5 mg, 20 mg, 100 mg, 140 mg, 180 mg, 250 mg hard capsules
temozolomide
What Temozolomide SUN is and what it is used for
Temozolomide SUN contains the medicine temozolomide. This medicine is used to treat tumors.
Temozolomide SUN is used to treat certain types of brain tumors:
- in adults with newly diagnosed glioblastoma multiforme. Temozolomide SUN is first used together with radiotherapy (concomitant treatment phase) and then alone (monotherapy phase).
- in children older than 3 years and adult patients with malignant glioma, e.g. glioblastoma multiforme or anaplastic astrocytoma. Temozolomide SUN is used for these tumors if they recur or worsen after standard treatment.
What you need to know before you take Temozolomide SUN
Do not take Temozolomide SUN
- if you are allergic to temozolomide or any of the other ingredients of this medicine (listed in section 6).
- if you have had an allergic reaction to dacarbazine (an anticancer medicine sometimes called DTIC). Signs of an allergic reaction may include itching , shortness of breath or wheezing, or swelling of the face, lips, tongue or throat.
- about the number of certain types of blood cells, e.g. white blood cells , or platelets , drop drastically (called myelosuppression). These blood cells are important as protection against infection and for functioning blood coagulation. The doctor will check your blood to make sure you have enough of these cells before you start treatment.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Temozolomide SUN
- because you should be closely monitored for the development of a serious form of pneumonia called Pneumocystis jirovecii pneumonia (PCP). If you have recently been diagnosed with glioblastoma multiforme , you can receive Temozolomide SUN for 42 days in combination with radiotherapy. In this case, your doctor also prescribes medication to help prevent this type of pneumonia (PCP).
- if you have ever had or possibly now have hepatitis B infection . Temozolomide SUN can cause hepatitis B to become active again and in some cases this can lead to death. Patients will be carefully examined by their doctor for signs of this infection before starting treatment.
- if you have a low number of red blood cells ( anaemia ), white blood cells and platelets , or have problems with blood clotting before starting treatment or if you develop this problem during treatment. Your blood will be tested frequently during treatment to monitor side effects of Temozolomide SUN on your blood cells. Your doctor may reduce the dose , interrupt, stop or change the treatment. You may also need some other treatment. In some cases, it may be necessary to stop treatment with Temozolomide SUN.
- because you may have a small risk of getting other blood cell changes, including leukemia .
- if you have nausea and vomiting, which are common side effects of Temozolomide SUN (see section 4), your doctor may prescribe a medicine ( antiemetic ) to prevent vomiting. If you often vomit before or during treatment, ask your doctor when it is best to take Temozolomide SUN until the vomiting is under control. If you vomit after taking your 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 older than 70, you may be more susceptible to infection and bruise or bleed more easily.
- if you have liver or kidney problems, the dose of Temozolomide SUN may need to be adjusted.
Children and young people
Do not give this medicine to children younger than 3 years because there is no experience. There is only limited information in patients older than 3 years 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 or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. You should not be treated with Temozolomide SUN if you are pregnant unless your doctor clearly tells you so.
Effective contraceptive methods must be used by both male and female patients taking Temozolomide SUN (see also below “Male Fertility”).
Breast-feeding should be discontinued during treatment with Temozolomide SUN.
Male fertility
Temozolomide SUN can cause permanent infertility . Male patients should use an effective method of contraception and not have children up to 6 months after finishing treatment. It is recommended to consult about sperm freezing before starting treatment.
Driving ability and use of machinery
Temozolomide SUN may make you feel tired or sleepy. If this is the case, do not drive or use tools or machines or cycle until you know how this medicine affects you (see section 4).
Temozolomide SUN contains lactose
Temozolomide SUN contains lactose (a type of sugar). If you have an intolerance to certain sugars, you should consult a doctor before taking this medicine.
How to take Temozolomide SUN
Always take this medicine as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.
Dosage and duration of treatment
Your doctor will determine the appropriate dose of Temozolomide SUN. It is based on your body size (height and weight) and whether you have a recurrent tumor and have previously received chemotherapy ( chemotherapy ).
You may be given 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 have recently received your diagnosis, treatment takes place in two phases:
- first treatment together with radiotherapy (concomitant treatment phase)
- followed by treatment with Temozolomide SUN alone (monotherapy phase).
