4 mg and 16 mg tablets of
methylprednisolone
What Methylprednisolone Orion is and what it is used for
The active substance in Methylprednisolone Orion is methylprednisolone. Methylprednisolone is a corticosteroid, which, among other things, relieves symptoms of inflammation and eliminates allergic symptoms.
Methylprednisolone Orion is used to treating inflammation that occurs in many different diseases. Examples of these are:
- rheumatic diseases of various kinds (eg rheumatoid arthritis )
- diseases affecting the connective tissue
- allergic conditions
- various skin diseases
- lung diseases
- liver diseases
- diseases related to the blood and the blood-forming organs (eg altered blood count)
- diseases related to the brain and nervous system (eg meningitis )
- eye diseases
- kidney diseases
- gastrointestinal diseases
- cancer
This drug is also used to prevent the rejection of transplanted organs and to reduce the pressure inside the skull due to brain swelling.
Other drugs are often combined with cortisone treatment.
Your doctor will tell you what condition or symptoms you are getting Methylprednisolone Orion.
Methylprednisolone contained in Methylprednisolone Orion may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you use Methylprednisolone Orion
Do not take Methylprednisolone Orion
- if you have a fungal infection that affects your entire body
- if you have another infection that affects the whole body and it is not treated with appropriate drugs
- if you are allergic to methylprednisolone or any other corticosteroid , or any of the other ingredients of this medicine (listed in section 6).
For vaccination, see section Warnings and precautions.
Warnings and cautions
Talk to your doctor before taking Methylprednisolone Orion if you have:
- known drug allergy (see also section: Do not take Methylprednisolone Orion). Allergic reactions, in rare cases also life-threatening allergic reactions (anaphylactic shock ), have occurred in connection with this medicine. Symptoms can e.g. be airway contractions, low blood pressure , slurred speech, fast or weak pulse , bluish skin, bluish lips and nail beds , diarrhea, nausea and vomiting).
- a parasitic infection, or suspect you may have such an infection .
- conditions caused by an excessive level of the hormone et cortisol in the body (Cushing’s syndrome). This medicine may cause or worsen the condition.
- hypothyroidism , as it may intensify the effects of this medicine
- cramps ( epilepsy ).
- a neuromuscular disease called myasthenia gravis , because it can make you more prone to acute generalized muscle disease.
- cardiovascular disease (eg heart failure , hypertension , recent myocardial infarction) or risk factors for cardiovascular disease (eg obesity, high cholesterol).
- gastric ulcer or duodenal ulcer, or sore throat, inflammatory bowel disease
- enteroanastomosis (surgical connection between different sections of intestine)
- blood clots in blood vessels or have an increased sensitivity to form blood clots
- tumor on the adrenal glands ( pheochromocytoma )
- severe depression, depressive disorder ( bipolar disorder ) or psychosis . This includes previous depression or psychosis during treatment with steroid drugs such as Methylprednisolone Orion or previous occurrence of these diseases in close relatives.
- scleroderma (also called systemic sclerosis, an autoimmune disease), because corticosteroids including methylprednisolone can increase the risk of a serious complication called acute kidney crisis. Signs of acute kidney crisis include increased blood pressure and decreased urine production. Your doctor may advise you to check your blood pressure and urine levels regularly.
Also, tell your doctor if you have
- tuberculosis
- diabetes . This medicine may raise your blood sugar level, make your diabetes worse or make you more prone to diabetes with long-term use.
- a diagnosis of emotional instability or psychosis .
- kidney disease or kidney failure
- shock due to severe infection
- used this medicine with acetylsalicylic acid or non-steroidal anti-inflammatory drugs (so-called NSAIDs)
- steroid-related withdrawal symptoms such as loss of appetite, nausea, vomiting, extreme fatigue, headache, fever, joint pain, peeling of the skin, muscle pain, weight loss and / or lowering of blood pressure .
- disturbance in liver function or in the bile ducts.
- nerve diseases that cause numbness, severe fatigue or muscle weakness.
- glaucoma (increased pressure in the eye) or if a family member has glaucoma .
- herpes infection in the eye.
- damage to optic nerve or cataracts (can be felt as loss of vision).
- central serous retinopathy which is an eye disease that causes visual impairment.
- head injury
Muscle symptoms
High doses of corticosteroids can cause an acute muscle disease that affects the whole body and also lead to complete paralysis. You should therefore tell your doctor immediately if you get any symptoms of infection during treatment.
Susceptibility to infection
This medicine may increase your susceptibility to infection or mask the symptoms of infection. To avoid any serious consequences due to this, tell your doctor immediately if you get any symptoms of infection during treatment.
