Active ingredient
- methotrexate disodium
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL00427/0233.
Methotrexate 2mg/ml Oral Solution
Package leaflet: Information for the user
Methotrexate 2mg/ml Oral Solution
Read all of this leaflet carefully before you start taking this medicine - because it contains important information for you.
What is in this leaflet:
1. What Methotrexate Oral Solution is and what it is used for
2. What you need to know before you take Methotrexate Oral Solution
3. How to take Methotrexate Oral Solution
4. Possible side effects
5. How to store Methotrexate Oral Solution
6. Contents of the pack and other information
1. What Methotrexate Oral Solution is and what it is used for
The full name of your medicine is Methotrexate 2mg/ml Oral Solution. In this leaflet the shorter name methotrexate is used.
Methotrexate belongs to a group of medicines called ‘cytotoxics’ which are most commonly used to kill cells and tumours. It is also known as an immunosuppressant which affects the reproduction of the body’s cells and reduces the activity of the immune system.
Methotrexate can be given alone or in combination to treat:
You should consult your doctor if you are unsure why you have been given Methotrexate 2mg/ml Oral Solution.
2. What you need to know before you take Methotrexate Oral Solution
Do not take methotrexate if:
Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking methotrexate.
Warnings and precautions
Important warning about the dose of methotrexate:
This oral solution contains 2 mg methotrexate in 1 ml solution and the scaling of the dosing syringe is in ml and not mg.
Take methotrexate only once a week for the treatment of rheumatic or skin diseases (RA, JIA and psoriasis or psoriatic arthritis).
Taking too much of methotrexate may be fatal.
Please read section 3 of this leaflet very carefully.
If you have any questions, please talk to your doctor or pharmacist before you take this medicine.
Methotrexate temporarily affects sperm and egg production. Methotrexate can cause miscarriage and severe birth defects. You and your partner should avoid having a baby if you are being given methotrexate at the time and for at least 6 months after the end of your treatment with methotrexate. See also section “Pregnancy, breast-feeding and fertility”.
Talk to your doctor, pharmacist or nurse before taking methotrexate if:
Acute bleeding from the lungs in patients with underlying rheumatologic disease has been reported with methotrexate. If you experience symptoms of spitting or coughing up blood you should contact your doctor immediately.
You must avoid excessive exposure to sunlight and tanning beds.
If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking methotrexate.
Regular check–ups
During your treatment, you will have a number of tests, such as regular blood tests to check that appropriate blood levels of methotrexate are attained and that your kidneys are eliminating excess drug properly.
Other tests are performed routinely at the start and during the course of therapy (e.g. chest X-ray, liver function test, full blood count, mouth checks for ulcers, urinalysis and a physical check for swelling of your lymph nodes (glands in your neck, armpits and groin). Any unusual swellings should be reported to your doctor.
If you are having long term treatment, the doctor may send you to the hospital for a liver biopsy.
Children, adolescents and elderly
Children, adolescents and elderly treated with methotrexate should have particularly careful medical monitoring in order to detect important side effects quickly.
This medicine is not recommended in children under 3 years of age as there is insufficient experience in this age group.
Other medicines and Methotrexate
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
This includes medicines obtained without a prescription and herbal medicines. This is because methotrexate can affect the way some other medicines work. Also, some other medicines can affect the way methotrexate works.
In particular tell your doctor or pharmacist if you are taking any of the following:
If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Methotrexate
Taking Methotrexate Oral Solution with food, drink and alcohol
Alcohol should be avoided while receiving methotrexate.
Methotrexate can be taken with or without food.
When you have taken your dose, drink some water and swallow it to ensure you have taken your full dose and there is no methotrexate left in your mouth.
Pregnancy, breast-feeding and fertility
Pregnancy
Do not use methotrexate during pregnancy except if your doctor has prescribed it for oncology treatment. Methotrexate can cause birth defects, harm the unborn child or cause miscarriage. It is associated with malformations of the skull, face, heart and blood vessels, brain, and limbs. It is therefore very important that methotrexate is not given to pregnant women or to women who are planning to become pregnant unless used for oncology treatment.
For non-oncological indications, in women of child-bearing age the possibility of a pregnancy must be ruled out, e.g. by pregnancy tests, before treatment is started.
