50 mg tablets
6-mercaptopurine 

What Puri-nethol is and what it is used for

Purinethol contains the active substance 6-mercaptopurine. 6-mercaptopurine belongs to a group of medicines called cytotoxic drugs (also called cytostatics ) and works by reducing the number of new blood cells that your body produces.

Purinethol is used to treat cancer of the blood ( leukemia ) in adults, adolescents, and children.

What you need to know before you take Puri-nethol

Do not take Purinethol:

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

Warnings and cautions

Talk to your doctor or pharmacist before taking Puri-nethol:

  • if you have recently been or will be vaccinated. If you are being treated with Puri-nethol, you should not be vaccinated with a live vaccine (such as the flu vaccine, measles vaccine, and BCG vaccine) until your doctor tells you it is safe. This is because some vaccines can lead to an infection if you are vaccinated while you are being treated with Purinethol.
  • if you have impaired liver function or liver damage.
  • 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 impaired kidney function.
  • Tell your doctor if you have, or have not, had chickenpox, shingles, or hepatitis B (a liver disease caused by a virus ).
  • if you have a genetic disorder called Lesch-Nyhan syndrome.

Taking immunosuppressive therapy and taking Puri-nethol may increase your risk of:

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

Taking Puri-nethol 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

Purinethol treatment can affect your bone marrow. This means that you may have a reduced number of white blood cells, platelets, and (less commonly) red blood cells in your blood. Your doctor will take blood samples every day at the beginning of your treatment ( induction ) and at least once a week later in your treatment (maintenance). This is to monitor the levels of these blood cells in your blood. If the treatment is stopped in time, the number of blood cells in your blood will return to normal.

Other laboratory samples

Additional laboratory tests (such as urine and blood) may also be taken as directed by your doctor.

Liver function

Purinethol is toxic to the liver. Therefore, your doctor will take liver function tests every week while you are being treated with Purinethol. If you already have liver disease, or if you are taking other medicines that may affect your liver, your doctor will take samples more often. Talk to your doctor immediately if you notice that the whites of the eyes or your skin turn yellow. This is a sign of jaundice and you may need to stop your treatment immediately.

Infection is

When you are treated with Puri-nethol, the risk of viral, fungal, and bacterial infections increases, and the infections can be more serious. See also section 4.

Tell your doctor before starting treatment if you have had chickenpox, shingles, 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 that is involved in the breakdown of Puri-nethol 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 Puri-nethol, you are more sensitive to the 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.

Children and young people

In some children treated with Puri-nethol, 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.

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Purinethol.

Other medicines and Puri-nethol

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 viruses )
  • other chemotherapy drugs (used to treat cancer)
  • allopurinol, thiopurine, oxypurinol, or febuxostat (used 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 intestinal ulcerative colitis )
  • methotrexate (is used to treat rheumatoid arthritis or severe psoriasis (skin disease)
  • 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 during treatment with Puri-nethol

Talk to a doctor or nurse before vaccination. If you are being treated with Puri-nethol, you should not be vaccinated with a live vaccine (such as the flu vaccine, measles vaccine, and BCG vaccine) until your doctor tells you it is safe. This is because some vaccines can lead to an infection if you are vaccinated while you are being treated with Purinethol.

Purinethol with food and drink

You can take Puri-nethol with food or on an empty stomach, but the method you choose should be the same from day today. You should take Puri-nethol 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 using this medicine.

Pregnancy

Purinethol treatment is not recommended during pregnancy, especially during the first three months of pregnancy, as it may cause birth defects. If you are pregnant, your doctor will consider the risks and benefits to you and your baby before prescribing Puri-nethol to you.

If you or your partner are being treated with Puri-nethol, you must use an effective method of contraception to avoid pregnancy during and at least 3 months after stopping treatment with Purinethol.

This applies to both men and women.

Breast-feeding

Purinethol should not be used during breastfeeding. 

Driving and using machines

Purinethol is not expected to affect the ability to drive or use machines, but no studies have been performed to confirm this.

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. Descriptions 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.

Purinethol 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.

3. How to take Puri-nethol

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

  • During treatment with Puri-nethol, your doctor will take regular blood tests. This is to check the number and type of cells in the blood and to check that your liver is functioning properly.
  • Your doctor may also prescribe other blood and urine tests to check how your kidneys are working and to measure 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 Purinethol. High levels of uric acid can damage the kidneys.
  • Your doctor may change your dose of Puri-nethol 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. You must take your medicine at the right time. The label on the package contains information on how many tablets to take and how often to take them. Consult a doctor, nurse, or pharmacist if the label lacks this information or if you are unsure.

The recommended dose for adults and children is 2.5 mg per kilogram body weight per day (or 50 to 75 mg per square meter (m 2 ) body surface area per day). Your doctor will calculate and adjust your dose based on your body weight, 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. The tablets should not be split or crushed. Do not chew the tablets either. If you or your caregiver handle broken tablets, wash your hands immediately afterward. You must know how to handle this medicine safely.

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 Puri-nethol at least 1 hour before or 2 hours after consuming milk or milk products.

If you take more Puri-nethol than you should:

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

If you forget to take Puri-nethol:

Talk to a doctor. Do not take a double dose to make up for a forgotten dose.

If you stop taking Purinethol

Talk to your doctor immediately if you stop taking Purinethol.

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

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 experience any of these symptoms, stop taking Purinethol.
  • Signs of fever or infection (sore throat, sore mouth, or difficulty urinating) or unexplained bruising or bleeding. Treatment with Puri-nethol 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:

Common (may affect up to 1 in 10 people)

  • Nausea or vomiting
  • Low red blood cell count ( anemia )

Uncommon (may affect up to 1 in 100 people)

  • Loss of appetite

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
  • Liver damage (liver necrosis)
  • Hair loss
  • Different types of cancer, including blood, lymph, and skin cancers

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

  • Blood cancer
  • Cancer of the spleen and liver (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

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

  • Increased sensitivity to sunlight and UV light

Additional side effects are in children

In some children treated with Puri-nethol, 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.

How to store Puri-nethol

Sensitive to light. Moisture sensitive. Store in the original package.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton.

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.

Contents of the pack and other information

Content declaration

The active substance is 6-mercaptopurine 50 mg per tablet

The other ingredients are stearic acid, lactose monohydrate magnesium stearate, corn starch, and modified corn starch.

What the medicine looks like and the contents of the pack

Purinethol tablets are yellow with a notched, imprinted PT / 50 on one side.

The tablets are supplied in a glass jar containing 25 tablets.

Marketing Authorization Holder and Manufacturer

Aspen Pharma Trading Limited

3016 Lake Drive,

Citywest Business Campus

Dublin 24, Ireland

+46 856 642 572

Manufacturer:

Excella GmbH & Co. KG

Nürnberger Strasse 12,

90537 Moisture,

Germany

Aspen Bad Oldesloe GmbH

Industriestrasse 32-36

23843 Bad Oldesloe

Germany

Muhammad Nadeem

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