NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.
SOLU-MEDROL®
Methylprednisolone sodium succinate
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about SOLU-MEDROL.It does not contain all the available information and it does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits.Your doctor has weighed the risks of you being treated with SOLU-MEDROL against the benefits it is expected to have for you.
Follow the instructions given to you by your doctor and the advice contained in this leaflet.
If you have any concerns about being treated with this medicine, ask your doctor or pharmacist.
Keep this leaflet.
You may need to read it again.
What SOLU-MEDROL is used for
Your doctor has prescribed SOLU-MEDROL for the treatment 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.
How your medicine works
Methylprednisolone sodium succinate, the active ingredient in SOLU-MEDROL, belongs to a group of medicines 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.
Ask your doctor if you have any questions about why SOLU-MEDROL has been prescribed for you.
SOLU-MEDROL is available only with a doctor’s prescription.
There is no evidence that SOLU-MEDROL is addictive.
Before treatment with SOLU-MEDROL
When SOLU-MEDROL must not be used
SOLU-MEDROL must not be used if you have an allergy to
methylprednisolone sodium succinate
any of the ingredients listed at the end of this leaflet.
The SOLU-MEDROL 40 mg product contains lactose from cow’s milk.
Tell your doctor if you are allergic or suspect you are allergic to cow’s milk or to any other dairy products.
Some symptoms of an allergic reaction (anaphylactic reactions) may include
skin rash
itching or hives on the skin
difficulty breathing
wheezing or coughing
swelling of the face, lips, tongue or other parts of the body.
If you are not sure if you have or have had an allergic reaction to SOLU-MEDROL, check with your doctor.
Do not start treatment with SOLU-MEDROL, if you have a severe fungal infection.
Your doctor will advise whether use of SOLU-MEDROL is appropriate in those particular circumstances.
SOLU-MEDROL must not be used with certain types of vaccines.
Tell your doctor if you have recently been vaccinated or immunised.
Your doctor will advise you whether use of SOLU-MEDROL is appropriate in those particular circumstances.
SOLU-MEDROL must be administered by intravenous or intramuscular injection.
Do not administer SOLU-MEDROL in the spinal cord (intrathecal or epidural) or by local injection due to the risk of serious side effects.
Do not administer this medicine to yourself.
Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.
If it has expired or is damaged, return it to your pharmacist for disposal.
If you are not sure if you should start treatment with SOLU-MEDROL, talk to your doctor.
Before treatment with SOLU-MEDROL
Tell your doctor if you are allergic to any other medicines or any other substances such as foods, preservatives or dyes.
Tell your doctor if you have or have had any of the following medical:
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.
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.
Tell your doctor if you are pregnant or plan to become pregnant or are breast-feeding.
Your doctor can discuss with you the risks and benefits involved.
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 him/her before you start treatment with SOLU-MEDROL.
Taking other medicines
Tell your doctor if you are taking any other medicines, including medicines that you buy without a prescription from a pharmacy, supermarket or health food shop.
Some medicines and food and SOLU-MEDROL may interfere with each other. 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 cyclosporin (a medicine used in kidney transplant patients)
some immunisations, inoculations or vaccinations
grapefruit juice.
You may need different amounts of SOLU-MEDROL or you may need to take different medicines. Your doctor or pharmacist can tell you what to do if you are taking any of these medicines. They also have a more complete list of medicines to be careful with or avoid while being treated with SOLU-MEDROL.
Ask your doctor or pharmacist if you are not sure if you are taking any of these medicines.
Treatment with SOLU-MEDROL
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 SOLU-MEDROL 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.
How long you should be given SOLU-MEDROL
Your doctor will continue giving you SOLU-MEDROL for as long as your condition requires.
If you are given too much (overdose)
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.
Immediately telephone your doctor or Poisons Information Centre on 13 11 26 for advice, or go to Accident and Emergency (Casualty) at your nearest hospital if you think your doctor may have been given too much SOLU-MEDROL.Do this even if there are no signs of discomfort or poisoning.
You may need urgent medical attention.
Keep the telephone numbers for these services handy.
While being treated with SOLU-MEDROL
Things you must 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 to be careful of
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.
Be careful when driving or operating machinery 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.
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 and SOLU-MEDROL may have unwanted side effects in a few people. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.
Do not be alarmed by this list of possible side effects.
You may not experience any of them.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor if you notice any of the following and they worry you:
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.
If these effects do not go away or they are worrying to you, tell your doctor.
Tell your doctor immediately if you experience any of the following:
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.
Tell your doctor immediately or go to Accident and Emergency (Casualty) at your nearest hospital if you experience any of the following:
signs of increased pressure in the skull, including drowsiness, vomiting, headache, weakness, numbness and /or eye problems such as double vision
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
convulsions or fits
blurred or loss of vision, distorted vision or a blind spot in your central vision, pressure in the eye
pain and tenderness in the leg, pain on extending the foot, swelling of the lower leg, ankle and foot
chest pain and breathlessness.
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.
This is not a complete list of all possible side effects. Some people may get other side effects while being treated with SOLU-MEDROL.
It is very important to tell your doctor if you notice any side effects during a course of treatment with SOLU-MEDROL.
After treatment with SOLU-MEDROL
Storage
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.
Disposal
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.
Product Description
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 containingthe 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
125 mg ACT-O-VIAL – 1s pack
500 mg vial with diluent – 1s pack
500mg plain vial – 1s and 5s pack
1g vial with diluent – 1s pack
2g vial with diluent – 1s pack
1g plain vial – 1s and 5s pack
Identification
SOLU-MEDROL can be identified by the Australian Registration Number on the carton:
40 mg ACT-O-VIAL, AUST R 171991
125 mg ACT-O-VIAL, AUST R 171992
500 mg vial with diluent, AUST R 12344
1g vial with diluent, AUST R 12340
2g vial with diluent, AUST R 12342
500mg plain vial, AUST R 50691
1g plain vial, AUST R 50698.
Not all presentations are available.
Ingredients
SOLU-MEDROL contains methylprednisolone sodium succinate as the active ingredient.
Each vial also contains the following inactive ingredients: monobasic sodium phosphate and dibasic sodium phosphate.In addition, the 40mg contain lactose monohydrate.
The diluent vials provided for mixing contains Water for Injections with benzyl alcohol.
Supplier
SOLU-MEDROL is supplied in Australia by:
Pfizer Australia Pty Ltd
Sydney, NSW
Toll free number: 1800 675 229.
This leaflet was revised in March 2020.
®Registered trademark
© Pfizer Australia Pty Ltd 2017.
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