Lanvis

Package Leaflet: Information for the Patient

Lanvis, 40 mg, Tablets

Tioguanine

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• 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 symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

• 1. What is Lanvis and what is it used for
• 2. Important information before taking Lanvis
• 3. How to take Lanvis
• 4. Possible side effects
• 5. How to store Lanvis
• 6. Contents of the pack and other information

1. What is Lanvis and what is it used for

Lanvis tablets contain the active substance tioguanine. This substance belongs to a group of medicines called cytotoxic medicines (also known as chemotherapy). Lanvis is used to treat certain blood disorders and blood cancers. The medicine works by reducing the number of new blood cells produced by the body.
Lanvis is used to treat acute (rapidly progressing) leukemias, such as:

• Acute myeloid leukemia- a rapidly progressing disease that causes an increase in the number of white blood cells produced by the bone marrow. This can lead to infections and bleeding.
• Acute lymphoblastic leukemia- a rapidly progressing disease that causes an increase in the number of immature white blood cells. These immature white blood cells cannot grow and function properly, and therefore cannot fight infections, and can cause bleeding.

You should ask your doctor if you need more information about these diseases.

2. Important information before taking Lanvis

When not to take Lanvis

Warnings and precautions

Before taking Lanvis, you should discuss with your doctor, pharmacist, or nurse if you:

• are taking this medicine for a long time. This may increase the risk of side effects, such as liver damage;
• have a condition where your body produces too little of a substance called TPMT or "thiopurine methyltransferase";
• have a condition called Lesch-Nyhan syndrome. This is a rare, inherited disease caused by a lack of a substance called HPRT or "hypoxanthine-guanine phosphoribosyltransferase".

Mutation of NUDT15
If you have a mutation of the NUDT15 gene, you may be at increased risk of a decrease in the number of white blood cells compared to other patients. This may increase the risk of infections.
This mutation may also increase the risk of hair loss. Patients of Asian descent are particularly at risk.
Your doctor may also order genetic tests for TPMT and/or NUDT15 before starting or during treatment to check if your genes may affect your response to this medicine.
If you are not sure if any of the above applies to you, you should talk to your doctor or pharmacist before taking Lanvis.

Infections in all age groups

You should immediately inform your doctor if you experience any of the following symptoms: severe chills, fever, sore throat, cough, flu-like symptoms, and headache with accompanying nausea, rash, and/or confusion while taking tioguanine with other anti-cancer medicines.
These symptoms may indicate a bacterial, viral, or fungal infection. Your doctor may prescribe anti-viral medicines or other supportive treatment.

Lanvis and exposure to sunlight

While taking Lanvis, you may be sensitive to sunlight, which can cause skin discoloration or rash. You should avoid excessive sun exposure, wear protective clothing, and use sunscreen.

Lanvis and other medicines

You should tell your doctor, nurse, or pharmacist about all medicines you are taking, or have recently taken, and any medicines you plan to take.
In particular, you should tell your doctor or pharmacist if you are taking any of the following medicines:

• olsalazine or mesalazine - used to treat a bowel disease called ulcerative colitis;
• sulfasalazine - used to treat rheumatoid arthritis or ulcerative colitis;
• medicines that may have a harmful effect on the bone marrow, such as other chemotherapy or radiotherapy. This may lead to bone marrow damage and may require a reduction in the dose of Lanvis.

Vaccinations while taking Lanvis

If you are planning to have a vaccination, you should talk to your doctor or nurse beforehand. This is because some vaccines (against polio, measles, mumps, and rubella) may cause infection if given while taking Lanvis.

Taking Lanvis with food, drink, and alcohol

You should discuss this with your doctor, pharmacist, or nurse, as food and vomiting may affect the absorption of Lanvis.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should ask your doctor for advice before taking this medicine.
Lanvis may harm sperm or eggs. Therefore, you should use effective contraception if you or your partner are taking Lanvis.

Driving and using machines

There is no available data on the effects of Lanvis on the ability to drive and use machines.

Lanvis contains lactose.

If you have been told that you have an intolerance to some sugars, you should contact your doctor before taking this medicine.

