Temozolomide fair-med

Package leaflet: 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
Read carefully the entire leaflet before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• Please contact your doctor, pharmacist, or nurse if you have any further questions.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them even if their symptoms are the same.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents:

1. What Temozolomide Fair-Med is and what it is used for
2. What you need to know before taking Temozolomide Fair-Med
3. How to take Temozolomide Fair-Med
4. Possible side effects
5. How to store Temozolomide Fair-Med
6. Contents of the pack and other information

1. What Temozolomide Fair-Med is and what it is used for

Temozolomide Fair-Med contains a substance called temozolomide. This medicine is an antineoplastic agent.
Temozolomide Fair-Med is indicated for the treatment of the following types of brain tumours:

• in adults with newly diagnosed glioblastoma multiforme. Temozolomide Fair-Med is first administered concomitantly with radiotherapy (concomitant treatment phase), followed by treatment with Temozolomide Fair-Med alone (monotherapy phase).
• in children aged 3 years and older and in adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma. Temozolomide Fair-Med is used to treat these tumours when there is evidence of tumour recurrence or progression after standard therapy.

2. Important information before using Temozolomide -

When not to use Temozolomide -

• if the patient is allergic to temozolomide or any of the other ingredients of this medicine (listed in section 6).
• if the patient has hypersensitivity to dacarbazine (an anticancer medicine, sometimes called DTIC). Symptoms of an allergic reaction include itching, difficulty breathing, wheezing, swelling of the face, lips, tongue or throat.
• if there is a significantly reduced number of certain blood cells (myelosuppression), such as white blood cells and platelets. These blood cells play an important role in fighting infections and forming clots to reduce bleeding. The treating physician will perform blood tests before starting treatment to ensure that the number of these cells is adequate.

Warnings and precautions
Before starting treatment with Temozolomide, discuss this with your doctor,
pharmacist or nurse:

• because the patient must be under close monitoring for the development of severe lung infection caused by the microorganism Pneumocystis jirovecii (Pneumocystis jirovecii pneumonia - PCP). If the patient has been newly diagnosed (glioblastoma multiforme), they may receive Temozolomide - as part of a 42-day treatment regimen combined with radiotherapy. In such a case, the treating physician will also prescribe a medicine to help prevent this type of lung infection (PCP).
• if the patient has ever had or may currently have hepatitis B virus infection. This is necessary because Temozolomide - may cause reactivation of hepatitis B virus infection, which in some cases may lead to death. Before starting treatment, patients will be carefully examined by the physician to detect signs of this infection.
• if the patient develops or has low red blood cell count (anaemia), low white blood cell or platelet count, or blood clotting disorders before or during treatment. In such cases, the treating physician may decide to reduce the dose, interrupt or change the treatment. Additional treatment may be required. In some cases, it may be necessary to discontinue treatment with Temozolomide - . During treatment, frequent blood tests will be performed to monitor the adverse effects of Temozolomide - on blood cells.
• because there is a small risk that the patient may develop other blood abnormalities, including leukaemia.
• if the patient experiences nausea and/or vomiting, which are very common side effects associated with the use of Temozolomide - (see section 4), the treating physician may prescribe antiemetic medicines (to prevent vomiting). If frequent vomiting occurs before or during treatment, ask the doctor for the most suitable time to take Temozolomide - until vomiting is controlled. If vomiting occurs after taking the medicine, do not take another dose on the same day.
• if fever or signs of infection occur, contact the treating physician immediately.
• if the patient is over 70 years of age, they may be more susceptible to infections, have an increased tendency to bruise or experience bleeding.
• if the patient has kidney or liver disease, a dose adjustment of Temozolomide - may be necessary.

