Package Leaflet: Information for the User

Temozolomida Accord 5 mg Hard Capsules

Temozolomida Accord 20 mg Hard Capsules

Temozolomida Accord 100 mg Hard Capsules

Temozolomida Accord 140 mg Hard Capsules

Temozolomida Accord 180 mg Hard Capsules

Temozolomida Accord 250 mg Hard Capsules

temozolomida

Read this package leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this package leaflet, as 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 they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist or nurse, even if they are not listed in this package leaflet. See section 4.

Temozolomida is a cancer medication

Temozolomida Accord capsules are taken for the treatment of specific forms of brain tumors:

• Adults with specific forms of newly diagnosed brain tumors (glioblastoma multiforme).
• Temozolomida is used first with radiation therapy (concomitant phase of treatment) and then alone (monotherapy phase of treatment)
• in children aged 3 years and older and adults with specific forms of brain tumors (e.g.: glioblastoma multiforme or anaplastic astrocytoma) if they recur or spread after standard treatment.

Do not take Temozolomida Accord

• if you are allergic to temozolomida or any of the other components of this medication (listed in section 6).
• if you have had an allergic reaction to another cancer medication called dacarbazina. Signs of allergic reactions include itching, shortness of breath or difficulty breathing, swelling in the face, lips, tongue, or throat.
• if you have a low number of blood cells, such as a low white blood cell or platelet count. These blood cells are important for fighting infection and proper blood clotting. Your doctor will perform blood tests to ensure you have enough of these cells before starting treatment.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Temozolomida Accord

• Your doctor will monitor for the possible development of a severe chest infection called Pneumocystis carinii jirovecii (PCP) pneumonia. If you are a newly diagnosed glioblastoma multiforme patient, you may be given temozolomida for 42 days in combination with radiation therapy. In this case, your doctor will also prescribe a medication to help prevent this type of pneumonia (PCP).

• if you have ever had or may have hepatitis B infection, as temozolomida Accord may reactivate the hepatitis B, which in some cases can be fatal. Before starting treatment, your doctor will thoroughly examine patients for signs of this infection.

• if you have anemia, low blood counts (e.g., white blood cells or platelets), or blood clotting problems before treatment or develop them during treatment. Your doctor may need to reduce your medication dose, interrupt your treatment, or require another treatment. Your doctor will decide if any changes to your treatment are necessary. In some cases, it may be necessary to stop treatment with temozolomida. You will have blood tests performed periodically to monitor your condition. If you have a fever or symptoms of infection, contact your doctor immediately.

• You may have a small risk of other changes in blood cells, including leukemia.

• if you experience nausea or vomiting, which is a very common side effect of temozolomida (see section 4). If you frequently vomit before or during treatment, ask your doctor about medications that help prevent vomiting or control vomiting and the best time to take temozolomida until you control the vomiting. If you vomit after taking a dose, do not take a second dose that day.

• if you have a fever or symptoms of an infection, contact your doctor immediately.

• if you are over 70 years old. Older patients are more prone to infections, bruises, and bleeding.

• if you have liver or kidney problems, as your dose may need to be adjusted.

Children and adolescents

Do not give this medication to children under 3 years old, as its effect in this age group has not been studied. There is limited information available for patients over 3 years old who have taken Temozolomida.

Taking Temozolomida Accord with other medications

Inform your doctor or pharmacist if you are taking or have recently taken any other medication.

Pregnancy, breastfeeding, and fertility

If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication, as you should not be treated with Temozolomida Accord during pregnancy unless clearly indicated by your doctor.

Effective contraceptive methods should be used in women of childbearing potential during treatment with Temozolomida Accord and for at least 6 months after completing treatment.

Do not breastfeed while undergoing treatment with Temozolomida Accord.

Male fertility

Temozolomida may cause permanent infertility. Male patients should use effective contraception and not leave their partner pregnant for at least 3 months after completing treatment. It is recommended to consult about sperm preservation before treatment.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

When taking temozolomida, you may feel tired or drowsy. In this case, do not drive, use tools or machines, or ride a bicycle until you see how this medication affects you (see section 4).