During the concomitant treatment phase, your doctor starts with a dose of 75 mg/m 2 of Temozolomide SUN (usual dose ). You take this dose every day for 42 to 49 days in combination with radiation therapy. Dose one of Temozolomide SUN may be delayed or interrupted, depending on your blood levels and how well you tolerate the medicine during the concomitant treatment phase.
You will have a treatment break for 4 weeks when the radiation treatment is finished. This break gives your body the opportunity to recover.
Then the monotherapy phase begins.
During the monotherapy phase, the dose and the way you take Temozolomide SUN may vary. Your doctor will calculate exactly what dose you should have. There can be up to 6 treatment periods (cycles). Each of these lasts for 28 days. The first dose will be 150 mg/m 2 . You will take your new dose of Temozolomide SUN once daily for the first 5 days (“dosing days”) of each cycle. Then you will have 23 days without Temozolomide SUN. This gives a treatment cycle of 28 days.
After day 28, the next treatment cycle begins. You take Temozolomide SUN again once daily for 5 days followed by 23 days without Temozolomide SUN. Dose one of Temozolomide SUN may be adjusted, delayed or discontinued, depending on your blood levels and how well you tolerate the medicine during each treatment cycle.
Patients with recurrent tumors or tumors that have worsened (malignant glioma , eg glioblastoma multiforme or anaplastic astrocytoma ) taking only Temozolomide SUN
A treatment cycle with Temozolomide SUN lasts 28 days.
You will only take Temozolomide SUN once a day for the first 5 days. The daily dose depends on whether you have received chemotherapy before.
If you have not previously been treated with chemotherapy , your first dose of Temozolomide SUN will be 200 mg/m2 once daily for the first 5 days. If you have previously been treated with chemotherapy , your first dose of Temozolomide SUN will be 150 mg/m 2 once daily for the first 5 days. Then you will have 23 days without Temozolomide SUN. This gives a treatment cycle of 28 days.
After day 28, the next treatment cycle begins. You take Temozolomide SUN again once daily for 5 days followed by 23 days without Temozolomide SUN.
Before each treatment cycle, your blood is tested to see if the dose of Temozolomide SUN needs to be adjusted. Your doctor may adjust your dose for the next treatment cycle, depending on your blood test results.
How to take Temozolomide SUN
Take your 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 eating breakfast. Swallow the capsules whole with a glass of water. Do not open, crush or chew the capsules. If a capsule is broken, avoid the powder coming into contact with the skin, eyes or nose. If you accidentally get something in your eyes or nose, rinse with water.
You may need to take more than one capsule at a time, depending on the dose you have been prescribed. You may need to take different strengths of the medicine to get the right dose . The labeling on the capsule indicates the strength of the medicine (see the table below).
| Strength | Marking |
| Temozolomide SUN 5 mg hard capsules | 890 & 5 mg |
| Temozolomide SUN 20 mg hard capsules | 891 & 20 mg |
| Temozolomide SUN 100 mg hard capsules | 892 & 100 mg |
| Temozolomide SUN 140 mg hard capsules | 929 & 140 mg |
| Temozolomide SUN 180 mg hard capsules | 930 & 180 mg |
| Temozolomide SUN 250 mg hard capsules | 893 & 250 mg |
Make sure you understand exactly how to do it and remember the following:
- the number of capsules you must take each dosing day. Ask the doctor or pharmacist to write down the dosage (including the label)
- which days are dosing days.
Review dose one with your doctor each time you start a new treatment cycle, as it may differ from the previous cycle.
Always take Temozolomide SUN exactly as your doctor has told you. It is very important to ask your doctor or pharmacist if you are unsure. Incorrect dosage of the medicine can have serious consequences for your health.
If you have taken too much Temozolomide SUN
If you accidentally take more Temozolomide SUN capsules than prescribed by your doctor, contact your doctor, pharmacist or nurse immediately.
If you forget to take Temozolomide SUN
Take the missed dose as soon as possible on the same day. If a full day has passed, contact a doctor. Do not take a double dose to make up for a missed dose , unless your doctor has instructed you to do so.
If you have further questions about this medicine, contact your doctor, pharmacist or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects , although not everybody gets them.