Children and adolescents
Temozolomide - should not be given to children under 3 years of age, as adequate studies have not been conducted. The amount of data in patients over 3 years of age who have received Temozolomide - is limited.
Other medicines and Temozolomide -
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Pregnancy, breastfeeding and effects on fertility
If the patient is pregnant, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine. Do not use Temozolomide - during pregnancy unless the treating physician clearly recommends such treatment.
During treatment with Temozolomide - , both women and men should use effective methods of contraception (see also section below “Male fertility”).
Breastfeeding must be discontinued during treatment with Temozolomide - .
Male fertility
Temozolomide - may cause permanent infertility. Men receiving Temozolomide - should use effective contraception and should not father a child during treatment and for 6 months after the end of treatment. It is recommended that the patient consult the doctor about sperm preservation before starting treatment.
Driving and operating machinery
Temozolomide - may cause fatigue or drowsiness. In such cases, the patient should not drive, operate machinery or ride a bicycle until they know how this medicine affects them (see section 4).
Temozolomide - contains lactose
Temozolomide - contains lactose (a type of sugar). If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.

3. How to use Temozolomide Fair-Med

This medicine should always be taken exactly as prescribed 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 Fair-Med for you.
The dose is based on body size (height and weight), and depends on whether
the tumor has recurred and whether you have previously received chemotherapy.

To prevent or reduce nausea and vomiting, additional medicines may be prescribed
to be taken before and (or) after Temozolomide Fair-Med.

Patients with newly diagnosed glioblastoma multiforme:

In newly diagnosed patients, treatment will consist of two phases:

• First, treatment combined with radiotherapy (concomitant treatment phase)
• Then, treatment with Temozolomide Fair-Med alone (monotherapy phase).

During the concomitant treatment phase, your doctor will start Temozolomide Fair-Med
at a dose of 75 mg/m² (the usual recommended dose). You will take this dose
daily for 42 days (up to 49 days) along with radiotherapy. Depending on blood test results and (or)
your tolerance to the medicine during concomitant treatment, the dose of Temozolomide Fair-Med
may be delayed or omitted. After radiotherapy ends, there will be a 4-week break
to allow your body to recover. Then, the monotherapy phase will begin.

During the monotherapy phase, the dose and method of taking Temozolomide Fair-Med
will differ (from the concomitant treatment phase). Your doctor will determine the exact dose
appropriate for you. You may receive up to 6 treatment cycles. Each cycle lasts 28 days.
You will take Temozolomide Fair-Med alone at a new dose once daily for the first 5 days
of each cycle (“treatment days”). The first dose is 150 mg/m². This is followed by a
23-day break from Temozolomide Fair-Med. Together, this makes a 28-day treatment cycle.
On day 28, the next cycle begins. You will again take the medicine once daily for five days,
followed by a 23-day break from Temozolomide Fair-Med. Depending on blood test results and (or)
your tolerance to the medicine in each cycle, the dose of Temozolomide Fair-Med may be adjusted,
or treatment may be delayed or interrupted.

Patients with recurrent tumor growth or disease progression (malignant glioma such as glioblastoma multiforme or anaplastic astrocytoma), receiving Temozolomide Fair-Med alone:

A treatment cycle with Temozolomide Fair-Med lasts 28 days.
You will receive Temozolomide Fair-Med alone once daily for the first 5 days of each cycle.
The daily dose depends on whether you have previously received chemotherapy.

If you have not received prior chemotherapy, the initial dose of Temozolomide Fair-Med
will be 200 mg/m² once daily for the first 5 days.
If you have received prior chemotherapy, the initial dose of Temozolomide Fair-Med
will be 150 mg/m² once daily for the first 5 days.

This is followed by a 23-day break from Temozolomide Fair-Med. Together, this makes a 28-day cycle.
On day 28, the next cycle begins. You will again receive Temozolomide Fair-Med once daily for 5 days,
followed by a 23-day break without Temozolomide Fair-Med.

Before starting each new cycle, you will have blood tests to assess whether the dose of
Temozolomide Fair-Med needs adjustment. Depending on blood test results, your doctor may adjust the dose in subsequent cycles.

How to take Temozolomide Fair-Med

Take the prescribed dose of Temozolomide Fair-Med once daily, preferably at the same time each day.
The medicine should be taken on an empty stomach, for example, at least one hour before breakfast.
Swallow the capsule(s) whole with a glass of water. Do not open, crush, or chew the capsules.
If a capsule is damaged, avoid contact of its contents with skin, eyes, or nose.
If the medicine accidentally comes into contact with eyes or nose, rinse the affected area thoroughly with water.

