Medrol

Package leaflet: Information for the patient

MEDROL 2 mg tablets, 4 mg tablets, 16 mg tablets

Methylprednisolone
Read this leaflet carefully before taking/giving this medicine to your child
because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor, the doctor treating your child, or your pharmacist.
• This medicine has been prescribed only for you or your child. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you or your child experience any adverse reactions, including those not listed in this leaflet, consult your doctor, the doctor treating your child, or your pharmacist. See section 4.

Contents of this leaflet:

1. What Medrol is and what it is used for
2. What you need to know before taking/giving Medrol to your child
3. How to take/give Medrol to your child
4. Possible side effects
5. How to store Medrol
6. Contents of the pack and other information

1. What Medrol is and what it is used for

Medrol contains the active substance methylprednisolone. Methylprednisolone belongs to a group of medicines called corticosteroids. Corticosteroids are substances naturally produced by the body and are important for many bodily functions.

Medrol is used for the treatment of:

• diseases in which the body is unable to produce sufficient amounts of natural corticosteroids, for example due to adrenal gland problems such as adrenal insufficiency;
• joint diseases (e.g. rheumatoid arthritis or psoriatic arthritis);
• skin diseases (e.g. pemphigus and severe psoriasis);
• allergic diseases (e.g. allergic rhinitis and bronchial asthma);
• eye diseases (e.g. diffuse posterior uveitis, optic neuritis, iritis and iridocyclitis);
• lung diseases (e.g. sarcoidosis and emphysema);
• blood diseases (e.g. leukaemia);
• intestinal diseases (e.g. regional enteritis and ulcerative colitis);
• brain diseases (e.g. tuberculous meningitis).

Medrol may be prescribed to treat conditions other than those listed above.
Consult your doctor if you are unsure why this medicine has been prescribed for you or your child.

2. What you should know before taking/giving Medrol to the child

Do not take/give Medrol to the child if you or your child:

• are allergic to methylprednisolone or to any of the other ingredients of this medicine (listed in section 6);
• have a fungal infection that has spread to certain organs or throughout the body.

You or your child must not be vaccinated with live or live attenuated vaccines during
treatment with Medrol.
Warnings and precautions
Talk to your doctor or pharmacist BEFORE taking/giving Medrol to the child if:

• you have or have previously had tuberculosis;
• you are under particular conditions of stress. In such cases, your doctor may prescribe a higher dose of this medicine;
• you have Cushing's syndrome, a disease characterized by excessive production of natural corticosteroids in the body. Medrol may worsen your or your child’s condition;
• your thyroid gland is underactive ( hypothyroidism ). In this case, Medrol doses should be reduced;
• you have diabetes;
• you suffer from myasthenia gravis, a disease causing muscle weakness and fatigue, or you are undergoing surgery with general anaesthesia involving the use of muscle-blocking drugs (e.g. pancuronium). In this case, there is an increased risk that Medrol may cause muscle problems;
• you suffer from seizures;
• you have an eye infection caused by the Herpes simplex virus;
• you have high blood pressure ( hypertension);
• you have high levels of fats in the blood ( dyslipidemia);
• you have heart problems ( heart failure);
• you suffer from or are predisposed to developing blood clots in the veins;
• you have a stomach ulcer or other serious stomach or intestinal problems;
• you have hepatic cirrhosis, a liver disease;
• you have kidney problems;
• you have scleroderma (also known as systemic sclerosis, an autoimmune disease), since the use of corticosteroids may increase the risk of a serious complication called scleroderma renal crisis;
• you have a brain injury caused by trauma;
• you are being treated with non-steroidal anti-inflammatory drugs (e.g. acetylsalicylic acid) (see section “Other medicines and Medrol”);
• you need to undergo skin sensitivity tests;
• you have a type of tumour called pheochromocytoma;
• you suffer from peritonitis or other gastrointestinal disorders, as glucocorticoid therapy may mask symptoms such as perforation, obstruction, or pancreatitis;
• your thyroid gland is overactive ( hyperthyroidism ). If you experience muscle weakness, muscle pain, cramps, or stiffness while using methylprednisolone, contact your doctor immediately. These may be symptoms of a condition called thyrotoxic periodic paralysis, which may occur in patients with overactive thyroid (hyperthyroidism) treated with methylprednisolone. Additional treatment may be required to relieve this condition.