Contact your doctor immediately if you experience any of the following:
- severe allergic (hypersensitivity) reaction (hives, wheezing or other breathing difficulties)
- uncontrolled bleeding
- seizures (convulsions)
- fever
- chills
- severe headache that does not go away.
Treatment with Temozolomide SUN may cause a decrease in the number of certain types of blood cells . This can mean that you get bruises or bleeding, anemia (lack of red blood cells ), fever and reduced resistance to infection . The decrease in the number of blood cells is usually short-lived. In some cases, it can be longer and lead to a very severe form of anemia ( aplastic anemia ). Your doctor will check your blood regularly for signs of any changes and decide if you need any special treatment. In some cases, the dose of Temozolomide SUN can be reduced or the treatment stopped.
Other side effects that have been reported are listed below:
Very common (may affect more than 1 in 10 users) :
- loss of appetite, difficulty speaking, headache
- vomiting, nausea, diarrhoea, constipation
- rash, hair loss
- fatigue.
Common (may affect up to 1 in 10 users) :
- infection er, infection er in the oral cavity, wound infections
- reduced number of blood cells ( neutropenia , lymphopenia, thrombocytopenia )
- allergic reaction
- elevated blood sugar
- impaired memory, depression, anxiety, confusion, inability to fall asleep or stay asleep
- impaired coordination and balance
- difficulty concentrating, changes in mood or attention, forgetfulness
- dizziness, impaired sensation, tingling, tremors, changes in taste
- partial vision loss, abnormal vision, double vision, dry or painful eyes
- deafness, ringing in the ears, earache
- blood clots in the lungs or legs, high blood pressure
- pneumonia , shortness of breath, bronchitis , cough, sinusitis
- stomach or abdominal pain, upset stomach/heartburn, difficulty swallowing
- dry skin, itching
- muscle damage, muscle weakness, muscle aches and pains
- joint pain, back pain
- frequent urges to urinate, difficulty holding tight
- fever, flu-like symptoms , aches, malaise, cold or flu
- fluid retention , leg swelling
- elevated levels of liver enzymes
- weight loss, weight gain
- radiation damage.
Uncommon (may affect up to 1 in 100 users) :
- infection in the brain (meningoencephalitis caused by herpes virus) which can be fatal
- new or reactivated (recurrent) infection with cytomegalovirus
- reactivated hepatitis B virus infections
- secondary cancer including leukemia
- reduced number of blood cells (pancytopenia, anemia , leukopenia )
- red dots under the skin
- diabetes insipidus (symptoms include increased urine output and thirst), low blood potassium levels
- mood swings, hallucinations
- partial paralysis, changes in the sense of smell
- impaired hearing, infection in the middle ear
- palpitations (you can feel the heartbeat), hot flushes
- bloated stomach, difficulty controlling bowel movements, hemorrhoids , dry mouth
- liver inflammation and liver damage (including fatal liver failure), cholestasis, increased level of bilirubin
- blisters on the body or in the mouth, scaly skin, skin reactions, painful reddening of the skin, severe rash with skin swelling (on the palms of the hands and soles of the feet)
- increased sensitivity to sunlight, urticaria (hives), increased sweating, change in skin color
- difficulty urinating
- vaginal bleeding, vaginal irritation, missed or heavy periods, pain in the breasts, sexual impotence
- tremors, swelling of the face, discoloration of the tongue, thirst, toothache.
How to store Temozolomide SUN
Keep this medicine out of the sight and reach of children, preferably in a locked cabinet. Accidental ingestion can be life-threatening for children.
Use this medicine before the expiry date which is stated on the label and carton. The expiration date is the last day of the specified month.
Store at a maximum of 25 °C.
Tell the pharmacist if you notice any visible changes in the appearance of the capsules.
Medicines must not be thrown into the drain or among household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is temozolomide. Each capsule contains 5 mg, 20 mg, 100 mg, 140 mg, 180 mg and 250 mg of temozolomide, respectively.