Stress
Talk to your doctor if you are or will be exposed to an unusual amount of stress during treatment. It may be necessary to adjust your treatment.
Mental disorders
Mental disorders such as euphoria, insomnia, mood swings, personality changes, deep depression, or obvious psychotic symptoms may occur or worsen with the use of this medicine. The symptoms usually appear after a few days or weeks from the start of treatment. Such psychiatric effects may also occur with dose reduction one or immediately after discontinuation of treatment. If you get similar symptoms, consult your doctor as your treatment may need to be adjusted.
Eye symptoms
This medicine can cause various eye diseases, including increased eye pressure. If you get any symptoms from the eyes, eye infection, or visual disturbances (blurred vision or other visual disturbances) during treatment, consult a doctor.
Vaccination
If you are given this medicine in a dose that lowers your immune system, do not give any live or attenuated vaccines. Talk to your doctor about which vaccinations are suitable for you during corticosteroid treatment.
Effects on blood pressure and laboratory values
In rare cases, high doses or long-term use of this medicine may increase blood pressure, increase sodium and water retention in the body (swelling), increase potassium and calcium excretion, or increase blood lipid levels. To deal with these side effects, your doctor may ask you to review your diet.
Hormonal effects
Too high a level of corticosteroids in the body, especially for a long period of time, can cause Cushing’s syndrome: fat accumulation around the neck, accumulations of fat over the face, and the formation of pink or purple stretch marks in the skin. Cushing’s syndrome can also lead to high blood pressure, osteoporosis, and sometimes diabetes. You will be followed up regarding this and if necessary, your doctor will adjust the treatment accordingly.
Prolonged use of this drug can also impair the body’s adrenal function and cortisol formation. To reduce the risk of such symptoms, treatment will be stopped by gradually reducing dose one. If the body’s own cortisol production is impaired, abrupt discontinuation of this drug may cause withdrawal symptoms or even a life-threatening situation with severe vomiting and diarrhea, low blood pressure, and unconsciousness.
Other
High-dose or prolonged corticosteroid therapy may also cause acute inflammation of the pancreas ( pancreatitis ), osteoporosis (osteoporosis), malignant tumors of the blood vessels ( Kaposi’s sarcoma ), or epidural lipomatosis (accumulation of adipose tissue in the area around the spinal canal). This medicine increases the risk of late rupture when used with antibiotics called fluoroquinolones, especially in elderly patients. You will be followed up regarding these effects and if necessary, your doctor will adjust the treatment accordingly.
Older
At an older age, the common side effects of this drug can have more serious consequences.
Children
In children, long-term use of high doses of this drug may cause growth and developmental disorders, increased intracranial pressure (symptoms: headache, nausea/vomiting, balance disorders, decreased consciousness), or inflammation of the pancreas (symptoms: pain in the upper abdomen). You should carefully observe your child for signs and symptoms of these conditions.
Other medicines and Methylprednisolone Orion
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.
The effect of certain medicines or the effect of Methylprednisolone Orion may change or you may experience side effects and your doctor may need to carefully monitor you if you are taking the following medicines while taking Methylprednisolone Orion:
- certain antibiotics ( fluoroquinolones , erythromycin, clarithromycin, troleandomycin)
- fungicides such as (itraconazole, amphotericin B) (used to treat fungal infections)
- ketoconazole in addition to shampoo (used to treat Cushing’s syndrome – when the body produces too much cortisol ).
- drugs used to treat myasthenia gravis – a muscle disease (distigmine, neostigmine)
- isoniazid , rifampicin (for the treatment of tuberculosis )
- aprepitant, fosaprepitant (for the prevention of nausea)
- medicines such as diltiazem or mibefradil (for the treatment of coronary heart disease and high blood pressure ) or any other medicine for the treatment of high blood pressure
- drugs used to treat heart failure such as digoxin
- certain anti- HIV agents such as indinavir, ritonavir and cobicistat
- ciclosporin (used after an organ transplant to prevent rejection of the transplanted organ)
- estrogen (used as a contraceptive or for menopausal symptoms)
- blood-thinning drugs taken orally to prevent blood clotting (eg warfarin )
- drugs used to treat high blood sugar
- drugs such as tacrolimus (used after an organ transplant to prevent rejection of the transplanted organ)
- drugs such as sirolimus, leflunomide, adalimumab, kanakimumab, azathioprine (used to inhibit the activity of the immune system)
- anti-inflammatory painkillers (such as ibuprofen ) or acetylsalicylic acid (aspirin)
- aminoglutethimide (for the treatment of Cushing’s syndrome and spread breast cancer)
- diuretics (diuretics used to treat a range of conditions such as high blood pressure and edema )
- St. John’s wort ( Hypericum perforatum), an herbal medicine used to treat depression
- laxatives (used to treat and prevent constipation)
- antiepileptic drugs (carbamazepine, phenobarbital, phenytoin , primidone)
- somatropin ( growth hormone )
- mifepristone (used for medical abortion).
