For more information, see Section 1. Why am I taking Methoblastin? in the full CMI.
For more information, see Section 2. What should I know before I take Methoblastin? in the full CMI.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.
Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are taking Methoblastin.
You and your partner must use a reliable method of contraception (birth control pills
or condom) while taking Methoblastin and for at least three months after you stop
treatment for men and six months after you stop treatment for women.
Discuss with your doctor how much water or fluids you should have as not enough fluid
intake can increase the side effects of this medicine.
Remind your doctor you are on Methoblastin if you are about to receive any vaccination.
Tell your doctor if you think you may be getting an infection (fever, chills, achiness,
sore throat).
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Things you should not do
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Do not go out in the sun without sunscreen and protective clothing. Do not use sun
lamps.
Do not breastfeed while taking Methoblastin.
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Driving or using machines
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Do not drive or operate machinery until you know how Methoblastin affects you. Methoblastin
may cause dizziness, drowsiness, blurred vision or tiredness, affecting alertness.
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Drinking alcohol
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You must not drink alcohol whilst you are taking this medicine. Alcohol may increase
the side effects of Methoblastin and cause liver damage.
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For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.
WARNING:
Methoblastin should only be taken for severe disease and when a diagnosis has been
made. It is a toxic medicine which can cause severe reactions and death. You should
be treated under the constant care and follow up of your doctor or specialist.
Methotrexate should only be taken ONCE A WEEK to treat psoriasis and rheumatoid arthritis.
Taking methotrexate more frequently than once a week may cause serious reactions and
death. Methoblastin is available in two strengths. You should check to make sure that
you are given the correct strength.
Methotrexate can cause blood disorders such as low numbers of red blood cells, white
blood cells or platelets. At high or repeated doses, methotrexate may be toxic to
your liver. Your doctor will need to do tests to check your liver regularly, before
and during treatment. Avoid alcohol while being treated with methotrexate.
Tell your doctor if you have cancer of the lymphatic system as methotrexate can affect
the treatment of this condition.
Serious infections leading to death may occur with methotrexate treatment.
Methotrexate can cause birth defects, harm the unborn child or cause miscarriage.
Methotrexate should not be taken by pregnant women or women who plan to become pregnant.
Methotrexate should not be started until it is confirmed you are not pregnant. If
you become pregnant during treatment or think you might be pregnant, speak to your
doctor as soon as possible. Your doctor will provide advice regarding the risk of
harmful effects on the child through treatment.
You must avoid becoming pregnant or avoid fathering a child during treatment and for
at least three months after the end of treatment for men and six months after the
end of treatment for women. Both you and your partner must use a reliable method of
contraception (birth control pills or condom) during this period.
Women should not breastfeed while taking methotrexate.
Methotrexate should not be taken if you have severe kidney problems.
Tell your doctor if you take medicines to relieve pain, swelling or inflammation (nonsteroidal
anti-inflammatory drugs - NSAIDs) as this can result in serious side effects when
taking methotrexate. It can affect your blood, stomach or gut and may lead to death.
Tell your doctor if you develop a dry, non-productive cough or shortness of breath.
Your doctor will stop treatment and monitor you closely as these may be signs of damage
to the lungs.
Use of methotrexate for non-cancer conditions in children has not been well established.
Tell your doctor if you are to have radiotherapy (also known as radiation therapy)
while on methotrexate as this can cause damage to tissue and bone.
Tell your doctor if you are to have any vaccinations while on methotrexate as this
may lead to serious infections or death.
