Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist.
1. Why am I given SOLU-MEDROL?
SOLU-MEDROL contains the active ingredient methylprednisolone sodium succinate. SOLU-MEDROL
is used for treatment of various medical conditions including skin diseases, allergic
reactions, inflammation of the eyes, respiratory diseases and certain respiratory
infections, diseases of the gut, multiple sclerosis, rheumatic disorders, diseases
of the blood and treatment of certain glandular conditions. For more information,
see Section
1. Why am I given SOLU-MEDROL? in the full CMI.
2. What should I know before I receive SOLU-MEDROL?
Do not use if you have ever had an allergic reaction to methylprednisolone sodium
succinate or any of the ingredients listed at the end of the CMI. Talk to your doctor
if you have any other medical conditions, take any other medicines, or are pregnant
or plan to become pregnant or are breastfeeding.
For more information, see Section
2. What should I know before I receive SOLU-MEDROL? in the full CMI.
3. What if I am taking other medicines?
Some medicines and food may interfere with SOLU-MEDROL and affect how it works. Tell
your doctor if you are taking any other medicines including medicines used to relieve
pain or swelling, some antibiotics, oral contraceptives, anticoagulants, anticonvulsants
and antidiabetic medicines.
A list of these medicines is in Section
3. What if I am taking other medicines? in the full CMI.
4. How is SOLU-MEDROL given?
This medicine will be administered under medical supervision. SOLU-MEDROL must be
administered by intravenous or intramuscular injection. You must not administer this
medicine to yourself.
The dose, how often and how long you are treated with SOLU-MEDROL will depend on your
medical condition and also on your weight. Your doctor may change the dose and how
many times a day you have it, as your condition changes.
More instructions can be found in Section
4. How is SOLU-MEDROL given? in the full CMI.
5. What should I know while on SOLU-MEDROL?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are being treated with
SOLU-MEDROL.
Tell your doctor immediately if you notice any unusual symptoms.
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Things you should not do
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Avoid drinking grapefruit juice while you are being treated with SOLU-MEDROL.
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Driving or using machines
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Be careful when driving or operating machinery until you know how SOLU-MEDROL affects
you.
It may cause dizziness, light headedness, visual disturbances, and fatigue in some
patients
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Looking after your medicine
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Normally your doctor will get SOLU-MEDROL from the hospital pharmacy or their consulting
rooms.
Store it in a safe place away from heat (below 25°C).
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6. Are there any side effects?
All medicines can have side effects and SOLU-MEDROL may have unwanted side effects
in a few people. Some of the common side effects are weight gain/loss, increased/decreased
appetite, muscle weakness or loss of muscle mass, increased sweating, headache/dizziness,
light headedness, fatigue, nausea, vomiting, itchy/peeling/thin fragile skin, acne
and stomach pain/ discomfort or diarrhoea. If you experience side effects such as
bone weakness/fracture, wounds not healing or red/purple/brown patches of skin, yellowing
of the skin/eyes, dark urine, you should tell your doctor immediately. If you experience
severe headache or stomach pain, blurred/double vision, convulsions or fits, chest
pain or any allergic-type reactions such as skin rash, itching and difficulty breathing,
tell your doctor immediately or go to Accident and Emergency at your nearest hospital.
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.
Active ingredient(s):
Methylprednisolone sodium succinate
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using SOLU-MEDROL. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using SOLU-MEDROL.
Where to find information in this leaflet:
1. Why am I given SOLU-MEDROL?
SOLU-MEDROL contains the active ingredient methylprednisolone sodium succinate.
SOLU-MEDROL belongs to a group of medicine called corticosteroids. SOLU-MEDROL acts
in the body by reducing inflammation (pain, swelling, redness and heat), which is
one of the body's reactions to injury, and by reducing the body's reaction to infection.