- Each 5 mg hard capsule contains : 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,
printing ink : shellac, propylene glycol, yellow iron oxide (E172), blue #1/Brilliant blue FCF Aluminum Lake (E133). - Each 20 mg hard capsule contains : 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
printing ink: shellac, propylene glycol, yellow iron oxide (E172). - Each 100 mg hard capsule contains : 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,printing ink : shellac, propylene glycol, red iron oxide (E172), yellow iron oxide (E172). - Each 140 mg hard capsule contains : 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,printing ink: shellac, propylene glycol, blue #1/Brilliant blue FCF Aluminum Lake (E133).
- Each 180 mg hard capsule contains: 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: shellac, propylene glycol, red iron oxide (E172).
- Each 250 mg hard capsule contains: 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: shellac, propylene glycol, black iron oxide (E172).
Appearance and package sizes of the medicine
Temozolomide SUN 5 mg hard gelatin capsules, with white opaque upper and lower capsule halves, printed in green ink. The upper half with print ‘890’. The lower half with print ‘5 mg’ and 2 stripes.
Temozolomide SUN 20 mg hard gelatin capsules, with white opaque upper and lower capsule halves, printed in yellow ink. The upper half with print ‘891’. The lower half with print ’20 mg’ and 2 stripes.
Temozolomide SUN 100 mg hard gelatin capsules, with white opaque upper and lower capsule halves, printed in pink ink. The upper half with print ‘892’. The lower half with print ‘100 mg’ and 2 stripes.
Temozolomide SUN 140 mg hard gelatin capsules, with white opaque upper and lower capsule halves, printed in blue ink. The upper half with print ‘929’. The lower half with print ‘140 mg’ and 2 stripes.
Temozolomide SUN 180 mg hard gelatin capsules, with white opaque upper and lower capsule halves, printed in red ink. The upper half with print ‘930’. The lower half with print ‘180 mg’ and 2 stripes.
Temozolomide SUN 250 mg hard gelatin capsules, with white opaque upper and lower capsule halves, printed in black ink. The upper half with print ‘893’. The lower half with print ‘250 mg’ and 2 stripes.
The hard capsules are available in blister cards containing 5 capsules. Packages of 20 capsules consist of a carton with 4 blister cards of 5 capsules.
Not all pack sizes may be marketed.
Sun Pharmaceutical Industries Europe BV
87 Polaris Avenue
2132 JH Hoofddorp
Netherlands
Contact the representative of the Marketing Authorization Holder if you would like to know more about this medicine:
België/Belgique/Belgien/България/Česká republika/
Denmark/Eesti/Ελλάδα/Croatia/Ireland/Ísland/
Κypros/Latvija/Lietuva/Luxembourg/Luxemburg/Magyarország/
Malta/Nederland/Norway/Austria/Portugal/
Slovenija/Slovenská republika/Suomi/Finland/Sweden
Sun Pharmaceutical Industries Europe BV
87 Polaris Avenue
2132 JH Hoofddorp
Nederland/Pays-Bas/Niederlande/Нидерландия/Holanda/
Nederlandene/Holland/Ολλανδία/Holanda/The Netherlands/Holland/
Holland/Netherlands/Nyderlandai/Pays-Bas/Niederlande/Hollandia/
L-Olanda/Nederland/Nederland/Niederlande/Países Baixos/
Holland/Holandsko/Alankomaat/Netherlands/Netherlands
Tel./тел./tel./τηλ./Sími/τηλ./Tlf./Puh./
+31 (0)23 568 5501
Deutschland
Sun Pharmaceuticals Germany GmbH
Hemmelrather Weg 201
51377 Leverkusen
Deutschland
tel. +49 (0) 214 403 990
Spain
Sun Pharma Laboratorios, SL
Rambla de Catalunya 53-55
08007 Barcelona
Spain
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
Italy
Sun Pharma Italia Srl
Viale Giulio Richard, 1
20143 – Milan
Italy
tel. +39 02 33 49 07 93
Polish
Ranbaxy (Poland) Sp. Z oo
ul. Kubickiego 11
02-954 Warsaw
Polish
Tel. +48 22 642 07 75
Romania
Terapia SA
Str. Fabricii No. 124
Cluj-Napoca, Cluj Judeţul
Romania
Tel. +40 (264) 501 500
United Kingdom
Ranbaxy UK Ltd
a Sun Pharma Company
11 Millington Road
Hyde Park, Hayes 3
5th Floor
UB3 4AZ HAYES
United Kingdom
Tel. +44 (0) 208 848 8688