Temozolomida Accord contains lactose

The capsules contain lactose (a type of sugar). If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Temozolomida Accord contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per capsule; it is essentially "sodium-free".

Follow exactly the administration instructions for Temozolomida Accord as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

How to open the package

Open the package by folding and tearing along the crease with the notch in the corner of the package.

Only specialists with experience in brain tumors should prescribe temozolomida

Dose and duration of treatment.

Your doctor will decide on the correct dose of temozolomida based on your build (height and weight) and whether you have previously received chemotherapy treatment. They may administer other medications for you to take before and/or after temozolomida to prevent or control vomiting.

Take the prescribed dose of Temozolomida Accord once a day, on an empty stomach; for example, at least one hour before breakfast. Take the capsule(s) whole with a glass of water. Do not open, crush, or chew the capsules.

If a capsule is damaged, avoid contact with the powder on the skin, eyes, or nose. Avoid inhaling the powder. If something accidentally enters your eyes or nose, rinse the area with water.

If you take Temozolomida Accord in combination with radiation therapy (newly diagnosed patients):

At the same time as you receive radiation therapy, your doctor will start the temozolomida treatment at a dose of 75 mg/m², and the actual dose you take will depend on your height and weight. You will take this dose once a day for 42 days (up to a maximum of 49 days) in combination with radiation therapy. Depending on blood counts and how you tolerate temozolomida, the dose may be postponed or suspended.

Once radiation therapy is completed, you will interrupt treatment for 4 weeks to give your body a chance to recover.

You may have up to 6 cycles of treatment, and each cycle lasts 28 days. You will take your new dose of temozolomida capsules initially at a dose of 150 mg/m² once a day for the first 5 days of each cycle ("administration days"), followed by 23 days without temozolomida. This adds up to a total treatment cycle of 28 days.

After day 28, you will start the next cycle, taking the medication once a day for 5 days, followed by 23 days without temozolomida. Depending on blood counts and how you tolerate temozolomida during each treatment cycle, the dose may be adjusted, postponed, or suspended.

If you take Temozolomida Accord capsules alone (without radiation therapy):

A treatment cycle with Temozolomida Accord consists of 28 days. You will take the capsules once a day for the first 5 days ("administration days"), followed by 23 days without temozolomida. This adds up to a total treatment cycle of 28 days.

After day 28, you will start the next cycle, taking the medication once a day for 5 days, followed by 23 days without temozolomida. Before each new treatment cycle, you will have a blood test to see if the temozolomida dose needs to be adjusted.

If you have not previously received chemotherapy treatment, your first dose of temozolomida will be 200 mg/m² once a day for the first 5 days ("administration days"), followed by 23 days without temozolomida. If you have previously received chemotherapy treatment, your first dose of temozolomida will be 150 mg/m² once a day for the first 5 days ("administration days"), followed by 23 days without temozolomida.

Depending on the blood test results, your doctor may adjust your dose for the next cycle.

Each time you start a new treatment cycle, make sure you understand exactly how many capsules of each concentration you need to take each day and how many days you need to take this dose.

All patients

Temozolomida is presented in capsules of different concentrations (shown on the box label in mg). Each concentration has a cap of a different color. Depending on the temozolomida dose prescribed by your doctor, you may need to take several capsules each day of administration in the treatment cycle.

• Make sure you understand exactly how many capsules of each concentration you need to take. Ask your doctor or pharmacist to write down the number of capsules of each concentration (including the color) you need to take each day of administration.
• Make sure you know exactly which are your administration days.
• Make sure you review the dose with your doctor each time you start a new cycle. Sometimes the dose or the combination of capsules you need to take may be different from the previous cycle.
• Once you have the medication at home, if you have doubts or need to clarify something about how to take the dose, call to have it explained again before starting the treatment cycle. Errors in taking this medication can have serious consequences for your health.