SOLU-MEDROL is used to treat of one or more of the following:
skin diseases
allergic reactions
inflammation of the eyes
respiratory diseases and certain respiratory infections
diseases of the gut (gastrointestinal tract)
multiple sclerosis
rheumatic disorders
diseases of the blood
treatment of certain glandular conditions.
Your doctor may have prescribed SOLU-MEDROL for another reason.
There is no evidence that SOLU-MEDROL is addictive.
2. What should I know before I receive SOLU-MEDROL?
Warnings
Do not use SOLU-MEDROL if:
1. you are allergic to methylprednisolone sodium succinate or any of the ingredients
listed at the end of this leaflet. The SOLU-MEDROL 40 mg product contains lactose
from cow's milk.
2. Always check the ingredients to make sure you can use this medicine.
3. you have a severe fungal infection.
Check with your doctor if you:
have or have had any of the following medical conditions:
disease of the heart, e.g., high blood pressure (hypertension) or congestive heart
failure
condition or tumour of the adrenal and/or pituitary glands
stomach ulcers
thin or weak bones, or bones that tend to break easily (osteoporosis)
kidney or liver disease
underactive thyroid gland
emotional and mental disorder
myasthenia gravis (ongoing chronic fatigue and muscle weakness)
tuberculosis (TB)
herpes simplex of the eye
any pus producing infections
disease of the bowel, e.g., ulcerative colitis or diverticulitis
recent head injuries
fits or convulsions
diabetes or increased sugar in your blood
blood clots
a cancer of the blood because you may be at risk of a very rare, potentially life-threatening
condition resulting from a sudden breakdown of tumour cells.
take any medicines for any other condition
have recently been vaccinated or immunised. SOLU-MEDROL must not be used with certain
types of vaccines
are allergic to any other medicines or any other substances such as foods, preservatives
or dyes, especially cow's milk or any other dairy products.
If you are scheduled to have any laboratory tests, e.g., blood or urine, tell your
doctor that you are being treated with SOLU-MEDROL.
The use of SOLU-MEDROL may disguise the signs of infections due to a decrease in the
body's response to the infection. If you are in any doubt please consult your doctor.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Children
Long term treatment with corticosteroids can affect growth and development in children.
It can also increase the risk of high pressure in the brain. Your doctor will monitor
your child closely if your child needs long term treatment with SOLU-MEDROL.
Some of the SOLU-MEDROL products contain benzyl alcohol. Benzyl alcohol has been associated
with a rare but serious side effect in infants. Your doctor will decide if treatment
is appropriate.
Elderly
If you are over 65 years old, you may have an increased chance of side effects such
as bone weakness possibly leading to fractures. You may also experience fluid retention
which may lead to increased blood pressure.
If you have not told your doctor about any of the above, tell them before you start
treatment with SOLU-MEDROL.
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
Your doctor can discuss with you the risks and benefits involved.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Some medicines and food may interfere with SOLU-MEDROL and affect how it works. These
include:
nonsteroidal anti-inflammatory such as salicylates or aspirin, medicines used to relieve
pain, swelling and other symptoms of inflammation including arthritis.
neuromuscular blocking drugs, e.g., pancuronium
some antibiotics, e.g., erythromycin
medicines used to treat TB, e.g. isoniazid
some anti-fungal agents, e.g., ketoconazole, amphotericin
medicines to treat HIV, e.g., indinavir, ritonavir
some medicines to treat blood pressure, heart conditions and stroke, e.g., digoxin
and diltiazem
some diuretics e.g., frusemide, a medicine to help kidneys get rid of salt and water
by increasing the amount of urine produced
medicine for nausea, e.g., aprepitant, fosaprepitant
oral contraceptives
medicines used for myasthenia gravis, glaucoma, Alzheimer's disease
medicines for psychiatric disorders
medicines to treat anxiety
bronchodilators (a type of medicine that opens up the airways in the lungs) used to
treat asthma, bronchitis, emphysema, and other lung diseases, e.g., salbutamol
medicines to treat breast cancer or hormone disorder
anticonvulsants e.g., phenytoin, phenobarbitone
anticoagulants e.g., heparin, warfarin
antidiabetic medicines e.g., insulin, glibenclamide and metformin
immunosuppressants e.g., methotrexate and ciclosporin (a medicine used in kidney transplant
patients)
some immunisations, inoculations or vaccinations
grapefruit juice.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect SOLU-MEDROL.
