Package Insert: Information for the User

Mercaptopurina Aspen 50mg Tablets

mercaptopurine monohydrate

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed for you only, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert. See section4.

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

Mercaptopurina Aspen is used in the treatment of blood cancer (leukemia) 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 correctly. Consequently, they cannot fight infections and may cause bleeding.

Ask your doctor if you would like more information about this disease.

Do not take Mercaptopurina Aspen:

• if you are allergic to the active ingredient or any of the other components of this medicine (listed in section6).
• do not get vaccinated against yellow fever while taking mercaptopurine monohydrate, as it can be fatal.

If you are unsure, consult your doctor or pharmacist before starting to take Mercaptopurina Aspen tablets.

Warnings and precautions

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

• if you have recently been given a vaccine or are to be vaccinated, or if you have been vaccinated against yellow fever.
• while taking Mercaptopurina Aspen, do not administer vaccines (such as the flu vaccine, mumps, measles, BCG, etc.) until your doctor tells you to do so. This is because some vaccines may cause an infection if administered while taking Mercaptopurina Aspen.
• if you have kidney or liver problems, as your doctor will need to check that your organs are functioning correctly.
• if you have a disease that makes your body 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 (which is also used to treat cancer).
• inform your doctor if you have had chickenpox, shingles or hepatitis B (a liver disease caused by a virus).
• if you have a genetic disorder called Lesch-Nyhan syndrome, a rare disease that includes congenital metabolic errors
• if you are planning to have a child. This applies to both men and women. Mercaptopurine may 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 T-cell lymphoma of the liver and spleen has appeared (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 no authorization has been obtained.

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

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

• treatment with Mercaptopurina Aspen increases your risk of developing a type of cancer called lymphoproliferative disorder and other malignant tumors. With a treatment that contains several immunosuppressants (including thiopurines), this may 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 unsure whether any of the above situations applies to you, speak with your doctor, nurse or pharmacist before taking mercaptopurine.

Blood tests

Treatment with Mercaptopurina Aspen may affect your bone marrow. This means that there may be a decrease in the number of white blood cells, platelets and (less frequently) red blood cells in your blood. Your doctor will perform blood tests every day during the initial period of your treatment (induction) and, at least, weekly during the more advanced period of your treatment (maintenance). This is done to control 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 ask you to have a blood test during treatment with Mercaptopurina Aspen to check your blood cell count, and may also ask you to have other genetic tests (e.g. examine 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

Mercaptopurine Aspen is toxic to the liver. For this reason, your doctor will perform weekly liver function tests while you are taking Mercaptopurine 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 white part of your eyes or your skin becomes yellow (jaundice), inform your doctor immediately, as it may be necessary to stop treatment immediately.

Pellagra

Inform your doctor immediately if you experience diarrhea, localized pigmentation (dermatitis), or decreased memory, reasoning or other thinking skills (dementia), as these symptoms may suggest a deficiency of vitamin B3(pellagra). It is likely that your doctor will prescribe vitamin supplements (niacin/nicotinamide) to help treat this condition.

Infections

When receiving treatment with Mercaptopurine Aspen, your risk of suffering from viral, fungal and bacterial infections is higher, and these infections may be more severe. See section 4.

Before starting treatment, inform your doctor if you have had or not chickenpox, herpes or hepatitis B (a liver disease caused by a virus).

NUDT15 gene mutation

If you have a hereditary mutation in the NUDT15 gene (a gene involved in the breakdown of Mercaptopurine Aspen in the body), you have a higher risk of infections and hair loss, and in this case, your doctor may give you a lower dose.

Sun and ultraviolet light

When taking Mercaptopurine Aspen, you are more sensitive to the sun and ultraviolet light. You must ensure that you limit your exposure to sunlight and ultraviolet light, wear protective clothing and use high-factor sunscreens.

Children and adolescents

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

If you are unsure whether any of the above situations applies to you, consult your doctor or pharmacist before taking Mercaptopurine Aspen.

Other medicines and Mercaptopurine Aspen

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

Particularly, inform your doctor or pharmacist if you are taking any of the following medicines:

• ribavirin (used in the treatment of viral infections). It is not recommended to administer it concomitantly due to the risk of severe myelosuppression (decrease in blood cell production).
• other cytotoxic medicines (chemotherapy – used to treat cancer).
• other medicines whose primary or secondary toxicity is myelosuppression (decrease in blood cell production).
• allopurinol, thiopurinol, oxipurinol and febuxostat (used to treat gout).
• olsalazine or mesalazine (used to treat Crohn's disease and a bowel disorder 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 concentration of mercaptopurine in the blood.
• infliximab (used to treat Crohn's disease and ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis or severe psoriasis).
• warfarin and acenocoumarol (used to ‘thin’ the blood).
• antiepileptics such as phenytoin, carbamazepine. You may need to monitor the blood levels of antiepileptics and adjust the dose as necessary.
• 6-mercaptopurine (antineoplastic), as there is cross-resistance between both medicines,
• Azathioprine if you have had an allergic reaction to mercaptopurine

Vaccinations during treatment with Mercaptopurine Aspen

If you have recently been given a vaccine or are to be vaccinated, it is essential that you consult your doctor or nurse before taking Mercaptopurine Aspen. While taking Mercaptopurine Aspen, it is not recommended to administer live vaccines (such as polio, measles, mumps and rubella) until your doctor tells you to do so. This is because some vaccines may cause an infection if administered while taking Mercaptopurine Aspen.

