MEDROL 4 mg Coated Tablet

Зміст інструкції

1. MEDROL 2 mg tablets, 4 mg tablets, 16 mg tablets
   1. What is Medrol and what it is used for
   2. What you need to know before taking/giving Medrol to the child
   3. How to take/give Medrol to the child
   4. Possible side effects
   5. How to store Medrol
   6. Package Contents and Other Information

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

Methylprednisolone

Read this leaflet carefully before taking/giving this medicine to the child as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or the doctor caring for your child or your pharmacist.
• This medicine has been prescribed only for you or your child. Do not give it to other people, even if their symptoms are the same as yours, as it could be dangerous.
• If you or your child experience any side effects, including those not listed in this leaflet, ask your doctor or the doctor caring for 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 the child
• 3. How to take/give Medrol to the child
• 4. Possible side effects
• 5. How to store Medrol
• 6. Contents of the pack and other information

1. What is Medrol and what it is used for

Medrol contains the active ingredient methylprednisolone. Methylprednisolone belongs to a category
of medicines called corticosteroids. Corticosteroids are substances produced naturally
by the body and are important for many functions of the body.
Medrol is used for the treatmentof:

• diseases in which the body is unable to produce a sufficient amount of natural corticosteroids, for example due to problems with the adrenal glandssuch 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. leukemia);
• 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 not sure why this medicine has been prescribed to you or to
your child.

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

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

• are allergicto methylprednisolone or to any of the other ingredients of this medicine (listed in section 6);
• have an infectioncaused by fungithat has spread to some organs or throughout the body.

You or your child should not be vaccinated with vaccines“live” or “live attenuated” during the
treatment with Medrol.

Warnings and precautions
Consult your doctor or pharmacist BEFOREtaking/giving Medrol to the child if:

• you have had or have had in the past tuberculosis;
• you are undergoing particular situations of stress. In this case, the doctor will prescribe a higher dose of this medicine to you or your child;
• you have Cushing's syndrome, a disease characterized by the excessive production of natural corticosteroids in the body. Medrol may worsen your or your child's condition;
• your thyroid gland is functioning less than normal (hypothyroidism). In this case, the doses of Medrol must be reduced;
• you have diabetes;
• you suffer from myasthenia gravis, a disease that causes muscle weakness and fatigue, or you need to undergo general anesthesiathat involves the use of drugs that block the muscles (e.g. pancuronium). In this case, the risk that Medrol causes muscle problems is greater;
• you suffer from convulsions;
• you have an infectionin the eyescaused by the Herpes simplexvirus;
• you suffer from 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 clotsin the veins;
• you have an ulcerin the stomachor other serious problems in the stomach or intestines;
• you have liver cirrhosis, a liver disease;
• you have kidney problems;
• you have scleroderma(also known as systemic sclerosis, an autoimmune disease), because the use of corticosteroids can increase the risk of a serious complication called scleroderma renal crisis;
• you have a brain injurycaused 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 tumor called pheochromocytoma;
• you suffer from peritonitis or other gastrointestinal diseases because glucocorticoid therapy may mask symptoms such as perforation, obstruction, or pancreatitis. If you have cancer, you have a high risk of developing tumor lysis syndrome, which can occur when corticosteroids are used during cancer treatment. Tell your doctor if you have cancer and experience symptoms of tumor lysis syndrome such as muscle cramps, muscle weakness, confusion, irregular heartbeat, vision loss or visual disturbances, and shortness of breath.

Inform your doctor or the doctor caring for your child if any of the following conditions
occur or worsen DURINGtreatment with Medrol (see also section 4 “Possible
side effects”):

• infections. This medicine may increase susceptibility to infections or worsen ongoing infections. For example, chickenpox and measles may have a more serious course, sometimes fatal;
• Kaposi's sarcoma, a skin tumor. In this case stoptreatment with Medrol;
• severe allergic reactions;
• swellingin different parts of the body, especially in the legs and ankles, or changes in normal levels of blood minerals;
• appearance or worsening of mental disorders(e.g. depression). Inform people who live with you about the possible effects of this medicine;
• eye problems;
• severe pancreatitis;
• osteoporosis(fragile bones);
• fat accumulationthat compresses the spinal cord;
• hepatobiliary diseases(reversible after discontinuation);
• blurred vision or other visual disturbances.

You or your child should not be vaccinated with “live” or “live attenuated” vaccines during the
treatment with Medrol (see section “Do not take/give Medrol to the child if you or your
child”). You can, however, be vaccinated with killedor inactivated vaccines, even if the effectiveness
of these vaccines may be reduced.

