Temozolomide Fair-med

Leaflet accompanying the packaging: information for the user

Temozolomide FAIR-MED, 5 mg, hard capsules
Temozolomide FAIR-MED, 20 mg, hard capsules
Temozolomide FAIR-MED, 100 mg, hard capsules
Temozolomide FAIR-MED, 140 mg, hard capsules
Temozolomide FAIR-MED, 180 mg, hard capsules
Temozolomide FAIR-MED, 250 mg, hard capsules
Temozolomide

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• You should consult a doctor, pharmacist, or nurse if you have any doubts.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If you experience any side effects, including any possible side effects not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

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

1. What is Temozolomide and what is it used for

Temozolomide contains the active substance temozolomide. This medicine is an antineoplastic medicine.
Temozolomide is indicated for the treatment of the following type of brain tumors:

• in adults with newly diagnosed glioblastoma multiforme. Temozolomide is first given in combination with radiotherapy (concomitant phase), and then as a single medicine (monotherapy phase).
• in children aged 3 years and older and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma. Temozolomide is used to treat this type of tumor if it recurs or progresses after standard treatment.

2. Important information before taking Temozolomide

When not to take Temozolomide

• if you are allergic to temozolomide or any of the other ingredients of this medicine (listed in section 6).
• if you have been diagnosed with hypersensitivity to dacarbazine (an antineoplastic medicine, sometimes called DTIC). Symptoms of an allergic reaction include itching, difficulty breathing, wheezing, swelling of the face, lips, tongue, or throat.
• if you have significantly reduced numbers of certain blood cells (myelosuppression), such as white blood cells and platelets. These cells play an important role in fighting infections and forming blood clots. Your doctor will examine your blood before starting treatment to ensure that the number of these cells is sufficient.

Warnings and precautions

Before starting treatment with Temozolomide, you should discuss it with your doctor, pharmacist, or nurse:

• because you need to be under close supervision due to the development of severe pneumonia caused by the microorganism Pneumocystis jirovecii (PCP). If you are newly diagnosed (glioblastoma multiforme), you may receive Temozolomide in a 42-day treatment regimen in combination with radiotherapy. In this case, your doctor will also prescribe a medicine to help prevent the development of this type of pneumonia (PCP).
• if you have ever had or may currently have a hepatitis B virus infection. This is necessary because Temozolomide may cause reactivation of hepatitis B virus infection, which in some cases can lead to death. Before starting treatment, patients will be carefully examined by a doctor to detect signs of this infection.
• if you experience a decrease in the number of red blood cells (anemia), white blood cells, and platelets, or blood clotting disorders during or before treatment. In this case, your doctor may decide to reduce the dose of Temozolomide, interrupt, or change the treatment. Other treatments may be necessary. In some cases, it may be necessary to discontinue Temozolomide treatment. During treatment, to monitor the unwanted effects of Temozolomide on blood cells, you will undergo frequent blood tests.
• because you may have a small risk of developing other blood cell changes, including leukemia.
• if you experience nausea (vomiting) and/or vomiting, which are very common side effects associated with Temozolomide (see section 4), your doctor may prescribe anti-emetic medicines. If you experience frequent vomiting before or during treatment, you should ask your doctor about the most convenient time to take Temozolomide, until vomiting is controlled. If vomiting occurs after taking the medicine, you should not take another dose on the same day.
• if you have a fever or signs of infection, you should contact your doctor immediately.
• if you are over 70 years old, you may be more susceptible to infections, have an increased tendency to bruise or bleed.
• if you have kidney or liver disease, it may be necessary to adjust the dose of Temozolomide.

Children and adolescents

Temozolomide should not be given to children under 3 years of age, as no appropriate studies have been conducted. The amount of data on patients over 3 years of age who have taken Temozolomide is limited.

Other medicines and Temozolomide

You should tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.

