TIOGUANINA 40 mg Tablet

Зміст інструкції

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

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

• Keep this leaflet. 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 be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

• 1. What TIOGUANINA ASPEN is and what it is used for
• 2. What you need to know before you take TIOGUANINA ASPEN
• 3. How to take TIOGUANINA ASPEN
• 4. Possible side effects
• 5. How to store TIOGUANINA ASPEN
• 6. Contents of the pack and other information

1. What is TIOGUANINA ASPEN and what it is used for

TIOGUANINA ASPEN contains an active ingredient called thioguanine which belongs to the
category of medicines called cytotoxic (also called chemotherapeutic). Thioguanine is used for some blood cancers. It works by reducing the number of
new blood cells produced by the body.
Thioguanine is used for acute leukemia (rapidly evolving) and particularly:
in acute myeloblastic leukemia(also called acute myeloid leukemia or AML), an
aggressive malignant tumor that increases the number of immature white blood cells; in acute
lymphoblastic leukemia(also called acute lymphocytic leukemia or ALL), a malignant tumor, of
a class of white blood cells, called lymphocytes.

2. What you need to know before taking TIOGUANINA ASPEN

Do not take TIOGUANINA ASPEN

• if you are allergic to thioguanine or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking TIOGUANINA ASPEN
Thioguanine is a cytotoxic (toxic to cells) agent that must be used only
under the supervision of doctors experienced in the use of such medicines.
Before taking TIOGUANINA ASPEN tell your doctor, pharmacist or nurse if:

• You have been taking thioguanine continuously for a long time
• This may increase the possibility of side effects such as liver problems.

.
During therapy, your doctor will monitor you carefully with tests to check your liver function.

• You have a condition in which your body produces a low amount of an enzyme called thiopurine methyltransferase (TPMT).
• If you have a mutation in the NUDT15 gene. This condition may expose you to a higher risk of having low white blood cell counts compared to other patients. This can lead to developing infections. The mutation can also lead to a higher risk of hair loss. Patients of Asian origin are at greater risk. Your doctor may decide to have you undergo genetic tests to check if you have changes in the TPMT and/or NUDT15 genes before or during treatment. This is to determine if your response to this medicine is affected by changes in your genes.
• You suffer from Lesch-Nyhan syndrome. This is a familial condition caused by a lack of the enzyme HPRT or hypoxanthine guanine phosphoribosyl transferase which may reduce your response to thioguanine therapy.

Effects on the blood
During the initial phase of therapy for leukemia, you should frequently undergo tests
to check the number of blood cells because these cells may be markedly reduced
and you may be more exposed to infections, bleeding and anemia.
While taking thioguanine with other anticancer treatments, immediately inform your
doctor if you experience severe chills, fever, sore throat, cough, flu-like symptoms and headache accompanied by nausea, rash, and/or confusion, as these symptoms may
be indicative of an ongoing bacterial, viral or fungal infection. Your doctor may
prescribe antiviral therapy and other supportive treatments.

TIOGUANINA ASPEN and exposure to sunlight
While taking thioguanine you may become sensitive to sunlight, which can cause
skin discoloration or erythema. Try to avoid excessive exposure to the sun, cover up in
adequate manner and use a sunscreen with a high protection factor.

Other medicines and TIOGUANINA ASPEN
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
Pay particular attention if you are taking any of the following medicines:

• busulfan, used to treat some cancers;
• medicines that can have a harmful effect on the bone marrow, such as other chemotherapies or radiotherapies. This can lead to bone marrow damage and the dose of thioguanine may need to be reduced;
• olsalazine or mesalazine used for a bowel problem called ulcerative colitis
• sulfasalazine, used for rheumatoid arthritis or ulcerative colitis
• allopurinol, a medicine used to inhibit the formation of uric acid.

Vaccinations while taking TIOGUANINA ASPEN
Tell your doctor or nurse before getting vaccinated, as live attenuated vaccines (such as
those used to protect against polio, measles, mumps, rubella) can
cause an infection if you get vaccinated while taking thioguanine.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking this
medicine.