Methylprednisolone can affect or be affected by muscle relaxants that can be used during surgery. Inform your doctor or nurse well in advance that you are using methylprednisolone if you are going to have surgery.
Methylprednisolone Orion with drink
Avoid drinking grapefruit juice during treatment. Grapefruit juice may aggravate the side effects of this medicine.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine, as it may inhibit your baby’s growth.
Cataracts have been observed in infants whose mothers have received long-term treatment with corticosteroids during pregnancy.
Only take this medicine during pregnancy and breastfeeding if your doctor considers that the benefit of treatment is greater than the potential risks to the embryo/fetus or infant.
Corticosteroids pass to breast milk.
Treatment with corticosteroids may impair sperm quality and cause amenorrhea (absence of menstruation in women of childbearing potential )
Driving and using machines
Side effects such as dizziness, blurred vision, and fatigue may occur with the use of this medicine. If they occur, do not drive or use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. 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.
Methylprednisolone Orion contains lactose
One 4 mg tablet contains 67 mg of lactose.
One 16 mg tablet contains 124 mg of lactose.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
How to use Methylprednisolone Orion
Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
The starting dose depends on the disease and the severity and is usually 4-48 mg/day.
Higher doses can be used in more severe conditions.
For long-term treatment, the minimum effective dose is preferably taken every other day in the morning.
Your doctor may have prescribed a different dose than the one recommended here. Always follow your doctor’s advice.
The tablet can be divided into equal doses.
Use for children
For children, the lowest possible dose and short treatment times are recommended.
If you use more Methylprednisolone Orion than you should
A high dose of Methylprednisolone Orion does not usually have serious side effects. Prolonged overdose may impair the body’s own cortisol production (impaired adrenal function).
If you have ingested too much medicine or if e.g. a child ingested the medicine accidentally contact a doctor, hospital, or the Poison Information Center tel. 112 for risk assessment and advice.
In case of overdose, you will receive appropriate treatment to relieve the symptoms.
If you are seeking medical attention, take this leaflet and the remaining tablets with you.
If you forget to use Methylprednisolone Orion
Take the missed dose as soon as possible. Do not take a double dose to make up for a forgotten dose.
Before a trip or vacation, make sure you have enough medicine.
If you stop using Methylprednisolone Orion
Do not stop the medication without consulting your doctor. Rapid discontinuation of this drug may lead to withdrawal symptoms, including loss of appetite, nausea, vomiting, lethargy, headache, fever, joint pain, peeling of the skin, muscle pain, weight loss, and/or lowering of blood pressure. To reduce the risk of such symptoms, treatment will be stopped by gradually reducing dose one.
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. The duration of treatment and the dose affect the possible side effects.
If you get a severe allergic reaction with or without a drastic drop in blood pressure, cardiac arrest, and bronchospasm (contraction of the muscles in the airways that cause wheezing), stop taking Methylprednisolone Orion and contact a doctor, health center, or emergency department immediately at the nearest hospital.
