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

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

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

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

Do not take Temozolomide Teva

• if you are allergic to temozolomide or to any of the other ingredients of this medicine (listed in section 6).
• if you have had a previous allergic reaction to dacarbazine (a cancer medicine, also called DTIC). 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 and platelets. These blood cells are important for fighting infections and for blood clotting. Your doctor will have blood tests to make sure the number of these cells is sufficient to start treatment.

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

• because you must be carefully monitored for the development of a severe lung infection called Pneumocystis jiroveciipneumonia (PCP). If you are a newly diagnosed patient (glioblastoma multiforme) you may be given Temozolomide Teva 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 hepatitis B may become active again during therapy with Temozolomide Teva, which in some cases can be fatal. Before starting treatment, patients will be carefully checked by their doctor for symptoms of this infection.
• if you have a low number of red blood cells (anemia), white blood cells and platelets, or problems with blood clotting before starting treatment, or if these develop 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 Teva. Blood samples will be analyzed frequently during treatment to check for the undesirable effects of Temozolomide Teva on your blood cells.
• because you may have a 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 Teva (see section 4), your doctor may prescribe you a medicine (an anti-emetic) to help prevent vomiting.
• if you vomit frequently before or during treatment, ask your doctor for the best time to take Temozolomide Teva 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 get 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 Teva 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 is
limited information in patients over 3 years of age who have taken Temozolomide Teva.

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

Male fertility
Temozolomide Teva can 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 Teva 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 Teva contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your
doctor before taking this medicine.

Temozolomide Teva contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. essentially
“sodium-free”.

Temozolomide Teva 20 mg hard capsules contains sunset yellow FCF (E110)
The excipient sunset yellow FCF (E110) is included in the capsule shell of Temozolomide Teva 20
mg hard capsules and may cause allergic reactions.

3. How to take Temozolomide Teva

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 determine your dose of Temozolomide Teva. It depends on your size (height and weight)
and, if you have recurrent cancer, on any previous chemotherapy treatment.
Other medicines (anti-emetics) may be prescribed to be taken before and/or after taking
Temozolomide Teva to prevent or control nausea and vomiting.

Patients with newly diagnosed glioblastoma multiforme:
If you are a patient who has been diagnosed with cancer for the first time, treatment will take place in two
phases:

• initially treatment in association with radiotherapy (concomitant phase)
• followed by treatment with Temozolomide Teva alone (monotherapy). During the concomitant phase, your doctor will start Temozolomide Teva at a dose of 75 mg/m (usual dose). You will take this dose every day for 42 days (up to a maximum of 49 days) in association with radiotherapy. Taking the dose of Temozolomide Teva may be delayed or interrupted based on the number of your blood cells and how you tolerate the medicine during the association phase. Once 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 Temozolomide Teva will be different.
Your doctor will determine your correct dose. There may be up to 6 treatment periods (cycles).
Each one lasts 28 days. You will take your new dose of Temozolomide Teva only once a day for the first 5 days (“therapy days”) of each cycle. The first dose will be 150 mg/m . Then
there will be 23 days without Temozolomide Teva. This completes the 28 days of the treatment
cycle. After Day 28, you will start the next cycle. You will still take Temozolomide Teva
once a day for 5 days followed by 23 days without Temozolomide Teva. The dose of
Temozolomide Teva may be adjusted, delayed or interrupted based on your blood count and
how you tolerate the medicine during each treatment cycle.

Patients with tumors that have recurred or worsened (malignant gliomas, such as glioblastoma

multiforme or anaplastic astrocytoma) treated with Temozolomide Teva alone:
A treatment cycle with Temozolomide Teva lasts 28 days.
You will take Temozolomide Teva only once a day for the first 5 days. This daily dose depends on any previous chemotherapy treatments.
If you have not been previously treated with chemotherapy, your first dose of Temozolomide Teva
will be 200 mg/m once a day for the first 5 days. If you have been treated previously with
chemotherapy, your first dose of Temozolomide Teva will be 150 mg/m once a day for the
first 5 days.
For the next 23 days you will no longer receive Temozolomide Teva. This completes the 28-day
cycle.
After Day 28, you will begin the next cycle. You will again take Temozolomide Teva once
a day for five days, followed by 23 days without Temozolomide Teva.
Before each new cycle, you will have blood tests to check if the dose of
Temozolomide Teva needs to be changed. Based on the results of your blood tests, the
doctor may change your dose for the next cycle.
How to take Temozolomide Teva
Take the dose of Temozolomide Teva that has been prescribed to you once a day, preferably
every day at the same time.
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. Do not open, crush or chew the capsules. If the capsule
is damaged, avoid contact of the powder with skin, eyes or nose. If some powder accidentally comes into contact with your eyes or nose, rinse the affected area with water. Depending on the prescribed dose, you may need to take more than one capsule
at a time, possibly with different dosages (content of the active substance in mg). The
color and the figure on the head of the capsule are different for each dosage (see the table below).
It
is necessary to make sure you understand and remember 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 color).
• what are the days of taking the therapy. Review the dose with your doctor each time you need to start a new cycle, as it may be different from the previous cycle.