3. How to take Lanvis

Lanvis should only be taken by a specialist doctor with experience in treating blood disorders.
This medicine should always be taken exactly as your doctor has told you. It is important to take the medicine at the right time. If you are unsure, ask your doctor, nurse, or pharmacist.

• Swallow the tablets whole with a glass of water.
• If you need to break the tablet in half, do not inhale the powder. Then wash your hands.
• While taking Lanvis, your doctor will regularly perform blood tests. This is to check the number and type of blood cells in your blood and to make sure your liver is working properly. Based on the results of these tests, your doctor may sometimes change the dose of Lanvis.

The dose of Lanvis is determined by your doctor based on:

• your body size (body surface area);
• blood test results;
• the disease being treated. The usual dose is between 100 and 200 mg/m2 per day. If you have kidney or liver disease, your doctor may use a lower dose of Lanvis.

Taking more Lanvis than prescribed

If you take more Lanvis than you should, or if someone else takes your medicine, you should immediately inform your doctor or pharmacist, or contact the nearest hospital emergency department.
You should take the package leaflet with you.

Missing a dose of Lanvis

You should tell your doctor. Do not take a double dose to make up for a forgotten dose.

Stopping treatment with Lanvis

Do not stop taking Lanvis without talking to your doctor.
If you have any further questions on the use of this medicine, ask your doctor, nurse, or pharmacist.

4. Possible side effects

Like all medicines, Lanvis can cause side effects, although not everybody gets them.

If you experience any of the following symptoms, you should immediately inform your doctor or go to the nearest hospital:

• any symptoms of fever or infection (sore throat, mouth ulcers, or problems urinating);
• any unusualbruising or bleeding, as this may indicate that there are too few blood cells of a certain type;
suddenlyfeel unwell (even if your temperature is normal);
• any yellowing of the whites of the eyes or skin (jaundice).

You should tell your doctor if you experience any of the following side effects, which may also occur when taking this medicine:

Very common (affects more than 1 in 10 people)

• reduction in the number of white blood cells and platelets;
• jaundice (yellowing of the skin and whites of the eyes) and severe liver damage (symptoms include tiredness and nausea, followed by itching, dark urine, and possibly rash or fever) - during long-term treatment with Lanvis or when taking high doses of Lanvis - this may also be visible in blood tests.

Common (affects less than 1 in 10 people):

• liver damage, which may cause jaundice (yellowing of the skin and whites of the eyes) or liver enlargement (swelling below the chest) - during short-term treatment with Lanvis - this may also be visible in blood tests;
• nausea or vomiting, diarrhea, and mouth ulcers;
• increased levels of uric acid in the blood (hyperuricemia), which may sometimes lead to kidney damage.

Rare (affects less than 1 in 1000 people)

• a bowel disease called necrotizing enterocolitis, which can cause severe abdominal pain, vomiting, diarrhea, and fever;
• severe liver damage if Lanvis is taken with other chemotherapy medicines, oral contraceptives, or alcohol.

Frequency not known (cannot be estimated from the available data)

• sensitivity to light.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Medicinal Product Monitoring, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02 222 Warszawa, 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Lanvis

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the carton and bottle after "EXP". The expiry date refers to the last day of that month.
• Store in a temperature below 25°C, in a dry place. Protect from light.
• If your doctor tells you to stop taking this medicine, return any unused tablets to your pharmacist. The pharmacist will dispose of them in accordance with the current regulations on the disposal of hazardous substances. Only keep the tablets if your doctor tells you to.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Lanvis contains

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

What Lanvis looks like and contents of the pack

Lanvis tablets are white or cream-colored, round, biconvex with a dividing line and engraved "T40" on the upper side, without a dividing line and engraving on the lower side.
The pack contains 25 tablets in an orange glass bottle, in a cardboard box.

Marketing authorization holder

Aspen Pharma Trading Limited
3016 Lake Drive
Citywest Business Campus
Dublin 24, Ireland
Tel: +48 22 104 21 00

Manufacturer

EXCELLA GmbH & Co. KG
Nürnberger Strasse 12
90537 Feucht, Germany

Date of last revision of the leaflet:

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