METILPREDNISOLONE 4 mg Tabletki

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

METILPREDNISOLONE EG 4 mg tablets, 16 mg tablets

Metilprednisolone

Read this leaflet carefully before you take/give 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 may be dangerous.
• If you or your child experience any side effects, including those not listed in this leaflet, tell your doctor or the doctor caring for your child, or your pharmacist. See section 4.

Contents of this leaflet:

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

1. What is METILPREDNISOLONE EG and what is it used for

METILPREDNISOLONE EG 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.
METILPREDNISOLONE EG 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, ulcerative colitis);
• brain diseases(e.g. tuberculous meningitis).

METILPREDNISOLONE EG 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 METILPREDNISOLONE EG to the child

Do not take/give METILPREDNISOLONE EG to the child if:

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

You or your child must not be vaccinatedwith “live” or “live attenuated” vaccines during the
treatment with METILPREDNISOLONE EG.

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

• you have 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’ssyndrome, a disease characterized by the excessive production of natural corticosteroids in the body. METILPREDNISOLONE EG may worsen your or your child’s condition;
• your thyroid gland is functioning less than normal (hypothyroidism). In this case, the doses of METILPREDNISOLONE EG must be reduced;
• your thyroid gland is overactive (hyperthyroidism);
• you have diabetes;
• you suffer from myastheniagravis, a disease that causes muscle weakness and fatigue, or are going to undergo general anesthesiathat involves the use of drugs that block the muscles (e.g. pancuronium). In this case, there is a greater risk that METILPREDNISOLONE EG may cause problems with the muscles;
• you suffer from convulsions;
• you have an infectionin the eyescaused by the Herpes simplex virus;
• 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 a stomach ulceror other serious problems with 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), as the use of corticosteroids may 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 METILPREDNISOLONE EG”);
• you need to undergo skin sensitivity tests;
• you have a 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 experience muscle weakness, muscle pain, cramps, and stiffness during the use of methylprednisolone, contact your doctor immediately. These may be symptoms of a condition called thyrotoxic periodic paralysis, which can occur in patients with an overactive thyroid gland (hyperthyroidism), treated with methylprednisolone. Additional treatment may be needed to relieve this condition;
Inform your doctor or the doctor caring for your child if any of the following conditions occur or worsen DURINGtreatment with METILPREDNISOLONE EG (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 METILPREDNISOLONE EG;
• severe allergic reactions;
• swellingin different parts of the body, especially in the legs and ankles, or changes in normal levels of blood minerals;
• the 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 must not be vaccinated with “live” or “live attenuated” vaccines during treatment
with METILPREDNISOLONE EG (see section “Do not take/give METILPREDNISOLONE
EG if you or your child”). You can, however, be vaccinated with killed or inactivated vaccines, even if
the effectiveness of these vaccines may be reduced.

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

Newborns and children
Treatments with METILPREDNISOLONE EG for long periods of time or at high doses can
cause delayed growth, increased pressure inside the skull, and inflammation of the pancreas in newborns and children.

Elderly
If you are elderly, long-term treatment with METILPREDNISOLONE EG 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 METILPREDNISOLONE EG
Tell your doctor or pharmacist if you or your child are taking, have recently taken, or
may take any other medicines, including over-the-counter medicines.
Some medicines may increase the effects of METILPREDNISOLONE EG and the doctor may
want to monitor you closely if you are taking these medicines.
The following medicines may affect the activity of METILPREDNISOLONE EG or
METILPREDNISOLONE EG may affect
the effectiveness and/or toxicity of the following medicines:

• isoniazid, troleandomycin, clarithromycinand erythromycin(antibiotics);
• rifampicin(antibiotic for tuberculosis);
• phenobarbital, phenytoinand carbamazepine(medicines for convulsions);
• aprepitantand fosaprepitant(medicines for vomiting);
• itraconazole, ketoconazoleand amphotericinB(medicines for fungal infections);
• medicines for the treatment of HIVsuch as indinavir, ritonavirand cobicistat((medicines for 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 for muscle diseases, such as myasthenia gravis and Alzheimer's);
• antidiabetics(medicines for diabetes);
• aspirin(acetylsalicylic acid);
• diuretics(medicines that increase urine production);
• xanthinesand beta-2-agonists(medicines for asthma).