Always take Temozolomide Teva following exactly the instructions of your doctor. If you have any doubts
ask your doctor or pharmacist. Errors in taking this medicine could cause serious
damage to your health.

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

If you forget to take Temozolomide Teva
Take the dose you forgot as soon as possible during the same day. If a whole
day has passed, contact your doctor. Do not take a double dose to make up for the forgotten
dose, unless you have been 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, this medicine can cause side effects, although not everyone will experience them.
Contact your doctor immediatelyif you experience:

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

Treatment with Temozolomide Teva may cause a reduction in certain types of blood cells.
This may lead to increased bruising or bleeding, anemia (reduced number of red blood cells), fever
and reduced resistance to infections. The reduction in the number of blood cells is usually of
short duration. 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 Teva will be reduced or the
treatment will be 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, inability to fall asleep or stay asleep
• coordination disorders 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, eye pain
• deafness, 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 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 been fatal
• wound infections
• new or reactivated infections from cytomegalovirus
• 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 thirst), 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 bloating, 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 hands and soles of 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 Teva

Keep this medicine out of the sight and reach of children, preferably in a locked cabinet. Accidental ingestion may cause death in children.
Do not use this medicine after the expiry date which is stated on the carton after “EXP”. The expiry date refers to the last day of that month.
Store in the original package.
Do not store at a temperature above 30 °C.
Keep the bottle tightly closed to protect the medicine from moisture.
Tell your pharmacist if you notice any signs of deterioration in the appearance of the capsules.
Do not dispose of any medicine in the 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 Teva contains
The active ingredient is temozolomide.

Temozolomide Teva 5 mg hard capsuleseach capsule contains 5 mg of temozolomide

Temozolomide Teva 20 mg hard capsuleseach capsule contains 20 mg of temozolomide

Temozolomide Teva 100 mg hard capsuleseach capsule contains 100 mg of temozolomide

Temozolomide Teva 140 mg hard capsuleseach capsule contains 140 mg of temozolomide

Temozolomide Teva 180 mg hard capsuleseach capsule contains 180 mg of temozolomide

Temozolomide Teva 250 mg hard capsuleseach capsule contains 250 mg of temozolomide
The excipients are:
Capsule contents:
lactose, anhydrous colloidal silicon dioxide, sodium carboxymethylcellulose type A, tartaric acid, stearic acid
(see section 2 “Temozolomide Teva contains lactose”).
Capsule shell:

Temozolomide Teva 5 mg hard capsules: (including printing ink):gelatin, titanium dioxide
(E171), shellac, propylene glycol, indigo carmine aluminium lake (E132), yellow iron oxide
(E172).

Temozolomide Teva 20 mg hard capsules: (including printing ink):gelatin, titanium dioxide
(E171), shellac, propylene glycol, sunset yellow FCF aluminium lake (E110).

Temozolomide Teva 100 mg hard capsules: (including printing ink):gelatin, titanium dioxide
(E171), red iron oxide (E172), shellac, propylene glycol and yellow iron oxide (E172).

Temozolomide Teva 140 mg hard capsules: (including printing ink):gelatin, titanium dioxide
(E171), shellac, propylene glycol, indigo carmine aluminium lake (E132).

Temozolomide Teva 180 mg hard capsules: (including printing ink):gelatin, titanium dioxide
(E171), shellac, propylene glycol, red iron oxide (E172).

Temozolomide Teva 250 mg hard capsules: (including printing ink):gelatin, titanium dioxide
(E171), shellac, propylene glycol, black iron oxide (E172), ammonium hydroxide (E527).

