40 mg/ml suspension or suspension, pre-filled syringe
methylprednisolone acetate
1. What Depo-Medrol is and what it is used for
Depo-Medrol contains methylprednisolone and belongs to a group of medicines called corticosteroids. Corticosteroids are produced naturally in the body and counteract and alleviate allergic problems, inflammation, and rheumatic problems.
Depo-Medrol can be given as:
- an injection in or near a joint, to treat local symptoms caused by inflammatory or rheumatic diseases
- an injection into a muscle to treat more widespread (systemic) ailments that affect the whole body e.g. asthma, seasonal allergies, inflammatory or rheumatic disorders
- an injection into the skin to treat certain skin conditions
- an enema in the treatment of ulcerative colitis ( inflammation of the colon).
Depo-Medrol can also be used to treat leukemia and certain tumor diseases.
Talk to your doctor if you are not sure why you are receiving Depo-Medrol.
2. What you need to know before using Depo-Medrol
Do not use Depo-Medrol
- if you are allergic to methylprednisolone acetate or any of the other ingredients of this medicine (listed in section 6).
- if you have a fungal infection that affects your whole body.
Depo-Medrol should not be used in a place where you have a local virus – or bacterial infection e.g. tuberculosis and gonorrhea.
Talk to a doctor if you have any of the above conditions.
Do not inject this medicine:
• directly in a vein ( intravenously ) or in or around the spinal cord (intrathecally or epidurally).
Warnings and cautions
Talk to your doctor before giving Depo-Medrol if you have any of the following conditions or conditions:
- An infection
- Mental illness
- Diabetes
- Epilepsy (seizures)
- Glaucoma (increased pressure in the eye)
- Heart failure
- Neuromuscular diseases e.g. Multiple Sclerosis (MS), Parkinson’s disease
- High blood pressure
- Hypothyroidism (underactive thyroid gland )
- Impaired renal function
- Scleroderma (also called systemic sclerosis, an autoimmune disease)
- Osteoporosis
- Stomach ulcers or other serious gastrointestinal problems
- Ulcerative colitis (inflammation of the colon)
- Tuberculosis
- An adrenal tumor ( pheochromocytoma )
- Recently underwent bowel surgery
- Blood clot
Your doctor may need to monitor your treatment more closely, change your dose or give you another medicine.
Contact a doctor if you experience blurred vision or other visual disturbances.
Tell your doctor that you have received Depo-Medrol if you are going to undergo a skin test, e.g. spot test for allergy or tuberculin test.
Depo-Medrol can affect the growth of children.
Other medicines and Depo-Medrol
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.
Some medicines may increase the effects of Depo-Medrol and your doctor may want to monitor you closely if you are taking these medicines (eg some HIV medicines: ritonavir, cobicistat).
Depo-Medrol can be affected by or affect the effect of many other medicines. The attending physician must therefore be aware of any other medication. This applies to both prescription and over-the-counter medicines.
Always tell Depo-Medrol to the doctor who prescribes another medicine for you.
Tell your doctor or nurse if you have recently been or should be vaccinated. Some types of vaccines are not suitable for treatment with Depo-Medrol.
Depo-Medrol with food, drink, and alcohol
Intake of grapefruit juice may affect treatment with Depo-Medrol. If you consume grapefruit or grapefruit juice, discuss this with your doctor.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
There is a risk that the fetus will be affected. In long-term treatment, low birth weight, withdrawal symptoms, and isolated cases of cataracts have been seen in infants. Do not use Depo-Medrol during pregnancy except on certain prescriptions from the doctor.
Breast-feeding
There is a risk that a breastfed baby is affected when small amounts of methylprednisolone pass into breast milk. Therefore, do not use Depo-Medrol during breast-feeding unless specifically prescribed by a doctor.
Driving and using machines
Depo-Medrol does not usually affect your ability to drive or use machines. However, you may experience side effects such as dizziness, visual disturbances, and fatigue that may affect your ability to drive.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Depo-Medrol contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per dose ie essentially ‘ sodium-free’. is next to “sodium-free”.
