5 mg, 2 – temozolomide0 mg, 100 mg, 140 mg, 180 mg and 250 mg hard capsules
temozolomide (temozolomidum)
What Temodal is and what it is used for
Temodal contains the medicine temozolomide. This medicine is used to treat tumors.
Temodal is used to treat patients with specific forms of brain tumors:
- in adults with newly diagnosed glioblastoma multiforme. Temodal is first used together with radiation (simultaneous treatment phase) and then alone (monotherapy phase of the treatment).
- in children older than 3 years and adult patients with malignant gliomas, such as glioblastoma multiforme or anaplastic astrocytoma. Temodal is used for these tumors if they return or continue to develop after standard treatment.
What you need to know before taking Temodal
Do not take Temodal
- 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 anti-cancer medicine, sometimes called DTIC). Signs of an allergic reaction include feeling itchy, shortness of breath or wheezing, and swelling of the face, lips, tongue, or throat.
- if certain types of blood cells are greatly reduced (myelosuppression), such as the white blood cells or platelets. These blood cells are important when it comes to fighting infection and for functioning blood coagulation. Your doctor will check your blood to make sure you have enough of these blood cells before you start treatment.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Temodal
- because you must be closely monitored for the development of a serious form of pneumonia called Pneumocystis jirovecii – pneumonia (PCP). If you have recently received your diagnosis ( glioblastoma multiforme ), you can receive Temodal for 42 days in combination with radiation. If so, your doctor will also prescribe medication to help you prevent this type of pneumonia (PCP).
- if you have ever had or possibly now have hepatitis B infection. Temodal 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 low numbers of red blood cells ( anemia ), white blood cells and platelets ( thrombocytes ), or blood clotting problems before starting treatment, or if you develop them during treatment. Your doctor may decide to lower the dose, stop, stop or change the treatment. You may also need other treatment. In some cases, it may be necessary to stop treatment with Temodal. Your blood will be tested regularly during treatment to monitor the side effects of Temodal on your blood cells.
- because you may have a small risk of other blood cell changes, including leukemia.
- if you experience nausea and/or vomiting, which are very common side effects of Temodal (see section 4), your doctor may prescribe medicine (an antiemetic ) to prevent vomiting.
If you vomit frequently before and during treatment, ask your doctor when it is best to take Temodal, 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 over 70, you may be more susceptible to infection, bruise, or bleeding more easily.
- if you have liver or kidney problems, your Temodal dose 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 on patients older than 3 years who have taken Temodal.
Other medicines and Temodal
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 breastfeeding, 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 Temodal if you are pregnant unless your doctor tells you so.
Effective contraceptive methods must be used by female patients who may become pregnant during treatment with Temodal and for at least 6 months after stopping treatment.
You must stop breastfeeding while receiving treatment with Temodal.
Male fertility
Temodal can cause permanent infertility. Male patients should use an effective method of contraception and not have children for at least 3 months after the end of treatment. It is recommended to consult about sperm freezing before starting treatment.
Driving ability and use of machinery
Temodal can make you feel tired or sleepy. If this is the case, do not drive, use machinery, or cycle until you know how this medicine affects you (see section 4).
Temodal contains lactose
This medicine contains lactose (a type of sugar). If your doctor has told you that you are intolerant to any sugar, you should therefore contact your doctor before taking this medicine.
Temodal contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per capsule, i.e. is almost “sodium-free”.
How to take Temodal
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 Temodal dose. It is based on your body size (height and weight) and whether you have a recurrent tumor and have previously received chemotherapy.
You may be prescribed other medicines (antiemetics) to be taken before and/or after you take Temodal to prevent or control nausea and vomiting.
Patients with newly diagnosed glioblastoma multiforme:
If you are a newly diagnosed patient, the treatment will take place in two phases:
- treatment together with radiation (concurrent phase) first
- followed by treatment with Temodal alone (monotherapy phase).