Taking Mercaptopurine Aspen with food and drinks

You can take Mercaptopurine Aspen with food or on an empty stomach, but you must choose the same method every day. You should take the medicine at least 1 hour before or 2 hours after consuming milk or dairy products, as milk or dairy products may reduce the effectiveness of the medicine.

Pregnancy, breastfeeding and fertility

Do not take Mercaptopurine Aspen if you are planning to have a child without consulting your doctor first. This applies to both men and women. Mercaptopurine may be harmful to sperm or eggs. You and your partner must use effective contraceptive methods to avoid pregnancy while one of you is taking Mercaptopurine 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, inform your doctor before taking Mercaptopurine Aspen.

Mercaptopurine Aspen should not be handled by pregnant women, women planning to become pregnant or breastfeeding women.

It is not recommended to breastfeed during treatment with Mercaptopurine Aspen. Consult your doctor, pharmacist or midwife.

Driving and operating machinery

No studies have been conducted on the effect of Mercaptopurine Aspen on the ability to drive vehicles and operate machinery. Mercaptopurine is not expected to affect your ability to drive or operate machinery. Consult your doctor or pharmacist.

Mercaptopurine Aspen contains lactose

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

Mercaptopurine Aspen should be prescribed only by a specialist doctor with experience in treating different types of blood cancer.

• When taking Mercaptopurine Aspen, your doctor will perform blood tests periodically to check the number and type of cells in your blood and ensure your liver is functioning correctly.
• 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 Mercaptopurine Aspen treatment. Elevated uric acid levels can damage the kidneys.
• Your doctor may adjust your Mercaptopurine Aspen dose based on the results of these tests.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

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

Your doctor will calculate and adjust the dose based on your body weight, blood test results, whether you are taking other chemotherapy medications, 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.

Mercaptopurine with food and drink

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

It is essential to take Mercaptopurine Aspen at night for the medication to be more effective.

If you take more Mercaptopurine Aspen than you should

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

If you forget to take Mercaptopurine Aspen

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

If you interrupt treatment with Mercaptopurine Aspen

Do not stop taking your medication unless your doctor instructs you to, as you may experience a relapse of your disease.

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

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

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

Allergic reaction, whose signs may be:

- skin eruptions

- elevated temperature

- joint pain

- facial edema

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

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

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

Yellow discoloration of the white part 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 the number of white blood cells and platelets (may be detected in blood tests)

Common (may affect up to 1 in 10 people)

• Nausea (nausea or vomiting)
• Liver damage - may be detected in blood tests
• Decrease in the number of red blood cells, which may cause fatigue, dizziness or shortness of breath - anemia
• Loss of appetite
• Pancreatitis in patients with inflammatory bowel disease

Uncommon (may affect up to 1 in 100 people)

• Pancreatitis
• Joint pain
• Skin eruptions
• Fever
• Permanent liver damage (hepatic 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 edema
• Various types of cancer, including blood, lymphatic and skin cancers
• Pancreatitis 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 side effects (of unknown frequency):

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

Adverse reactions and precautions)

• Sensitivity to sunlight that causes skin reactions
• Decrease in blood sugar levels
• Nodules on the skin (erythema nodosum)
• Burning sensation or tingling in the mouth or lips (inflammation of the mucosa, 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 side effects in children and adolescents

Cases of hypoglycemia (decreased blood glucose) have been reported, which may manifest with increased sweating, nausea, dizziness, confusion, etc., in children who received Mercaptopurina Aspen, of unknown frequency. However, most reported cases were in children under six years old and with low body weight.

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 leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: http://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, preferably in a locked cabinet. Accidental ingestion can be fatal for children.

Do not use this medication after the expiration date that appears 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 disposed of through drains or in the trash.Deposit the containers and medicines you no longer need at the SIGRE collection pointof the pharmacy. In case of doubtask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

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, cornstarch, modified cornstarch, stearic acid, and purified water.

Appearance of the product and contents of the packaging

Mercaptopurina Aspen are yellowish pale tablets, round, biconvex, scored on one side, with the imprint PT above the score and 50 below the score, without markings on the other side.

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

Packaging size: 25 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Aspen Pharma Trading Limited

3016 Lake Drive,

Citywest Business Campus,

Dublín 24, Ireland

Tel: 0034 952010137

Responsible for manufacturing

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, Office 4

08006 Barcelona

Spain

Last review date of this leaflet: December 2024

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