4. How is SOLU-MEDROL given?
This medicine will be administered under medical supervision.
SOLU-MEDROL must be administered by intravenous or intramuscular injection. It must
not be given in the spinal cord (intrathecal or epidural) or by local injection due
to the risk of serious side effects.
You must not administer this medicine to yourself.
SOLU-MEDROL powder is reconstituted with the diluent provided or Sterile Water for
Injections by your doctor or pharmacist.
How much you should be given
The dose and how often you are treated with SOLU-MEDROL will depend on your medical
condition and also on your weight. Your doctor may change the dose and how many times
a day you have it, as your condition changes.
Your doctor will continue giving you SOLU-MEDROL for as long as your condition requires.
If you are given too much SOLU-MEDROL
SOLU-MEDROL will be administered under medical supervision, so an overdose is unlikely.
However, repeated frequent doses over a long period of time may cause an increase
in side effects.
If you think that you have been given too much SOLU-MEDROL, you may need urgent medical
attention.
You should immediately:
contact your doctor, or
phone the Poisons Information Centre
(by calling
13 11 26), or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
Keep the telephone numbers for these services handy.
5. What should I know while on SOLU-MEDROL?
Things you should do
Tell your doctor immediately if you notice any unusual symptoms.
If you are about to start taking any new medicines, tell your doctor or pharmacist
that you are being treated with SOLU-MEDROL.
Tell any doctor, dentist or pharmacist who treats you that you are being treated with
SOLU-MEDROL.
Tell your doctor immediately if you become pregnant while taking SOLU-MEDROL.
If you are about to have any blood test, tell you doctor that you are taking SOLU-MEDROL.
It may interfere with some of the results.
Keep all your doctor's appointments so that your progress can be checked.
Things you should not do
Avoid drinking grapefruit juice while you are being treated with SOLU-MEDROL.
Grapefruit may interact with SOLU-MEDROL and affect the way your body uses the medicine.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how SOLU-MEDROL
affects you.
SOLU-MEDROL may cause dizziness, light headedness, visual disturbances, and fatigue
in some patients.
Do not drive or operate machinery or do anything else that could be dangerous, if
you have any of these symptoms.
Looking after your medicine
Normally your doctor will get SOLU-MEDROL from the hospital pharmacy or their consulting
rooms. If you do take your SOLU-MEDROL from the pharmacy to your doctor, it is important
to store it in a safe place away from heat (below 25°C).
Do not leave SOLU-MEDROL in a car.
If for any reason you take your SOLU-MEDROL home, always ensure that it is stored
in a place where children cannot reach it.
Getting rid of any unwanted medicine
If your doctor stops treating you with SOLU-MEDROL, your hospital pharmacist will
dispose of any unused medicine.
The expiry date is printed on the labels. SOLU-MEDROL should not be used after this
date has passed.
6. Are there any side effects?
Tell your doctor or pharmacist as soon as possible if you do not feel well while you
are being treated with SOLU-MEDROL.
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Do not be alarmed by this list of possible side effects. You may not experience any
of them.
Common side effects
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Common side effects
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What to do
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weight gain as a result of fluid retention or increased appetite
muscle weakness or loss of muscle mass
loss of ability to feel pain in the joint and instability of the joint
pain when putting weight or pressure on a joint
increased sweating
headache or dizziness
light headedness
changes in your menstrual periods
mood changes and other mental disorders such as memory loss, reduced perception and
problem-solving abilities
nausea
vomiting
itchy or peeling skin
loss of appetite or weight loss
thin fragile skin or bruising
acne
facial redness or bands, stripes or lines on the skin
excessive hairiness, particularly in women
benign tumour-like lumps as a result of fat deposits in the tissues
persistent hiccups
stomach pain or discomfort
diarrhoea
fatigue or generally feeling unwell
pain, redness at the injection site.