For athletes
The use of the drug without therapeutic need constitutes doping and may still
result in a positive anti-doping test.

Infants and children
Treatments with Medrol for long periods of time or at high doses may cause delays in growth, increased pressure inside the skull, and inflammation of the
pancreas in infants and children.

Elderly
If you are elderly, long-term treatment with Medrol may increase the risk of
developing osteoporosis, excessive fluid retention in the body, and increased blood pressure. The doctor will assess your condition and administer this medicine with caution.

Other medicines and Medrol
Inform your doctor or pharmacist if you or your child are taking, have recently taken
or may take any other medicine, including over-the-counter medicines.
Some medicines may increase the effects of Medrol and the doctor may want to monitor you closely if you are taking these medicines.
The following medicines may affect the activity of Medrol or Medrol may affect
the effectiveness and/or toxicity of the following medicines:

• isoniazid, troleandomycin, clarithromycinand erythromycin(antibiotics);
• rifampicin(antibiotic against tuberculosis);
• phenobarbital, phenytoinand carbamazepine(medicines against convulsions);
• aprepitantand fosaprepitant(medicines against vomiting);
• itraconazole, ketoconazoleand amphotericin B(medicines against fungal infections);
• medicines for the treatment of HIVsuch as indinavir, ritonavirand cobicistat(medicines against the HIV virus);
• aminoglutethimide(medicine against the excessive production of natural corticosteroids);
• diltiazem(medicine used for the treatment of heart problems or high blood pressure);
• ethinylestradiol/norethindrone(hormones used in combination as oral contraceptives);
• cyclosporine, cyclophosphamideand tacrolimus, medicines against rejection after organ transplantation and against autoimmune diseases;
• oral anticoagulants, medicines used to thin the blood;
• neuromuscular blockers(medicines that cause muscle relaxation);
• anticholinesterases(medicines against muscle diseases, such as myasthenia gravis and Alzheimer's);
• antidiabetics(medicines against diabetes);
• aspirin(acetylsalicylic acid);
• diuretics(medicines that increase urine production);
• xanthinesand beta-2-agonists(medicines against asthma).

Medrol with beverages
You or your child must notdrink grapefruit juiceduring treatment with Medrol, because
the effectiveness and toxicity of this medicine may increase.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
If you take this medicine during pregnancy, especially for a long period of time, your
baby may experience side effects at birth. Therefore, if you are pregnant, your doctor will prescribe Medrol only if strictly necessary.

Breastfeeding
Medrol passes into breast milk and this may cause side effects in the baby. If you are
breastfeeding, your doctor will prescribe Medrol only if strictly necessary.

Fertility
Based on the information available so far, this medicine may reduce fertility.

Driving and operating machinery
Do not drivevehicles or operate machinery if you experience dizziness,
vertigo, visual disturbances and fatigue during treatment with Medrol.

Medrol contains lactose and sucrose
Medrol contains lactose and sucrose, two types of sugar. If you have been diagnosed
with an intolerance to certain sugars, contact your doctor before taking this medicine.
This medicine contains lactose produced from cow's milk and may contain traces of milk proteins.
If you have been diagnosed or suspect an allergy to cow's milk proteins, contact your
doctor before taking this medicine.

3. How to take/give Medrol to the child

Take/give this medicine to the child following the doctor's or pharmacist's instructions exactly. If you have any doubts, consult your doctor or pharmacist.
The recommended initial dose varies from 4 mg to 48 mg per day. Based on your condition or your child's condition and the type of illness, the doctor will advise you on the dose, how many times a day to take/give the medicine to the child, and the duration of treatment with Medrol.
When the doctor is satisfied with the improvement of the illness, they will advise you to reduce the dose gradually to reach the most suitable minimum dose (maintenance dose).
Swallow the tablets whole with a sip 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 never take more tablets than prescribed.
Seek immediate medical attention if you or your child have accidentally taken an excessive dose of Medrol.

If you forget to use Medrol
Do not use a double dose to make up for a missed dose. If you realise you have forgotten a dose, consult your doctor.