If you have cancer, you are at increased risk of developing tumour lysis syndrome, which may
occur when corticosteroids are used during cancer treatment.
Inform your doctor if you have cancer and experience symptoms of tumour lysis syndrome such as
muscle cramps, muscle weakness, confusion, irregular heartbeat, vision loss or visual disturbances, or shortness of breath.
Inform your doctor or your child’s doctor if any of the following conditions appear or worsen DURING
treatment with Medrol (see also section 4 “Possible side effects”):

• infections. This medicine may reduce resistance to various infections, mask certain infection symptoms, worsen existing infections, or cause reactivation or worsening of hidden old infections. New infections may also occur during Medrol use. Therefore, certain infections may occur more easily during treatment, such as chickenpox and measles. These infections may be mild, severe, or sometimes fatal. Your doctor will closely monitor you for the development of infections and may consider, if necessary, stopping treatment or reducing the dose;
• Kaposi's sarcoma, a skin tumour. In this case, discontinue treatment with Medrol;
• severe allergic reactions;
• swelling in various parts of the body, especially in the legs and ankles, or changes in normal blood electrolyte levels;
• onset or worsening of mental disorders (e.g. depression). Inform people living with you about the possible effects of this medicine;
• eye problems;
• severe inflammation of the pancreas;
• osteoporosis (fragile bones);
• fat accumulation compressing the spinal cord;
• hepatobiliary disorders (reversible after discontinuation);
• blurred vision or other visual disturbances.

You or your child must not be vaccinated with live or live attenuated vaccines during
treatment with Medrol (see section “Do not take/give Medrol to the child if you or your
child”). However, you may receive killed or inactivated vaccines, although their
effectiveness may be reduced.
Oral anticoagulants (medicines taken by mouth to prevent blood clotting) may increase the risk of bleeding when taken together with Medrol. In some cases, the effectiveness of oral anticoagulants may be reduced. Your doctor may need to frequently monitor your bleeding risk by performing additional blood tests during Medrol treatment. Your doctor may also need to adjust the Medrol dose if necessary.
For those engaged in sports
Using the medicine without therapeutic need constitutes doping and may lead to a positive result in anti-doping tests.
Newborns and children
Long-term or high-dose treatment with Medrol may cause growth retardation, increased intracranial pressure, and pancreatitis in newborns and children.
Elderly
If you are elderly, long-term treatment with Medrol may increase the risk of developing osteoporosis, excessive fluid retention, and increased blood pressure. Your doctor will assess your condition and administer this medicine cautiously.
Other medicines and Medrol
Inform your doctor or pharmacist if you or your child are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.
Some medicines may increase the effects of Medrol, and your doctor may wish to monitor you closely if you are taking these medicines.
The following medicines may affect the activity of Medrol, or Medrol may affect the efficacy and/or toxicity of the following medicines:

• isoniazid, troleandomycin, clarithromycin, and erythromycin (antibiotics);
• rifampicin (antibiotic for tuberculosis);
• phenobarbital, phenytoin, and carbamazepine (medicines for seizures);
• aprepitant and fosaprepitant (medicines for nausea and vomiting);
• itraconazole, ketoconazole, and amphotericin B (medicines for fungal infections);
• medicines for HIV treatment such as indinavir, ritonavir, and cobicistat (medicines against HIV virus);
• aminoglutethimide (medicine for excessive natural corticosteroid production);
• diltiazem (medicine used to treat heart problems or high blood pressure);
• ethinylestradiol/norethisterone (hormones used in combination as oral contraceptives);
• cyclosporine, cyclophosphamide, and tacrolimus, medicines to prevent organ transplant rejection and for autoimmune diseases;
• oral anticoagulants (medicines taken by mouth to prevent blood clotting);
• neuromuscular blockers (medicines causing muscle relaxation);
• anticholinesterases (medicines for muscle diseases such as myasthenia gravis and Alzheimer’s);
• antidiabetics (medicines for diabetes);
• aspirin (acetylsalicylic acid);
• diuretics (medicines that increase urine production);
• xanthines and beta-2 agonists (medicines for asthma).

