MERCAPTOPURINE ASPEN 50 mg TABLETS

Introduction

Package Leaflet: Information for the User

Mercaptopurina Aspen 50mg Tablets

mercaptopurine monohydrate

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

• 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

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

1. What is Mercaptopurina Aspen and what is it used for

Mercaptopurina Aspen contains the active substance mercaptopurine monohydrate. Mercaptopurine monohydrate belongs to a group of medicines called cytotoxics (also known as chemotherapy) and works by reducing the number of new blood cells produced by the body.

Mercaptopurina Aspen is used to treat blood cancer (leukaemia) in adults, adolescents, and children.

This is a rapidly spreading disease that causes an increase in the number of new white blood cells. These new white blood cells are immature (not fully formed), so they cannot grow or function properly. As a result, they cannot fight infections and can cause bleeding.

Ask your doctor if you want more information about this disease.

2. What you need to know before you take Mercaptopurina Aspen

Do not take Mercaptopurina Aspen:

• if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).
• do not get vaccinated against yellow fever while taking mercaptopurine monohydrate, as it can be fatal.

If you are not sure, consult your doctor or pharmacist before taking Mercaptopurina Aspen.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before taking Mercaptopurina Aspen:

• if you have recently been vaccinated or are going to be vaccinated, or if you have been vaccinated against yellow fever.
• while taking Mercaptopurina Aspen, it is not recommended to receive live vaccines (such as flu, mumps, BCG, etc.) until your doctor tells you to do so. This is because some vaccines can cause infection if given while taking Mercaptopurina Aspen.
• if you have kidney or liver problems, as your doctor will need to check that your organs are working properly.
• if you have a disease that causes your body to produce insufficient amounts of an enzyme called TPMT (thiopurine methyltransferase), as your doctor may need to adjust your dose.
• if you are allergic to a medicine called azathioprine (also used to treat cancer).
• tell your doctor if you have had chickenpox, shingles, or hepatitis B (a liver disease caused by a virus).
• if you have a rare genetic disorder called Lesch-Nyhan syndrome, a congenital metabolic disorder.
• if you plan to have a child. This applies to both men and women. Mercaptopurina can be harmful to sperm or eggs (see 'Pregnancy, breastfeeding, and fertility' below).

In some patients with inflammatory bowel disease who have received treatment with mercaptopurine monohydrate, a rare and aggressive type of cancer called hepatosplenic T-cell lymphoma has occurred (see section 4).

Taking Mercaptopurina Aspen may increase your risk of:

developing a serious condition called macrophage activation syndrome (excessive activation of white blood cells associated with inflammation), which usually occurs in people with certain types of arthritis.

Inflammatory bowel disease (IBD) is an indication for which authorization has not been obtained.

If you are receiving immunosuppressive treatment, taking Mercaptopurina Aspen may increase your risk of:

• tumors, including skin cancer. Therefore, when taking Mercaptopurina Aspen, avoid excessive exposure to sunlight, wear protective clothing, and use high-protection sunscreens.
• lymphoproliferative disorders

• treatment with Mercaptopurina Aspen increases your risk of having a type of cancer called lymphoproliferative disorder and other malignant tumors. With treatment containing multiple immunosuppressants (including thiopurines), this can be fatal.
• • the combination of multiple immunosuppressants, administered simultaneously, increases the risk of lymphatic system disorders due to viral infection (lymphoproliferative disorders associated with Epstein-Barr virus (EBV)).

If you are not sure if any of the above situations apply to you, talk to your doctor, nurse, or pharmacist before taking mercaptopurine.

Blood tests

Treatment with Mercaptopurina Aspen may affect your bone marrow. This means that the number of white blood cells, platelets, and (less frequently) red blood cells in your blood may decrease. Your doctor will perform blood tests every day during the initial period of your treatment (induction) and at least weekly during the later period of your treatment (maintenance). This is done to monitor the levels of these cells in your blood. If you stop taking the treatment soon enough, the levels of your cells will return to normal.

Your doctor may also ask for a blood test during treatment with Mercaptopurina Aspen to check the blood cell count, and may also ask for other genetic tests (e.g., examining TPMT and/or NUDT15 genes) before or during treatment to determine if your response to the medicine may be affected by your genes. Your doctor will adjust the dose of Mercaptopurina Aspen based on the results of these tests.

Liver function

Mercaptopurina Aspen is toxic to the liver. For this reason, your doctor will perform weekly liver function tests while you are taking Mercaptopurina Aspen. If you have pre-existing liver disease or are taking other medicines that may affect the liver, your doctor will perform tests more frequently. If you notice that the whites of your eyes or your skin turn yellow (jaundice), tell your doctor immediately, as it may be necessary to stop treatment immediately.

Pellagra

Tell your doctor immediately if you experience diarrhea, localized pigmented rash (dermatitis), or decreased memory, reasoning, or other thinking abilities (dementia), as these symptoms may suggest a deficiency of vitamin B3 (niacin/niacinamide deficiency/pellagra). Your doctor will likely prescribe vitamin supplements (niacin/nicotinamide) to help treat this condition.