Depending on the prescribed dose, you may need to take more than one capsule at a time, possibly of different strengths (active substance content in mg). The cap color of the capsule differs for each strength (see table below).

The patient must be certain that they have fully understood and remembered the following points:

• how many capsules of each strength they must take each day of drug administration. The patient should ask their treating physician or pharmacist to write down the number of capsules of each strength (also the color) that they must take each day of drug administration.
• which days are the days of drug administration. Before starting a new cycle, the patient should receive dose instructions again from their treating physician, as the dose may differ from that used in the previous cycle.

Temozolomide - must always be taken exactly as prescribed by the physician. It is very important to contact the physician or pharmacist if there are any doubts. Errors in the way the drug is used may have serious consequences for the patient's health.

Taking a higher than recommended dose of Temozolomide -
If the patient accidentally takes more capsules of Temozolomide FAIR-MED than prescribed, they should contact their physician, pharmacist, or nurse immediately.

Missing a dose of Temozolomide -
A missed dose should be taken as soon as possible, within the same day. If the drug has not been taken within the entire day, the patient should seek advice from their physician. The patient must not take a double dose to make up for the missed dose, unless instructed to do so by the physician.

If there are any further doubts regarding the use of this medicine, the patient should consult their physician, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
You should contact your doctor immediately if any of the following symptoms occur:

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

Treatment with Temozolomide FAIR-MED may cause a reduction in the number of certain blood cells. This may lead to increased bruising or bleeding, anaemia (reduced number of red blood cells), fever and reduced resistance to infections. Decreased blood cell counts are usually temporary. In some cases, they may be prolonged and may lead to severe forms of anaemia (aplastic anaemia). Your doctor will recommend regular blood tests to detect any changes and will decide whether specific treatment is necessary.
In some cases, the dose of Temozolomide FAIR-MED may be reduced or treatment discontinued.

Other reported adverse reactions are listed below:

Very common adverse reactions (may affect more than 1 in 10 people):

• loss of appetite, difficulty speaking, headache
• vomiting, nausea, diarrhoea, constipation
• rash, hair loss
• fatigue

Common adverse reactions (may affect up to 1 in 10 people):

• infections, oral infections, wound infections
• decreased blood cell count (neutropenia, lymphopenia, thrombocytopenia)
• allergic reaction
• increased blood glucose levels
• memory disturbances, depression, anxiety, confusion, difficulty falling or staying asleep
• coordination and balance disorders
• difficulty concentrating, change in mental state or alertness, forgetfulness
• dizziness, sensory disturbances, tingling sensation, tremors, taste disturbances
• partial loss of vision, visual disturbances, double vision, dry or painful eyes
• deafness, tinnitus, ear pain
• blood clots in the lungs or legs, high blood pressure
• pneumonia, shortness of breath, bronchitis, cough, sinusitis
• abdominal or stomach pain, upset stomach/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, cold or flu symptoms
• fluid retention, swelling of legs
• increased liver enzyme activity
• weight loss, weight gain
• radiation-induced tissue damage

Uncommon adverse reactions (may affect up to 1 in 100 people):

• brain infections (herpes simplex encephalitis), including fatal cases
• new or reactivation of cytomegalovirus infection
• reactivation of hepatitis B virus infection
• secondary tumours, including leukaemia
• decreased blood cell count (pancytopenia, anaemia, leukopenia)
• red spots under the skin
• diabetes insipidus (symptoms include increased urination and thirst), low blood potassium levels
• mood changes, hallucinations
• partial paralysis, changes in sense of smell
• hearing disorders, middle ear infection
• palpitations (awareness of heartbeat), hot flushes
• stomach swelling, difficulty controlling bowel movements, haemorrhoids, dry mouth
• hepatitis and liver damage (including fatal liver failure), cholestasis, increased bilirubin levels
• blisters on the body or in the mouth, skin peeling, skin eruptions, painful redness of the skin, severe rash with skin swelling (including hands and feet)
• increased sensitivity to sunlight, urticaria, excessive sweating, skin colour changes
• difficulty passing urine
• vaginal bleeding, vaginal irritation, absence or heavy menstruation, breast pain, sexual impotence
• chills, facial swelling, tongue discolouration, thirst, dental problems

