Mercaptopurine Aspen 50 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Mercaptopurine 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, 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 and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

Mercaptopurina Aspen contains the active substance mercaptopurine monohydrate. Mercaptopurine monohydrate belongs to a group of medicines called cytotoxic agents (also known as chemotherapy) and works 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 progressing disease that causes an increase in the number of new white blood cells. These new white blood cells are immature (not fully developed), so they cannot grow or function properly. As a result, they are unable to fight infections and may cause bleeding.

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

2. What you need to know before taking Mercaptopurina Aspen

Do not take Mercaptopurina Aspen:

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

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

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before taking Mercaptopurina Aspen:

• if you have recently received a vaccine or are due to be vaccinated, or if you have been vaccinated against yellow fever.
• while taking Mercaptopurina Aspen, vaccination (such as flu, mumps, BCG, etc.) is not recommended until your doctor advises it. This is because some vaccines may cause you an infection if administered while you are taking Mercaptopurina Aspen.
• if you have kidney or liver problems, as your doctor will need to check that these organs are functioning properly.
• if you have a condition causing 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 in cancer treatment).
• 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 condition classified as an inborn error of metabolism.
• 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 (IBD) 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 marketing authorization has not been obtained.

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

• tumors, including skin cancer. Therefore, while taking Mercaptopurina Aspen, avoid excessive sun exposure, wear protective clothing, and use high-protection-factor sunscreen.

• lymphoproliferative disorders

• treatment with Mercaptopurina Aspen increases your risk of developing a type of cancer called lymphoproliferative disorder and other malignant tumors. When treatment includes multiple immunosuppressants (including thiopurines), this may result in death.

  • the combination of multiple immunosuppressants administered simultaneously increases the risk of lymphatic system disorders due to viral infection (Epstein-Barr virus (EBV)-associated lymphoproliferative disorders).

If you are unsure whether any of the above situations apply 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 the number of white blood cells, platelets, and (less frequently) red blood cells in your blood may decrease. Your doctor will perform blood tests daily during the initial phase of your treatment (induction) and at least weekly during the later phase (maintenance). These tests monitor the levels of these cells in your blood. If you stop treatment early enough, your cell counts will return to normal.

Your doctor may request blood tests during treatment with Mercaptopurina Aspen to monitor blood cell counts. They may also request other genetic tests (for example, testing for TPMT and/or NUDT15 genes) before or during treatment to determine whether your genetic makeup may affect your response to the medicine. 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 may perform tests more frequently. If you notice yellowing of the whites of your eyes or your skin (jaundice), inform your doctor immediately, as treatment may need to be stopped promptly.

Pellagra

Inform your doctor immediately if you experience diarrhea, pigmented skin rash (dermatitis), or decreased memory, reasoning, or other thinking skills (dementia), as these symptoms may suggest vitamin B3 deficiency (nicotinic acid deficiency/pellagra). Your doctor may prescribe vitamin supplements (niacin/niacinamide) 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 may be more severe. See also section 4.

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

NUDT15 gene mutation

If you have an inherited mutation in the NUDT15 gene (a gene involved in breaking down Mercaptopurina Aspen in the body), you have a higher risk of infections and hair loss, and in this case your doctor may prescribe a lower dose.

Sun and ultraviolet light

When taking Mercaptopurina Aspen, you become more sensitive to sunlight and ultraviolet light. You should limit your exposure to sunlight and ultraviolet light, wear protective clothing, and use sunscreen with a high sun protection factor (SPF).

Children and adolescents

Occasionally, low blood sugar levels (excessive sweating, nausea, dizziness, confusion, etc.) have been observed in children, particularly in children under six years of age or with low body mass index. If this occurs, consult your child’s doctor.

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

Other medicines and Mercaptopurina Aspen

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

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

• ribavirin (used to treat viral infections). Concomitant use is not recommended, as it may cause severe myelosuppression (reduced blood cell formation).
• other cytotoxic medicines (chemotherapy – used to treat cancer).
• other medicines whose primary or secondary toxicity is myelosuppression (reduced blood cell formation).
• allopurinol, thiopurinol, oxipurinol, and febuxostat (used to treat gout).
• olsalazine or mesalazine (used to treat Crohn’s disease and an intestinal 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 blood levels of mercaptopurine.
• 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).
• antiepileptic medicines such as phenytoin, carbamazepine. Blood levels of antiepileptics may need to be monitored and the dose adjusted if necessary.
• 6-thioguanine (antineoplastic), as cross-resistance between the two medicines may occur.
• azathioprine if you have had an allergic reaction to mercaptopurine.