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Speak to your doctor if you have any of these common side effects and they worry you.
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Serious side effects
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Serious side effects
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What to do
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Call your doctor immediately:
bone weakness possibly leading to fractures
wounds that will not heal
red, purple or brown patches on your skin
loss of sensation or problems with your reflexes (slow or too fast)
yellowing of the skin or eyes, dark urine, loss of appetite.
Seek Emergency medical attention:
signs of increased pressure in the skull, including drowsiness, vomiting, headache,
weakness, numbness and /or eye problems such as double vision
convulsions or fits
blurred or loss of vision, distorted vision or a blind spot in your central vision,
pressure in the eye
signs of frequent infections such as fever, severe chills, sore throat or mouth ulcers
allergic-type reactions, e.g., skin rash, itching and difficulty breathing, wheezing
or coughing (anaphylactic reactions)
swelling of hands, ankles or feet
swelling of the face, lips, mouth, tongue or throat which may cause difficulty in
swallowing or breathing
inflammation of the food pipe. You may experience difficulty or pain when swallowing
or heartburn
poor appetite, fever, chills, nausea and a persistent stomach-ache that becomes worse
with movement
uncomfortable or severe stomach pains or belching after eating
pain and tenderness in the leg, pain on extending the foot, swelling of the lower
leg, ankle and foot
chest pain and breathlessness
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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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Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
SOLU-MEDROL can also cause chemical imbalances in the blood and urine, swelling of
the pancreas (pancreatitis), bleeding in the stomach, masking of infections, increased
risk of infection, hormone changes, metabolic changes, changes in liver enzymes, increased
blood pressure or increased number of white blood cells (leucocytosis). Some of these
side effects can only be found when your doctor does tests from time to time to check
on your progress.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What SOLU-MEDROL contains
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Active ingredient
(main ingredient)
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methylprednisolone sodium succinate
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Other ingredients
(inactive ingredients)
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40 mg ACT-O-VIAL System
monobasic sodium phosphate
dibasic sodium phosphate
lactose monohydrate
sodium hydroxide
water for injections (diluent)
125 mg ACT-O-VIAL System
monobasic sodium phosphate
dibasic sodium phosphate
sodium hydroxide
water for injections (diluent)
500 mg, 1 g and 2 g Vials with Diluent
monobasic sodium phosphate
dibasic sodium phosphate
sodium hydroxide
benzyl alcohol (diluent)
water for injections (diluent)
500 mg and 1 g Plain Vials
monobasic sodium phosphate
dibasic sodium phosphate
sodium hydroxide
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Do not use this medicine if you are allergic to any of these ingredients.
What SOLU-MEDROL looks like
SOLU-MEDROL powder for injection is a white, or nearly white powder in a vial.
SOLU-MEDROL is supplied as:
one vial with separate sections containing the powder and the liquid to dissolve the
powder ready for injection (ACT-O-VIAL system), or
two vials, one containing the powder and the other containing the liquid to dissolve
the powder ready for injection, or
plain vials containing only the powder.
Available pack sizes:
40 mg ACT-O-VIAL - 5s pack (AUST R 171991)
125 mg ACT-O-VIAL - 1s pack (AUST R 171992)
500 mg vial with diluent - 1s pack (AUST R 12344)
1 g vial with diluent - 1s pack (AUST R 12340)
2 g vial with diluent - 1s pack (AUST R 12342)
500 mg plain vial - 1s and 5s pack (AUST R 50691)
1 g plain vial - 1s and 5s pack (AUST R 50698)
Not all presentations are available.
Who distributes SOLU-MEDROL
Pfizer Australia Pty Ltd
Sydney NSW
Toll Free Number: 1800 675 229
This leaflet was prepared in June 2023.