Medrol and drinks
You or your child must not drink grapefruit juice during treatment with
Medrol, as the effectiveness and toxicity of this medicine may increase.
Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
If you take this medicine during pregnancy, especially for a prolonged period, your baby may experience adverse effects at birth. Therefore, if you are pregnant, your doctor will prescribe Medrol only if strictly necessary.
Breastfeeding
Medrol passes into breast milk and may cause adverse effects in the baby. If you are breastfeeding, your doctor will prescribe Medrol only if strictly necessary.
Fertility
Based on currently available information, this medicine may reduce fertility.
Driving and using machines
Do not drive or operate machinery if you experience dizziness, vertigo, visual disturbances, or fatigue during treatment with Medrol.
Medrol contains lactose and sucrose
Medrol contains lactose and sucrose, two types of sugar. If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.
This medicine contains lactose derived from bovine milk and may contain traces of milk proteins. If your doctor has diagnosed or suspects an allergy to bovine milk proteins, contact him before taking this medicine.

3. How to take/give Medrol to the child

Take/give this medicine to the child exactly as directed by the
doctor or pharmacist. If in doubt, consult the doctor or pharmacist.
The recommended starting dose ranges from 4 mg to 48 mg per day. Depending on your condition or
your child's condition and the type of disease, the doctor will advise you on the appropriate dose, how many
times per day to take/give the medicine, and the duration of treatment with
Medrol.
When the doctor is satisfied with the improvement of the disease, he/she will advise you to gradually reduce
the dose until reaching the lowest effective dose (maintenance dose).
Swallow the tablets whole with a glass of water. Do not chew or break the tablets.
If you use more Medrol than you should
It is important that you or your child do not take more tablets than prescribed.
Contact your doctor immediately if you or your child have accidentally taken an excessive dose of Medrol.
If you forget to use Medrol
Do not take a double dose to make up for the missed dose. If you realize you have missed a dose, consult your doctor.
If you stop treatment with Medrol
You or your child must not stop taking Medrol suddenly. Taking Medrol may cause reduced function of the adrenal glands, which produce natural corticosteroids, and abrupt discontinuation may lead to death.
Moreover, if Medrol treatment is stopped abruptly, you or your child may develop withdrawal symptoms such as: anorexia, nausea, vomiting, drowsiness,
headache, fever, muscle and joint pain, skin desquamation, weight loss, low blood pressure, and mental disturbances.
When stopping treatment, the dose must be gradually reduced. Your doctor will advise you on the correct way to do this.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Contact your doctor if you experience any of the following side effects:
Frequency not known (frequency cannot be estimated from the available data):

