Prospect: information for the patient

Mercaptopurina Silver 50 mg tablets

Read this prospect carefully before starting to take this medicine,because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult yourdoctor or pharmacist.

-This medicine has been prescribedonlyto you, and you must not give it to other people even iftheyhave the same symptomsas you,as it may harm them.

• If you experience any adverse effects,consult your doctor or pharmacist, evenifthey are not listed in this prospect. See section 4.

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

2.What you need to know beforestartingto take Mercaptopurina Silver

3.How to take Mercaptopurina Silver

4.Possible adverse effects

5Storage of Mercaptopurina Silver

6 Contents of the package and additional information

Mercaptopurina Silver contains an active ingredient called mercaptopurine monohydrate.It belongs to a group of medicines called cytotoxics (also known as chemotherapy). Mercaptopurine is used to treat leukemia (blood cancer). It works by reducing the number of new blood cells produced by your body.

Mercaptopurine is used for:

• Acute myeloid leukemia (also known as acute myeloid leukemia 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 as acute lymphocytic leukemia or ALL) - a rapidly growing disease that increases the number of immature white blood cells. These immature white blood cells are unable to grow and function correctly. Therefore, they cannot fight infections and may cause bleeding.

Do not take Mercaptopurina Silver:

• if you are allergic to mercaptopurine or any of the other components of this medication (listed in section 6).
• if you have recently received the yellow fever vaccine while taking mercaptopurine, because it can be fatal.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Mercaptopurina Silver if:

• you have been vaccinated against yellow fever.
• you have kidney or liver problems; your doctor will monitor your renal and hepatic function.
• you have a disease in which your body produces insufficient amounts of an enzyme called TPMT (thiopurine methyltransferase), as your doctor may need to adjust your dose.
• 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 6-mercaptopurine, a rare and aggressive type of cancer called T-cell lymphoma of the liver and spleen has appeared (see section 4).

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

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

• lymphoproliferative disorders

Infections

When receiving treatment with Mercaptopurina Silver, the risk of developing 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 or not varicella, 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 Mercaptopurina Silver 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.

Vitamin B3 deficiency (pellagra)

Inform your doctor immediately if you have diarrhea, localized pigmented rashes (dermatitis), or deterioration of memory, reasoning, and thinking ability (dementia), as these symptoms may indicate a vitamin B3 deficiency. Your doctor will prescribe vitamin supplements (niacin/nicotinamide) to improve your condition.

Taking Mercaptopurina Silver may increase your risk of:

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

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

Taking Mercaptopurina Silver with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including those purchased without a prescription.

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

• other cytotoxic drugs (chemotherapy) - when used with mercaptopurine, there is a higher likelihood of side effects, such as respiratory problems
• other medications whose primary or secondary toxicity is myelosuppression
• allopurinol, oxipurinol, or tiopurinol (used to treat gout)
• warfarin (used to thin the blood)
• olsalazine or mesalazine (used for a bowel condition called ulcerative colitis)
• sulfasalazine (used for rheumatoid arthritis or ulcerative colitis)
• Antiepileptic drugs such as phenytoin or carbamazepine. You may need to monitor blood levels of antiepileptic drugs and adjust the dose as necessary.
• 6-thioguanine (antineoplastic), as there is cross-resistance between both medications
• ribavirin, cases of severe myelosuppression have been reported after concurrent administration with mercaptopurine
• methotrexate, (used to treat cancer, rheumatoid arthritis, or skin diseases [severe psoriasis]). Oral administration of methotrexate increases the blood concentration of mercaptopurine
• infliximab (used to treat certain bowel diseases [Crohn's disease and ulcerative colitis], rheumatoid arthritis, ankylosing spondylitis, or skin diseases [severe psoriasis])

If you are to be vaccinated while taking mercaptopurine, it is essential to consult with your doctor or nurse beforehand. This is because some vaccines (such as polio, measles, mumps, and rubella) may cause infection if given while taking mercaptopurine.

Taking Mercaptopurina Silver with food and drinks

Mercaptopurine Silver can be taken with food or on an empty stomach. However, the chosen method must be the same every day.

Do not take mercaptopurine with milk or dairy products, as they may reduce the effectiveness of the medication. Mercaptopurine Silver should be taken at least 1 hour before or 3 hours after consuming milk or dairy products.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy:

If you are planning to have a baby, do not take mercaptopurine. This applies to both men and women. Mercaptopurine may be harmful to sperm or eggs. You should take effective contraceptive precautions to avoid pregnancy while you or your partner are taking this medication. Consult your doctor.

If you are already pregnant, inform your doctor before taking mercaptopurine.