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to:
Department of Monitoring Adverse Drug Reactions, 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
Adverse reactions can also be reported to the marketing authorisation holder. Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Temozolomide Fair-Med -

Keep the medicine out of the sight and reach of children, preferably in a locked cabinet.
Accidental ingestion of the medicine may be fatal to a child.
Do not use this medicine after the expiry date stated on the label and carton following the term "EXP". The expiry date refers to the last day of the specified month.
HDPE bottle
Store below 30°C.
Keep in the original packaging to protect from moisture.
Keep the bottle tightly closed.
Blister packs
5 mg and 20 mg capsules: store below 25°C.
100 mg, 140 mg, 180 mg, and 250 mg capsules: store below 30°C.
Inform the pharmacist if any changes in the appearance of the capsules are noticed.
Medicines must not be disposed of via wastewater or household waste. Ask the pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Temozolomide contains -

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

Contents of the capsule:
Anhydrous lactose
Anhydrous colloidal silicon dioxide
Sodium carboxymethyl starch Type A
Tartaric acid
Stearic acid
(see section 2 “Temozolomide FAIR-MED contains lactose”).

Capsule shell, size 0:
Capsules 5 mg:
Gelatin
Titanium dioxide (E 171)
Iron oxide yellow (E 172)
Indigo carmine (E 132)

Capsules 20 mg:
Gelatin
Titanium dioxide (E 171)
Iron oxide red (E 172)
Iron oxide yellow (E 172)

Capsules 100 mg:
Gelatin
Titanium dioxide (E 171)
Iron oxide red (E 172)
Indigo carmine (E 132)

Capsules 140 mg:
Gelatin
Titanium dioxide (E 171)
Indigo carmine (E 132)

Capsules 180 mg:
Gelatin
Titanium dioxide (E 171)
Iron oxide red (E 172)
Iron oxide black (E 172)
Iron oxide yellow (E 172)

Capsules 250 mg:
Gelatin
Titanium dioxide (E 171).

Printing ink, black:
Shellac
Propylene glycol
Purified water
Concentrated ammonia solution
Potassium hydroxide
Iron oxide black (E 172).

What Temozolomide looks like and contents of the pack
Capsules 5 mg: Hard gelatin capsules, size 0, composed of a green opaque cap and a white opaque body. The number "5" printed in black ink on the body.
Capsules 20 mg: Hard gelatin capsules, size 0, composed of an orange opaque cap and a white opaque body. The number "20" printed in black ink on the body.
Capsules 100 mg: Hard gelatin capsules, size 0, composed of a purple opaque cap and a white opaque body. The number "100" printed in black ink on the body.
Capsules 140 mg: Hard gelatin capsules, size 0, composed of a blue opaque cap and a white opaque body. The number "140" printed in black ink on the body.
Capsules 180 mg: Hard gelatin capsules, size 0, composed of a chocolate-brown opaque cap and a white opaque body. The number "180" printed in black ink on the body.
Capsules 250 mg: Hard gelatin capsules, size 0, composed of a white opaque cap and a white opaque body. The number "250" printed in black ink on the body.

HDPE bottle
5 capsules in an HDPE bottle with a child-resistant PP closure, containing a polyester coil and a moisture-absorbing agent, in a cardboard box.

Blister packs
5 or 20 capsules in individual blisters made of Paper/LDPE/Aluminium/Ethylene and acrylic acid copolymer, in a cardboard box.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Fairmed Healthcare GmbH
Dorotheenstraße 48
22301 Hamburg
Germany
[email protected]

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 authorised for sale in the European Economic Area under the following names:
Netherlands: Temozolomide FAIR-MED 5mg/20mg/100mg/140mg/180mg/250mg, Capsules harde
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