Infections

When receiving treatment with Mercaptopurina Aspen, the risk of viral, fungal, and bacterial infections is higher, and these infections can be more severe. See also section 4.

Before starting treatment, tell your doctor if you have had chickenpox, shingles, or hepatitis B (a liver disease caused by a virus).

NUDT15 gene mutation

If you have a inherited mutation in the NUDT15 gene (a gene involved in the breakdown of Mercaptopurina Aspen in the body), you are at higher risk of infection and hair loss, and your doctor may give you a lower dose.

Sun and ultraviolet light

When taking Mercaptopurina Aspen, you are more sensitive to the sun and ultraviolet light. You should limit your exposure to sunlight and ultraviolet light, wear protective clothing, and use a high-protection sunscreen.

Children and adolescents

Low blood sugar levels (more sweating than usual, nausea, dizziness, confusion, etc.) have been seen in children, mainly in children under six years old or with a low body mass index. If this happens, consult your child's doctor.

If you are not sure if any of the above situations apply to you, consult your doctor or pharmacist before taking Mercaptopurina Aspen.

Other medicines and Mercaptopurina Aspen

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

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

• ribavirin (used to treat viral infections). It is not recommended to take it together, as it can cause severe bone marrow suppression.
• other cytotoxic medicines (chemotherapy - used to treat cancer).
• other medicines whose primary or secondary toxicity is bone marrow suppression.
• allopurinol, tiopurinol, oxipurinol, and febuxostat (used to treat gout).
• olsalazine or mesalazine (used to treat Crohn's disease and a bowel condition called ulcerative colitis).
• sulfasalazine (used to treat rheumatoid arthritis or ulcerative colitis).
• methotrexate (used to treat rheumatoid arthritis or severe psoriasis), oral administration of methotrexate increases the blood concentration of mercaptopurine.
• infliximab (used to treat Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, or severe psoriasis).
• warfarin and acenocoumarol (used to 'thin' the blood).
• antiepileptics such as phenytoin, carbamazepine. It may be necessary to monitor the blood levels of antiepileptics and adjust the dose if necessary.
• 6-thioguanine (antineoplastic), as there is cross-resistance between the two medicines.
• azathioprine if you have had an allergic reaction to mercaptopurine.

Vaccinations during treatment with Mercaptopurina Aspen

If you have recently been vaccinated or are going to be vaccinated, it is important that you consult your doctor or nurse before doing so. While taking Mercaptopurina Aspen, it is not recommended to receive live vaccines (such as polio, measles, mumps, and rubella) until your doctor tells you to do so. This is because some vaccines can cause infection if given while taking Mercaptopurina Aspen.

Taking Mercaptopurina Aspen with food and drink

You can take Mercaptopurina Aspen with food or on an empty stomach, but the method chosen must be the same every day. You must take the medicine at least 1 hour before or 2 hours after consuming milk or dairy products, as milk or dairy products can make the medicine less effective.

Pregnancy, breastfeeding, and fertility

Do not take Mercaptopurina Aspen if you are planning to have a child without consulting your doctor first. This applies to both men and women. Mercaptopurina Aspen can be harmful to sperm or eggs. You and your partner must use effective contraceptive methods to avoid pregnancy while either of you is taking Mercaptopurina Aspen. Both men and women must use an effective contraceptive method for at least 3 months after receiving the last dose of treatment. If you are already pregnant, tell your doctor before taking Mercaptopurina Aspen.

Mercaptopurina Aspen should not be handled by pregnant women, women who plan to become pregnant, or women who are breastfeeding.

Breastfeeding is not recommended during treatment with Mercaptopurina Aspen. Consult your doctor, pharmacist, or midwife.

Driving and using machines

No studies have been conducted on the effect of Mercaptopurina Aspen on the ability to drive vehicles and use machines. It is not expected that mercaptopurine will affect your ability to drive or use machines. Consult your doctor or pharmacist.

Mercaptopurina Aspen contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Mercaptopurina Aspen

Mercaptopurina Aspen should only be prescribed by a specialist doctor with experience in the treatment of different types of blood cancer.

• When taking Mercaptopurina Aspen, your doctor will perform regular blood tests to check the number and type of cells in your blood and to ensure that your liver is working properly.
• Your doctor may also request other blood and urine tests to monitor your kidney function and measure uric acid levels. Uric acid is a natural substance produced by the body, and its levels may increase during treatment with Mercaptopurina Aspen. High levels of uric acid can damage the kidneys.
• It is possible that your doctor may change your dose of Mercaptopurina Aspen based on the results of these tests.

Follow the instructions for taking this medicine exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

The usual initial dose in adults and children is 25 to 75 mg per m2 of body surface area per day.

Your doctor will calculate and adjust the dose based on your body weight, blood test results, whether or not you are taking other medicines for chemotherapy, and your kidney and liver function.

Consult your doctor or nurse if you have any doubts about the dose you should take.

Swallow the tablets whole. Do not chew the tablets. The tablets should not be broken or crushed.If you or your caregiver handle broken tablets, wash your hands immediately.

