Package Leaflet: Information for the User

Lanvis 40mg Tablets

tioguanine

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

• Keep this leaflet, as 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 harm them.
• If you experience any side effects, talk to your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

1. What is Lanvis and what it is used for

2. What you need to know before you start taking Lanvis

3. How to take Lanvis

4. Possible side effects

5. Storage of Lanvis

6. Contents of the pack and additional information

Lanvis tablets contain a medicine called tioguanine. This belongs to a group of medicines called cytotoxics (also known as chemotherapy). Lanvis is used for certain blood problems and blood cancers. It acts by reducing the amount of new blood cells produced by your body.

Lanvis is used for acute leukemias (rapidly growing), especially:

• Acute myeloid leukemia(also known asacute myeloid leukaemia or AML): a rapidly growing disease that increases the number of white blood cells produced by the bone marrow. This can cause infections and bleeding.
• Acute lymphoblastic leukemia(also known asacute lymphocytic leukemia or ALL): a rapidly growing disease that increases the number of white blood cells produced by the bone marrow. These immature white blood cells cannot grow and function properly and, therefore, cannot fight infections and may cause bleeding.

Consult your doctor if you wish to learn more about these diseases.

Do not take Lanvis:

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

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Lanvis:

• if you have a liver problem, so that your doctor can monitor liver function through blood tests,
• if you have been taking this medication for a long period of time. This may increase the risk of side effects, such as liver problems,
• if you have a condition in which your body produces very little of a substance called TPMT or "thiopurine methyltransferase",
• if you have a mutation in the NUDT15 gene, you may have a higher risk of presenting low white blood cell counts in the blood compared to other patients. This may lead to infections. The mutation may also put you at a higher risk of hair loss. Patients of Asian descent may be particularly at risk

• if you have "Lesch-Nyhan syndrome". This is a rare disease that occurs in families, caused by the lack of a substance called HPRT or "hypoxanthine-guanine phosphoribosyltransferase".

If you are unsure whether any of the above situations affect you, speak with your doctor, pharmacist, or nurse before taking Lanvis.

Infections in all populations

Inform your doctor immediately if you experience intense chills, fever, sore throat, cough, symptoms similar to the flu, and headache, accompanied by nausea, hives, and/or confusion, while taking thioguanine with other cancer treatments, as these symptoms may indicate that you have a bacterial, viral, or fungal infection. Your doctor may prescribe antiviral treatment and other supportive treatments.

Blood tests

Your doctor may ask you to have a blood test while taking Lanvis. This is to check your blood cell count. Your doctor may also perform genetic tests (i.e., examine your genes TPMT and/or NUDT15) before or during treatment to determine if your response to this medication may be affected by your genetics. Your doctor may change the dose of Lanvis after these tests.

Lanvis and the sun

While taking Lanvis, you may become sensitive to sunlight, which may cause skin discoloration or skin rash. Take precautions to avoid excessive sun exposure, cover up, and use sunscreen.

Other medications and Lanvis

Inform your doctor, pharmacist, or nurse if you are taking, have taken recently, or may need to take any other medication.

In particular, inform your doctor or pharmacist if you are taking any of the following:

• olsalazine or mesalamine: used for a bowel problem called ulcerative colitis.
• sulfasalazine: used for rheumatoid arthritis or ulcerative colitis.
• mercaptopurine - cytotoxic drug (patients with a tumor resistant to mercaptopurine will not respond to Lanvis).
• medications that may have a harmful effect on the bone marrow, such as other chemotherapy or radiation therapy. This may lead to bone marrow damage and the dose of Lanvis may need to be reduced.

Vaccination while taking Lanvis

If you are to be vaccinated, speak with your doctor or nurse before the vaccine is administered. This is because some vaccines (such as polio, measles, mumps, and rubella) may cause an infection if administered while taking Lanvis.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor before using this medication. This applies to both men and women. Lanvis may damage your semen or eggs. Reliable contraceptive measures should be taken to avoid pregnancy while you or your partner are taking this medication.

Driving and operating machinery

No data are available on the effects of Lanvis on the ability to drive and operate machinery.

Lanvis contains lactose

If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

Lanvis should only be administered by a specialist doctor with experience in treating blood-related problems.

Follow exactly the medication administration instructions provided by your doctor. It is essential to take the medication at the right time. The label on the packaging will indicate how many tablets to take and how often to take them. If in doubt, consult your doctor, pharmacist, or nurse again.

