5 mg, 20 mg, 100 mg, 140 mg, 180 mg, 250 mg hard capsules
temozolomide
What Temozolomide Accord is and what it is used for
Temozolomide Accord is a medicine against cancer.
Temozolomide Accord capsules are used to treat specific forms of brain tumors:
- adults with a newly diagnosed specific form of brain tumor ( glioblastoma multiforme ).
Temozolomide is first used together with radiation (concomitant treatment phase) and then alone (the monotherapy phase of treatment). - children older than 3 years and adult patients with specific forms of brain tumor (eg glioblastoma multiforme or anaplastic astrocytoma ) that have recurred or where cancer has spread after standard treatment.
What you need to know before you take the Temozolomide Accord
Do not take Temozolomide Accord
- 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 a cancer medicine called dacarbazine. Signs of an allergic reaction include feeling itchy, shortness of breath or wheezing, and swelling of the face, lips, tongue, or throat.
- if you have a reduced number of blood cells, such as 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 Temozolomide Accord
- because you must be closely monitored for the development of a serious form of pneumonia called Pneumocystis jiroveci – pneumonia (PCP). If you have recently received your diagnosis ( glioblastoma multiforme ), you may receive temozolomide 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 . Temozolomide Accord 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 anaemia , low blood cell counts (such as white blood cells and platelets ), or problems with blood clotting before starting treatment, or if you develop them during treatment. Your doctor may need to reduce your dose or stop your treatment or you may need a different treatment. Your doctor will decide whether your treatment needs to be changed. In some cases, it may be necessary to stop treatment with temozolomide. Your blood will be tested regularly to measure your condition. If you develop a fever or symptoms of an infection , contact your doctor immediately.
- because you may have a small risk of other blood cell changes , including leukaemia .
- if you feel sick or are vomiting, which are very common side effects of temozolomide (see section 4). If you vomit frequently before or during treatment, ask your doctor about medicines that can help prevent or control vomiting and the best time to take temozolomide 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 years old. Elderly patients are more susceptible to infection , more bruising or bleeding.
- if you have liver or kidney problems as your dose of temozolomide 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 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 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 Accord unless your doctor has clearly indicated that you can do so.
Effective contraceptive methods must be used by female patients who may become pregnant during treatment with Temozolomide Accord and for at least 6 months after stopping treatment.
You must not breast-feed while you are being treated with Temozolomide Accord.
Male fertility
Temozolomide Accord 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.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving ability and use of machinery
When taking Temozolomide Accord you may feel tired or sleepy. If this is the case, you should not drive, use tools and machines or cycle until you know how this medicine affects you (see section 4).
Temozolomide Accord contains lactose and sodium
Temozolomide Accord contains lactose
The capsules contain lactose (a type of sugar). If you have an intolerance to some sugars, you should consult your doctor before taking this medicine.
Temozolomide Accord contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. it is almost “sodium-free”.
How to take Temozolomide Accord
Always take this medicine as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.
This is how you open the sachet
Open the sachet by folding and tearing along the fold line with the notch in the corner of the sachet.
Temozolomide Accord should only be prescribed by specialists experienced in brain tumours.
Dosage and duration of treatment
Your doctor will determine the correct dose of temozolomide for you to take based on your size (height and weight) and whether you have previously received any chemotherapy. You may be given other medicines to take before and/or after temozolomide to avoid or control vomiting.
Take the prescribed dose of Temozolomide Accord once daily. Take one dose on an empty stomach, for example at least one hour before you plan to eat breakfast. Swallow the capsule(s) whole with a glass of water. Do not open, crush or chew the capsule.
If a capsule is damaged, avoid contact between the powder and your skin, eyes or nose. Avoid inhaling the powder. If you accidentally get it in your eyes or nose, rinse the area with water.
If you take Temozolomide Accord in combination with radiation (newly diagnosed patients):
During radiation, your doctor will start you with a dose of temozolomide 75 mg/m 2 and the actual daily dose you take will depend on your height and weight. You will take that dose for 42 days (up to 49 days) in combination with radiation. Depending on your blood levels and how well you tolerate temozolomide, treatment may be delayed or discontinued.
After the radiation is finished, you will take a break from treatment for 4 weeks to give your body a chance to recover.
After that, there can be up to 6 treatment cycles, each lasting 28 days. You will take the new dose of temozolomide initially at 150 mg/m 2 for the first 5 days (“dosing days”) of each cycle followed by 23 days without temozolomide. In total, there will be a 28-day treatment cycle.
After day 28, the next cycle begins where you will again take the drug once daily for 5 days followed by 23 days without temozolomide. Depending on your blood levels and how well you tolerate temozolomide during each treatment cycle, the dose may be adjusted, delayed or stopped.
If you take Temozolomide Accord alone (without radiation):
A treatment cycle with Temozolomide Accord lasts 28 days. You will take the capsules once a day for the first 5 days (“dosing days”) followed by 23 days without temozolomide, making a total of 28 days of treatment.
After day 28, the next treatment cycle begins. You will again receive Temozolomide Accord once daily for 5 days, followed by 23 days without temozolomide. Before each new treatment cycle, your blood levels will be tested to see if the dose of temozolomide needs to be adjusted.
