Recormon Consumer Medicine Information

Epoetin beta (recombinant human erythropoietin)
1000IU/0.3mL, 2000IU/0.3mL, 3000IU/0.3mL, 4000IU/0.3mL, 5000IU/0.3mL, 6000IU/0.3mL, 10,000IU/0.6mL solution for injection in pre-filled syringes

What is in this leaflet

This leaflet answers some common questions about RECORMON.

It does not contain all 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 having RECORMON against the benefits they expect it will have for you.

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

Keep this leaflet with the medicine.

You may need to read it again.

What RECORMON is used for

RECORMON contains the active ingredient epoetin beta (recombinant human erythropoietin).

The active ingredient in RECORMON is a hormone that stimulates the production of red blood cells.

RECORMON is used to treat anaemia (a condition in which the amount of oxygen-carrying haemoglobin in the blood and the number of red blood cells are below normal). RECORMON may be used:-

  • to treat anaemia caused by kidney disease
  • to prevent anaemia in babies born more than six weeks early
  • to prevent or treat anaemia caused by some anti-cancer medicines
  • to treat anaemia caused by some cancers of the blood (multiple myeloma, certain forms of non-Hodgkin's lymphoma or leukaemia)
  • to increase the amount of blood that can be given if you are donating your own blood for an up-coming operation (increasing the yield of your own blood).

Your doctor, however, may have prescribed RECORMON for another purpose.

Ask your doctor if you have any questions about why RECORMON has been prescribed for you.

This medicine is available only with a doctor's prescription.

Before you use RECORMON

When you must not use it

Do not use RECORMON if:

  1. you have had an allergic reaction to RECORMON or any ingredients listed at the end of this leaflet
  2. you have hypertension (high blood pressure) that is not well controlled
  3. you have:
    • had a heart attack or stroke in the previous month
    • angina that is not well controlled
    • or have had, problems with blood clots in your veins
    when you are using RECORMON to increase the yield of your own blood
  4. the package is torn or shows signs of tampering
  5. the expiry date printed on the pack has passed
    If you have this medicine after the expiry date has passed, it may not work as well.

If you are not sure if you should be using RECORMON, talk to your doctor.

Before you start to use it

Tell your doctor if:

  1. you are pregnant or plan to become pregnant

    It is not known whether RECORMON is harmful to an unborn baby when taken by a pregnant woman. If there is a need to use RECORMON when you are pregnant your doctor will discuss the risks and benefits to you and the unborn baby.
  2. you are breastfeeding or plan to breastfeed

    It is not known whether RECORMON passes into breast milk. Your doctor will discuss the risks and benefits of using RECORMON if you are breast-feeding.
  3. you have any other health problems, especially the following:
    • refractory anaemia (anaemia where previous treatments have not been successful)
    • epilepsy
    • increased level of platelets in the blood (thrombocytosis)
    • liver disease
    • a deficiency in folic acid or Vitamin B12
    • excess levels of aluminium in the blood as a result of kidney disease treatment
    • you have had problems with another erythropoietin-type medicine
    • severe phenylketonuria - each RECORMON pre-filled syringe contains up to 0.3mg phenylalanine
    • you have a shunt in place
  4. you are using RECORMON for increasing the yield of your own blood and you weigh less than 50kg
  5. you are allergic to any other medicines, foods, dyes or preservatives

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

NOTE: Misuse of RECORMON by healthy people may lead to an excessive increase in the number of blood cells in the blood. Such an increase may cause life-threatening effects on the heart and circulation systems.

Taking other medicines

Tell your doctor if you are taking any other medicines, including any that you have bought from a pharmacy, supermarket or health food shop.

Generally, RECORMON is unlikely to have any effect on other medications you may be taking. However, your doctor or pharmacist may have more information on medicines to be careful with or avoid while having RECORMON.

Ask your doctor or pharmacist if you are not sure about any medicine.

How to use RECORMON

RECORMON can be given by your doctor or nurse. Alternatively your doctor, nurse or pharmacist may teach you or your carer how to inject RECORMON. Do not inject yourself with RECORMON unless you have received training.