Vaccinations during treatment with Mercaptopurina Aspen

If you have recently received a vaccine or are due to be vaccinated, it is important to discuss this with your doctor or nurse beforehand. While taking Mercaptopurina Aspen, administration of vaccines containing live microorganisms (such as vaccines against polio, measles, mumps, and rubella) is not recommended until your doctor advises it. This is because some vaccines may cause you an infection if administered while you are taking Mercaptopurina Aspen.

Taking Mercaptopurina Aspen with food and drinks

You may take Mercaptopurina Aspen with food or on an empty stomach, but the chosen method should be consistent 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 Mercaptopurina Aspen if you are planning to have a child without first consulting your doctor. This applies to both men and women. Mercaptopurina Aspen may be harmful to sperm or eggs. You and your partner should use effective contraception to prevent pregnancy while either of you is taking Mercaptopurina Aspen. Both men and women should use effective contraception for at least 3 months after receiving the last dose of treatment. If you are already pregnant, inform your doctor before taking Mercaptopurina Aspen.

Mercaptopurina Aspen must not be handled by women who are pregnant, planning to become pregnant, or 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 or operate machinery. Mercaptopurine is not expected to affect your ability to drive or use machines. Consult your doctor or pharmacist.

Mercaptopurina Aspen contains lactose

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

3. How to take Mercaptopurine Aspen

Mercaptopurine Aspen must be prescribed only by a specialist doctor experienced in the treatment of various types of blood cancer.

• While taking Mercaptopurine Aspen, your doctor will perform periodic blood tests to monitor the number and types of blood cells and to ensure your liver is functioning properly.
• Your doctor may also request additional blood and urine tests to monitor 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 Mercaptopurine Aspen. Elevated uric acid levels can damage the kidneys.
• Your doctor may adjust your dose of Mercaptopurine Aspen based on the results of these tests.

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If in doubt, 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 daily.

Your doctor will calculate and adjust your dose based on your body weight, blood test results, whether you are taking other chemotherapy medicines, 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 must not be split or crushed. If you or your caregiver handle split tablets, you must wash your hands immediately.

Mercaptopurine with food and drink

You may take Mercaptopurine with food or on an empty stomach, but the chosen method should be consistent every day. You should take the medicine at least 1 hour before or 2 hours after consuming milk or dairy products.

It is important to take Mercaptopurine Aspen at night for optimal effectiveness of the medicine.

If you take more Mercaptopurine Aspen than you should

If you take more Mercaptopurine Aspen than prescribed, inform your doctor or go to a hospital immediately. You may experience nausea, vomiting, or diarrhea. Take the medicine pack and this leaflet with you. In case of overdose, call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Mercaptopurine Aspen

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

If you stop taking Mercaptopurine Aspen

Do not stop taking this medicine unless instructed by your doctor, as you may experience 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 everyone experiences them.

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

Allergic reaction, which may include the following signs:

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

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

Any unexpected bruising or bleeding, as this could indicate that your body is producing an insufficient number of certain types of blood cells.

Sudden feeling of being unwell (even if your temperature is normal), with abdominal pain and nausea, as this could be a sign of inflammation of the pancreas.

Yellowing of the whites of the eyes or skin (jaundice)

Contact your doctor if you experience any of the following adverse effects, which 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 (can be detected in blood tests)

Common (may affect up to 1 in 10 people)

• 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 – a condition called anemia
• loss of appetite
• inflammation of the pancreas (pancreatitis) in patients with inflammatory bowel disease

Uncommon (may affect up to 1 in 100 people)

• inflammation of the pancreas (pancreatitis)
• joint pain
• skin rash
• 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 causing facial swelling
• various types of cancer, including blood, lymphatic, and skin cancers
• inflammation of the pancreas (pancreatitis) in patients with leukemia (blood cancer)

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

• a different type of leukemia than 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)
• sensitivity to sunlight causing 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 cognitive functions
• decrease in blood clotting factors

Other adverse effects in children and adolescents

Cases of hypoglycemia (low blood glucose) have been reported in children treated with Mercaptopurina Aspen, with frequency not known. Hypoglycemia may present as excessive sweating, nausea, dizziness, confusion, etc. However, most of the reported cases occurred in children under six years of age and with low body weight.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: http://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Mercaptopurine Aspen

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Store below 25 ºC. Keep the bottle tightly closed to protect it from moisture.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point in your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Mercaptopurine Aspen

• The active substance 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 contents of the container

Mercaptopurine Aspen are pale yellow, round, biconvex tablets, scored on one side, with the imprint PT above the score and 50 below the score; the other side is unmarked.

Mercaptopurine Aspen is packed in amber glass bottles with high-density polyethylene child-resistant closures and induction heat-sealed liners.

Pack 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 most recent revision of this leaflet: December 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/