For more information, see Section 1. Why am I using DBL Methotrexate Injection? in the full CMI.
For more information, see Section 2. What should I know before I use DBL Methotrexate Injection? 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 using DBL Methotrexate.
You and your partner must use a reliable method of contraception (birth control pills
or condom) during treatment with DBL Methotrexate and for at least 3 months after
you stop treatment for men and 6 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 DBL Methotrexate 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 using DBL Methotrexate.
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Driving or using machines
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Do not drive or operate machinery until you know how DBL Methotrexate affects you.
DBL Methotrexate 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 being given this medicine. Alcohol may increase
the side effects of DBL Methotrexate 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:
DBL Methotrexate Injection should only be used for severe disease and when 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 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 be 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 used in 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 3 months after the end of treatment for men and 6 months after the end of
treatment for women .
Women should not breastfeed while being treated with methotrexate.
Methotrexate should not be used if you have severe kidney problems.
Tell your doctor if you take medicines to relieve pain, swelling of inflammation (nonsteroidal
anti-inflammatory drugs - NSAIDs) as this can result in serious side effects when
being treated with 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 psoriasis conditions in children has not been well established.
Methotrexate should only be used once a week to treat certain conditions. Using methotrexate
more frequently than once a week for these conditions may cause serious reactions
and death.
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 use DBL Methotrexate Injection 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 use this medicine
2. you have severe kidney problems
3. you have lowered immunity due to diseases or due to other treatments
4. you are breastfeeding
5. you are taking vitamin A derivatives (such as acitretin), medicines used to treat psoriasis and other skin conditions
6. you are receiving radiatiotherapy (radiation therapy) e.g. x-rays, ultra violet radiotherapy
7. you are receiving a live vaccine
Do not use DBL Methotrexate Injection to treat psoriasis or rheumatoid arthritis if you:
8. are pregnant
9. have poor nutrition
10. have any blood disorders, or conditions which cause a low number of red blood cells, white blood cells, or platelets
11. have bone marrow disease
12. have low iron in the blood (anaemia)
13. have liver or severe kidney problems
14. are an alcoholic
15. have infectious disease or severe infections
16. have stomach ulcers (peptic ulcer disease)
17. have a condition where your large bowel is inflamed and has ulcers (ulcerative colitis)
Check with your doctor if you:
Pregnancy and breastfeeding
Children and elderly
How much and when is it given
How DBL Methotrexate Injection is given
If you use too much DBL Methotrexate Injection
(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)
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Speak to your doctor if you have any of these side effects and they worry you.
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Side effects
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What to do
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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
injection site reactions
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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)
Eye related
temporary blindness
Lung related
persistent dry, non-productive cough
shortness of breath, wheezing, difficulty breathing or chest pain (may be due to accumulation
of fluid in the lungs called pulmonary oedema)
spitting or coughing blood
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
headache, dizziness, vomiting, loss of coordination or confusion (may be due to accumulation
of fluid in the brain called brain oedema).
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
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)
dark red or black patches of skin around the injection site
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 DBL Methotrexate Injection contains
Active ingredient
(main ingredient)
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methotrexate
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Other ingredients
(inactive ingredients)
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water for injections
sodium chloride (except for 1 g/10 mL)
sodium hydroxide
hydrochloric acid (as pH-adjustment agent)
sodium hydroxide (as pH-adjustment agent)
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