Follow all directions given to you by your doctor, nurse or pharmacist carefully.

They may differ from the information contained in this leaflet.

How much to use

The dosage of RECORMON is expressed in international units (IU).

The dose of RECORMON can vary greatly for different people depending on their condition, their weight and their stage of treatment. Your doctor will determine the dose of RECORMON that is right for you and how often you should have it.

Use RECORMON exactly as your doctor has prescribed.

The dose may be adjusted by your doctor depending on your response to RECORMON.

Do not exceed or change the dose recommended by your doctor.

How to use it

RECORMON can be injected in two ways - intravenously (injection directly into a vein) and subcutaneously (injection just under the skin). Your doctor will decide which way is right for you.

Intravenous administration

Only a health professional should administer RECORMON intravenously.

Subcutaneous administration

RECORMON would normally be given to premature babies by a health professional.

You may be able to administer RECORMON yourself. It is recommended that your doctor or nurse administer the first dose.

First wash your hands!

  • Remove one syringe from the pack and check that the solution is clear, colourless and practically free from visible particles. Remove the cap from the syringe.
  • Remove one needle from the pack, fix it on the syringe and remove the protective cap from the needle.
  • Expel air from the syringe and needle by holding the syringe vertically and gently pressing the plunger upwards. Keep pressing the plunger until the amount of RECORMON in the syringe is as prescribed.
  • Clean the skin at the site of subcutaneous injection using an alcohol wipe. Form a skin fold by pinching the skin between thumb and forefinger. Hold the syringe barrel near to the needle and insert the needle into the skin fold with a quick, firm action. Inject the RECORMON solution. Withdraw the needle quickly and apply pressure over the injection site with a dry, sterile pad.
  • Dispose of the syringe and needle immediately after injection into a sturdy glass container, a hard plastic container or a specified 'Sharps' container. Keep the container away from children. Do not replace the needle cap cover.

Note: The instructions from your doctor or nurse on how to inject RECORMON yourself may be different from the method given above.

Never put used needles and syringes into your normal household wastebin.

If you are not sure how to properly dispose of the needles and syringes, consult your doctor, nurse or pharmacist.

RECORMON in prefilled syringes is a sterile but unpreserved product.

Under no circumstances should more than one dose be administered from the syringe.

When to use it

Depending on your condition, RECORMON can be injected daily, weekly or fortnightly, according to the instructions your doctor has given you.

Inject RECORMON at about the same time on the days that you have it.

Having RECORMON at the same time on these days will have the best effect. It will also help you remember when to have it.

How long to use it

How long you have RECORMON will depend on the condition you have. Some conditions may require long-term treatment.

Continue using RECORMON until your doctor tells you to stop.

It is important to keep having RECORMON even if you feel well.

If you forget to have it

If it is almost time for your next dose, skip the dose you missed and have your next dose when you are meant to.

Otherwise, have it as soon as you remember and then go back to having your medicine as you would normally.

Do not have a double dose to make up for the dose that you missed.

This may increase the chance of you getting an unwanted side effect.

If you are not sure what to do, ask your doctor or pharmacist.

If you have trouble remembering your dose, ask your pharmacist for some hints.

In case of an overdose

Immediately telephone your doctor or National Poisons Information Centre (telephone 0800 POISON or 0800 764 766) or go to your nearest Accident and Emergency Centre if you think that you or anyone else may have had too much RECORMON. Do this even if there are no signs of discomfort or poisoning.

You may need urgent medical attention.

Keep telephone numbers for these places handy.

If you are not sure what to do, contact your doctor or pharmacist.

While you are using RECORMON

Things you must do

Tell all doctors, dentists and pharmacists who are treating you that you are having RECORMON.

Tell your doctor if you become pregnant while having RECORMON.

Tell your doctor if, for any reason, you have not had your medicine exactly as prescribed.

Otherwise your doctor may think that it was not effective and change your treatment unnecessarily.

Tell your doctor if you feel that RECORMON is not helping your condition.

Be sure to keep all of your appointments with your doctor so that your progress can be checked.