If you have not previously been treated with chemotherapy , the first dose of temozolomide will be 200 mg/m 2 once daily for the first 5 days (“dosing days”) followed by 23 days without temozolomide. If you have previously been treated with chemotherapy , the first dose of temozolomide will be 150 mg/m 2 once daily for the first 5 days (“dosing days”) followed by 23 days without temozolomide.
Depending on the results of your blood tests, your doctor may adjust the dosage one to the next cycle. Each time you start a new treatment cycle, be sure you understand exactly how many capsules of each strength you need to take each day and for how many days you should take that dose .
All patients
Temozolomide Accord is supplied in capsules of various strengths (shown on the outer label in mg). Each force has a special colored top. Depending on the dose of temozolomide your doctor prescribes, you may need to take several different capsules each dosing day of the treatment cycle.
- Be sure you understand exactly how many capsules you need to take of each strength. Ask your doctor or pharmacist to write down the number of each strength (including color) that you need to take each dosing day.
- Be sure you know exactly which days are your dosing days.
- Be sure to review dose one with your healthcare professional each time you start a new treatment cycle. Sometimes the dose or mixture of capsules you need to take may differ from the previous treatment cycle.
- If you are taking the medicine at home and feel confused or unsure about how to take your dose , call for further instructions before each treatment cycle. Errors in the way you take this medicine can have serious health consequences.
If you have taken too much Temozolomide Accord
If you accidentally take more capsules than you were told to, contact your doctor, pharmacist or nurse immediately.
If you forget to take Temozolomide Accord
Take the missed dose as soon as possible on the same day. If a full day has passed, check with your doctor. Do not take a double dose to make up for a missed dose unless your doctor has told you to.
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.
Patients taking temozolomide in combination with radiation may experience different side effects than patients taking temozolomide alone.
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 temozolomide can cause a reduced number of certain blood cells . This can lead to you bruising or bleeding more easily, anemia (lack of red blood cells ), fever and/or a reduced resistance to infection . The reduction in blood cells is often temporary, but 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 changes and will decide if any specific treatment is needed. In some cases, your dose of temozolomide may need to be reduced or stopped.
Other side effects that have been reported are listed below:
Very common side effects (may affect more than 1 in 10 users):
- loss of appetite, difficulty speaking, headache
- vomiting, nausea, diarrhoea, constipation
- rash, hair loss
- fatigue.
Common side effects (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 side effects (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, haemorrhoids, 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 Accord
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 on the carton. The expiration date is the last day of the specified month.
Can
Store at a maximum of 25 ºC. Store in the original packaging.
Close the jar well. Moisture sensitive.
Dosing bag
Store at a maximum of 25 °C.
Store in the original packaging. Moisture sensitive
Tell the pharmacist if you notice any change 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.
Temozolomide Accord 5 mg hard capsules: One capsule contains 5 mg temozolomide.
Temozolomide Accord 20 mg hard capsules: One capsule contains 20 mg temozolomide.
Temozolomide Accord 100 mg hard capsules: One capsule contains 100 mg temozolomide.
Temozolomide Accord 140 mg hard capsules: One capsule contains 140 mg temozolomide.
Temozolomide Accord 180 mg hard capsules: One capsule contains 180 mg temozolomide.
Temozolomide Accord 250 mg hard capsules: One capsule contains 250 mg temozolomide.
- Other ingredients are
Contents of the capsule:
Anhydrous lactose , colloidal anhydrous silicon dioxide, sodium starch glycolate type A, tartaric acid, stearic acid.
The 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), yellow iron oxide (E 172), water.
Temozolomide Accord 100 mg hard capsules: gelatin, titanium dioxide (E 171), red iron oxide (E 172), water.
Temozolomide Accord 140 mg hard capsules: gelatin, titanium dioxide (E 171), indigo carmine (E 132), water.
Temozolomide Accord 180 mg hard capsules: gelatin, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172), water.
Temozolomide Accord 250 mg hard capsules: gelatin, titanium dioxide (E 171), water.
Ink for printing:
Shellac, propylene glycol, black iron oxide (E 172) and potassium hydroxide.
Appearance and package sizes of the medicine
Temozolomide Accord 5 mg is a hard capsule with a white body and green top. The top is marked “TMZ” and the body “5” in black ink.
Temozolomide Accord 20 mg is a hard capsule with a white body and yellow cap. The top is marked “TMZ” and the body “20” in black ink.
Temozolomide Accord 100 mg is a hard capsule with a white body and pink cap. The top is marked “TMZ” and the body “100” in black ink.
Temozolomide Accord 140 mg is a hard capsule with a white body and blue cap. The top is marked “TMZ” and the body “140” in black ink.
Temozolomide Accord 180 mg is a hard capsule with a white body and red-purple cap. The top is marked “TMZ” and the body “180” in black ink.
Temozolomide Accord 250 mg is a hard capsule with a white body and white top. The top is marked “TMZ” and the body “250” in black ink.
The hard capsules are packaged in amber glass jars containing 5 or 20 capsules.
Each carton contains 1 jar.
The hard capsules are packaged in a sachet containing 1 capsule.
Each carton contains 5 or 20 sachets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Accord Healthcare SLU
World Trade Center, Moll de Barcelona, s/n,
Edifici Est 6ª planta,
08039 Barcelona,
Spain
Manufacturer
Accord Healthcare Polska Sp.z oo,
ul. Lutomirska 50,95-200 Pabianice, Poland
Accord Healthcare BV,
Winthontlaan 200,
3526 KV Utrecht,
Netherlands