Pregnancy, breastfeeding, and fertility

If you are pregnant, think you may be pregnant, or plan to have a baby, you should consult your doctor or pharmacist before taking this medicine. You should not take Temozolomide during pregnancy, unless your doctor has clearly recommended it.
During treatment with Temozolomide, both women and menshould use effective contraceptive methods (see also the section below "Male fertility").
You should stop breastfeeding while taking Temozolomide.

Male fertility

Temozolomide may cause permanent infertility. Men taking Temozolomide should use effective contraceptive methods and not father a child during treatment and for 6 months after treatment ends. It is recommended that the patient consult a doctor about sperm preservation before starting treatment.

Driving and using machines

Temozolomide may cause fatigue or drowsiness. In this case, you should not drive vehicles or operate machines, or ride a bicycle, until you know how the medicine affects you (see section 4).

Temozolomide contains lactose

Temozolomide contains lactose (a type of sugar). If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking the medicine.

3. How to take Temozolomide

This medicine should always be taken as directed by your doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist.
Dosage and duration of treatment
Your doctor will determine the appropriate dose of Temozolomide for you.
The dose is determined based on body size (height and weight), depending on whether the tumor has recurred and whether you have previously undergone chemotherapy.
To prevent nausea and vomiting or limit them, other medicines may be prescribed to be taken before and/or after taking Temozolomide.
Patients with newly diagnosed glioblastoma multiforme:
Treatment will be administered in two phases:

• first, treatment in combination with radiotherapy (concomitant treatment phase)
• then, treatment with Temozolomide only (monotherapy phase).

During the concomitant treatment phase, your doctor will start giving you Temozolomide at a dose of 75 mg/m2 (the usual dose). You will take this dose every day for 42 days (up to 49 days) with radiotherapy. Considering the results of blood tests and/or your tolerance to the medicine during the concomitant treatment phase, the dose of Temozolomide may be delayed or not given. After completing radiotherapy, there will be a 4-week break in treatment to allow your body to recover. Then, the monotherapy phase will begin.
In the monotherapy phase, the dose and method of administration of Temozolomide will be different (than in the concomitant treatment phase). Your doctor will determine the exact dose for you. You may receive up to 6 cycles of treatment. Each cycle lasts 28 days. You will take Temozolomide only once a day for the first 5 days of each cycle ("days of taking the medicine"). The first dose is 150 mg/m2. Then, there will be a 23-day break in taking Temozolomide. This gives a total of 28 days per treatment cycle. After day 28, the next cycle will begin. You will take the medicine again once a day for 5 days, followed by a 23-day break without Temozolomide. Before starting each new cycle, you will undergo a blood test to assess whether the dose of Temozolomide needs to be adjusted. Depending on the results of the blood tests, your doctor may adjust the dose in subsequent cycles.
How to take Temozolomide
You should take the prescribed dose of Temozolomide once a day, preferably at the same time every day.
The medicine should be taken on an empty stomach, for example, at least one hour before planned breakfast. You should swallow the capsule(s) whole, with a glass of water. Do not open, crush, or chew the capsules. If a capsule is damaged, you should avoid contact with its contents on the skin, eyes, or nose. If the medicine accidentally comes into contact with the eyes or nose, you should rinse the affected area thoroughly with water.
Depending on the prescribed dose, you may take more than one capsule at a time, also of different strengths (active substance content, in mg). The color of the capsule cap is different for each strength (see the table below).

You must be sure that you have fully understood and remembered the following:

• how many capsules of each strength you should take each day of taking the medicine. You should ask your doctor or pharmacist to write down the number of capsules of each strength (also the color) that you should take each day of taking the medicine.
• which days are the days of taking the medicine. Before starting a new cycle, you should receive instructions from your doctor about the dose, as it may differ from the dose used in the last cycle.

Temozolomide should always be taken as directed by your doctor. It is very important to contact your doctor or pharmacist if you have any doubts. Errors in taking the medicine can have serious consequences for your health.

Taking a higher dose of Temozolomide than recommended

If you accidentally take more Temozolomide capsules than recommended, you should contact your doctor, pharmacist, or nurse immediately.

