Methotrexate 500 mg/20 ml

Methotrexate Fresenius is an anti-metabolite medicine (medicine which affects how the body’s cells grow) and immunosuppressant (medicine which reduces the activity of the immune system). Methotrexate Fresenius is used in large doses (on its own or in combination with other medicines) to treat certain types of cancer such as breast cancer, cancers of the blood, lung cancer. In smaller doses it can be used to treat severe psoriasis (a skin disease with thickened patches of inflamed red skin, often covered by silvery scales), when it has not responded to other treatments. It is also used for the treatment of rheumatoid arthritis.

METHOTREXATE FRESENIUS should not be administered to you

• if you are allergic (hypersensitive) to Methotrexate or any of the other ingredients of Methotrexate Fresenius.
• if you have significant kidney or liver problems.
• if you consume excessive amounts of alcohol.
• if you have been told you have (or think you have) a blood disorder such as low levels of white blood cells, red blood cells (anaemia) or platelets.
• if your immune system is not working as well as it should.
• if you are pregnant or breastfeeding (see section ‘Pregnancy and breastfeeding and fertility’).

Safety and efficacy in children have not been established other than in cancer chemotherapy.

Do not share medicines prescribed for you with any other person. You will not be expected to give yourself Methotrexate Fresenius. It will be given to you by a person who is qualified to do so. This medicine may be given to you for oral ingestion, by injection into a vein (intravenous injection), into muscle (intramuscular injection) or into the spine (intrathecal injection). It may also be given by infusion (drip) into a vein. It may be diluted before it is given.

Recommended dose

Your doctor will work out the correct dose of Methotrexate Fresenius for you and how often it must be given. The dose of medicine given to you will depend on the disease being treated. Before treatment is started your doctor may carry out blood tests to check the levels of cells in your blood, and also to check how well your kidneys and liver are working. You may also have a chest X-ray. Further tests may also be done during and after treatment.

If you take more METHOTREXATE FRESENIUS than you should

Since a healthcare provider will administer Methotrexate Fresenius, he / she will control the dosage. However, in the event of overdosage your doctor will manage the overdosage.

If you forget to take METHOTREXATE FRESENIUS

Since a healthcare provider will administer Methotrexate Fresenius, it is unlikely that the dose will be missed.

If you stop using METHOTREXATE FRESENIUS

Since a healthcare provider will administer Methotrexate Fresenius, it is unlikely that the dose will be stopped before the end of treatment regimen.

Methotrexate Fresenius can have side effects. Not all side effects reported for Methotrexate Fresenius are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking Methotrexate Fresenius, please consult your healthcare provider for advice.

If any of the following happens, stop using Methotrexate Fresenius and tell your doctor immediately or go to the casualty department at your nearest hospital:

• severe allergic reaction - you may experience a sudden itchy rash (hives), swelling of the hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty in swallowing or breathing), and you may feel you are going to faint
• inflammation of the lung with breathlessness – you may develop a persistent cough, experience pain or difficulty breathing, or become breathless. This may be associated with changes in a particular type of white cell in your blood.
• symptoms of an infection e.g. fever, chills, achiness, sore throat
• unexpected bleeding e.g. bleeding gums, blood in the urine or in vomit, or the appearance of unexpected bruises or broken blood vessels (broken veins)
• black tarry stools
• a sore mouth, particularly if you have a number of ulcers or blisters inside of the mouth or on the tongue
• skin rashes or blistering to the surfaces of the eyes, nose, vagina or anus (back passage)
• diarrhoea
• stroke/ weakness on one side of the body
• abdominal pain, fatty stools, vomiting
• chest pain (which may be due to heart or lung problems)
• unconsciousness

Taking Methotrexate Fresenius incorrectly can result in severe side effects and even death. These are all very serious side effects. If you have them, you may have had a serious reaction to Methotrexate Fresenius. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• fits
• blurred vision
• difficulty/inability to talk
• abnormally easily broken bones (osteoporosis)
• pain or redness of the blood vessels (vasculitis)
• yellowing of the skin and whites of the eyes (jaundice)
• pain in the stomach, loins or abdomen
• you may need to pass urine more often than normal, which may be painful (cystitis)
• irregular periods in women (periods may stop completely)
• blood clot which causes pain, swelling or redness (cerebral, deep vein, retinal vein or arterial vein)
• inflammation of the lungs, which causes breathlessness, cough and raised temperature, pneumonia
• shingles (Herpes Zoster)
• bleeding from the lungs
• lymph proliferative disorders (excessive growth of white blood cells) (frequency very rare)
• bone damage in the jaw (secondary to excessive growth of white blood cells) (frequency not known)
• problems with a particular part of your brain, leading to shaking, abnormal balance or staggering.
• irritability and confusion
• confusion and loss of memory

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

• low blood pressure (you may feel faint)
• dizziness
• hair loss
• muscle weakness
• headache
• back or shoulder pain
• difficulty with bending your head down
• fever
• mood alterations
• ringing in the ears
• joint and muscle pain
• you may feel the need to drink more than usual (diabetes)
• stiffness
• sleepiness
• drowsiness
• generally feeling tired or unwell
• increased sensitivity to sunlight
• acne
• itching or the appearance of lightened patches on the skin, bruises, boils
• reduced appetite, feeling or being sick

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor or pharmacist or nurse. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8 . By reporting side effects, you can help provide more information on the safety of Methotrexate Fresenius. Patients are asked to report any suspected adverse drug reactions to their healthcare provider or Holder of the Certificate of Registration at the following email address: [email protected] and to the relevant medicine’s regulatory authority in the country where the product is marketed.

Store all medicines out of reach of children. Since a healthcare provider will administer METHOTREXATE FRESENIUS, he/she will ensure the following storage conditions are met:

• Store at or below 25 °C.
• Protect from light.
• Do not use after the expiry date stated on the label.
• The medicine will be disposed by the healthcare professional.

Do not use Methotrexate Fresenius if you notice visible signs of deterioration.