During the concurrent phase, your doctor will start Temodal at a dose of 75 mg/m2 (usual dose ). You will take this dose every day for 42 days (up to 49 days) in combination with radiotherapy. Temodal dose one can be postponed or interrupted depending on your blood values and on how you tolerate the drug during the simultaneous phase.
When the radiation treatment is finished, you will have a treatment break of 4 weeks. It will allow your body to recover.
You will then begin the monotherapy phase.
During the monotherapy phase, the dose and the way you take Temodal will be different. Your doctor will work out exactly what amount you should have. You can have up to 6 treatment periods (cycles). Each of these lasts for 28 days. You will take only the new Temodal dose once a day for the first 5 days (“dosing days”) of each cycle. The first dose will be 150 mg/m 2. After that, you will have 23 days without Temodal. In total, there will be a 28-day treatment cycle.
After day 28, the next cycle begins. You will again take Temodal once a day for 5 days followed by 23 days without Temodal. The Temodal dose can be adjusted, postponed, or discontinued depending on your blood values and how well you tolerate the medicine during each treatment cycle.
Patients with tumors that have returned or worsened (malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma ) receiving Temodal alone:
A treatment cycle with Temodal lasts 28 days.
You will take only Temodal once daily for the first 5 days. The daily dose depends on whether you have previously received chemotherapy or not.
If you have not previously been treated with chemotherapy, the first dose of Temodal will be 200 mg/m 2 once daily for the first 5 days. If you have previously been treated with chemotherapy, the first dose of Temodal will be 150 mg/m 2 once daily for the first 5 days. After that, you will have 23 days without Temodal. In total, there will be a treatment cycle of 28 days.
After day 28, the next treatment cycle begins. You will again receive Temodal once daily for 5 days, followed by 23 days without Temodal.
Before each new treatment cycle, your blood will be tested to see if the Temodal dose needs to be adjusted. Depending on the results of your blood tests, your doctor may adjust the dosage from one to the next cycle.
How to take Temodal
Take the prescribed dose of Temodal once a day, preferably at the same time each day.
Take the capsules on an empty stomach; for example, at least one hour before you intend to eat breakfast. Swallow the capsule(s) 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.
Depending on the dose you have been prescribed, you may need to take several capsules at the same time, possibly in different strengths (the active substance in mg). The color of the lid of the capsule is different for the different strengths (see the table below).
| Strength | The color of the outer half of the capsule |
| Temodal 5 mg hard capsules | Green |
| Temodal 20 mg hard capsules | yellow |
| Temodal 100 mg hard capsules | pink |
| Temodal 140 mg hard capsules | blue |
| Temodal 180 mg hard capsules | orange |
| Temodal 250 mg hard capsules | White |
Make sure you understand exactly and remember the following:
- how many capsules do you need to take each dosing day? Ask your doctor or pharmacist to write it down (including the color).
- which days are your dosing days?
Be sure to review the dosage with your doctor each time you start a new treatment period, as it may differ from the previous period.
Always take Temodal as directed by your doctor. Ask your doctor or pharmacist if you are unsure. Mistakes in how you take your medication can have serious consequences on your health.
If you have taken too much Temodal
If you accidentally take more Temodal capsules than you were prescribed, contact your doctor, pharmacist or nurse immediately.
If you forget to take Temodal
Take the missed dose as soon as possible on the same day. If a day has already passed, contact your doctor. Do not take a double dose to make up for a missed dose, unless your doctor has told 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:
- a 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 Temodal can cause a reduction in certain types of blood cells. This can mean that you bruise or bleed more easily, anemia (lack of red blood cells ), fever, and reduced resistance to infection. The reduced number of blood cells is usually transient. In some cases, it can be more prolonged and lead to a very severe form of anemia ( aplastic anemia ). Your doctor will measure your blood levels regularly to detect any changes and determine if any special treatment is required. In some cases, your dose of Temodal 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, diarrhea, constipation
- rash, hair loss
- fatigue
Common (may affect up to 1 in 10 users):
- infection, infection in the oral cavity
- 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, 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 the herpes virus) which can be fatal
- wound infections
- 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, a 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, breast pain, sexual impotence
- tremors, swelling of the face, discoloration of the tongue, thirst, toothache
- dry eyes
How Temodal should be stored
Keep this medicine out of the sight and reach of children, preferably in a locked cabinet. Accidental ingestion can be fatal for children.