Missing a dose of Temozolomide

A missed dose of the medicine should be taken as soon as possible on the same day. If the medicine is not taken within the entire day, you should consult your doctor. You should not take a double dose to make up for a missed dose, unless your doctor recommends it.
If you have any further doubts about taking this medicine, you should consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Temozolomide can cause side effects, although not everybody gets them.
You should immediatelycontact your doctor if you experience any of the following symptoms:

• severe allergic reactions (hypersensitivity) (hives, wheezing, or other breathing difficulties),
• uncontrolled bleeding,
• seizures (convulsions),
• fever,
• chills,
• severe, persistent headaches.

Treatment with Temozolomide may cause a decrease in the number of certain blood cells. This can lead to increased bruising or bleeding, anemia (reduced red blood cell count), fever, and reduced resistance to infections. The decrease in blood cells is usually temporary. In some cases, it may be long-lasting and may lead to a very severe form of anemia (aplastic anemia). Your doctor will recommend regular blood tests to detect any changes and decide whether specific treatment is needed.
In some cases, the dose of Temozolomide will be reduced or treatment will be interrupted.
Other reported side effects are listed below:

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

• loss of appetite, speech difficulties, headache
• vomiting, nausea, diarrhea, constipation
• rash, hair loss
• fatigue

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

• infections, oral infections, wound infections
• reduced blood cell count (neutropenia, lymphopenia, thrombocytopenia)
• allergic reaction
• increased blood sugar levels
• memory disorders, depression, anxiety, confusion, insomnia, or sleep disturbances
• coordination and balance disorders
• concentration difficulties, changes in mental state or alertness, forgetfulness
• dizziness, sensation disturbances, tingling, tremors, taste disorders
• partial loss of vision, abnormal vision, double vision, dryness, or eye pain
• hearing loss, middle ear infection
• palpitations (feeling your heartbeat), hot flashes
• stomach or abdominal pain, stomach upset/heartburn, 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, malaise, colds, or flu
• fluid retention, swelling of the legs
• increased liver enzyme activity
• weight loss, weight gain
• radiation damage

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

• brain infections (herpes simplex encephalitis), including fatal cases
• new or reactivated cytomegalovirus infection
• reactivation of hepatitis B virus infection
• secondary tumors, including leukemia
• reduced blood cell count (pancytopenia, anemia, leukopenia)
• red spots under the skin
• diabetes insipidus (symptoms include frequent urination and thirst), low potassium levels in the blood
• mood changes, hallucinations
• partial paralysis, changes in smell perception
• hearing disorders, middle ear infection
• blood clots in the lungs or legs, high blood pressure
• pneumonia, shortness of breath, bronchitis, cough, sinusitis
• abdominal or stomach pain, stomach upset/heartburn, difficulty swallowing
• liver inflammation and damage (including fatal liver failure), cholestasis, increased bilirubin levels
• blisters on the body or in the mouth, skin peeling, skin rashes, painful redness of the skin, severe skin rash with skin swelling (including on the hands and feet)
• increased sensitivity to sunlight, hives, increased sweating, skin color changes
• difficulty urinating
• vaginal bleeding, vaginal irritation, absence, or heavy menstrual periods, breast pain, sexual impotence
• chills, facial swelling, tongue discoloration, thirst, dental problems

Reporting side effects

If you experience any side effects, including any possible side effects not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to:
Department for Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
PL-02 222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Temozolomide

The medicine should be stored out of sight and reach of children, preferably in a locked cabinet. Accidental ingestion of the medicine can cause death in a child.
Do not use this medicine after the expiration date stated on the label and carton after the abbreviation "EXP". The expiration date refers to the last day of the specified month.
HDPE bottle
Store at a temperature below 30°C.
Store in the original packaging to protect from moisture.
Store the bottle tightly closed.
Sachets
Capsules of 5 mg and 20 mg: store at a temperature below 25°C.
Capsules of 100 mg, 140 mg, 180 mg, and 250 mg: store at a temperature below 30°C.
You should inform your pharmacist if you notice any changes in the appearance of the capsules.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Temozolomide contains

