ALLMERCAP

Main information

  • Trade name:
  • ALLMERCAP mercaptopurine monohydrate 20mg/mL oral liquid suspension bottle
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ALLMERCAP mercaptopurine monohydrate 20mg/mL oral liquid suspension bottle
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 213881
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

213881

ALLMERCAP mercaptopurine monohydrate 20mg/mL oral liquid suspension bottle

ARTG entry for

Medicine Registered

Sponsor

Link Medical Products Pty Ltd T/A Link Pharmaceuticals

Postal Address

PO Box 718,Mona Vale, NSW, 1660

Australia

ARTG Start Date

16/06/2014

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. ALLMERCAP mercaptopurine monohydrate 20mg/mL oral liquid suspension bottle

Product Type

Single Medicine Product

Effective date

7/12/2016

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

ALLMERCAP oral liquid suspension is indicated for:

Treatment of Acute Lymphoblastic Leukaemia (ALL) in paediatric patients.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Bottle

Glass Type III

Coloured

1 Years

Store below 25

degrees Celsius

Not recorded

Protect from Light

Pack Size/Poison information

Pack Size

Poison Schedule

1 x 100mL bottle

(S4) Prescription Only Medicine

Components

1. ALLMERCAP mercaptopurine 20mg/mL oral liquid suspension bottle

Dosage Form

Oral Liquid, suspension

Route of Administration

Oral

Visual Identification

A pink brown viscous suspension

Active Ingredients

mercaptopurine monohydrate

20 mg/mL

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 26.11.2017 at 10:47:33 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

Patient Information leaflet

ALLMERCAP CMI

Page 1

ALLMERCAP

®

mercaptopurine 20 mg/mL oral suspension

Consumer Medicine Information (CMI)

What is in this leaflet

This leaflet answers some common questions about ALLMERCAP

. It does not contain all of the

available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking

ALLMERCAP

against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine.

You may need to read it again.

What ALLMERCAP® is used for

ALLMERCAP

contains mercaptopurine as the active ingredient. It belongs to a group of medicines

called cytotoxics (also called chemotherapy).

ALLMERCAP

is used solely or in combination with other medicines to treat acute leukaemia, a cancer

of certain blood cells.

It works by interfering with the growth of cancer cells.

Ask your doctor if you have any questions about why ALLMERCAP

®

has been prescribed for you.

Your doctor may have prescribed it for another purpose. This medicine is only available with a doctor's

prescription.

There is no evidence that it is addictive.

Before you take it

When you must not take it

Do not take ALLMERCAP

®

if you have ever had an allergic reaction to:

mercaptopurine

any of the oral suspension ingredients listed at the end of this leaflet.

Symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty in breathing;

swelling of the face, lips, tongue or any other parts of the body; rash, itching or hives on the skin.

Do not take ALLMERCAP

®

if you are planning to become pregnant or father a child unless you

and your doctor have discussed the risks and benefits involved.

As with all cytotoxic drugs, ALLMERCAP

may harm eggs and sperm. Reliable contraceptive methods

must be taken to avoid pregnancy whilst you or your partner is taking this medicine.

Do not take ALLMERCAP

if you are pregnant unless you and your doctor have discussed the

risks and benefits involved.

It may affect your developing baby if you take it during pregnancy.

Do not take this medicine whilst breast feeding.

It is not recommended for use while breast feeding as it is found in breast milk.

Do not take ALLMERCAP

®

after the expiry date printed on the bottle.

If you take it after the expiry (EXP) date has passed, it may not work as well.

Do not take it if the packaging is torn or shows signs of tampering.

ALLMERCAP CMI

Page 2

Before you start to take it

Tell your doctor if you are allergic to any other medicines or any other foods, dyes or preservatives.

Tell your doctor if you have or have had any of the following conditions:

you have recently received or are receiving radiotherapy or chemotherapy

you have recently been vaccinated or are planning to be vaccinated

kidney or liver disease

a condition where your body produces too little of a natural chemical called thiopurine

methyltransferase (TPMT).

If you have not told your doctor about any of the above, tell them before you start taking

ALLMERCAP

®

.

Taking other medicines

Tell your doctor if you are taking any other medicines, including any that you buy without a

prescription from a pharmacy, supermarket or health food shop.