Pregnancy
Thioguanine, like other cytotoxic agents, can cause serious birth defects.
Men and women of childbearing potential must use reliable contraceptive methods to
avoid pregnancy while undergoing therapy with thioguanine.

Breastfeeding
It is not known whether thioguanine is excreted in breast milk, therefore if you are
being treated with thioguanine you should not breastfeed.

Driving and operating machinery
No studies have been performed on the ability to drive vehicles and operate machinery.

TIOGUANINA ASPEN contains lactose
If your doctor has diagnosed you with intolerance to some sugars, contact him before
taking this medicine.

3. How to take TIOGUANINA ASPEN

Take this medicine following exactly the instructions of your doctor. If you have any doubts
consult your doctor.
The dose of thioguanine that you will have to take will be established by your doctor based on:

• Your body build (body surface area)
• The results of your blood tests
• The disease being treated

If you have liver or kidney problems you may be given a lower dose of
thioguanine.

Children and adolescents
In children, dosages similar to those used in adults are used (corrected based on
body surface area).

• Swallow the tablets whole with a glass of water
• If you need to divide a tablet in half, do not inhale the powder. Afterwards, wash your hands.
• During the intake of thioguanine, your doctor will regularly perform blood tests. This is necessary to check the number and type of cells present in the blood and ensure that your liver is working properly. Your doctor, following these tests, may modify the dose.

If you take more TIOGUANINA ASPEN than you should
If you take more TIOGUANINA ASPEN than you should, immediately inform your doctor or
go immediately to the nearest hospital. Bring the package of the medicine with you.

If you forget to take TIOGUANINA ASPEN
Inform your doctor. Do not take a double dose to make up for a missed
dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If any of the following occur, inform your specialist doctor or go
immediately to the nearest hospital:

• Any sign of fever or infection (sore throat, mouth pain, urinary problems)
• Any unexplained bruising or bleeding unexpected
• If you feel suddenlyunwell (even with a normal body temperature)
• Any sign of yellowing of the whites of the eyes and skin (jaundice)

Inform your doctor if you experience any of the following side effects that can
occur with the use of this medicine:

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

• Reduction in the number of blood cells (red blood cells, white blood cells and platelets)
• Jaundice (yellowing of the skin and eyes).
• Severe liver damage (symptoms may include fatigue, nausea, itching, dark urine, hives, fever, enlarged liver) - with long-term use or high doses of thioguanine

Common (may affect up to 1 in 10 people)

• Liver damage that can cause jaundice (yellowing of the skin and eyes) or enlarged liver - during short-term cyclical therapy
• Gastrointestinal disorders, diarrhea and mouth ulcers
• Increased concentrations of uric acid in the blood (hyperuricemia) and in the urine (hyperuricosuria), with possible decreased kidney function

Rare (may affect up to 1 in 1,000 people)

• A problem with the intestine known as necrotizing colitis which can cause pain, discomfort, diarrhea and fever, perforation of the intestine
• Severe liver damage in combination chemotherapy, or in patients taking oral contraceptives and alcohol.

Not known

• photosensitivity

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor, pharmacist or nurse. You can also report side effects directly through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the
safety of this medicine.

5. How to store TIOGUANINA ASPEN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label after Exp.
The expiry date refers to the last day of that month.
Store at a temperature below 25°C.
Protect the medicine from light and moisture.
Disposal
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What TIOGUANINA ASPEN contains

• The active ingredient is thioguanine. One tablet contains 40 mg of thioguanine.
• The other ingredients are: lactose, potato starch, gum arabic, stearic acid, magnesium stearate.

Description of the appearance of TIOGUANINA ASPEN and contents of the pack
Tablets, in a bottle containing 25 tablets.

Marketing Authorisation Holder
Aspen Pharma Trading Limited
3016 Lake Drive,
Citywest Business Campus,
Dublin 24, Ireland
Tel. 0039 0687502429

Manufacturer
Excella GmbH & Co. KG, - Nürnberger Strasse 12, 90537 Feucht, Germany