• Swallow the tablets whole with a glass of water.
• If you need to break the tablet in half, do not inhale any powder from the tablet. Wash your hands afterwards

• When taking Lanvis, your doctor will perform periodic blood tests. This is to check the number and type of blood cells and to ensure the liver is functioning correctly. Your doctor may change the dose sometimes, depending on the blood test results.

The dose of Lanvis that will be administered to you will be prepared by your doctor based on the following:

• your body size (surface area),
• blood test results,
• the disease being treated.

The usual dose is between 60 and 200mg/m2of body surface area per day. If you have a problem with your kidneys or liver, you may be given a lower dose of Lanvis.

If you take more Lanvis than you should

Inform your doctor immediately or go to the hospital immediately. Bring the medication packaging with you.

If you forget to take Lanvis

Inform your doctor.Do not take a double dose to make up for the missed doses.

If you interrupt treatment with Lanvis

Do not stop treatment with Lanvis without consulting your doctor.

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

If you have any of the following symptoms, consult your specialist doctor or go to the hospital immediately, as you may need to stop taking Lanvis:

• any sign of fever or infection (sore throat, mouth pain or urinary problems)
• Treatment with Lanvis may cause a decrease in white blood cell count. White blood cells fight infection, and when there are very few white blood cells, infections can occur,

• any unexpected hematoma or hemorrhage,since this could mean that very few blood cells of a particular type are being produced,
• ifyou suddenlyfeel unwell (even with normal temperature),
• any yellowish discoloration of the whites of the eyes or skin (jaundice).

Consult your doctor if you experience any of the following side effects that may also occur with this medicine:

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

• decrease in white blood cell count (leucopenia),
• decrease in platelet count in the blood (cells that help blood to clot),
• jaundice (the skin and whites of the eyes turn yellow) and intense liver damage (symptoms include fatigue and nausea followed by itching, dark urine, and may include rash or fever) - with long-term use or high doses of Lanvis - this may also appear in blood tests.

Common (may affect up to 1 in 10 people)

• Liver damage that can cause jaundice (the skin and whites of the eyes turn yellow) or liver enlargement (swelling below the chest); with short-term use of Lanvis, this may also appear in blood tests.
• Feeling dizzy or vomiting (nausea or vomiting), diarrhea, and mouth ulcers,
• increase in uric acid concentrations in the blood (hyperuricemia), which sometimes can lead to decreased kidney function.

Rare (may affect up to 1 in 10,000 people)

• A problem with the intestines, called necrotizing colitis, which can cause severe stomach pain, vomiting, diarrhea, and fever,
• intense liver damage when used with other chemotherapy medications, oral contraceptives, and alcohol.

Other side effects have been reported with low frequency: skin rash, light sensitivity, heart problems, ringing in the ears and deafness, and unusual eye movements.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly throughtheSpanish System for the Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

• Keep this medication out of the sight and reach of children.
• Do not use this medication after the expiration date that appears on the label of the bottle and on the box after "CAD". The expiration date is the last day of the month indicated. Do not store Lanvis tablets at a temperature above 25°C. Store in the original packaging to protect them from light. Keep the container perfectly closed to protect it from moisture.
• If your doctor tells you to stop taking the tablets, it is important that you return any remaining tablets to your pharmacist, who will dispose of them according to hazardous substance disposal guidelines. Store the tablets only if your doctor instructs you to do so.

Lanvis Composition

• The active ingredient is tioguanine. Each Lanvis tablet contains 40mg of tioguanine.
• The other components are lactose monohydrate, potato starch, arabic gum, stearic acid, and magnesium stearate.

Product appearance and packaging contents

Lanvis tablets are white to off-white, round, biconvex, bisected, and imprinted with «T40» on the upper side, without a bisect or engraving on the lower side.

Lanvis tablets are supplied in bottles of 25 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Aspen Pharma Trading Limited

3016 Lake Drive, Citywest Business Campus,

Dublín 24,

Irlanda

Tel: +34 952 010 137

Manufacturer:

EXCELLA GmbH & Co. KG, Nürnberger Strasse 12,

90537 Feucht,

Alemania

Local representative:

Aspen Pharmacare España S.L.

Avenida Diagonal, 512

Planta Interior 1, Office 4

08006 Barcelona

España

Last review date of this leaflet: December 2022

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/