Some medicines may be affected by ALLMERCAP

®

or may affect how well it works. You may need

to take different amounts of your medicine or you may need to take different medicines. These

include:

allopurinol, oxipurinol and/or thiopurinol

medicines to treat or prevent blood clots e.g. warfarin

6-thioguanine

aminosalicylate derivatives such as olsalazine, mesalazine or sulphasalazine

vaccinations with 'live' organism vaccines

Other medicines used to suppress the body’s immune defence system agents

ribavirin

Your doctor or pharmacist has more information on medicines to be careful with or avoid while taking

this medicine.

How to take it

How much to take

Take ALLMERCAP

®

exactly as directed by your doctor.

Your doctor will decide what dose and for how long you will be taking ALLMERCAP

®

. This depends

on factors such as:

your age and weight

any pre-existing conditions such as kidney or liver disease

your response to the treatment

other medicines taken in combination with ALLMERCAP®.

Your doctor may change the dose and frequency of your medicine as your condition changes. Your doctor

may order regular blood cell count, liver function and urine tests while you are taking ALLMERCAP

®

order to monitor your condition and to change your dose if necessary.

How to take it

It is important to take ALLMERCAP in the evening to make the medicine more effective.

You can take your medicine with food or on an empty stomach but the choice of method should be

consistent from day to day. You should take your medicine at least 1 hour before or 2 hours after having

milk or dairy products.

ALLMERCAP CMI

Page 3

Your pack of ALLMERCAP contains a bottle of medicine, a cap, a bottle adaptor and two dosing

syringes (a purple 1 mL syringe and an orange 5 mL syringe). Always use the syringes provided to take

your medicine. The syringes provided must only be used with ALLMERCAP.

It is important that you use the correct dosing syringe for your medicine. Your doctor or pharmacist will

advise which syringe to use depending on the dose that has been prescribed.

The smaller 1 mL syringe (purple), marked from 0.1 mL to 1 mL, is for measuring doses of less than or

equal to 1 mL. You should use this one if the total amount you have to take is less than or equal to 1 mL

(each graduation of 0.1 mL contains 2 mg of mercaptopurine).

The larger 5 mL syringe (orange), marked 1 mL to 5 mL, is for measuring doses of more than 1 mL. You

should use this one if the total amount you have to take is more than 1 mL (each graduation of 0.2 mL

contains 4 mg of mercaptopurine).

If you are a parent or care giver administering the medicine, wash your hands before and after

administering a dose. Wipe up spillages immediately. To decrease the risk of exposure disposable gloves

should be used when handling ALLMERCAP.

If ALLMERCAP comes into contact with skin, eyes or nose, it should be washed immediately and

thoroughly with soap and water.

When you use the medicine follow the instructions below:

1. Put on disposable hand gloves before handling ALLMERCAP.

Shake the bottle vigorously for at least 30 seconds

to ensure the medicine is well mixed

(figure 1)

3. Remove the bottle cap

(figure 2)

and push the adaptor firmly into the top of the bottle and leave in

place for future doses

(figure 3)

4. Push the tip of the dosing syringe into the hole in the adaptor

(figure 4)

Your doctor or pharmacist

will advise you of the correct syringe to use, either the 1 mL (purple syringe) or the 5 mL (orange

syringe) in order to give the correct dose

5. Turn the bottle upside down

(figure 5)

6. Pull the plunger of the syringe back so that the medicine is drawn from the bottle into the syringe. Pull

the plunger back to the point on the scale that corresponds to the dose prescribed

(figure 5)

. If you are not

sure about how much medicine to draw into the syringe, always ask your doctor or nurse for advice.

7. Turn the bottle back the right way up and carefully remove the syringe from the adaptor, holding it by

the barrel rather than the plunger.

8. Gently put the tip of the syringe into your mouth and to the inside of your cheek.

9. Slowly and gently push the plunger down to gently squirt the medicine into the inside of your cheek

and swallow it. DO NOT forcefully push down the plunger, or squirt the medicine to the back of your

mouth or throat, as you may choke.

10. Remove the syringe from your mouth.

ALLMERCAP CMI

Page 4

11. Swallow the dose of oral suspension then drink some water, making sure no medicine is left in your

mouth.

12. Put the cap back on the bottle with the adaptor left in place. Ensure that the cap is tightly closed.

13. Wash the syringe with warm ‘soapy’ water and rinse well. Hold the syringe under water and move the

plunger up and down several times to make sure the inside of the syringe is clean. Let the syringe dry

completely before you use that syringe again for dosing. Store the syringe in a hygienic place with the

medicine.

Repeat the above for each dose as instructed by your doctor or pharmacist.

Like all cytotoxic drugs, ALLMERCAP

is irritant to the eyes and skin. To prevent irritation it is

important to wash your hands immediately after handling the oral suspension, to avoid contact with the

eyes.

