Consumer medicine information

Allmercap 20 mg/mL Oral suspension

Mercaptopurine monohydrate

BRAND INFORMATION

Brand name

Allmercap

Active ingredient

Mercaptopurine monohydrate

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Allmercap 20 mg/mL Oral suspension.

1. Why am I using ALLMERCAP®?


ALLMERCAP® contains mercaptopurine monohydrate as the active ingredient. ALLMERCAP® is used solely or in combination with other medicines to treat acute leukaemia, a cancer of certain blood cells.
For more information, see Section 1. Why am I using ALLMERCAP®? in the full CMI.

2. What should I know before I take ALLMERCAP®?


Do not use if you have ever had an allergic reaction to mercaptopurine monohydrate or any of the oral liquid suspension ingredients listed at the end of this CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines, have received the yellow fever vaccine, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I take ALLMERCAP®? in the full CMI.

3. What if I am taking other medicines?


Some medicines may be affected by ALLMERCAP® or may affect how well 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 take ALLMERCAP®

  • ALLMERCAP® is taken in the evening as an oral liquid suspension.
  • Your doctor will decide what dose and for how long you will be taking ALLMERCAP® depending on factors such as your age and weight, pre-existing 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 take ALLMERCAP®? in the full CMI.

5. What should I know while taking ALLMERCAP®?

Things you must do
  • Tell your doctor if, for any reason, you have not taken your medicine exactly as directed.
  • Tell any other specialist, doctor, dentist or pharmacist that you are on ALLMERCAP®.
  • Tell your doctor if you become pregnant, are trying to become pregnant or trying to father a child.
  • Use a sunscreen with a high SPF and protective clothing and limit exposure to sunlight and UV light.
Things you must not do
  • Do not give this medicine to anyone else, even if their symptoms seem similar to yours.
  • Do not use ALLMERCAP® to treat any other complaints unless your doctor says to.
Driving or using machines
  • Be careful driving or operating machinery until you know how ALLMERCAP® affects you.
Looking after your medicine
  • Keep it in a cool, dry place, protected from light, where the temperature stays below 25°C.
  • Do not leave it in a car, on window sills, near a sink or in the bathroom.
  • Keep it where children cannot reach it.

For more information, see Section 5. What should I know while taking ALLMERCAP®? in the full CMI.

6. Are there any side effects?


If you get any of the following side effects, tell your doctor immediately or go to Accident and Emergency at your nearest hospital: wheezing, swelling of the lips/mouth, difficulty in breathing, lumpy rash (hives), fainting, sudden abdominal pain with nausea and vomiting.
Tell your doctor if you notice any of the following: nausea and vomiting, diarrhoea, fever, severe chills, sore throat or mouth ulcers, bruising or bleeding more easily than normal, loss of appetite and/or weight loss, jaundice, tiredness, headache, shortness of breath, dizziness, looking pale, painful/swollen joints, skin rash, hair loss, skin nodules.
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

Allmercap

Active ingredient

Mercaptopurine monohydrate

Schedule

S4

 

1 Name of Medicine

Mercaptopurine monohydrate.

2 Qualitative and Quantitative Composition

Allmercap oral liquid suspension contains 20 mg/mL mercaptopurine monohydrate.
Excipients with known effect. Hydroxybenzoates, sorbates, and aspartame.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Allmercap is a pink/brown oral liquid suspension.

4 Clinical Particulars

4.9 Overdose

For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).
Symptoms. Gastrointestinal effects, including nausea, vomiting, 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.
The risk of overdosage is also increased when allopurinol is being given concomitantly with mercaptopurine. 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 overdose unless the procedure can be undertaken within 60 minutes of ingestion.

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Mercaptopurine in common with other anti-metabolites is potentially mutagenic and chromosome damage has been reported in rats and humans.
Carcinogenicity. Given its genotoxic potential, mercaptopurine is potentially carcinogenic. See Section 4.4, Carcinogenicity.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Mercaptopurine monohydrate is odourless or practically odourless, yellow crystalline powder, with a solubility of 0.26 mg/mL in water at 37°C.
The chemical name of mercaptopurine monohydrate is 1,7-dihydro-6H-purine-6-thione hydrate.
Relative molecular mass: 170.2.
Molecular formula: C5H4N4S.H2O.
Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSMERMON.gif CAS number. 6112-76-1 (monohydrate).

7 Medicine Schedule (Poisons Standard)

S4 - Prescription Only Medicine.

Summary Table of Changes

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