What is in this leaflet
This leaflet answers some common questions about Methotrexate Ebewe. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.
All medicines have benefits and risks. Your doctor has weighed the risks of you taking Methotrexate Ebewe against the benefits this medicine is expected to have for you.
This medicine is likely to be used while you are at the clinic or in hospital. If possible, please read this leaflet carefully before this medicine is given to you. In some cases this leaflet may be given to you after the medicine has been used.
If you have any concerns about taking this medicine, ask your doctor or pharmacist. For any further information please see your doctor or pharmacist.
Keep this leaflet. You may need to read it again.
What Methotrexate Ebewe is used for
Methotrexate Ebewe belongs to a group of anticancer drugs known as antineoplastics. Methotrexate Ebewe works by preventing the growth of certain cells. It is used for different types of cancer and also severe psoriasis (a skin condition).
Methotrexate Ebewe may be used for the treatment of other conditions that are not mentioned above. Your doctor will be able to tell you about the specific condition for which you have been prescribed Methotrexate Ebewe.
This medicine is available only with a doctor's prescription.
Methotrexate is not recommended for use in children, as there is not enough information on its effects in children.
Before you are given Methotrexate Ebewe
When you must not be given it
Do not use Methotrexate Ebewe if:
- you have an allergy to Methotrexate Ebewe or any of the ingredients listed at the end of this leaflet
- you have kidney disease or poor kidney function
- you have liver disease or poor liver function
- you are pregnant or planning to get pregnant
- you are breastfeeding
- you have a problem with your immune system such as severe or repeated infections
- you have a problem with your blood such as anaemia
- you are receiving radiotherapy e.g. X-rays, ultra violet radiotherapy
- you have a stomach ulcer or ulcerative colitis (bleeding from your bowel)
- bone marrow disease
- you are an alcoholic
- you have an infection
If you are not sure whether any of these apply to you, check with your doctor.
Do not use this medicine if you are taking acitretin or etretinate, a medicine used to treat psoriasis and other skin conditions.
Do not use live vaccine while you are using Methotrexate Ebewe.
Do not use this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.
If it has expired or is damaged, return it to your pharmacist for disposal.
If you are not sure whether you should start taking this medicine, talk to your doctor.
Before you are given it
The medicine may cause birth defects if either you or your partner is taking it. Both you and your partner must use a reliable method of contraception (birth control or condom) using treatment with Methotrexate Ebewe and for at least 6 months after you stop treatment. Your doctor will discuss with you what forms of contraception are suitable and when it is safe to stop using contraception if you wish to do so.
Tell your doctor if:
- you have any allergies to:
- any other medicine
- any other substances, such as foods, preservatives or dyes
- if you are pregnant or intend to become pregnant.
Methotrexate Ebewe may affect your developing baby if you take/use it during pregnancy. If it is necessary for you to be given it, your doctor or pharmacist will discuss the risks and benefits of taking/using it during pregnancy.
- you are breastfeeding or plan to breastfeed
Methotrexate Ebewe passes into breast milk and should not be used when breastfeeding.
- you have or have had any medical conditions, especially the following:
- any sort of infection or immune system disorder e.g. sinusitis, tooth abscess etc
- stomach ulcer or ulcerative colitis (bleeding from your bowel)
- fluid or swelling in your abdomen or stomach
- fever, chills, sore throat or mouth ulcers
- bleeding or bruising more than usual
- tiredness, headaches, shortness of breath, dizziness, looking pale
- folate deficiency
If you have not told your doctor or pharmacist about any of the above, tell them before you are given Methotrexate Ebewe.
Your carer will also need to take some precautions, such as wearing of gloves, when handling the injection.
Taking other medicines
Tell your doctor if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.
If your doctor tells you to take folic acid, do not take it on the same day as methotrexate.
Some medicines and Methotrexate Ebewe may interfere with each other. These include:
- other anticancer drugs such as cisplatin, mercaptopurine or asparaginase
- antibiotics or antimalarial drugs including tetracyclines, penicillins, sulphonamides, trimethoprim and chloramphenicol, pyrimethamine
- aspirin and other pain killers
- medicines to relieve swelling or inflammation including medicines for arthritis
- non-steroidal anti-inflammatory drugs, used to help with pain relief, such as azapropazone, diclofenac, indomethacin and ketoprofen
- medicines for epilepsy such as phenytoin
- corticosteroids such as hydrocortisone and prednisolone
- medicines for diabetes such as sulphonylureas
- medicines that reduce cholesterol such as cholestyramine
- medicines for gout such as probenecid and allopurinol
- vitamin preparations that contain folic acid
- medicines for psoriasis such as etretinate
- medicines for heart problems such as amiodarone
- medicines used to treat asthma and related compounds such as theophylline
- azathioprine, a medicine used to prevent transplant organ rejection
- retinoids (acitretin or etretinate) medicines used to treat skin conditions
- proton pump inhibitors, such as omeprazole, esomeprazole or pantoprazole
Methotrexate Ebewe can also be affected by the following:
- blood transfusions
- nitrous oxide anaesthetics
- radiation e.g. X-rays, radiotherapy
Your doctor will advise you about continuing to take other medicines while you are receiving methotrexate.