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Do not take Methoblastin if:
1. you are allergic to methotrexate, or any of the ingredients listed at the end of this leaflet. Always check the ingredients to make sure you can take this medicine
2. you are pregnant
3. you are breastfeeding
4. you have severe kidney problems
5. you have severe liver problems
6. are an alcoholic
7. you have lowered immunity due to diseases or due to other treatments
8. have bone marrow disease
9. have any blood disorders, or conditions which cause a low number of red blood cells, white blood cells, or platelets
10. have low iron in the blood (anaemia)
11. have infectious disease or severe infections
12. you are receiving a live vaccine
13. you are taking vitamin A derivatives (such as acitretin), medicines used to treat psoriasis and other skin conditions
In addition, do not take Methoblastin to treat psoriasis or rheumatoid arthritis if:
Check with your doctor if you:
Pregnancy and breastfeeding
Children and elderly
How much to take
When to take
How to take it
If you forget to take Methoblastin
If you take too much Methoblastin
(by calling 13 11 26), or
Things you should do
Things you should not do
Things to be careful of
Driving or using machines
Drinking alcohol
Looking after your medicine
Side effects
Side effects
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What to do
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Stomach or gut related
nausea, vomiting, diarrhoea
upset stomach or stomach pains
lack of appetite or weight loss
Nervous system related
dizziness, drowsiness, headaches
numbness, weakness, tingling, burning or cold sensations
irritability, depression, confusion or mood changes
Skin and nails related
skin rash, itchiness
sensitivity or increased burning of the skin from sun exposure
acne or boils or skin ulcers
infection of hair roots or hair loss, especially of the scalp
changes in the toenails/ fingernails or skin around the nails
Eye and ear related
conjunctivitis (itchy eyes and crusty eyelids)
sore eyes, blurred vision
ringing in the ears
Blood related
tiredness, headaches, shortness of breath, dizziness, looking pale (signs of anaemia)
Other
unusual or excessive thirst
changes in menstrual cycle (periods), unusual vaginal discharge
enlarged breast
impotence or loss of interest in sex
back pain, stiff neck
painful joints or muscles
muscle cramps or spasms
brittle bones
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Speak to your doctor if you have any of these side effects and they worry you.
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Serious side effects
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What to do
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Allergic reaction related
signs of an allergic reaction, such as shortness of breath, wheezing or difficulty
breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching,
or hives on the skin.
Heart and blood related
chest pain, shortness of breath, fast or irregular heart beats, weakness or fatigue
pain, swelling, redness and warmth in the leg (signs of a blood clot in the leg)
weakness or paralysis on one side of the body or face, difficulty speaking or swallowing,
headache, loss of balance or vision (signs of stroke)
rapid weight gain, fluid retention, swollen ankles
Eye related
temporary blindness
Lung related
persistent dry, non-productive cough
wheezing, difficulty breathing, chest pain
shortness of breath, which may be worse when lying down, cough, spitting or coughing
up blood or pinkish mucus (may be due to buildup of fluid in the lungs called pulmonary
oedema).
Nervous system related
fits, seizures or convulsions
difficulty speaking, writing or understanding language
weakness in the legs that spreads to the upper limbs and the face, which may result
in paralysis
Infection related
fever and chills, sore throat, sweats, body aches or feel generally unwell
sore mouth (mouth ulcers, blisters), difficulty swallowing, cold sores, swollen glands
headache, dizziness, vomiting, loss of coordination or confusion (may be due to buildup
of fluid in the brain called brain oedema).
Severe skin reaction related
skin redness/rash, pinpoint red spots, ulceration, blistering; hives or itchy skin
severe blisters and bleeding in the lips, eyes, mouth, nose and genitals (Stevens-Johnson
syndrome)
Bleeding related
blood in urine, vomit or bowel motion (e.g. black tarry stools, black vomit)
bleeding or bruising more easily than usual (e.g. bleeding gums, broken blood vessels)
Kidney related
swelling of hands, ankles or feet
frequent or painful urination, difficulty urinating, blood in urine, lower back or
side pain
Liver related
yellowing of the skin and eyes, nausea, vomiting, loss of appetite, feeling generally
unwell, fever, itchy or lighter patches on the skin, pale coloured stools, dark coloured
urine
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Call your doctor straight away, or go straight to the Emergency Department at your
nearest hospital if you notice any of these serious side effects.
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Reporting side effects
What Methoblastin contains
Active ingredient
(main ingredient)
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methotrexate (as sodium)
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Other ingredients
(inactive ingredients)
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lactose monohydrate
microcrystalline cellulose
magnesium stearate
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