If you take more Temozolomida Accord than you should

If you accidentally take more capsules than indicated, consult your doctor, pharmacist, or nurse immediately.

If you forgot to take Temozolomida Accord

Take the dose you forgot as soon as possible during the same day. If a full day has passed, consult your doctor. Do not take a double dose to compensate for the missed dose, unless your doctor tells you to do so.

If you have any other doubts about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Patients taking temozolomida in combination with radiation therapy may experience different side effects than those taking temozolomida alone.

Seek medical attention immediately if you experience any of the following:

• Severe allergic reaction (hypersensitivity) (hives, wheezing, or other breathing difficulties),
• Uncontrolled bleeding,
• Seizures,
• Fever,
• Chills,
• Intense headache that does not subside.

Treatment with temozolomida may cause a reduction in certain types of blood cells. This may increase the likelihood of bruising or bleeding, anemia (red blood cell deficiency), fever, and/or decreased resistance to infections. Blood cell count reduction is generally temporary, but in some cases, it may be prolonged and cause a severe form of anemia (aplastic anemia). Your doctor will perform frequent blood tests to detect any changes, and decide if you need specific treatment. In some cases, they will reduce or discontinue temozolomida dosing.

Other reported side effects include:

Very common side effects (may affect more than 1 in 10 people):

• Loss of appetite, difficulty speaking, headache
• Vomiting, nausea, diarrhea, constipation
• Rash, hair loss
• Fatigue

Common side effects (may affect up to 1 in 10 people):

• Infections, oral infections, wound infections
• Reduced blood cell count (neutropenia, lymphopenia, thrombocytopenia)
• Allergic reaction
• Increased blood sugar
• Memory alterations, depression, anxiety, confusion, inability to fall asleep or stay asleep
• Balance and coordination alterations
• Difficulty concentrating, changes in mental state or lack of alertness, forgetfulness
• Dizziness, altered sensations, numbness, tremors, abnormal taste
• Partial vision loss, abnormal vision, double vision, eye dryness or pain
• Deafness, ear noises, ear pain
• Pulmonary embolism or leg clots, high blood pressure
• Pneumonia, respiratory difficulty, bronchitis, cough, sinusitis
• Abdominal or stomach pain, stomach burning, difficulty swallowing
• Dry skin, itching
• Muscle damage, muscle weakness, muscle pain
• Joint pain, back pain
• Frequent urination, difficulty controlling urination
• Fever, flu-like symptoms, pain, feeling unwell, a cold or flu
• Fluid retention, leg swelling
• Liver enzyme elevation
• Weight loss, weight gain

Radiation injury

Uncommon side effects (may affect up to 1 in 100 people):

• Brain infections (herpetic encephalitis) including fatal cases
• New or reactivated cytomegalovirus infections
• Reactivated hepatitis B virus infections
• Secondary cancers including leukemia
• Reduced blood cell count (pancytopenia, anemia, leucopenia)
• Red spots under the skin
• Diabetes insipidus (symptoms including increased urination and thirst), low potassium levels in the blood
• Mood changes, hallucinations
• Partial paralysis, changes in sense of smell
• Alterations in hearing, 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 fatal liver failure), cholestasis, elevated bilirubin
• Blisters on the body and in the mouth, skin peeling, skin rash, painful and swollen skin (including palms and soles)
• Increased sensitivity to sunlight, hives, increased sweating, skin color change
• Difficulty urinating
• Vaginal bleeding, vaginal irritation, absent or heavy menstrual periods, breast pain, impotence
• Chills, facial swelling, tongue discoloration, thirst, dental problems

Reporting side effects

If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this prospectus. You can also report them directly through the national notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children, preferably in a locked cabinet. Accidental ingestion of the capsules can be fatal in children.

Do not use this medication after the expiration date that appears on the label and in the box. The expiration date is the last day of the month indicated.