You may need different amounts of your medicines, or you may need to take/use different medicines. Your doctor or pharmacist will advise you.
You should not receive certain vaccinations while being treated with methotrexate.
How Methotrexate Ebewe is given
How much is given
Your doctor will decide what dose of Methotrexate Ebewe you will receive. This depends on your condition and other factors, such as your weight, and other medicines you are being given. This medicine may be given alone or in combination with other drugs. It may be given as a short course or on an ongoing basis. Additional treatment may not be repeated until your blood cell numbers return to acceptable levels and any unwanted effects have been controlled. For cancer treatment, several courses of Methotrexate Ebewe therapy may be needed depending on your response to treatment. For the treatment of psoriasis, Methotrexate Ebewe therapy is usually required on an ongoing basis.
Ask your doctor if you want to know more about the dose of Methotrexate Ebewe you receive.
How it is given
Methotrexate Ebewe may be given as an injection into a vein. Methotrexate Ebewe must only be given by a doctor or nurse.
If you are given too much (overdose)
This rarely happens as Methotrexate Ebewe is administered under the care of a highly trained doctor.
However, if you are given too much methotrexate, you may experience some of the effects listed under "Side effects" below.
Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26 in Australia or call 0800 764 766 in New Zealand) for advice, or go to Accident and Emergency at your nearest hospital, if you think you or anyone else may have given you too much Methotrexate. Do this even if there are no signs of discomfort or poisoning.
You may need urgent medical attention.
Your doctor has information on how to recognise and treat an overdose.
Ask your doctor if you have any concerns.
While you are being treated with Methotrexate Ebewe
Things you must do
If you are about to be started on any new medicine, remind your doctor and pharmacist that you are being given Methotrexate Ebewe.
Tell any other doctors, dentists, and pharmacists who are treating you that you are being given this medicine.
If you are going to have surgery, tell the surgeon, anaesthetist or dentist that you are taking this medicine. It may affect other medicines used during surgery.
Keep all of your doctor's appointments so your progress can be checked. Your doctor may want to check your blood pressure and do some blood and other tests from time to time to check on your progress and to check for any unwanted side effects.
Both you and your partner must use a reliable method of contraception (birth control) during and for at least 6 months after treatment with Methotrexate Ebewe. Your doctor will discuss with you what forms of contraception are suitable and when it is safe to stop using contraception if you wish to do so.
If you or your partner becomes pregnant while you are being treated with Methotrexate Ebewe, or for up to 6 months afterwards, tell your doctor immediately. This is because methotrexate can cause damage to the baby during pregnancy and can also cause genetic problems if the baby is conceived while you are taking methotrexate.
Protect your skin when you are in the sun, especially between 10am and 3pm. If outdoors, wear protective clothing and use a 30+ sunscreen. Avoid exposure to sunlamps. Methotrexate Ebewe may cause your skin to be much more sensitive to sunlight than it is normally, cause severe reactions and increase risk of skin cancer (non-melanoma and melanoma). Exposure to sunlight may cause a skin rash, itching, redness, swelling, blistering or a severe sunburn.
Methotrexate Ebewe 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. The following precautions should be taken to reduce your risk of infection or bleeding:
- Avoid people who have infections. Check with your doctor immediately if you think you may be getting an infection, or if you get a fever, chills, cough, hoarse throat, lower back or side pain or find it painful or difficult to urinate.
- Be careful when using a toothbrush, toothpick or dental floss. Your doctor, dentist, nurse or pharmacist may recommend other ways to clean your teeth and gums. Check with your doctor before having any dental work.
- Be careful not to cut yourself when you are using sharp objects such as a razor or nail cutters.
- Avoid contact sports or other situations where you may bruise or get injured.
Methotrexate Ebewe may be excreted in body fluids and waste, including blood, urine, faeces, vomitus and semen. In general, precautions to protect other people should be taken while you are receiving Methotrexate Ebewe and for one week after the treatment period by:
- Flushing the toilet twice to dispose of any body fluids and waste.
- Wearing gloves to clean any spill of body fluid or waste. Use paper towels or old rags, a strong solution of non-bleaching detergent and large amounts of water to mop up the spill. Discard the towels or rags into a separate waste bag and dispose of fluids in the toilet.