Common adverse s (can occur in more than 1 in 10):
- infection
- inhibition of the body’s own corticotropin – and cortisol secretion (applies to long-term treatment)
- rounder face and weight gain
- sodium and fluid retention in the body
- depression, euphoric mood
- cataracts (indicated by loss of vision)
- high blood pressure
- gastric ulcer or duodenal ulcer or sore throat (which may become perforated and bleed)
- swollen joints
- bruising, thinning and brittleness of the skin, acne
- osteoporosis
- muscle weakness
- impaired wound healing
- constipation, extreme fatigue, muscle weakness, cramps and spasms due to low potassium levels in the blood
In some cases (frequency can not be calculated from the available data), this drug has caused the following serious side effects:
- severe metabolic disorders (tumor lysis syndrome) associated with the start of cancer treatment
- brown / purple / red elevated spots on the skin or in the mouth ( Kaposi’s sarcoma )
- an increase in white blood cells e.g. when you have an infection or in an allergic reaction
- severe allergic reactions
- increased intracranial pressure (with swollen optic nerve ), convulsions, memory loss, intellectual disability, dizziness, headache
- abnormal heart rhythm, heart failure (exposed patients), heart rupture ( heart failure ) due to heart attack, low blood pressure , arterial embolism (a sudden stop in the blood circulation in an organ or a body part due to a blood clot)
- skeletal degradation due to poor blood circulation, fractures , decreased muscle size, acute muscle disease, joint disorder (neuropathic arthropathy ), joint pain, muscle pain
- increase in liver enzymes
- lipid disorders (accumulation of adipose tissue in isolated places on the body)
- increased clotting of the blood
- Eye disorders: retinal and varicose vein disease, swollen eyes, glaucoma (increased pressure in the eye), thinning of the clear part of the anterior eye ( cornea ) or of the white part of the eye (sclera), blurred vision
- infection due to weakened immune system
- impaired ability of the pituitary gland
- withdrawal symptoms due to the corticosteroids
- increased appetite
- increased urea level in the blood (seen in blood tests)
- increased blood sugar content and increased insulin requirements or the need for blood glucose lowering drugs – hormones or drugs that regulate blood sugar levels
- low potassium levels in the blood which appear in blood tests as too high an alkaline content or too low an acid content
- accumulation of large amounts of acids in the body (metabolic acidosis )
- greater nitrogen intake than nitrogen loss
- mood swings, psychological dependence, suicidal thoughts, psychotic disorders, confusion, nervousness, mental disorders, personality changes, abnormal behavior, insomnia, irritability
- hiccups, pulmonary embolism (blood clots in the lungs) with symptoms such as sudden, sharp chest pain, shortness of breath and coughing up of blood
- gastric bleeding, intestinal perforation, pancreatitis, peritonitis, esophagitis with or without ulcers, abdominal pain, abdominal swelling, diarrhea, indigestion, nausea
- acute , painless blistering of the skin or swelling under the skin ( angioedema ), small blood spots under the skin, blood vessel damage caused by dilation of a group of small blood vessels (teleangiectasia), stretch marks, pigment spots on the skin (paler or more colored skin than normal), severe hair growth on the face or body of women, skin rash, redness of the skin, itching , raised spots on the skin, excessive sweating
- irregular menstruation
- fatigue, general malaise
- impaired sugar and starch tolerance
- elevated calcium levels in the urine
- no reaction during skin tests
- tendon rupture (especially in the heel tendon), skeletal degradation
In rare cases, steroid-related panniculitis ( inflammation of the adipose tissue under the skin) has been reported at the end of treatment. Red, firm, stinging lumps that appear under the skin approximately two weeks after the end of treatment have been reported. They disappear by themselves.
The following side effects may also occur during corticosteroid treatment: increased clotting of the blood, elevated blood fat levels, increased risk of arteriosclerosis (the walls of the arteries become thicker and stiffer), vasculitis (red, swollen, painful blood vessels due to inflammation ). Corticosteroid treatment may impair sperm quality and cause missed periods.
The elderly are more susceptible than other adults to certain side effects such as stomach ulcers, osteoporosis or skin thinning.
With long-term treatment, side effects can be reduced by using the lowest effective dose and taking that dose every other morning.
Additional side effects are in children
In children, the most common side effects are mood swings, abnormal behavior, insomnia, and irritability. This medicine may also cause growth retardation.
Reporting of side effects ar
If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects that are not mentioned in this information. You can also report side effects directly via (see details below). By reporting side effects, you can help increase information about drug safety.
The Medical Products Agency
Box 26
751 03 Uppsala
Website: www.lakemedelsverket.se
5. How to store Methylprednisolone Orion
Do not store above 25 ° C.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. and on the label after EXP. The expiration date is the last day of the specified 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 package and other information
Content declaration
– The active substance is methylprednisolone. Each tablet contains 4 mg or 16 mg of methylprednisolone
The other ingredients are lactose monohydrate, corn starch, gelatin, magnesium stearate, and talc.
What the medicine looks like and contents of the pack
White to off-white, round, flat with beveled edges, tablet with a scoreline.
The diameter for the 4 mg tablet is 7 mm and for the 16 mg tablet 9 mm. The 16 mg tablet is labeled ORN 346.
Pack sizes: 10, 20, 30, 50 and 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland
Manufacturer
Orion Corporation Orion Pharma
Orionintie 1
FI-02200 Espoo
Finland
Orion Corporation Orion Pharma
Joensuunkatu 7
FI-24100 Salo
Finland
For further information on this medicine, please contact your local representative:
Orion Pharma AB, Danderyd
medinfo@orionpharma.com 2018-09-27