Container

Do not store above 25°C.

Store in the original container. Store the container tightly closed to protect it from moisture.

Pouch

Do not store above 25°C

Store the original packaging to protect it from moisture.

Inform your pharmacist if you notice any change in the appearance of the capsules.

Do not dispose of the medications through the drains or in the trash. Ask your pharmacist where to dispose of the unused medications. This will help protect the environment.

Composition of Temozolomida Accord

The active ingredient is temozolomide.

Temozolomida Accord 5 mg hard capsule: Each capsule contains 5 mg of temozolomide.

Temozolomida Accord 20 mg hard capsule: Each capsule contains 20 mg of temozolomide.

Temozolomida Accord 100 mg hard capsule: Each capsule contains 100 mg of temozolomide.

Temozolomida Accord 140 mg hard capsule: Each capsule contains 140 mg of temozolomide.

Temozolomida Accord 180 mg hard capsule: Each capsule contains 180 mg of temozolomide.

Temozolomida Accord 250 mg hard capsule: Each capsule contains 250 mg of temozolomide.

• The other components are:

Hard capsule content:

anhydrous lactose, colloidal anhydrous silica, sodium starch glycolate type A, tartaric acid, stearic acid.

Hard capsule coating:

Temozolomida Accord 5 mg hard capsule: gelatin, titanium dioxide (E 171), iron oxide yellow (E 172), indigo carmine (E 132), water.

Temozolomida Accord 20 mg hard capsule: gelatin, titanium dioxide (E 171), iron oxide yellow (E 172), water.

Temozolomida Accord 100 mg hard capsule: gelatin, titanium dioxide (E 171), and iron oxide red (E172), water.

Temozolomida Accord 140 mg hard capsule: gelatin, titanium dioxide (E 171), indigo carmine (E132), water.

Temozolomida Accord 180 mg hard capsule: gelatin, titanium dioxide (E 171), iron oxide yellow (E172), iron oxide red (E172), water.

Temozolomida Accord 250 mg hard capsule: gelatin, titanium dioxide (E 171), water. printing ink:

shellac, propylene glycol, iron oxide black (E172) and potassium hydroxide.

Appearance of the product and contents of the pack

Temozolomida Accord 5 mg hard capsules have a white body, a green cap and are printed with black ink, TMZ on the cap and “5” on the body of the capsule.

Temozolomida Accord 20 mg hard capsules have a white body, a yellow cap and are printed with black ink, TMZ on the cap and “20” on the body of the capsule.

Temozolomida Accord 100 mg hard capsules have a white body, a pink cap and are printed with black ink, TMZ on the cap and “100” on the body of the capsule.

Temozolomida Accord 140 mg hard capsules have a white body, a blue cap and are printed with black ink, TMZ on the cap and “140” on the body of the capsule.

Temozolomida Accord 180 mg hard capsules have a white body, a garnet cap and are printed with black ink, TMZ on the cap and “180” on the body of the capsule.

Temozolomida Accord 250 mg hard capsules have a white body, a white cap and are printed with black ink, TMZ on the cap and “250” on the body of the capsule.

Hard capsules are presented in amber glass bottles containing 5 or 20 capsules. Each pack contains one bottle.

Hard capsules are dispensed in sachets containing 1 capsule.

Each box contains 5 or 20 sachets.

Only some pack sizes may be marketed.

Marketing authorisation holder and responsible person for manufacturing:

Marketing authorisation holder

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona, s/n,

Edifici Est 6th floor,

08039 Barcelona, Spain

Manufacturer

Accord Healthcare Polska Sp.z o.o.,

ul. Lutomierska 50,95-200 Pabianice, Poland

Accord Healthcare B.V.,

Winthontlaan 200,

3526 KV Utrecht,

Netherlands

Last review of this leaflet was in XX/YYYY

Other sources of information

Detailed information on this product is available on the European Medicines Agency (EMA) websitehttp://www.ema.europa.eu/