Mercaptopurina with food and drink

You can take Mercaptopurina with food or on an empty stomach, but the method chosen must be the same every day. You must take the medicine at least 1 hour before or 2 hours after consuming milk or dairy products.

It is important to take Mercaptopurina Aspen at night for the medicine to be more effective.

If you take more Mercaptopurina Aspen than you should

If you take more Mercaptopurina Aspen than you should, tell your doctor or go to the hospital immediately. You may have nausea, vomiting, or diarrhea. Bring the medicine box and this leaflet with you. In case of overdose, call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Mercaptopurina Aspen

Tell your doctor. Do not take a double dose to make up for forgotten doses.

If you stop taking Mercaptopurina Aspen

Do not stop taking your medicine unless your doctor tells you to do so, or you may have a relapse of your disease.

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

If you experience any of the following side effects, consult your specialist doctor or go to a hospital immediately:

Allergic reaction, whose signs may be:

• skin rashes
• high temperature
• joint pain
• facial swelling

Any sign of fever or infection (sore throat, mouth sores, or urinary problems)

Any bruising or unexpected bleeding, as it could indicate that you are producing an insufficient number of a certain type of blood cells.

If you suddenly feel unwell (even if your temperature is normal), with abdominal pain and nausea, as it could be a sign of pancreatitis.

Yellowing of the white part of the eyes or skin (jaundice)

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

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

• decrease in the number of white blood cells and platelets (can be detected in blood tests)

Common (may affect up to 1 in 10 people)

• nausea or vomiting
• liver damage - can be detected in blood tests
• decrease in the number of red blood cells that can cause fatigue, dizziness, or shortness of breath - a disease (called anemia)
• loss of appetite
• pancreatitis (inflammation of the pancreas) in patients with inflammatory bowel disease

Uncommon (may affect up to 1 in 100 people)

• pancreatitis (inflammation of the pancreas)
• joint pain, skin rash
• fever
• permanent liver damage (liver necrosis)
• bacterial and viral infections, infections associated with neutropenia

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

• hair loss
• mouth ulcers
• in men: temporary decrease in sperm count
• allergic reaction that causes facial swelling
• various types of cancer, including blood, lymphatic, and skin cancers
• pancreatitis (inflammation of the pancreas) in patients with leukemia (blood cancer)

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

• a type of leukemia different from the one being treated
• ulcers in the intestine; symptoms may include abdominal pain and bleeding

Other adverse effects (frequency not known):

• a rare type of cancer (hepatosplenic T-cell lymphoma) in patients with a condition called inflammatory bowel disease), (see section 2, Warnings and precautions)

Consult your doctor if you experience any of the following adverse effects:

• sensitivity to sunlight that produces skin reactions
• decrease in blood sugar levels
• skin nodules (erythema nodosum)
• burning or tingling sensation in the mouth or lips (mucosal inflammation, stomatitis)
• cracked or swollen lips (cheilitis)
• vitamin B3 deficiency (pellagra) with localized pigmented skin rash, diarrhea, or decreased memory, reasoning, or other thinking abilities
• decrease in coagulation factors

Other adverse effects in children and adolescents

There have been reports of hypoglycemia (low blood sugar) that can manifest with excessive sweating, nausea, dizziness, confusion, etc., in children who had received Mercaptopurina Aspen, with unknown frequency. However, most reported cases were in children under six years old and with low body weight.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that does not appear in this prospectus. You can also report it directly through the Spanish Pharmacovigilance System for human use medicines: http://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Mercaptopurina Aspen

Keep this medicine out of the sight and reach of children, preferably in a locked cabinet. Accidental ingestion can be fatal for children.

Do not use this medicine after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Store below 25°C. Keep the bottle perfectly closed to protect it from moisture.

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Mercaptopurina Aspen

• The active ingredient is mercaptopurine monohydrate. Each tablet contains 50 mg of mercaptopurine.
• The other components (excipients) are: magnesium stearate, lactose, cellulose, corn starch, modified corn starch, stearic acid, and purified water.

Appearance of the Product and Package Contents

Mercaptopurina Aspen is a pale yellow, round, biconvex tablet, scored on one side, with the inscription PT above the score and 50 below the score, with no markings on the other side.

Mercaptopurina Aspen is packaged in amber glass bottles with high-density polyethylene child-resistant closures with heat-sealed induction seals.

Package size: 25 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Aspen Pharma Trading Limited

3016 Lake Drive,

Citywest Business Campus,

Dublin 24, Ireland

Tel: 0034 952010137

Manufacturer

EXCELLA GmbH & Co. KG

Nürnberger Strasse 12

90537 Feucht, Germany

Aspen Bad Oldesloe GmbH

Industriestrasse 32-36

23843 Bad Oldesloe, Germany

Local Representative

Aspen Pharmacare España S.L.

Avenida Diagonal, 512

Planta Interior 1, Oficina 4

08006 Barcelona

Spain

Date of the last revision of this prospectus: December 2024

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/