METILPREDNISOLONE 4 mg Coated Tablet

Зміст інструкції

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

METILPREDNISOLONE DOC 4 mg tablets, 16 mg tablets

Generic medicine

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

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

METILPREDNISOLONE DOC 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 body functions.
METILPREDNISOLONE DOC 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 DOC 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 DOC to the child

Do not take/give METILPREDNISOLONE DOC 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 must not be vaccinatedwith “live” or “live attenuated” vaccines during treatment
with METILPREDNISOLONE DOC.

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

• you have or have had in the past tuberculosis;
• you are undergoing particular situations of stress. In this case, your doctor will prescribe a higher dose of this medicine to you or your child;
• you have Cushing's syndrome, a disease characterized by excessive production of natural corticosteroids in the body. METILPREDNISOLONE DOC may worsen your or your child's condition;
• your thyroid gland is functioning less than normal (hypothyroidism). In this case, the doses of METILPREDNISOLONE DOC must be reduced;
• your thyroid gland is overactive (hyperthyroidism);
• 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 muscles (e.g. pancuronium). In this case, there is a greater risk that METILPREDNISOLONE DOC will cause muscle problems;
• you suffer from convulsions;
• you have an eye infectioncaused 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 prone 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 DOC”);
• 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, consult 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. 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, loss of vision, or shortness of breath. Tell your doctor or the doctor caring for your child if any of the following conditions occur or worsen DURINGtreatment with METILPREDNISOLONE DOC (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 DOC;
• 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 must not be vaccinated with “live” or “live attenuated” vaccines during treatment
with METILPREDNISOLONE DOC (see section “Do not take/give METILPREDNISOLONE DOC to the child
if you or your child”). You may instead be vaccinated with killed or inactivated vaccines, even though
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
doping test.

Newborns and children
Treatments with METILPREDNISOLONE DOC for long periods of time or at high doses can cause
delays in 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 DOC 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 DOC
Inform 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 DOC and your doctor may want to
monitor you closely if you are taking these medicines.
The following medicines may affect the activity of METILPREDNISOLONE DOC
or METILPREDNISOLONE DOC 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 amphotericin B(medicines for fungal infections);
• medicines for the treatment of HIVsuch as indinavir, ritonavirand cobicistat(medicines for the HIV virus);
• aminoglutethimide(medicine against 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 blocking agents(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 DOC with beverages
You or your child must notdrink grapefruit juiceduring treatment with METILPREDNISOLONE
DOC, because the effectiveness and toxicity of this medicine may increase.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect or are planning a pregnancy, or if you 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 DOC only if strictly necessary.

Breastfeeding
METILPREDNISOLONE DOC passes into breast milk and this may cause undesirable effects in
the child. If you are breastfeeding, your doctor will prescribe METILPREDNISOLONE DOC 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 METILPREDNISOLONE DOC.

METILPREDNISOLONE DOC contains lactose and sucrose
METILPREDNISOLONE DOC 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.

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

Take/give this medicine to the child following the instructions of the doctor or pharmacist exactly at all times. 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 DOC.
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 DOC 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 DOC.

If you forget to use METILPREDNISOLONE DOC
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 the treatment with METILPREDNISOLONE DOC
You or your child must not suddenly stop taking METILPREDNISOLONE DOC.
Taking METILPREDNISOLONE DOC 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 DOC, 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 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 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 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 from the pituitary gland (a gland located at the base of the brain)
• withdrawal syndrome (see section 3 “If you stop taking METILPREDNISOLONE DOC”)
• 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 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 internal eye 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 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 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), rupture of tendons, particularly 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 introduced 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, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system at the address: 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 DOC

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 box, 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 the
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What METILPREDNISOLONE DOC contains
The active ingredient is methylprednisolone.
Each METILPREDNISOLONE DOC 4 mg tablet contains 4 mg of methylprednisolone.
The other ingredients are :lactose monohydrate, sucrose, corn starch, sodium starch glycolate, calcium
stearate.
Each METILPREDNISOLONE DOC 16 mg tablet contains 16 mg of methylprednisolone.
The other ingredients are: lactose monohydrate, sucrose, corn starch, liquid paraffin, calcium stearate.

Description of the appearance of METILPREDNISOLONE DOC and contents of the pack
METILPREDNISOLONE DOC 4 mg tablets are flat, elliptical, white in colour, with a
cross imprinted on one side; length 7.9 mm and width 5.7 mm. The tablets are available in opaque PVC/PVDC blisters
and aluminium in a pack containing 30 tablets.
METILPREDNISOLONE DOC 16 mg tablets are flat, elliptical, white in colour, imprinted with an
“H” on one side and a cross on the other side; length 10.2 mm and width 7.3 mm. The tablets are available in
opaque PVC/PVDC and aluminium blisters in packs containing 20 or 30 tablets.
It is possible that not all pack sizes are marketed.

Marketing authorisation holder and manufacturer
DOC Generici S.r.l. - Via Turati, 40 - 20121 Milano - Italy