4 mg, 16 mg tablets
methylprednisolone

What Medrol is and what it is used for

Medrol, which is a cortisone preparation, has an inhibitory effect on allergies and inflammation.

Medrol is used to e.g. treat inflammatory diseases such as rheumatism, ulcerative colitis, and asthma as well as in other conditions such as certain blood changes and severe allergic conditions.

Methylprednisolone contained in Medrol may also be approved for the treatment of other conditions not mentioned in this leaflet. 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 Medrol

Do not take Medrol

  • if you are allergic to methylprednisolone or any of the other ingredients of this medicine (listed in section 6)
  • if you have a fungal infection that affects your entire body.

Warnings and cautions

Talk to your doctor or pharmacist before taking Medrol

  • if you suffer from osteoporosis
  • if you suffer from any seizure disorder
  • if you suffer from glaucoma and herpes infection of the eye
  • if you suffer from stomach ulcers or other serious gastrointestinal problems
  • if you suffer from kidney failure
  • if you suffer from scleroderma (also called systemic sclerosis, an autoimmune disease)
  • if you suffer from adrenal tumor ( pheochromocytoma )
  • if you suffer from certain mental disorders
  • if you suffer from diabetes
  • if you suffer from high blood pressure
  • if you suffer from heart disease
  • if you suffer from hypothyroidism
  • if you suffer from myasthenia gravis
  • if you have chickenpox or measles
  • if you have an infection , or get an infection while using Medrol

People treated with drugs such as Medrol can developmental disorders that can develop into thoughts of harming themselves or committing suicide. If you ever have these problems or thoughts, contact your doctor immediately. These symptoms can especially occur during or just after dose changes or during discontinuation of cortisone treatment.

Contact a doctor if you experience blurred vision or other visual disturbances.

Infection can be exacerbated by treatment with cortisone.

If you are going to be vaccinated, you should tell them that you are being treated with Medrol.

Medrol treatment may mean that allergy tests on the skin do not give reliable answers.

Children and young people

Growth in children can be inhibited by long-term use. The doctor will regularly check the baby’s growth.

Other medicines and 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.

Medrol can affect or be affected by other medicines such as:

  • certain medicines for vomiting and nausea (aprepitant, fosaprepitant)
  • certain drugs used i.a. in connection with transplantation (cyclosporine, tacrolimus)
  • drugs used in heart disease ( diltiazem )
  • certain antibiotics for bacterial infections (erythromycin, clarithromycin, telithromycin, triacetyloleandomycin, amphotericin B)
  • certain medicines for tuberculosis (rifampicin, isoniazid )
  • certain antifungal agents, which are taken in tablets or capsules ( ketoconazole , itraconazole, voriconazole, posaconazole)
  • anticholinergic drugs (eg pancuronium and vecuronium)
  • certain medicines for HIV (ritonavir, cobicistat). Your doctor may want to monitor you closely if you are taking these medicines. 
  • certain contraceptives (ethinyl estradiol, norethindrone)
  • certain medicines used in epilepsy (phenobarbital, phenytoin , carbamazepine)
  • herbal medicine containing St. John’s wort (used for depression)
  • drugs that affect coagulation (the ability of the blood to clot)
  • medicines used to treat fever and pain ( acetylsalicylic acid )
  • anti-inflammatory drugs ( NSAIDs , eg ibuprofen , diclofenac )
  • blood sugar lowering drugs (antidiabetic drugs)
  • anticholinesterases (used to treat myasthenia gravis )
  • certain anticancer medicines (cyclophosphamide, aminoglutethimide)
  • Potassium-lowering drugs (eg diuretics )
  • medicines containing xanthene
  • medicines for asthma (beta-2 agonists ).

Medrol with food, drink and alcohol

You should avoid a concomitant intake of grapefruit juice and Medrol as grapefruit juice can affect how Medrol works in your body. Grapefruit juice inhibits liver function so that Medrol is not broken down properly.

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 or pharmacist for advice before taking this medicine.

Pregnancy

There is a risk that the fetus is affected. In long-term treatment, low birth weight, withdrawal symptoms, and isolated cases of cataracts have been seen in infants. Do not use Medrol during pregnancy except on certain prescriptions from the doctor.

Breast-feeding

There is a risk that a breastfed baby is affected, as small amounts of methylprednisolone pass into breast milk. Do not use Medrol while breastfeeding except on certain prescriptions from the doctor.

Driving and using machines

Medrol usually has no or negligible influence on the ability to drive and use machines. Side effects such as dizziness, visual disturbances, and fatigue may occur after treatment with cortisone. If you get these side effects, 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.

