Consumer medicine information

Mercaptopurine-Link 50 mg Tablets

Mercaptopurine monohydrate

BRAND INFORMATION

Brand name

Mercaptopurine-Link

Active ingredient

Mercaptopurine monohydrate

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Mercaptopurine-Link 50 mg Tablets.

1. Why am I using MERCAPTOPURINE-LINK?


MERCAPTOPURINE-LINK contains the active ingredient mercaptopurine monohydrate. MERCAPTOPURINE-LINK is used to treat acute leukaemia, a cancer of certain blood cells.
For more information, see Section 1. Why am I using MERCAPTOPURINE-LINK? in the full CMI.

2. What should I know before I use MERCAPTOPURINE-LINK?


Do not use if you have ever had an allergic reaction to MERCAPTOPURINE-LINK, the active ingredient mercaptopurine, or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions or take any other medicines. Do not take MERCAPTOPURINE-LINK if you are planning to become pregnant or father a child, or if you are already pregnant or breastfeeding until you have discussed the risk and benefits with your doctor.
Tell your doctor if you are allergic to azathioprine, a medicine used to suppress the immune system.
For more information, see Section 2. What should I know before I use MERCAPTOPURINE-LINK? in the full CMI.

3. What if I am taking other medicines?


Some medicines may interfere with MERCAPTOPURINE-LINK and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use MERCAPTOPURINE-LINK?

  • Take MERCAPTOPURINE-LINK exactly as directed by your doctor.

Your doctor will decide what dose and for how long you will be taking MERCAPTOPURINE -LINK depending on factors such as your age and weight, medical condition, whether you are taking any other medications, and your response to treatment.
More instructions can be found in Section 4. How do I use MERCAPTOPURINE-LINK? in the full CMI.

5. What should I know while using MERCAPTOPURINE-LINK?

Things you should do
  • Remind any doctor, dentist or pharmacist you visit that you are using MERCAPTOPURINE-LINK.
  • Tell your doctor if for any reason you have not taken your medicine exactly as directed.
  • Visit your doctor regularly so they may monitor your condition and the effectiveness of medicine.
  • Tell your doctor if you become pregnant, are trying to become pregnant or trying to father a child.
Things you should not do
  • Do not stop using this medicine or change the dose without consulting your doctor.
  • Do not take a double dose to make up for the one you have missed.
Driving or using machines
  • Be careful driving or operating machinery until you know how MERCAPTOPURINE-LINK affects you.
Looking after your medicine
  • Store below 25°C, keep dry and protect from light.
  • Keep out of reach of children.

For more information, see Section 5. What should I know while using MERCAPTOPURINE-LINK? in the full CMI.

6. Are there any side effects?


Side effects of this medicine include: A reduced number of red cells, white cells or platelets in the blood, which can be measured by a blood test; nausea; vomiting; liver problems. Side effects that require urgent medical attention include: Signs of an allergic reaction, such as chest tightness, difficulty breathing, swelling of face lips and tongue, rash; frequent infections such as fever, severe chills, sore throat or mouth ulcers, bruising or bleeding more easily than normal, weight loss, jaundice, a yellowing of the whites of the eyes or the skin, painful, swollen joints, skin rash.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

BRAND INFORMATION

Brand name

Mercaptopurine-Link

Active ingredient

Mercaptopurine monohydrate

Schedule

S4

 

1 Name of Medicine

Mercaptopurine monohydrate.

2 Qualitative and Quantitative Composition

Mercaptopurine-Link tablets contain 50 mg mercaptopurine monohydrate.
Mercaptopurine monohydrate is odourless or practically odourless, yellow crystalline powder, with a solubility of 0.26 mg/mL in water at 37°C.
Contains anhydrous lactose.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Tablets, uncoated and scored on one side. The score line is not intended for breaking the tablet.

4 Clinical Particulars

4.9 Overdose

Gastrointestinal effects, including nausea, vomiting and diarrhoea and anorexia may be early symptoms of overdosage having occurred. The principal toxic effect is on the bone marrow and haematological toxicity is likely to be more profound with chronic overdosage than with a single ingestion of Mercaptopurine-Link.
The risk of overdosage is also increased when allopurinol is being given concomitantly with Mercaptopurine-Link. Liver dysfunction and gastroenteritis may also occur.
Treatment. As there is no known antidote blood counts should be closely monitored and general supportive measures, together with appropriate blood transfusion, instituted if necessary. Active measures (such as the use of activated charcoal) may not be effective in the event of mercaptopurine monohydrate overdose unless the procedure can be undertaken within 60 minutes of ingestion.
Further management should be as clinically indicated. For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. See Section 4.4 Special Warnings and Precautions for Use, Carcinogenesis and mutagenesis.
Carcinogenicity. See Section 4.4 Special Warnings and Precautions for Use, Carcinogenesis and mutagenesis, Carcinogenicity.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

The chemical name of mercaptopurine monohydrate is 6H-purine-6-thione, 1,7- dihydro-, monohydrate, it has a relative molecular mass of 170.2, its molecular formula is C5H4N4S.H2O, (monohydrate) and the chemical structure is:
Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSMERMON.gif CAS number. 6112-76-1.

7 Medicine Schedule (Poisons Standard)

S4 (Prescription only medicine).

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/MERLNKST.gif