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 all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• You should keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information:

• 1. What Temozolomide is and what it is used for
• 2. Before you take 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 Temozolomide is and what it is used for

Temozolomide contains the active substance temozolomide. This medicine is an anti-cancer medicine.
Temozolomide is used for the treatment of the following types of brain tumors:

• in adults with newly diagnosed glioblastoma multiforme. Temozolomide is first given together with radiotherapy (concomitant phase) and then alone (monotherapy phase).
• in children aged 3 years and older and adults with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma. Temozolomide is used to treat this type of tumor if it has come back or has worsened after standard treatment.

2. Before you take 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 previously been treated with dacarbazine (another anti-cancer medicine, also known as DTIC). Signs of an allergic reaction include itching, difficulty breathing, wheezing, swelling of the face, lips, tongue, or throat.
• if you have a severely reduced number of certain blood cells (myelosuppression), such as white blood cells and platelets. These cells are important for fighting infections and for the formation of blood clots that stop bleeding. Your doctor will check your blood before starting treatment to make sure that you have enough of these cells.

Warnings and precautions

Before taking Temozolomide, talk to your doctor, pharmacist, or nurse if:

• you have a weakened immune system (e.g., due to HIV infection or AIDS).
• you have had a previous severe allergic reaction to a medicine called dacarbazine.
• you have liver or kidney problems.
• you have a low number of red blood cells (anemia), white blood cells (leukopenia), or platelets (thrombocytopenia).
• you have had or might have a hepatitis B infection. This is because Temozolomide may cause reactivation of hepatitis B infection, which can be fatal in some cases.
• you are taking any other medicines, including those that you have bought without a prescription.
• you are pregnant or breast-feeding (see section "Pregnancy and breast-feeding").

Children and adolescents

Temozolomide should not be given to children under 3 years of age, as there is no experience with this medicine in this age group.

Other medicines and Temozolomide

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

Pregnancy, breast-feeding, 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 taking this medicine.
Do not take Temozolomide if you are pregnant unless your doctor considers it absolutely necessary.
During treatment with Temozolomide, both men and women must use effective contraceptive methods (see also "Male fertility" below).
Do not breast-feed while taking Temozolomide.

Male fertility

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

Driving and using machines

Temozolomide may cause fatigue or drowsiness. If this happens to you, do not drive or operate machinery, or ride a bicycle, until you know how this medicine affects you (see section 4).

Temozolomide contains lactose

Temozolomide contains lactose (a type of sugar). If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Temozolomide

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Dosage and duration of treatment
Your doctor will decide the correct dose of Temozolomide for you based on your body size (height and weight) and whether you have had chemotherapy before.
To prevent nausea and vomiting, other medicines may be given before and/or after taking Temozolomide.
Patients with newly diagnosed glioblastoma multiforme:
Treatment will be given in two phases:

• first, together with radiotherapy (concomitant phase)
• then, only Temozolomide (monotherapy phase).

During the concomitant phase, your doctor will start Temozolomide at a dose of 75 mg/m² (the usual dose) once daily for 42 days (up to 49 days) together with radiotherapy. Based on blood tests and your tolerance to Temozolomide during the concomitant phase, the dose may be delayed or not given. After radiotherapy, there will be a 4-week treatment break to allow your body to recover. Then, the monotherapy phase will start.
During the monotherapy phase, the dose and way of taking Temozolomide will be different from the concomitant 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 alone once daily for the first 5 days of each cycle ("dosing days"). The first dose is 150 mg/m². Then, there is a 23-day break from taking Temozolomide. This adds up to a 28-day treatment cycle. After day 28, the next cycle starts. You will take Temozolomide once daily for 5 days, followed by a 23-day break from Temozolomide. Before each new cycle, you will have a blood test to check if your dose of Temozolomide needs to be changed. Based on blood tests and your tolerance to Temozolomide during each treatment cycle, the dose may be changed or treatment may be delayed or stopped.
Patients with recurrent or progressive glioblastoma multiforme (or anaplastic astrocytoma):
The treatment cycle with Temozolomide lasts 28 days.
You will take Temozolomide alone once daily for the first 5 days.
The daily dose depends on whether you have had chemotherapy before.
If you have not had chemotherapy before, your first dose of Temozolomide will be 200 mg/m² once daily for the first 5 days. If you have had chemotherapy before, your first dose of Temozolomide will be 150 mg/m² once daily for the first 5 days.
Then, there is a 23-day break from taking Temozolomide. This adds up to a 28-day treatment cycle.
After day 28, the next cycle starts. You will take Temozolomide once daily for 5 days, followed by a 23-day break from Temozolomide. Before each new cycle, you will have a blood test to check if your dose of Temozolomide needs to be changed. Based on blood tests, your doctor may adjust your dose in the next cycles.
How to take Temozolomide
Take the prescribed dose of Temozolomide once daily, at the same time each day.
Take the medicine on an empty stomach, for example, at least one hour before breakfast. Swallow the capsules whole with a glass of water. Do not open, crush, or chew the capsules. If a capsule is damaged, avoid contact with the contents and wash your hands thoroughly. If the contents come into contact with your eyes, nose, or mouth, wash the area with plenty of water.

