Methotrexate 5g/50ml solution for injection vials

Medicines are used to treat, control or prevent a condition. Some medicines will give you immediate relief from your symptoms while others take much longer to work.

Methotrexate sodium is an injection that is usually given by a healthcare professional. The person responsible for giving you your medicine will make sure that you get the right dose. If you feel that the medicine is making you feel unwell or you think it is not working, you should talk to someone who is involved in your care.

Methotrexate sodium, in the treatment of cancer and psoriasis, helps to destroy cells that grow too quickly.

The person with responsibility for giving you your medicine will make sure that you have your medicine at the prescribed times.

This medicine will be given to you as an injection. If you have any concerns about this medicine or how this will be given to you, talk to someone who is involved in your medical care.

Having extra doses of some medicines can be harmful. In some cases even one extra dose can cause you problems.

In the case of Methotrexate sodium, the person who is responsible for giving you your medicine will make sure that you are given the correct dose.

The person in charge of your care will make the decision about when you should stop this medicine. If you experience any problems while having this medicine, talk to someone who is involved in your medical care.

As Methotrexate sodium will be given to you as an injection, it will usually be stored by the medical team.

Methotrexate sodium is not suitable for everyone and some people should never use it. Other people should only use it with special care. It is important that the person prescribing this medicine knows your full medical history.

Your prescriber may only prescribe this medicine with special care or may not prescribe it at all if you:

Furthermore the prescriber may only prescribe this medicine with special care or may not prescribe it at all for a child under the age of three.

As part of the process of assessing suitability to take this medicine a prescriber may also arrange tests:

Over time it is possible that Methotrexate sodium can become unsuitable for some people, or they may become unsuitable for it. If at any time it appears that Methotrexate sodium has become unsuitable, it is important that the prescriber is contacted immediately.

A medicine is only made available to the public if the clinical trials have shown that the benefits of taking the medicine outweigh the risks.

Once a medicine has been licensed, information on the medicine's effects, both intended and unintended, is continuously recorded and updated.

Some side-effects may be serious while others may only be a mild inconvenience.

Everyone's reaction to a medicine is different. It is difficult to predict which side-effects you will have from taking a particular medicine, or whether you will have any side-effects at all. The important thing is to tell your prescriber or pharmacist if you are having problems with your medicine.

The frequency of these side-effects is unknown

• abnormal laboratory test results
• abortion
• acne
• amenorrhoea
• anaphylactic reactions
• aphasia
• bleeding
• bleeding under the skin or bruising
• blood and bone marrow problems
• blood in the urine
• blurred vision
• bowel problems
• brain or central nervous system problems
• chills
• chromosome problems
• convulsions
• cystitis
• death
• epidermal necrolysis
• feeling dizzy
• feeling drowsy
• fever
• foetal abnormalities and death
• gastrointestinal problems - these may be fatal. If you get any types of gastrointestinal problems or diarrhoea you should tell your prescriber
• general feeling of being unwell
• hair loss
• headaches
• infections - if you think you may have an infection, you should tell your prescriber
• infertility
• irritation or inflammation of the vagina or vaginal ulcers
• itching
• kidney problems
• liver problems - these may be fatal
• loss of appetite
• lung problems - some of the lung problems caused by Methotrexate sodium may be fatal. If you get a dry persistent cough, dyspnoea, or develop fever you must immediately seek medical help
• malabsorption
• melaena
• menstrual problems
• metabolic problems
• mouth problems - if you get any mouth problems you should tell your prescriber. You should particularly look out for sores and ulcers or irritation and inflammation in the mouth
• nausea
• osteonecrosis
• osteoporosis
• pharyngitis
• photosensitivity
• precipitation of diabetes
• recall phenomenon
• reduced resistance to infection
• septicaemia
• skin colour changes
• skin infections
• skin rash or rashes
• soft tissue necrosis
• Stevens-Johnson syndrome
• stomach pain and discomfort
• telangiectasia
• tiredness
• urticaria
• vomiting
• vomiting blood
• weakness on one side of the body

These side effects have been reported when Methotrexate sodium is given intrathecally

• abnormal laboratory test results
• back pain
• balance or coordination problems
• brain or central nervous system problems
• coma
• confusion
• convulsions
• death
• dementia
• feeling irritable
• fever
• Guillain Barré syndrome
• headaches
• increased cerebrospinal fluid pressure
• metabolic problems
• nerve problems
• nuchal rigidity
• osteoporosis
• paralysis below the waist
• precipitation of diabetes
• shoulder pain
• sleepiness
• spasticity
• temporary paresis

If you feel unwell or if you have concerns about a side-effect, you will need to seek advice. If you feel very ill, get medical help straight away. Contact your prescriber, pharmacist, nurse or call NHS Direct on 0845 46 47.