Taking Mercaptopurina Silver during pregnancy may cause intense and excessive itching without a skin rash. You may also experience nausea and loss of appetite at the same time, which may indicate a condition called cholestasis of pregnancy (a liver disease during pregnancy). Speak with your doctor immediately, as this condition may cause harm to the fetus.

Breastfeeding:

It is not recommended to breastfeed while taking mercaptopurine. Consult your doctor, pharmacist, or midwife.

Driving and operating machinery

Mercaptopurine is not expected to affect your ability to drive or operate machinery, although no studies have been conducted to confirm this.

Mercaptopurina Silver contains lactose and sodium

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

This medication contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially 'sodium-free'.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist.This medication should be administered exactly as directed.Consult your doctor or pharmacist again if you are unsure.In case of doubt, consult your doctor or pharmacist again.

Mercaptopurina should be administered only by a specialist doctor with experience in treating blood diseases.

• Swallow the tablets whole with a glass of water.
• If you need to break the tablet in two, do not inhale the powder from the tablet. Then, wash your hands.
• When taking Mercaptopurina Silver, your doctor will periodically perform blood tests to verify the number and type of cells present in your blood and to also check that your liver is functioning correctly.
• Your doctor may also ask you to undergo other blood and urine tests to monitor your uric acid concentration. Uric acid is a natural chemical in the body, but its concentrations may rise during treatment with Mercaptopurina Silver..
• Your doctor may adjust your Mercaptopurina Silver dose based on the results of these tests.

The usual initial dose in adults, adolescents, and children is 25-75 mg/m2of body surface area per day. Your doctor will prescribe the correct dose for you. In some cases, your doctor may change your Mercaptopurina Silver dose based on the results of different tests. Consult your doctor or nurse if you have any doubts about the dose you should take.

It is essential to take Mercaptopurina Silver at night for the medication to be more effective.

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

If you take more Mercaptopurina Silver than you should

If you take more Mercaptopurina Silver than you should, inform your doctor or go to the hospital immediately. You may experience nausea, vomiting, or diarrhea. Carry the medication packaging and this leaflet with you.

In case of overdose, call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Mercaptopurina SilverMercaptopurina Silver

Inform your doctor.

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

If you interrupt treatment with Mercaptopurina Silver

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

If you have any other questions about the use of 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 rashes
• high temperature
• joint pain
• facial swelling
• skin nodules (erythema nodosum)

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 cells.

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

Yellow discoloration of the white part of the eyes or skin (jaundice).

If you have diarrhea.

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

Very frequent may affect more than 1 in 10 people

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

Frequent: 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 - a disease called anemia
• loss of appetite
• diarrhea
• inflammation of the mouth (stomatitis)

Rare: may affect up to 1 in 100 people

• mouth ulcers
• pancreatitis inflammation
• joint pain
• skin rash
• fever
• permanent liver damage (hepatic necrosis)

Rare: may affect up to 1 in 1,000 people

• hair loss
• in men: temporary decrease in sperm count
• facial swelling
• various types of cancer, including blood, lymphatic and skin cancers.

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

• a type of leukemia different from the one being treated
• intestinal ulcers

Other side effects (unknown frequency)

• a rare type of cancer (hepatosplenic T-cell lymphoma), (see Section 2)).
• skin nodules (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 thinking abilities
• decrease in coagulation factors

Other side effects in children

-low blood sugar (hypoglycemia); unknown frequency

If you consider that any of the side effects you are experiencing are severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, 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: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children,preferably in a closed cabinet with a lock.Accidental ingestion can be fatal for children.

Do not usethis medicationafter the expiration date that appears onthe blister pack or in the boxafter CAD:. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. Ask your pharmacist how to dispose of packaging and medications you no longer need. This will help protect the environment.

Composition of Mercaptopurina Silver

• The active ingredient ismercaptopurine (as monohydrate). Each tablet contains 50 mg of mercaptopurinemonohydrate.

- The other components(excipients)are:microcrystalline cellulose, povidone, sodium croscarmellose, lactose monohydrate, magnesium stearate, and stearic acid..

Appearance of the product and content of the packaging

Mercaptopurina Silver are yellowish circular tablets

Packaging size: 24 or 25 tablets.

Only some packaging sizes may be commercially marketed.

In the 24-tablet presentation, Mercaptopurina Silver is packaged in two Alu-PVC or ALU/PVC-PVDC blisters of 12 tablets each, inside a cardboard case.

In the 25-tablet presentation, Mercaptopurina Silver is packaged in a single Alu-PVC or ALU/PVC-PVDC blister of 25 tablets, inside a cardboard case.

Holder of the marketing authorization

SILVER PHARMA S.L.

Avda. Camino de lo Cortao 16

28703 San Sebastian de los Reyes, (Madrid)

Spain

Responsible for manufacturing

Revision date of thisleaflet: August 2024

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