• infections, including infections occurring when the body's immune defenses are very low
• increased number of white blood cells in the blood
• inflammation of the abdomen (peritonitis)
• hypersensitivity to the medicine
• severe allergic reaction, e.g. swelling of the face, tongue and throat with difficulty swallowing and breathing (angioedema)
• round or moon-shaped face (Cushingoid appearance)
• reduced secretion of hormones from the pituitary gland (a gland located at the base of the brain)
• withdrawal syndrome (see section 3 “If you stop taking Medrol”)
• disorders due to interference with the balance between hormones produced by the pituitary gland and those produced by the adrenal glands
• loss or excess of acidic substances from the body
• fluid and sodium retention in the body
• elevated levels of fats in the blood
• decreased potassium levels in the blood
• glucose metabolism disorder (impaired glucose tolerance)
• worsening of pre-existing diabetes
• accumulation of fatty tissue in specific body areas
• increased appetite and body weight
• mental disorders such as: emotional disturbances (depression, euphoria, emotional and drug dependence, suicidal ideation), manic behaviour, delirium, hallucinations, schizophrenia, thought disorders, personality changes, confusion, anxiety, mood swings, abnormal behaviour, insomnia, irritability
• fat accumulation compressing the spinal cord
• increased pressure of the fluid within the skull
• seizures
• difficulty remembering
• thought disorders affecting awareness of reality
• dizziness
• vertigo
• headache
• cataract
• protruding eyes
• increased internal eye pressure (glaucoma)
• reduced central vision
• diseases of the retina and choroid
• increased or decreased blood pressure
• warmth and skin redness (flushing)
• increased blood clotting
• hiccups
• formation of blood clots in veins and lungs
• stomach and intestinal disorders, such as stomach ulcers with possible bleeding and perforation
• abdominal distension and pain
• diarrhoea, nausea
• difficulty digesting
• stomach bleeding
• intestinal perforation
• inflammation of the oesophagus with or without ulcers
• inflammation of the pancreas
• bruising
• skin redness, rashes
• increased hair growth
• excessive sweating
• appearance of small red spots or thin purplish streaks on the skin
• itching
• hives
• acne
• skin atrophy
• disturbances in water and electrolyte levels. This condition may rarely lead to high blood pressure and heart problems (heart failure)
• muscle weakness
• muscle and joint pain, muscle disorders, reduced muscle mass
• bone fragility (osteoporosis), bone tissue death and loss
• joint rupture (especially in the foot) causing pain and/or swelling
• vertebral fractures (from trauma or spontaneous), tendon rupture, particularly of the Achilles tendon
• irregular menstruation
• delayed wound healing
• fatigue
• malaise
• abnormal laboratory tests assessing liver function
• increased liver enzymes
• increased levels of calcium in urine
• reduced response to skin tests
• increased blood urea
• tendency to lose more proteins from the body than those ingested through diet (metabolic acidosis)
• blurred vision

Additional side effects in children
Frequency not known (frequency cannot be estimated from the available data):

• growth retardation
• disturbances in growth

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet,
contact your doctor or pharmacist. You can also report side effects
directly via the national reporting system at the following address:
http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting
side effects, you can help provide more information on the safety of this
medicine.

5. How to store Medrol

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the carton, blister, and container after "Exp.". The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Medrol Contains
The active substance is methylprednisolone.
Each 2 mg Medrol tablet contains 2 mg of methylprednisolone.
The other components are: monohydrate lactose, sucrose (see section 2 “Medrol contains lactose and sucrose”), maize starch, dried maize starch, calcium stearate, colouring mixture (New Rose).
Each 4 mg Medrol tablet contains 4 mg of methylprednisolone.
The other components are: monohydrate lactose, sucrose (see section 2 “Medrol contains lactose and sucrose”), maize starch, calcium stearate.
Each 16 mg Medrol tablet contains 16 mg of methylprednisolone.
The other components are: monohydrate lactose, sucrose (see section 2 “Medrol contains lactose and sucrose”), liquid paraffin, calcium stearate, maize starch.

Description of the Appearance of Medrol and Contents of the Package
The 2 mg Medrol tablets are pink, elliptical tablets, with the inscription “UPJOHN” engraved on one side and a score line on the other side.
The tablets are available in transparent PVC and aluminium blisters in packs containing 30 tablets.

The 4 mg Medrol tablets are white, semi-oval, elliptical tablets, with the inscription “MEDROL 4” engraved on one side and a cross-shaped score on the other side. The tablets are available either in high-density polyethylene (HDPE) bottles containing 10 tablets or in transparent PVC and aluminium blisters in packs containing 30 tablets.

The 16 mg Medrol tablets are white, convex, elliptical tablets, with the inscription “MEDROL 16” engraved on one side and a cross-shaped score on the other side. The tablets are available in transparent PVC and aluminium blisters in packs containing 20 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Pfizer Italia S.r.l.
Via Isonzo, 71
04100 Latina
Italy

Manufacturer
Pfizer Italia S.r.l.
Località Marino del Tronto 63100
Ascoli Piceno (AP)
Italy