Description of the appearance of Temozolomide Teva and contents of the pack
Temozolomide Teva 5 mg hard capsules have an opaque white body, a cap with two lines of
green ink and “T 5 mg” is printed in green ink on the capsule body. Each capsule is
approximately 16 mm long.
Temozolomide Teva 20 mg hard capsules have an opaque white body, a cap with two lines of
orange ink and “T 20 mg” is printed in orange ink on the capsule body. Each
capsule is approximately 18 mm long.
Temozolomide Teva 100 mg hard capsules have an opaque white body, a cap with two lines of
pink ink and “T 100 mg” is printed in pink ink on the capsule body. Each capsule is
approximately 19.5 mm long.
Temozolomide Teva 140 mg hard capsules have an opaque white body, a cap with two lines of
blue ink and “T 140 mg” is printed in blue ink on the capsule body. Each capsule is approximately
22 mm long.
Temozolomide Teva 180 mg hard capsules have an opaque white body, a cap with two lines of
red ink and “T 180 mg” is printed in red ink on the capsule body. Each capsule is
approximately 22 mm long.
Temozolomide Teva 250 mg hard capsules have an opaque white body, a cap with two lines of
black ink and “T 250 mg” is printed in black ink on the capsule body. Each capsule is
approximately 22 mm long.
The hard capsules are supplied in amber glass bottles containing 5 or 20 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Teva B.V.
Swensweg 5
2031GA Haarlem
Netherlands

Manufacturer
NerPharMa S.r.l.
Viale Pasteur, 10
20014 Nerviano (MI)
Italy
Haupt Pharma Amareg GmbH
Donaustaufer Stra β e 378
93055 Regensburg
Germany
For further information on this medicine, contact the local representative of the marketing
authorisation holder:

Lietuva
UAB Teva Baltics
Tel: +370 52660203

България
Тева Фарма ЕАД
Teл: +359 24899585

België/Belgique/Belgien
Teva Pharma Belgium N.V./S.A./AG
Tél/Tel: +32 38207373

Luxembourg/Luxemburg
Teva Pharma Belgium N.V./S.A./AG
Belgique/Belgien
Tél/Tel: +32 38207373

Česká republika
Teva Pharmaceuticals CR, s.r.o.
Tel: +420 251007111

Magyarország
Teva Gyógyszergyár Zrt.
Tel: +36 12886400

Danmark
Teva Denmark A/S
Tlf: +45 44985511

Malta
Teva Pharmaceuticals Ireland
L-Irlanda
Tel: +44 2075407117

Deutschland
TEVA GmbH
Tel: +49 73140208

Nederland
Teva Nederland B.V.
Tel: +31 8000228400

Eesti
UAB Teva Baltics Eesti filiaal
Tel: +372 6610801

Norge
Teva Norway AS
Tlf: +47 66775590

Ελλάδα
TEVA HELLAS Α.Ε.
Τηλ: +30 2118805000

Österreich
ratiopharm Arzneimittel Vertriebs-GmbH
Tel: +43 1970070

España
Teva Pharma, S.L.U.
Tel: +34 913873280

Polska
Teva Pharmaceuticals Polska Sp. z o.o.
Tel: +48 223459300

France
Teva Santé
Tél: +33 155917800

Portugal
Teva Pharma - Produtos Farmacêuticos,
Lda.
Tel: +351 214767550

Hrvatska
Pliva Hrvatska d.o.o.
Tel: + 385 13720000

România
Teva Pharmaceuticals S.R.L.
Tel: +40 212306524

Ireland
Teva Pharmaceuticals Ireland
Tel: +44 2075407117

Slovenija
Pliva Ljubljana d.o.o.
Tel: +386 15890390

Ísland
Teva Pharma Iceland ehf.
Sími: +354 5503300

Slovenská republika
TEVA Pharmaceuticals Slovakia s.r.o.
Tel: +421 257267911

Italia
Teva Italia S.r.l.
Tel: +39 028917981

Suomi/Finland
Teva Finland Oy
Puh/Tel: +358 201805900

Κύπρος
TEVA HELLAS Α.Ε.
Ελλάδα
Τηλ: +30 2118805000

Sverige
Teva Sweden AB
Tel: +46 42121100

United Kingdom (Northern Ireland)
Teva Pharmaceuticals Ireland
Ireland
Tel: +44 2075407117

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.

Latvija
UAB Teva Baltics filiāle Latvijā
Tel: +371 67323666