- Wash linen or clothing that is heavily contaminated by body fluids or waste separately from other items. Use a strong solution of non-bleaching detergent and large amounts of water.
- Place soiled disposable nappies and other pads in a plastic bag, seal and dispose into the garbage.
- Carers and other people who handle the injection should wear disposable gloves to avoid direct contact with the injection fluid.
- Pregnant women should not handle the medicine at all.
- Be careful not to drip the solution on any surfaces.
- If you do, wipe up the area with paper towels and throw them into the ‘Sharps Bin’. Clean the area with lots of soap and water.
Things you must not do
You must not drink alcohol whilst you are being given this medicine. Alcohol may increase the side effects of Methotrexate Ebewe and may cause permanent liver damage.
Things to be careful of
Do not drive or operate machinery until you know how Methotrexate Ebewe affects you. This medicine may cause dizziness, drowsiness or tiredness in some people. If you have any of these symptoms, do not drive, operate machinery or do anything else that could be dangerous.
Tell your doctor or nurse as soon as possible if you do not feel well while you are being given Methotrexate Ebewe. Like other medicines, methotrexate can cause some side effects. If they occur, most are likely to be minor or temporary. However, some may be serious and need medical attention.
Ask your doctor or nurse to answer any questions that you may have. Do not be alarmed by this list of possible side effects. You may not experience any of them.
If any of the following happen, tell your doctor or nurse immediately or go to Accident and Emergency at your nearest hospital:
- severe abdominal pain, upset stomach, or diarrhoea
- nausea or vomiting, especially vomiting blood, loss of appetite
- mild dizziness
- mild chills
- mild headache
- sore eyes
- an increased tendency to bleed, unusual bruising or get infections
- swelling of the face, lips or tongue or other parts of the body e.g. hands ankles or feet
- rash, redness, hives, itching, pinpoint red spots or painful blistering resulting in peeling of layers of the skin
- lighter patches on the skin, yellowing of the skin/eyes (jaundice)
- severe blisters and bleeding in the lips, eyes, mouth, nose and genitals (Stevens-Johnson syndrome)
These are very serious side effects. You may need urgent medical attention or hospitalisation.
All of these side effects are very rare.
Tell your doctor or nurse immediately if you notice any of the following:
- infection of hair roots or hair loss, especially of the scalp
- frequent or painful urination (cystitis/dysuria), or blood in the urine, or bowel motions
- changes in the menstrual cycle (periods)
- bleeding gums, sore mouth, difficulty swallowing, cold sores, mouth ulcers, swollen glands (lymph nodes)
- coughing, wheezing, difficulty breathing, chest pain
- black tarry stools or blood in the stools
- fits, seizures or convulsions
These may be serious side effects. You may need urgent medical attention.
Tell your doctor or nurse if you notice any of the following and they worry you:
- blurred vision, short term blindness
- ringing in the ears
- conjunctivitis (itchy eyes and crusty eyelids)
- fever and chills, sore throat, sweats or feel generally unwell
- tiredness, headaches, shortness of breath, dizziness, looking pale
- sensitivity to the sun
- acne or boils or skin ulcers
- lack of appetite or weight loss
- difficulty speaking, writing etc
- weakness, numbness or paralysis, muscle cramps, spasms
- feeling thirsty
- irritability, depression, confusion or mood changes
- changes in the toenails or fingernails
- impotence or loss of interest in sex
- painful muscles and joints
- back pain
- stiff neck
These are the more common side effects of methotrexate.
Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor. Other side effects may be only seen by blood urine or other tests. Your doctor will carry out any necessary tests. Some side effects of methotrexate may occur after you stop taking it.
Methotrexate Ebewe will be stored in the pharmacy, doctor’s surgery or on the ward. The injection is kept in a cool dry place, protected from light, where the temperature stays below 25°C. Do not freeze.
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.
What it looks like
Methotrexate Ebewe is a clear yellow liquid in glass vials.
Methotrexate Ebewe contains Methotrexate as the active ingredient. It also contains:
- water for injections
- sodium hydroxide
This medicine does not contain lactose, sucrose, gluten, tartrazine or any other azo dyes.
Methotrexate Ebewe comes in the following strengths and pack sizes:
500 mg in 5 mL vial - AUST R 98546
1000 mg in 10 mL vial - AUST R 98547
5000 mg in 50 mL vial - AUST R 120618
EBEWE Pharma Ges.m.b.H. Nfg. KG
Methotrexate Ebewe is distributed in Australia by:
Sandoz Pty Ltd
ABN 60 075 449 553
54 Waterloo Road
Tel: 1800 634 500
Methotrexate Ebewe is distributed in New Zealand by:
Novartis New Zealand Ltd
PO Box 99102
Tel: 0800 354 335
This leaflet was updated on June 2020.
Published by MIMS August 2020