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

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding, 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
child may experience undesirable effects at birth. Therefore, if you are pregnant, your doctor
will prescribe METILPREDNISOLONE EG only if strictly necessary.

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

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

Driving and operating machinery
Do notdrive vehicles or operate machinery if you experience dizziness, vertigo, visual disturbances and fatigue during treatment with METILPREDNISOLONE EG.

METILPREDNISOLONE EG contains lactose and sucrose
METILPREDNISOLONE EG 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.

3. How to take/give to the child METILPREDNISOLONE EG

Take/give this medicine to the child following the instructions of the doctor or pharmacist 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 the condition of your child 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 METILPREDNISOLONE EG.
When the doctor is satisfied with the improvement of the illness, they will advise you to reduce the dose gradually to reach the minimum most suitable dose (maintenance dose).
Swallow the tablets whole with a sip of water. Do not chew or break the tablets.

If you use more METILPREDNISOLONE EG 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 METILPREDNISOLONE EG.

If you forget to use METILPREDNISOLONE EG
Do not use a double dose to compensate for a missed dose.
If you realize you have forgotten a dose, consult your doctor.

If you stop the treatment with METILPREDNISOLONE EG
You or your child must not suddenly stop taking METILPREDNISOLONE EG.
Taking METILPREDNISOLONE EG 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 METILPREDNISOLONE EG, 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 suspension, the doses must be reduced gradually. The doctor will advise you on the correct way to do it.
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 everybody gets them.
Contact your doctor if you experience any of the following side effects:
Frequency not known (frequency cannot be estimated from available data):

• infections, including infections that occur when the human body's 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 METILPREDNISOLONE EG”)
• disorders due to interference of 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 levels of fat in the blood
• decreased levels of potassium in the blood
• abnormality of glucose metabolism (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 pressure inside the eye (glaucoma)
• reduced vision in the central part of the visual field
• diseases of the retina and choroid
• increased or decreased blood pressure
• increased blood clotting
• 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
• perforation of the intestine
• inflammation of the esophagus with or without ulcers
• inflammation of the pancreas
• bruising
• redness of the skin, skin rashes
• increased hair growth
• excessive sweating
• appearance of small red spots or thin purple lines 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 levels of calcium in the urine
• reduced response to skin tests
• increased urea in the blood
• tendency to lose more protein from the body than is taken in with the diet (metabolic acidosis)
• blurred vision

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

• growth retardation
• growth alterations

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not
listed in this leaflet. You can also report side effects directly through the national reporting system at:
https://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 METILPREDNISOLONE EG

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 eliminate
medicines that you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What METILPREDNISOLONE EG contains
The active ingredient is methylprednisolone.
Each METILPREDNISOLONE EG 4 mg tablet contains 4 mg of methylprednisolone.
The other ingredients are : lactose monohydrate, sucrose(see section 2 “METILPREDNISOLONE
EG contains lactose and sucrose”), corn starch, sodium starch glycolate, calcium stearate.
Each METILPREDNISOLONE EG 16 mg tablet contains 16 mg of methylprednisolone.
The other ingredients are: lactose monohydrate, sucrose(see section 2 “METILPREDNISOLONE
EG contains lactose and sucrose”), corn starch, liquid paraffin, calcium stearate.

Description of the appearance of METILPREDNISOLONE EG and package contents
METILPREDNISOLONE EG 4 mg tablets are flat, elliptical, white in color, with a cross imprinted
on one side, measuring 7.9 mm in length and 5.7 mm in width. The tablets are available in opaque PVC/PVDC
blisters and aluminum in a pack containing 30 tablets.
METILPREDNISOLONE EG 16 mg tablets are flat, elliptical, white tablets,
imprinted with an “H” on one side and a cross on the other side; measuring 10.2 mm in length and 7.3 mm in width. The tablets
are available in opaque PVC/PVDC blisters and aluminum in packs containing 20 or 30 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
EG S.p.A. Via Pavia, 6 – 20136 Milan

Manufacturer
Special Product’s Line S.p.A., Via Fratta Rotonda Vado Largo, 1 - 03012 Anagni (FR)