50 mg Tablets
Mercaptopurine

What Purimmun is and what it is used for

Purimmun contains the active substance 6-mercaptopurine.

6-mercaptopurine belongs to a group of medicines called cytotoxic drugs (also called cytostatics ). Purimmun is used to treat a certain type of cancer in the blood ( acute promyelocytic leukemia ). It works by reducing the number of new blood cells your body forms.

Mercaptopurine contained in Purimmun may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions

What you need to know before you use Purimmun

Do not use Purimmun

if you are allergic to 6-mercaptopurine or any of the other ingredients of this medicine (listed in section 6).

You should not be vaccinated with the yellow fever vaccine when you take Purimmun as it can be fatal.

Warnings and cautions

Talk to your doctor before taking Purimmun:

  • if you have recently been vaccinated or are about to be vaccinated
  • if you have a genetic disorder called TPMT deficiency (thiopurine methyltransferase)
  • if you are allergic to a medicine called azathioprine (also used to treat cancer)
  • if you have liver disease
  • if you have a genetic disorder called Lesch-Nyhan syndrome
  • if you are planning to have children. This applies to both men and women. Purimmun can damage sperm or egg cells (see section “Pregnancy, breastfeeding and fertility” below).
  • if you have impaired kidney function.

The tablets should be handled with care.

Women who are pregnant, planning to become pregnant, or breastfeeding should not take Purimmun. See “Safe handling of tablets” in section 3 “How to take Purimmun”.

Taking immunosuppressive therapy and taking Purimmun may increase your risk of:

  • tumor er, including skin cancer. When taking Purimmun, you should therefore avoid excessive sunbathing as well as wear protective clothing and use sunscreen with a high protection factor.
  • lymphoproliferative disorders.- Treatment with Purimmun increases your risk of developing a type of cancer called a lymphoproliferative disorder. During treatment regimens that contain several immunosuppressive drugs (including thiopurines), this can lead to death- A combination of several concomitant immunosuppressive drugs increases the risk of disorders of the lymphatic system due to a viral infection (lymphoproliferative disorders associated with Epstein-Barr virus ( EBV )).

Taking Purimmun may increase your risk of:

  • development of 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.

Blood tests

Purimmun can affect your bone marrow. Your doctor will take blood samples every day at the beginning of your treatment and at least once a week later in your treatment (maintenance). This is to monitor the levels of these blood cells in your blood. After treatment, the number of blood cells in your blood will return to normal.

Liver function

When you take Purimmun, your doctor will take regular blood tests. This is to check the number and type of cells in the blood and to ensure that the liver is functioning properly.

Infection is

When you take Purimmun you may be at increased risk of infection. Infections can also be more severe than in people who have not been treated with Purimmun. Tell your doctor immediately if you suspect you have an infection.

NUDT15 gene mutation

If you have a hereditary mutation in the NUDT15 gene (a gene that is involved in the breakdown of Purimmun in the body), then the risk is higher for you to get infection and hair loss and in this case, the doctor can give you a lower dose.

Sun and UV light

During your treatment with Purimmun, you are more sensitive to sun and UV light. You need to make sure you limit your exposure to sunlight and UV light, wear protective clothing, and use sunscreen with a high sun protection factor. If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Purimmun.

Other medicines and Purimmun

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)
  • other chemotherapy drugs (used to treat cancer)
  • allopurinol, thiopurine, oxypurinol, or febuxostat (used mainly to treat gout )
  • olsalazine (used to treat intestinal ulcerative colitis )
  • mesalazine (used to treat intestinal diseases Crohn’s disease and ulcerative colitis )
  • sulfasalazine (used to treat rheumatoid arthritis or ulcerative colitis )
  • methotrexate (used mainly to treat cancer)
  • infliximab (used to treat intestinal diseases Crohn’s disease and ulcerative colitis, rheumatoid arthritis, inflammation of the spine ( ankylosing spondylitis ), or severe psoriasis (skin disease))
  • warfarin or acenocoumarol (blood thinner).

Vaccination

If you are going to be vaccinated during or after treatment, talk to your doctor or nurse beforehand. The reason for this is that some vaccines (such as the polio vaccine and MPR vaccine [measles, mumps, and rubella]) can lead to an infection if given before your immune system has recovered.

You should not be vaccinated with the yellow fever vaccine when you take Purimmun as it can be fatal.

Purimmun with food, drink, and alcohol

You can take Purimmun with food or on an empty stomach, but the method you choose should be the same from day today. You should take Purimmun at least 1 hour before or 2 hours after consuming milk or milk products.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.

Purimmun treatment is not recommended during pregnancy, especially during the first three months of pregnancy, as it may cause permanent birth defects.

If you are pregnant, your doctor will consider the risks and benefits to you and your baby before prescribing Purimmun to you.

Do not take Purimmun if you are planning to have children. This applies to both men and women. If you or your partner are being treated with Purimmun, you must use an effective contraceptive to avoid pregnancy during and at least 3 months after stopping treatment with Purimmun.

Purimmun should not be used during breastfeeding. If you have any further questions, ask your doctor, pharmacist, or midwife.