If you are taking more than one medicine they may interact with each other. At times your prescriber may decide to use medicines that interact, in other cases this may not be appropriate.

The decision to use medicines that interact depends on your specific circumstances. Your prescriber may decide to use medicines that interact, if it is believed that the benefits of taking the medicines together outweigh the risks. In such cases, it may be necessary to alter your dose or monitor you more closely.

Tell your prescriber the names of all the medicines that you are taking so that they can consider all possible interactions. This includes all the medicines which have been prescribed by your GP, hospital doctor, dentist, nurse, health visitor, midwife or pharmacist. You must also tell your prescriber about medicines which you have bought over the counter without prescriptions.

The following medicines may interact with Methotrexate sodium:

The following types of medicine may interact with Methotrexate sodium:

If you are taking Methotrexate sodium and one of the above medicines or types of medicines, make sure your prescriber knows about it.

Medicines can interact with complementary preparations and vitamins.

Make sure you tell your prescriber the names of all the complementary preparations and vitamins that you are taking or are planning to take.

Your prescriber can then decide whether it is appropriate for you to take combinations that are known to interact.

In the case of Methotrexate sodium:

If you are taking something on the above list, or vitamin preparations containing folic acid, you must inform your prescriber.

When taking any medicine you should be aware that it might interfere with your ability to drive or operate machinery safely.

In the case of Methotrexate sodium:

You should see how this medicine affects you before you judge whether you are safe to drive or operate machinery. If you are in any doubt about whether you should drive or operate machinery, talk to your prescriber.

Medicines can interact with certain foods. In some cases, this may be harmful and your prescriber may advise you to avoid certain foods.

In the case of Methotrexate sodium:

Alcohol can interact with certain medicines.

In the case of Methotrexate sodium:

It is best to avoid drinking alcohol while you are having this medicine.

Most medicines, in some way, can affect the development of a baby in the womb. The effect on the baby differs between medicines and also depends on the stage of pregnancy that you have reached when you take the medicine.

In the case of Methotrexate sodium:

Careful consideration needs to be given to the risks and the benefits of using this medicine during pregnancy.

You need to discuss your specific circumstances with your doctor to make a decision about whether you are going to take this medicine during pregnancy. You should only take this medicine during pregnancy if your doctor thinks you need to take it. If the decision is that you should not have Methotrexate sodium, then you should discuss whether there is an alternative medicine that you could take during pregnancy.

Certain medicines can pass into breast milk and may reach your baby through breast-feeding.

In the case of Methotrexate sodium:

Before you have your baby you should discuss breast-feeding with your doctor or midwife. They will help you decide what is best for you and your baby based on the benefits and risks associated with this medicine. If you wish to breast-feed you should discuss with your prescriber whether there are any other medicines you could take which would also allow you to breast-feed. You should not stop this medicine without taking advice from your doctor.

Medicines contain active ingredients. They may also contain other, additional ingredients that help ensure the stability, safety and effectiveness of the medicine. They are also added to improve the medicine's taste and appearance and to make it easier to take. Some may be used to prolong the life of the medicine.

This medicine contains methotrexate sodium.

We are unable to list all of the ingredients for your medicine here. For a full list, you should refer to the patient information leaflet that comes with this medicine. You should check that you are able to take the ingredients of your medicine, especially if you have any allergies. You should also check whether any of these ingredients are known to have side-effects.

If you are not able to take any of the ingredients in your medicine, talk to your prescriber or pharmacist to see if they can suggest an alternative medicine. If you have reacted badly to Methotrexate sodium before, do not take Methotrexate sodium. Talk to your prescriber, pharmacist or nurse as soon as possible.