Tioguanine Aspen

Package leaflet: Information for the patient

Please 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 give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including 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 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

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

TIOGUANINA ASPEN contains an active substance called thioguanine, which belongs to a
group of medicines known as cytotoxic agents (also called chemotherapeutic agents).
Thioguanine is used in the treatment of certain blood cancers. It works by reducing the number of
new blood cells produced by the body.
Thioguanine is used in acute (rapidly progressing) leukaemias, particularly:
in acute myeloblastic leukaemia (also known as acute myeloid leukaemia or AML), an
aggressive malignant tumour that increases the number of immature white blood cells; and in acute lymphoblastic leukaemia (also known as acute lymphocytic leukaemia or ALL), a
malignant tumour affecting a class of white blood cells called lymphocytes.

2. What you need to know before taking TIOGUANINE ASPEN

Do not take TIOGUANINE ASPEN

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

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking TIOGUANINE ASPEN.
Thioguanine is an active cytotoxic agent (toxic to cells) and must be used only under the supervision of physicians experienced in the use of such medicines.
Before taking TIOGUANINE ASPEN, inform your doctor, pharmacist, or nurse if:

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

During treatment, your doctor will monitor you closely with liver function tests.

• You have a condition in which your body produces low levels of an enzyme called thiopurine methyltransferase (TPMT).
• You have a mutation in the NUDT15 gene. This condition may increase your risk of developing low levels of white blood cells in the blood compared to other patients. This may lead to infections. The mutation may also increase the risk of hair loss. Patients of Asian origin are at higher risk. Your doctor may decide to perform genetic testing to check for changes in the TPMT and/or NUDT15 genes before or during treatment. This is to determine whether your response to this medicine is influenced by genetic variations.
• You have Lesch-Nyhan syndrome. This is an inherited condition caused by deficiency of the enzyme HPRT (hypoxanthine-guanine phosphoribosyltransferase), which may reduce your response to thioguanine therapy.

Effects on blood
During the initial phase of leukemia treatment, you must have frequent blood tests to monitor blood cell counts, as you may experience a marked reduction in these cells and be more susceptible to infections, bleeding, and anemia.
While taking thioguanine along with other anticancer treatments, inform your doctor immediately if you develop severe chills, fever, sore throat, cough, flu-like symptoms, or headache accompanied by nausea, rash, and/or confusion, as these symptoms may indicate an ongoing bacterial, viral, or fungal infection. Your doctor may prescribe antiviral therapy and other supportive treatments.

TIOGUANINE ASPEN and sun exposure
While taking thioguanine, you may become sensitive to sunlight, which may cause skin discoloration or erythema. Try to avoid excessive sun exposure, cover yourself adequately, and use sunscreen with a high protection factor.

Other medicines and TIOGUANINE ASPEN
Inform 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 in the treatment of certain cancers;
• medicines that may have a harmful effect on bone marrow, such as other chemotherapies or radiotherapies. This may lead to bone marrow damage, and the dose of thioguanine may need to be reduced;
• olsalazine or mesalazine, used for a bowel condition called ulcerative colitis;
• sulfasalazine, used for rheumatoid arthritis or ulcerative colitis;
• allopurinol, a medicine used to inhibit uric acid formation.

Vaccinations while taking TIOGUANINE ASPEN
Inform your doctor or nurse before being vaccinated, as live attenuated vaccines (such as those used to protect against polio, measles, mumps, rubella) may cause infection if administered while you are taking thioguanine.

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
Thioguanine, like other cytotoxic agents, may cause severe birth defects in the unborn child.
Men and women of reproductive age must use reliable contraceptive methods to avoid pregnancy during treatment with thioguanine.

Breastfeeding
It is not known whether thioguanine is excreted in breast milk; therefore, you must not breastfeed while receiving thioguanine treatment.

Driving and using machines
No studies on the ability to drive and use machines have been conducted.

TIOGUANINE ASPEN contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.

3. How to take TIOGUANINA ASPEN

Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor.
Your doctor will determine the dose of thioguanine based on:

• Your body size (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, doses similar to those used in adults are administered (adjusted according to body surface area).

• Swallow the tablets whole with a glass of water
• If you need to split a tablet in half, do not inhale the powder. Wash your hands afterwards.
• During treatment with thioguanine, your doctor will regularly perform blood tests. These are necessary to monitor the number and types of blood cells and to ensure your liver is functioning properly. Based on these test results, your doctor may adjust your dose.

If you take more TIOGUANINA ASPEN than you should
If you take more TIOGUANINA ASPEN than prescribed, inform your doctor immediately or go immediately to the nearest hospital. Take the medicine package 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 you experience any of the following, inform your specialist doctor or go immediately to the nearest hospital:

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

Inform your doctor if you experience any of the following side effects, which may 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, rash, fever, liver enlargement) – with long-term use or high doses of thioguanine

Common (may affect up to 1 in 10 people)

• Liver damage which may cause jaundice (yellowing of the skin and eyes) or liver enlargement – during short-term cyclic therapy
• Gastrointestinal disorders, diarrhoea and mouth ulcers
• Increased levels of uric acid in the blood (hyperuricaemia) and in the urine (hyperuricosuria), possibly leading to reduced kidney function

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

• A bowel problem known as necrotising colitis which may cause pain, malaise, diarrhoea and fever, intestinal perforation
• Severe liver damage in case of combination chemotherapy, or in patients taking oral contraceptives and alcohol

Not known

• Photosensitivity (increased sensitivity to light)

Reporting of side effects
If you get any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse.
You can also report side effects directly via 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 stated on the label after "Exp".
The expiry date refers to the last day of that month.
Store below 25°C.
Protect the medicine from light and moisture.
Disposal
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. This will help protect the environment.

6. Pack contents and other information

What TIOGUANINE ASPEN contains

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

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