Do not use methotrexate if you are trying to become pregnant. You must avoid becoming pregnant during treatment with methotrexate and for at least 6 months after the end of treatment. Therefore, you must ensure that you are taking effective contraception for the whole of this period (see also section "Warnings and precautions").
If you become pregnant during treatment or suspect you might be pregnant, speak to your doctor as soon as possible. If you do become pregnant during treatment, you should be offered advice regarding the risk of harmful effects on the child through treatment.
If you want to become pregnant, you should speak with your doctor, who may refer you for specialist advice before the planned start of treatment.
Breast-feeding
Methotrexate is excreted in human milk. Because of the potential for serious adverse reactions in infants, breast-feeding must be discontinued before starting treatment.
Fertility
Male fertility
The available evidence does not indicate an increased risk of malformations or miscarriage if the father takes methotrexate less than 30 mg/week. However, a risk cannot be completely excluded and there is no information regarding higher methotrexate doses. Methotrexate can have a genotoxic effect. This means that the medicine can cause genetic mutations. Methotrexate can affect the production of sperm, which is associated with the possibility of birth defects.
You should avoid fathering a child or to donate semen during treatment with methotrexate and for at least 6 months after the end of treatment. As treatment with methotrexate at higher doses commonly used in cancer treatment can cause infertility and genetic mutations, it may be advisable for male patients treated with methotrexate doses higher than 30 mg/week to consider sperm preservation before the beginning of treatment (see also section "Warnings and precautions").
Driving and using machines
Do not drive, cycle or use any tools or machines until you know how this medicine affects you. This is because you may feel drowsy, you may have a loss of co-ordination and you may get blurred vision. If you are in doubt about whether you can do a particular activity, talk to your doctor or pharmacist.
Methotrexate contains sodium methyl parahydroxybenzoate, sodium ethyl parahydroxybenzoate, propylene glycol and sulphites
3. How to take Methotrexate Oral Solution
Important warning about the dose of methotrexate:
Use methotrexate only once a week for the treatment of arthritis (including juvenile idiopathic arthritis or JIA) and psoriasis. Using too much of methotrexate may be fatal. Please read section 3 of this leaflet very carefully. If you have any questions, please talk to your doctor or pharmacist before you take this medicine.
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Taking this medicine
Measuring your dose
Instructions for use
WASH YOUR HANDS THOROUGHLY with soap and warm water.
How much to take
Recommended dose:
Dose in rheumatoid arthritis
Take methotrexate only once a week.
Adults
Dose in polyarthritic forms of juvenile idiopathic arthritis
Use methotrexate once a week.
Children and adolescents:
The doctor will calculate the dose required from the child’s body surface area (m2), and the dose is expressed as mg/m2.
Dose in psoriasis
Take methotrexate only once a week.
Adults and the Elderly
Children and adolescents:
Not recommended for use in children and adolescents.
Dosage for treatment of cancer:
Adults, the Elderly and Children
If you take more Methotrexate than you should
If you forget to take Methotrexate
If you stop taking Methotrexate
Keep taking this medicine until your doctor tells you to stop. Do not stop taking this medicine just because you feel better.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may happen with this medicine:
Stop taking methotrexate and see a doctor or go to a hospital straight away if you notice the following serious side effect - you may need urgent medical treatment:
Stop taking methotrexate and see a doctor or go to a hospital straight away if you notice the symptoms listed above.
Tell your doctor straight away if you have any of the following side effects:
The following side-effects have been reported. If any of these cause you problems or if they last for more than one week, you should contact your doctor.
Common: affects 1 to 10 users in 100
Uncommon: affects 1 to 10 users in 1,000
Rare: affects 1 to 10 users in 10,000
Very rare: affects less than 1 user in 10,000
Not known:
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow card scheme.
Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Methotrexate Oral Solution
6. Contents of the pack and other information
What Methotrexate Oral Solution contains
What Methotrexate Oral Solution and contents of the pack
Methotrexate is a clear yellow solution. It comes in a brown glass bottle holding 35ml or 65ml of solution with a 10 ml syringe and bottle adaptor.
The Marketing Authorisation Holder and Manufacturer is
This leaflet was last revised in 11/2020.
E3RG3RBJ8
Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, Yorkshire, LS11 9XE
+44 (0)113 244 1400
+44 (0)800 919 312
+44 (0)113 245 3567
+44 (0)7836 557 879