Use before the expiry date stated on the label and carton. The expiration date is the last day of the specified month.
Glass jars
Store at a maximum of 30°C.
Store in the original packaging. Moisture sensitive.
Close the package well.
Dose bags
Store at a maximum of 30°C
Tell the pharmacist if you notice any change in the appearance of the capsules.
Medicines must not be thrown into the drain or among the 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.
Temodal 5 mg hard capsules: One capsule contains 5 mg temozolomide.
Temodal 20 mg hard capsules: One capsule contains 20 mg temozolomide.
Temodal 100 mg hard capsules: One capsule contains 100 mg temozolomide.
Temodal 140 mg hard capsules: One capsule contains 140 mg temozolomide.
Temodal 180 mg hard capsules: One capsule contains 180 mg temozolomide.
Temodal 250 mg hard capsules: One capsule contains 250 mg temozolomide.
Other ingredients are
the contents of the capsule:
anhydrous lactose, colloidal anhydrous silica, sodium starch glycolate type A, tartaric acid, and stearic acid (see section 2 “Temodal contains lactose”).
capsule shell:
Temodal 5 mg hard capsules: gelatin, titanium dioxide (E 171), sodium lauryl sulfate, yellow iron oxide (E 172), indigo carmine (E 132),
Temodal 20 mg hard capsules: gelatin, titanium dioxide (E 171), sodium lauryl sulfate, yellow iron oxide (E 172),
Temodal 100 mg hard capsules: gelatin, titanium dioxide (E 171), sodium lauryl sulfate, red iron oxide (E 172),
Temodal 140 mg hard capsules: gelatin, titanium dioxide (E 171), sodium lauryl sulfate, indigo carmine (E 132),
Temodal 180 mg hard capsules: gelatin, titanium dioxide (E 171), sodium lauryl sulfate, yellow iron oxide (E 172), and red iron oxide (E 172),
Temodal 250 mg hard capsules: gelatin, titanium dioxide (E 171), sodium lauryl sulfate.
ink for printing:
shellac, propylene glycol (E 1520), purified water, ammonium hydroxide, potassium hydroxide, and black iron oxide (E 172).
Appearance and package sizes of the medicine
Temodal 5 mg hard capsules have an opaque white inner half and an opaque green outer half and are marked with black ink
Temodal 20 mg hard capsules have an opaque white inner half and an opaque yellow outer half and are marked with black ink.
Temodal 100 mg hard capsules have an opaque white inner half and an opaque pink outer half and are marked with black ink.
Temodal 140 mg hard capsules have an opaque white inner half and a blue outer half and are marked with black ink.
Temodal 180 mg hard capsules have an opaque white inner half and an opaque orange outer half and are marked with black ink.
Temodal 250 mg hard capsules have an opaque white inner half and an opaque white outer half and are marked with black ink.
Glass jars
The hard capsules for oral use are packaged in brown glass jars containing 5 or 20 capsules.
The carton contains one jar.
Dose bags
The hard capsules (capsules) for oral use are packaged in cartons containing 5 or 20 hard capsules, each in a sealed sachet.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Merck Sharp & Dohme BV
Waarderweg 39
2031 BN Haarlem
The Netherlands
Manufacturer: SP Labo NV, Industriepark 30, B-2220
Heist-op-den-Berg, Belgium
Contact the representative of the Marketing Authorization Holder if you would like to know more about this medicine:
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