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

• how many capsules of each strength to take each day of dosing. Ask your doctor or pharmacist to write down the number of capsules of each strength (and color) that you should take each day of dosing.
• which days are the dosing days. Before starting a new cycle, you should be given instructions about the dose from your doctor, as it may be different from the dose in the previous cycle.

Temozolomide should always be taken as instructed by your doctor. It is very important to contact your doctor or pharmacist if you are not sure. Mistakes in the way you take Temozolomide can have serious effects on your health.

Taking more Temozolomide than you should

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

Missing a dose of Temozolomide

Take the missed dose as soon as possible on the same day. If you do not take the missed dose on the same day, consult your doctor. Do not take a double dose to make up for a missed dose unless your doctor tells you to.

4. Possible side effects

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

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

Treatment with Temozolomide may cause a reduction in the number of certain blood cells. This can increase the risk of bleeding or infections, anemia (reduced red blood cells), fever, and a reduced ability to fight infections. The reduction in blood cells is usually temporary. In some cases, it may be long-lasting and may lead to very severe anemia (aplastic anemia). Your doctor will regularly check your blood to detect any changes and decide whether any specific treatment is needed.
Other side effects that have been reported are listed below:

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

• 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) include:

• infections, mouth infections, wound infections
• reduced number of blood cells (neutropenia, lymphopenia, thrombocytopenia)
• allergic reaction
• increased blood sugar levels
• memory problems, depression, anxiety, confusion, insomnia, or sleep disturbances
• coordination and balance problems
• difficulty concentrating, changes in mental status or alertness, forgetfulness
• dizziness, sensory disturbances, tingling, tremors, taste disturbances
• partial loss of vision, abnormal vision, double vision, dryness, or pain in the eyes
• hearing loss, ear infection, ringing in the ears
• blood clots in the lungs or legs, high blood pressure
• pneumonia, shortness of breath, bronchitis, cough, sinusitis
• abdominal or stomach pain, gastrointestinal upset/heartburn, difficulty swallowing
• dry skin, itching
• muscle damage, muscle weakness, muscle pain
• joint pain, back pain
• urinary frequency, difficulty controlling urination
• fever, flu-like symptoms, pain, malaise, colds, or flu
• fluid retention, swelling of the feet
• increased liver enzyme activity
• weight loss, weight gain
• radiation injury

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

• brain infections (e.g., herpes simplex encephalitis), including fatal cases
• new or reactivated cytomegalovirus infection
• reactivation of hepatitis B infection
• secondary tumors, including leukemia
• reduced number of blood cells (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 sense of smell
• hearing disturbances, ear infection
• palpitations (feeling of heartbeat), hot flashes
• gastric swelling, difficulty controlling bowel movements, hemorrhoids, dry mouth
• liver inflammation and damage (including fatal liver failure), cholestasis, increased bilirubin levels
• blisters on the skin or in the mouth, skin peeling, skin rashes, painful redness of the skin, severe skin rash with skin peeling (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 of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. Side effects can be reported to the national reporting system listed below.
Department of Drug Safety and Pharmacovigilance, 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.

5. How to store Temozolomide

Keep this medicine out of the sight and reach of children, preferably in a locked cupboard. Accidental ingestion can be fatal in children.
Do not use this medicine after the expiry date which is stated on the label and carton after "EXP". The expiry date refers to the last day of that month.
HDPE bottle
Store in a temperature below 30°C.
Store in the original package to protect from moisture.
Store the bottle tightly closed.
Blisters
Capsules of 5 mg and 20 mg: store in a temperature below 25°C.
Capsules of 100 mg, 140 mg, 180 mg, and 250 mg: store in a temperature below 30°C.
Tell your pharmacist if you notice any change in the appearance of the capsules.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will 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:

Capsule content:
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 the number "5" in black ink.
Capsules of 20 mg: Hard gelatin capsules, size 0, with an orange opaque cap and a white opaque body. The body is printed with the number "20" in black ink.
Capsules of 100 mg: Hard gelatin capsules, size 0, with a purple opaque cap and a white opaque body. The body is printed with the number "100" in black ink.
Capsules of 140 mg: Hard gelatin capsules, size 0, with a blue opaque cap and a white opaque body. The body is printed with the number "140" in black ink.
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 the number "180" in black ink.
Capsules of 250 mg: Hard gelatin capsules, size 0, with a white opaque cap and a white opaque body. The body is printed with the number "250" in black ink.
HDPE bottle
5 capsules in an HDPE bottle with a PP child-resistant closure, containing a polyester coil and a desiccant, in a cardboard box.
Blisters
5 or 20 capsules in individual blisters (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 package leaflet: October 2021