Driving and using machines

There are no data on the effect of 6-mercaptopurine on the ability to drive and use machines. No effect on the ability to perform these activities can be predicted based on the pharmacological properties of the drug.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Purimmun contains Lactose

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

How to use Purimmun

Purimmun should only be prescribed to you by a specialist doctor who has experience in the treatment of blood diseases.

  • During treatment with Purimmun, your doctor will take regular blood tests. This is to check the number and type of cells in the blood and to ensure that the liver is functioning properly.
  • Your doctor may also prescribe other blood and urine tests to check your uric acid levels. Uric acid is a natural substance that is formed in the body and the levels of uric acid can rise during treatment with Purimmun.
  • Your doctor may change your dose of Purimmun depending on the results of these tests.

Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

Your doctor will calculate and adjust your dose based on your body weight or body surface area, the results of your blood tests, if you are taking other chemotherapy drugs, and your kidney and liver function.

Swallow the tablets whole with a little water. You can take your medicine with food or on an empty stomach, but the way you choose should be the same from day today. You should take Purimmun at least 1 hour before or 2 hours after consuming milk or milk products. The tablets should be taken in the evening.

Safe handling of Purimmun tablets

If you are a parent or caregiver giving the medicine, wash your hands before and after giving a dose. Spilled tablets should be cleaned immediately. To reduce the risk of exposure, wear disposable gloves when handling Purimmun.

If Purimmun comes in contact with the skin, eyes, or nose, rinse immediately with plenty of soap and water.

Women who are pregnant, planning to become pregnant, or breastfeeding should not take Purimmun.

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

If you use more Purimmun than you should 

If you have ingested too much medicine or if e.g. a child ingested the medicine accidentally contact a doctor or hospital for risk assessment and advice.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

If you forget to use Purimmun

If you miss a dose, tell your doctor. Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Possible side effects

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

If you get any of the following side effects, talk to your specialist doctor or hospitalize immediately:

  • An allergic reaction with swelling of the face and in some cases mouth and throat (this is a very rare side effect )
  • An allergic reaction with joint pain, rash, fever (this is a rare side effect )
  • Yellow-colored skin or yellow-colored whites of the eyes. If you get any of these symptoms, stop taking Purimmun.
  • Signs of fever or infection (that you feel very tired or unwell, have a sore throat, sore mouth or have difficulty urinating) or unexplained bruising or bleeding. Treatment with Purimmun affects the bone marrow and causes a decrease in white blood cells and platelets (this is a very common side effect ). 

Talk to your doctor if you experience any of the following side effects, which may also occur with this medicine:

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

  • Decreased number of white blood cells and platelets (seen in blood samples)

Common (may affect up to 1 in 10 people)

  • Nausea or vomiting
  • Low red blood cell count ( anemia )
  • Liver damage seen in blood tests

Uncommon (may affect up to 1 in 100 people) 

  • Loss of appetite
  • Infection, general malaise, the tendency to sore throat, and fever. This can be serious. If you get a fever, contact a doctor or emergency room.

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

  • Cold sores
  • Inflammation of the pancreas ( pancreatitis ), with symptoms such as abdominal pain, nausea, or vomiting
  • Severe liver damage (liver necrosis)
  • Hair loss
  • Different cancers include cervical, lymph, and skin cancer and cancer of the body’s supporting tissue
  • Joint pain, rash, fever due to hypersensitivity

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

  • Blood cancer ( leukemia )
  • Cancer of the liver and spleen (in patients with a disease called inflammatory bowel disease)
  • Sores in the intestines, with symptoms such as abdominal pain and bleeding
  • Low sperm count in men
  • Swollen face due to hypersensitivity

Has been reported (occurs in an unknown number of users) 

  • Increased sensitivity to sunlight and UV light

Additional side effects in children and adolescents

In some children treated with Purimmun, low blood sugar levels, with symptoms such as more sweating than usual, nausea, dizziness, and confusion, have been reported. Most of these children were younger than 6 years old and had a low body weight.

Reporting of side effects ar

If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly (see details below). By reporting side effects, you can help increase drug safety information.

The Medical Products Agency

Box 26

751 03 Uppsala

www.lakemedelsverket.se 

How to store Purimmun

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

Do not use this medicine after the expiry date which is stated on the can after EXP. The expiration date is the last day of the specified month.

Any unused product or waste material should be disposed of by local requirements for the handling and destruction of cytotoxic drugs.

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

Store in the original glass jar. Sensitive to light.

Contents of the pack and other information

Content declaration

The active substance is 6-mercaptopurine. One tablet contains 50 mg mercaptopurine.

Other ingredients are:

lactose

corn starch

pregelatinized starch

stearic acid

magnesium stearate     

What the medicine looks like and the contents of the pack

Purimmun is round, yellowish tablets, 6 mm.

The tablets are packaged in a brown glass jar with a child-resistant propylene seal and silica gel.

Pack sizes:

25 tablets, 50 (2×25) tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

2care4 Generics ApS

Stenhuggervej 12-14

6710 Esbjerg V

Denmark

Manufacturer

Idifarma Desarrollo Pharmacéutico SL

Polígono Mocholi, C / Noain, n ° 1 de Noaín

31110, Navarre, Spain

Muhammad Nadeem

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