If you stop taking Medrol
You or your child must not suddenly stop taking Medrol. Taking Medrol can cause a reduction in the function of the adrenal glands that produce natural corticosteroids, and abrupt discontinuation can lead to death.
Furthermore, in case of abrupt discontinuation of treatment with Medrol, you or your child may develop withdrawal symptomssuch as: anorexia, nausea, vomiting, drowsiness, headache, fever, muscle and joint pain, skin flaking, weight loss, low blood pressure and mental disorders.
In case of discontinuation, the doses must be reduced gradually. The 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 that occur when the human 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 hormone secretion by 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 increase of acidic substances from the body
• retention of fluids and sodium in the body
• high amount of fats in the blood
• decreased potassium levels in the blood
• glucose metabolism abnormality (impaired glucose tolerance)
• worsening of existing diabetes
• accumulation of adipose tissue in localized parts of the body
• increased appetite and body weight
• mental disorders such as: disorders in experiencing emotions (depression, euphoria, emotional and drug dependence, suicidal ideation), manic behavior, delirium, hallucinations, schizophrenia, thought disorders, personality changes, confusion, anxiety, mood swings, abnormal behavior, insomnia, irritability
• accumulation of fat compressing the spinal cord
• increased pressure of fluid in the skull
• convulsions
• difficulty remembering
• thought disorders that impair awareness of reality
• dizziness
• vertigo
• headache
• cataract
• protruding eyes
• increased intraocular pressure (glaucoma)
• reduced vision in the central part of the visual field
• diseases of the retina and choroid
• increased or decreased blood pressure
• heat and redness of the skin (flushing)
• increased blood coagulation
• hiccups
• formation of blood clots in the veins and lungs
• stomach and intestinal disorders, such as stomach ulcers with possible bleeding and perforation
• abdominal distension and pain
• diarrhea, nausea
• difficulty digesting
• stomach bleeding
• intestinal perforation
• inflammation of the esophagus with or without ulcers
• pancreatitis
• bruising
• redness of the skin, skin rashes
• increased hair growth
• excessive sweating
• appearance of small red spots or thin purple streaks on the skin
• itching
• urticaria
• acne
• skin atrophy
• alteration of water and mineral salt levels. This condition can rarely cause high blood pressure and heart problems (heart failure)
• muscle weakness
• muscle and joint pain, muscle diseases, reduced muscle mass
• fragile bones (osteoporosis), death and loss of bone tissue
• joint rupture (especially of the foot) causing pain and/or swelling
• fractures of the vertebrae (from trauma or spontaneously), tendon rupture, particularly of the Achilles tendon
• irregular menstruation
• delayed wound healing
• fatigue
• malaise
• alteration of laboratory tests to evaluate liver function
• increased liver enzymes
• increased calcium levels in the urine
• reduced response to skin tests
• increased urea in the blood
• tendency to lose more protein from the body than is introduced with the diet (metabolic acidosis)
• blurred vision

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

• growth retardation
• growth alterations

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your
doctor or pharmacist. You can also report side effects directly through the
national reporting system at: http://www.aifa.gov.it/content/segnalazioni-reazioni-
avverse.Reporting side effects can help provide more information about 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 which is stated on the package, blister and
bottle after “Exp.”. The expiry date refers to the last day of that month.
Do not dispose of any medicine in 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 ingredient is methylprednisolone.
Each Medrol 2 mg tablet contains 2 mg of methylprednisolone.
The other ingredients are: lactose monohydrate, sucrose(see section 2 “Medrol contains
lactose and sucrose”), corn starch, dried corn starch, calcium stearate, coloring mixture (New
Rose).
Each Medrol 4 mg tablet contains 4 mg of methylprednisolone.
The other ingredients are: lactose monohydrate, sucrose(see section 2 “Medrol contains
lactose and sucrose”), corn starch, calcium stearate.
Each Medrol 16 mg tablet contains 16 mg of methylprednisolone.
The other ingredients are: lactose monohydrate, sucrose(see section 2 “Medrol contains lactose
and sucrose”), liquid paraffin, calcium stearate, corn starch.

Description of the appearance of Medrol and package contents
Medrol 2 mg tablets are elliptical, pink tablets, with the inscription “UPJOHN”
on one side and a score line on the other side.
The tablets are available in transparent PVC and aluminum blisters in a package containing 30
tablets.
Medrol 4 mg tablets are semi-oval, elliptical, white tablets, with the inscription “MEDROL 4”
on one side and a cross-shaped incision on the other side. The tablets are available in
high-density polyethylene (HDPE) bottles containing 10 tablets or in transparent PVC
and aluminum blisters in a package containing 30 tablets.
Medrol 16 mg tablets are convex, elliptical, white tablets, with the inscription “MEDROL 16”
on one side and a cross-shaped incision on the other side. The tablets are available in
transparent PVC and aluminum blisters in a package containing 20 tablets.
Not all pack sizes may be marketed.

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

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