How long to take it

Your doctor will tell you how long to take ALLMERCAP

®

for. Do not stop taking it or change the

dose without first checking with your doctor.

After first opening of the bottle, discard any unused contents after 8 weeks (56 days). Write the date of

first opening on the bottle to help you remember.

If you take too much (overdose)

Immediately telephone your doctor or the Poisons Information Centre (in Australia telephone

131126, in New Zealand telephone 0800 764 766) for advice, if you think you or anyone else may

have taken too much ALLMERCAP

®

, even if there are no signs of discomfort or poisoning.

You may need urgent medical attention.

While you are taking it

Things you must do

Tell your doctor if, for any reason, you have not taken your medicine

exactly as directed.

Otherwise, your doctor may think that it was not working as it should and change your treatment

unnecessarily.

Do not take a double dose to make up for the one you have missed. Visit your doctor regularly so

they can check your progress and make sure your medicine is working.

Tell any other specialist, doctor, dentist or pharmacist that you are on ALLMERCAP

®

, especially

if you are about to be started on any new medicines, immunisations, vaccinations or radiotherapy.

Tell your doctor if you become pregnant, are trying to become pregnant or trying to father a child.

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.

Things to be careful of

Be careful driving or operating machinery until you know how ALLMERCAP

®

affects you.

Do not have any vaccinations without your doctor's approval.

ALLMERCAP

®

can lower the number of white blood cells and platelets in your blood. This means that

you have an increased chance of getting an infection or bleeding.

ALLMERCAP CMI

Page 5

Side effects

Tell your doctor as soon as possible if you do not feel well while you are taking ALLMERCAP

®

All medicines can cause some side effects. Sometimes they are serious, most of the time they are not.

You may need medical treatment if you get some of the side effects.

The following side effects have been reported with ALLMERCAP

®

production of bone marrow cells may be reduced. You may notice an increase in infections. Your

doctor will do regular blood tests, but you should tell them at once if you notice any signs of fever or

infection or any unexpected bruising, bleeding or signs of blood in your urine

increased risk of liver disease or damage

in men, sperm production may be reduced

as with all cytotoxic medicines, there is an increased risk of some cancers

as with all cytotoxic medicines, there is an increased risk of damage to the genes in some cells.

Tell your doctor if you notice any of the following:

nausea and vomiting

diarrhoea

infections such as fever, severe chills, sore throat or mouth ulcers

bruising or bleeding more easily than normal

loss of appetite and/or weight loss

jaundice, a yellowing of the whites of the eyes or the skin

a condition in which there is a decreased number of red blood cells, called anaemia. Symptoms

include tiredness, headaches, shortness of breath, dizziness and looking pale.

painful, swollen joints

skin rash

hair loss.

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

hayfever

lumpy rash (hives)

fainting

sudden abdominal pain with nausea and vomiting.

Tell your doctor if you notice anything else that is making you feel unwell, even if you think the

problems are not connected with this medicine and are not referred to in this leaflet.

Other side effects not listed above may also occur in some people.

Do not be alarmed by this list of possible side effects.

You may not experience any of them.

After taking it

Storage

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.

Heat and dampness can affect some medicines.

ALLMERCAP CMI

Page 6

Keep it where children cannot reach it.

A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

After first opening of the bottle, discard any unused contents after 8 weeks (56 days). Write the date of

first opening on the bottle to help you remember.

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.

Product description

What it looks like

ALLMERCAP

®

oral suspension is a pink to brown oral suspension. It comes in bottles of 100 mL capped

with a child-resistant closure. Each pack contains one bottle, a bottle adaptor and two dosing syringes (a

purple syringe graduated to 1 mL and an orange syringe graduated to 5 mL). Your doctor or pharmacist

will advise which syringe to use depending on the dose that has been prescribed.

Ingredients

Active ingredient:

One mL of suspension contains 20 mg of mercaptopurine.

Inactive ingredients:

xanthan gum

aspartame (E951)

concentrated raspberry juice

sodium methylhydroxybenzoate (E219)

sodium ethylhydroxybenzoate (E215)

potassium sorbate (E202)

sodium hydroxide

purified water.

Sponsor

In Australia:

Link Medical Products Pty Ltd

5 Apollo Street,

Warriewood NSW 2012

Australia

In New Zealand:

Level 31, Vero Centre

48 Shortland Street

Auckland 1140

New Zealand

Australian Registration Number: AUST R 213881

This leaflet was prepared in January 2017.

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