Your doctor will keep track of your response to RECORMON by asking questions and doing tests, such as taking your blood pressure or taking a blood sample.

Things you must not do

Do not stop using RECORMON or change the dose without first checking with your doctor.

Do not let yourself run out of RECORMON over the weekend or on holidays.

Do not give RECORMON to anyone else even if they have the same condition as you.

Do not use RECORMON to treat other complaints unless your doctor says to.

Do not take any other medicines whether they require a prescription or not without first telling your doctor or consulting a pharmacist.

Things to be careful of

Be careful driving or operating machinery until you know how RECORMON affects you.

However, RECORMON is not expected to affect your ability to drive a car or operate machinery.

Side Effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are having RECORMON.

RECORMON helps most people but it may have unwanted side effects in some people.

All medicines can have side effects. Sometimes they are serious. You may need medical treatment if you get some of the side effects.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor if you notice any of the following and they worry you:

  • looking pale, feeling tired or lacking energy, this may be due to changes in your blood levels of iron. Your doctor may prescribe an iron supplement for you.
  • headache

These are the more common side effects of RECORMON.

Tell your doctor immediately or go to your nearest Accident and Emergency Centre if you notice any of the following:

  • severe headache, particularly sudden stabbing migraine-like headaches
  • confusion
  • slurred speech or unsteady gait
  • numbness or weakness of the arms and legs
  • seizures (fits)
  • collapse
  • severe pain in the chest
  • very painful and swollen calf muscle (muscle of the lower leg)
  • sudden signs of allergy such as rash, itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or trouble breathing

These may be serious side effects. You may need urgent medical attention.

This is not a complete list of all possible side effects. Others may occur in some people and there may be some side effects not yet known.

Tell your doctor if you notice anything else that is making you feel unwell, even if it is not on this list.

Ask your doctor or pharmacist if you don't understand anything in this list.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

After using RECORMON

Storage

Keep RECORMON in the pack until it is time to have it. This will protect RECORMON from being affected by light.

Keep RECORMON in the refrigerator where the temperature stays between 2C and 8C.

When away from home, RECORMON prefilled syringes may be removed from the refrigerator and stored at room temperature (below 25C) for no longer than one single period of up to 3 days.

Do not store RECORMON or any other medicine in a bathroom or near a sink or any other place where there is high humidity.

Do not leave RECORMON in the car or on window sills.

Heat and dampness can destroy some medicines.

Keep RECORMON where young children cannot reach it.

Disposal

If your doctor tells you to stop having RECORMON, or the injections have passed their expiry date, ask your pharmacist what to do with any medicine that is left over.

Product description

Availability

RECORMON prefilled syringes come in seven strengths - 1000IU in 0.3mL, 2000IU in 0.3mL, 3000IU in 0.3mL, 4000IU in 0.3mL, 5000IU in 0.3mL, 6000IU in 0.3mL and 10,000IU in 0.6mL.

Each pre-filled syringe pack contains 6 pre-filled syringes with solution for injection and 6 needles.

Ingredients

Active ingredient - epoetin beta

  • each 1000IU prefilled syringe contains 1000IU (8.3 g) epoetin beta
  • each 2000IU prefilled syringe contains 2000IU (16.6 g) epoetin beta
  • each 3000IU prefilled syringe contains 3000IU (24.9 g ) epoetin beta
  • each 4000IU prefilled syringe contains 4000IU (33.2 g) epoetin beta
  • each 5000IU prefilled syringe contains 5000IU (41.5 g ) epoetin beta
  • each 6000IU prefilled syringe contains 6000IU (49.8 g) epoetin beta
  • each 10,000IU prefilled syringe contains 10,000IU (83 g ) epoetin beta

Inactive ingredients - each strength of RECORMON also contains urea, sodium chloride, polysorbate 20, sodium dihydrogen phosphate, sodium monohydrogen phosphate, calcium chloride, glycine, leucine, isoleucine, threonine, glutamic acid, phenylalanine and water for injection.

This leaflet was prepared on 5 April 2004.

Reference: Recormon Data Sheet dated 30 March 2004.