3. How to use Depo-Medrol
Depo-Medrol is given as an injection. Your doctor will decide where the injection one should be, how much medicine, and how many injections, you will get, depending on the condition being treated. Your doctor will inject as low a dose for as short a time as possible to effectively relieve your symptoms.
If you use more Depo-Medrol then you should
As this medicine will be given to you by your doctor, it is unlikely that you will be given too much medicine.
If you stop using Depo-Medrol
When you stop taking Depo-Medrol, do so step by step to avoid withdrawal symptoms.
If after having stopped taking Depo-Medrol to develop signs of acute failure of the adrenal glands are example fatigue, chills, or dizziness, you should contact a doctor immediately.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Depo-Medrol and contact your doctor immediately if you get any of the following symptoms:
- Swelling of the face, tongue, or throat; difficulty swallowing; hives and difficulty breathing ( angioedema or anaphylactic reaction )
- Severe abdominal pain that may be a sign of bleeding or a hole in the intestine
- Symptoms of infection such as fever and chills and malaise. This medicine may reduce your resistance to infection or hide or alter the signs and symptoms of certain infections which may make them more difficult to detect.
Common (may affect up to 1 in 10 people)
Decreased infection defense, lower levels of certain hormones, symptoms similar to Cushing’s syndrome (eg weight gain with fat storage, muscle weakness, easy bruising, pimples, osteoporosis, mood swings), growth retardation, osteoporosis, local muscle and skin wasting deterioration of wound healing, worsening or activation of dormant diabetes, low potassium level which can cause fatigue, high sodium level with fluid accumulation as a result.
Uncommon (may affect up to 1 in 100 people)
Activation of mental illness, cataracts, glaucoma (increased pressure in the eye), high blood pressure, stretch marks in the skin, and soft tissues.
Rare (may affect up to 1 in 1,000 people)
Allergic reaction increased pressure in the central nervous system that can cause headaches and blurred vision, stomach ulcers, eczema, tissue death in bone tissue that can cause skeletal pain, tendon rupture.
Has been reported (occurs in an unknown number of users)
Infection, increased white blood cell count ( leukocytosis ), drug hypersensitivity, severe allergic reaction, pheochromocyte-related crisis (symptoms such as palpitations, headache, and sweating), withdrawal symptoms on tapering, lipid disorders, increased appetite (which may result in weight gain), accumulation of adipose tissue in isolated places on the body, emotional symptoms (eg depression, feelings of happiness, mood swings, drug addiction or suicidal thoughts), mental disorders, personality changes, confusion, anxiety, increased pressure in the central nervous system which can cause headache and blurred vision, abnormal behavior, sleep problems, irritability, cramps, memory problems, intellectual disorder, dizziness, headache, blurred vision, blurred vision, dizziness, low blood pressure, increased tendency to get blood clots, hiccups, holes in the intestine, esophagitis, swelling of the esophagus, abdominal pain, diarrhea, heartburn, nausea.
Methylprednisolone can damage the liver: hepatitis (inflammation of the liver) and increase in liver enzymes have been reported, short-term and limited swelling (mainly in the skin) which is often caused by allergies, increased male body hair in women, rash, redness, excessive sweating, stretch marks, itching, itching, hives, acne, muscle aches, muscle wasting, joint pain, fluid retention (ankles, feet, and legs), fatigue, malaise, increased calcium in the urine, increased urea in the blood (blood test value).
The risk of suffering from the above-mentioned side effects is lower with short-term treatment than with long-term treatment.
5. How to store Depo-Medrol
Keep this medicine out of the sight and reach of children.
No special storage instructions.
Do not use this medicine after the expiry date which is stated on the carton after EXP: The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration
- The active substance is methylprednisolone acetate. 1 ml solution for injection contains 40 mg methylprednisolone acetate.
- The other ingredients are macrogol 3350, sodium chloride, miripirium chloride, water for injections.
What the medicine looks like and the contents of the pack
Injection 40 mg / ml: Vial of glass 1 ml, 1 × 10 ml, 25×1 ml, 1 × 50 ml, 2 ml, 2 × 10 ml and 5 ml.
Single dose syringe 40 mg / ml: 2 ml.
Not all pack sizes may be marketed.