Medrol contains lactose and sucrose

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 Medrol

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

Dose one should be determined by a doctor who will tailor it individually for you. It is very important to follow the dosage prescribed by your doctor. Medrol can be dosed very differently for different patients. Often a high dose is given on the first day, dose one is then gradually reduced. During long-term treatment, your doctor may sometimes recommend that you take the tablets every other day. The way Medrol is dosed can be crucial to the outcome of treatment.

Medrol treatment must not be stopped without consulting your doctor. Also, consult your doctor if fever or other symptoms occur during treatment.

The notch is not intended for splitting the tablet.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

During cortisone treatment, several side effects can occur, among other things as a result of the body’s cortisone production being suppressed. Different dosing schedules can reduce the risk of side effects, especially with long-term use.

Stop taking Medrol and contact a 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 ).

Common (may affect up to 1 in 10 people)

Decreased defense of infection, lower levels of certain hormones, a side effect complex that can occur with long-term use manifests itself in the form of fat accumulation on the face and between the shoulder blades, growth retardation in children, local loss of muscle and skin with deterioration of wound healing, osteoporosis, worsening of diabetes, low potassium level which can cause fatigue, high sodium level with fluid retention as a result.

Uncommon (may affect up to 1 in 100 people)

Activation of mental illness, high blood pressure, cataracts, glaucoma (increased pressure in the eye).

Rare (may affect up to 1 in 1,000 people)

Allergic reactions increased pressure in the skull, stomach ulcers, allergic skin reactions, hypersensitivity reaction, bone tissue damage, tendon rupture (especially the hamstrings).

Has been reported (occurs in an unknown number of users)

Infection , increased white blood cell count ( leukocytosis ), hypersensitivity to drugs, severe allergic reaction , pheochromocyte-related crisis (symptoms such as attacking headache, palpitations, sweating and pallor), withdrawal symptoms on tap, elevated pHin the blood, in the blood, lipid disorders, accumulation of adipose tissue in isolated places on the body, emotional symptoms (including depression, feelings of happiness, rapid mood swings, drug addiction, suicidal thoughts), psychotic disorders (including mania, delusions, hallucinations, exacerbation, hallucinations and exacerbation) , anxiety, mood swings, abnormal behavior, sleep problems, irritability, cramps, memory problems, intellectual disorder, dizziness, headache, blurred vision, protruding eyeballs, blurred vision, heart failure (in sensitive patients), increased tendency to get blood clots, hiccups, inflammation in the intestines,in the pancreas, esophagitis, bloated stomach, abdominal pain, nausea, increase in liver enzymes, short-term and limited swelling (mainly in the skin) which is often caused by allergies, increased male body hair in women, bleeding in the skin, bruising, skin wasting, reddening of the skin, redness stretch marks (blue-red streaks on the chest and abdomen), itching , hives , acne , muscle disease, muscle weakness, fracture without previous trauma, irregular menstruation, swollen legs and feet, general malaise, increased appetite (which may result in weight gain), increased calcium in urine, increased level of urea in the blood (blood test value) and decreased reaction to skin tests. 

Since Medrol is used in conditions of illness which in many cases are considered serious, it is important not to interrupt treatment, e.g. due to side effects, without first consulting a doctor.

How to store Medrol

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. day. 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.

Contents of the pack and other information

Content declaration

4 mg tablet

  • The active substance is methylprednisolone. One tablet contains 4 mg of methylprednisolone.
  • The other ingredients are lactose monohydrate (80 mg), calcium stearate, sucrose (1.5 mg) and corn starch.

16 mg tablet

  • The active substance is methylprednisolone One tablet contains 16 mg methylprednisolone.
  • The other ingredients are lactose monohydrate (159 mg), calcium stearate, sucrose (2.80 mg), liquid paraffin and corn starch.

What the medicine looks like and contents of the pack

4 mg: Oval, white cross-scored tablet, debossed with “Medrol 4” on one side. The notch is not intended for splitting the tablet.

16 mg: Oval, white cross-scored tablet, debossed with “Medrol 16” on one side. The notch is not intended for splitting the tablet.

Tablets 4 mg: Glass jar 98 and 100 tablets

Tablets 16 mg: Glass jar 49 and 50 tablets

Tablets 4 mg: Plastic jar with child-resistant lid 100 tablets

Tablets 16 mg: Plastic jar with child-resistant lid 50 tablets

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Pfizer AB

191 90 Sollentuna

Tel: 08 – 550 520 00

Email: eumedinfo@pfizer.com

Muhammad Nadeem

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