• The active substance of the medicine is temozolomide. Each capsule contains 5 mg of temozolomide.
• The active substance of the medicine is temozolomide. Each capsule contains 20 mg of temozolomide.
• The active substance of the medicine is temozolomide. Each capsule contains 100 mg of temozolomide.
• The active substance of the medicine is temozolomide. Each capsule contains 140 mg of temozolomide.
• The active substance of the medicine is temozolomide. Each capsule contains 180 mg of temozolomide.
• The active substance of the medicine is temozolomide. Each capsule contains 250 mg of temozolomide.
• Other ingredients are:

Contents of the capsule:
Anhydrous lactose
Colloidal anhydrous silica
Sodium starch glycolate Type A
Tartaric acid
Stearic acid
(see section 2 "Temozolomide FAIR-MED contains lactose").
Capsule shell, size 0:
Capsules of 5 mg:
Gelatin
Titanium dioxide (E 171)
Yellow iron oxide (E 172)
Indigo carmine (E 132)
Capsules of 20 mg:
Gelatin
Titanium dioxide (E 171)
Red iron oxide (E 172)
Yellow iron oxide (E 172)
Capsules of 100 mg:
Gelatin
Titanium dioxide (E 171)
Red iron oxide (E 172)
Indigo carmine (E 132)
Capsules of 140 mg:
Gelatin
Titanium dioxide (E 171)
Indigo carmine (E 132)
Capsules of 180 mg:
Gelatin
Titanium dioxide (E 171)
Red iron oxide (E 172)
Black iron oxide (E 172)
Yellow iron oxide (E 172)
Capsules of 250 mg:
Gelatin,
Titanium dioxide (E 171).
Black printing ink:
Shellac
Propylene glycol
Purified water
Concentrated ammonia solution
Potassium hydroxide
Black iron oxide (E 172).

What Temozolomide looks like and contents of the pack

Capsules of 5 mg: hard gelatin capsules, size 0, with a green opaque cap and a white opaque body. The body is printed with black ink with the number "5".
Capsules of 20 mg: hard gelatin capsules, size 0, with an orange opaque cap and a white opaque body. The body is printed with black ink with the number "20".
Capsules of 100 mg: hard gelatin capsules, size 0, with a purple opaque cap and a white opaque body. The body is printed with black ink with the number "100".
Capsules of 140 mg: hard gelatin capsules, size 0, with a blue opaque cap and a white opaque body. The body is printed with black ink with the number "140".
Capsules of 180 mg: hard gelatin capsules, size 0, with a chocolate brown opaque cap and a white opaque body. The body is printed with black ink with the number "180".
Capsules of 250 mg: hard gelatin capsules, size 0, with a white opaque cap and a white opaque body. The body is printed with black ink with the number "250".
HDPE bottle
5 capsules in an HDPE bottle with a PP closure, child-resistant, containing a polyester coil and a desiccant, in a cardboard box.
Sachets
5 or 20 capsules in separate sachets Paper/LDPE/Aluminum/Ethylene-acrylic acid copolymer, in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder
Fairmed Healthcare GmbH
Dorotheenstraße 48
22301 Hamburg
Germany
pv@fair-med.com
Manufacturer
Fairmed Healthcare GmbH
Maria-Göppert-Straße 3
23562 Lübeck
Germany
EirGen Pharma Ltd.
64/65 Westside Business Park
Old Kilmeaden Road, Waterford
Ireland

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Netherlands:
Temozolomide FAIR-MED 5mg/20mg/100mg/140mg/180mg/250mg, hard capsules
Germany:
Temozolomid Fair-Med Healthcare 5mg/20mg/100mg/140mg/180mg/250mg Hartkapseln
Denmark:
Temozolomid FAIR-MED
Ireland:
Temozolomide FAIR-MED 5mg/20mg/100mg/140mg/180mg/250mg hard capsules

Date of last revision of the leaflet: October 2021