Package leaflet: Information for the patient

METILPREDNISOLONE DOC 4 mg tablets, 16 mg tablets

Equivalent medicine
Please read all of this leaflet carefully before you or your child take this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask 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 may be harmful.
If you or your child experience any side effects, including those not listed in this leaflet, contact your doctor, the doctor treating your child, or your pharmacist. See section 4.

Contents of this leaflet:

What METILPREDNISOLONE DOC is and what it is used for
What you need to know before taking/giving METILPREDNISOLONE DOC to your child
How to take/give METILPREDNISOLONE DOC to your child
Possible side effects
How to store METILPREDNISOLONE DOC
Contents of the pack and other information

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

METILPREDNISOLONE DOC 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.

METILPREDNISOLONE DOC is used for the treatment of:

conditions 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, ulcerative colitis);
brain diseases (e.g. tuberculous meningitis).

METILPREDNISOLONE DOC may be prescribed to treat conditions other than those listed above.
Please consult your doctor if you are unsure why this medicine has been prescribed for you or 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 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 one or more organs or throughout the body.

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

you have or have had tuberculosis in the past;
you are under particular conditions of stress. In such cases, your doctor will prescribe a higher dose of this medicine for 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 underactive ( hypothyroidism ). In this case, doses of METILPREDNISOLONE DOC should be reduced;
your thyroid gland is overactive (hyperthyroidism);
you have diabetes ;
you suffer from myasthenia gravis , a disease causing muscle weakness and fatigue, or you are scheduled for surgery with general anaesthesia involving the use of muscle-blocking drugs (e.g. pancuronium). In this case, there is an increased risk that METILPREDNISOLONE DOC 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 ( dyslipidaemia );
you have heart problems ( heart failure );
you suffer from or are predisposed to develop blood clots in the veins;
you have a stomach ulcer or other serious stomach or intestinal problems;
you have liver 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 METILPREDNISOLONE DOC”);
you need to undergo skin sensitivity tests ;
you have a type of tumour called phaeochromocytoma ;
you suffer from peritonitis or other gastrointestinal disorders, because glucocorticoid therapy may mask symptoms such as perforation, obstruction or pancreatitis.

If, during treatment with methylprednisolone, you experience muscle weakness, muscle pain, cramps and stiffness,
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 high 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, loss of vision or visual disturbances, and shortness of breath.
Inform your doctor or the doctor treating your child if any of the following conditions appear or worsen DURING treatment with METILPREDNISOLONE DOC (see also section 4 “Possible side effects”):

infections . This medicine may increase susceptibility to infections or worsen existing infections. For example, chickenpox and measles may have a more severe, sometimes fatal, course;
Kaposi's sarcoma , a skin tumour. In this case, discontinue treatment with METILPREDNISOLONE DOC;
severe allergic reactions ;
swelling in different 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);
accumulation of fat 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 METILPREDNISOLONE DOC (see section “Do not take/give METILPREDNISOLONE DOC to the child if you or your child”). However, you may receive vaccination with inactivated or killed vaccines, although the effectiveness of these vaccines may be reduced.
For athletes
Using this medicine without therapeutic need constitutes doping and may lead to a positive anti-doping test.
Newborns and children
Long-term treatment or high-dose treatment with METILPREDNISOLONE DOC may cause growth retardation, increased intracranial pressure and pancreatitis 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 and high blood pressure. Your doctor will assess your condition and administer this medicine cautiously.
Other medicines and METILPREDNISOLONE DOC
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 METILPREDNISOLONE DOC, and your doctor may wish 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 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 (anti-nausea/vomiting medicines);
itraconazole , ketoconazole and amphotericin B (medicines for fungal infections);
medicines for HIV treatment such as indinavir , ritonavir and cobicistat (anti-HIV medicines);
aminoglutethimide (medicine for excessive production of natural corticosteroids);
diltiazem (medicine used to treat heart problems or high blood pressure);
ethinylestradiol / norethindrone (hormones used in combination as oral contraceptives);
cyclosporine , cyclophosphamide and tacrolimus , medicines to prevent organ transplant rejection and for autoimmune diseases;
oral anticoagulants , medicines used to thin the blood;
neuromuscular blockers (medicines causing muscle relaxation);
anticholinesterases (medicines for muscle diseases such as myasthenia gravis and Alzheimer's disease);
antidiabetics (medicines for diabetes);
aspirin (acetylsalicylic acid);
diuretics (medicines that increase urine production);
xanthines and beta-2 agonists (medicines for asthma).

METILPREDNISOLONE DOC with beverages
You or your child must not drink grapefruit juice during treatment with METILPREDNISOLONE DOC, as the efficacy and toxicity of this medicine may increase.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant or are planning to become pregnant, or if you 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, your doctor will prescribe METILPREDNISOLONE DOC only if strictly necessary.
Breastfeeding
METILPREDNISOLONE DOC passes into breast milk and may cause adverse effects in the infant. If you are breastfeeding, your doctor will prescribe METILPREDNISOLONE DOC 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 during treatment with METILPREDNISOLONE DOC you experience dizziness, vertigo, visual disturbances or fatigue.
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/her before taking this medicine.

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

Take/give this medicine to the child exactly as directed by the doctor or
pharmacist. If you have any doubts, consult the doctor or pharmacist.
The recommended starting dose ranges from 4 mg to 48 mg per day. Depending on the patient's condition or the child's condition and the type of disease, the doctor will advise you on the correct dose, how many times a day to take/give the medicine, and the duration of treatment with METILPREDNISOLONE DOC.
When the doctor is satisfied with the improvement in the disease, he/she will advise reducing the dose gradually to reach the lowest effective maintenance dose.
Swallow the tablets whole with a glass of water. Do not chew or break the tablets.

If you use more METILPREDNISOLONE DOC than you should
It is important that neither you nor your child take more tablets than prescribed.
Contact your doctor immediately if you or your child have accidentally taken an excessive dose of METILPREDNISOLONE DOC.

If you forget to use METILPREDNISOLONE DOC
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 METILPREDNISOLONE DOC
You or your child must not stop taking METILPREDNISOLONE DOC suddenly.
Taking METILPREDNISOLONE DOC may cause reduced function of the adrenal glands that produce natural corticosteroids, and sudden discontinuation may lead to death.
Moreover, if treatment with METILPREDNISOLONE DOC is stopped abruptly, you or your child may develop withdrawal symptoms such as: loss of appetite, nausea, vomiting, drowsiness, headache, fever, muscle and joint pain, skin peeling, weight loss, low blood pressure, and mental disturbances.
When stopping treatment, the dose must be reduced gradually. Your doctor will advise you on the correct way to do this.

If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody 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 defences 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 treatment with 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 gain 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 gain
psychiatric disorders such as: emotional disturbances (depression, euphoria, emotional and drug dependency, 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 in remembering
thought disorders affecting 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 membrane
increased or decreased blood pressure
warmth and redness of the skin (flushing)
increased blood coagulation
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, skin rashes
increased hair growth
excessive sweating
appearance of small red spots or thin purplish lines on the skin
itching
hives
acne
skin atrophy
disturbances in water and mineral salt levels. This condition may rarely lead to high blood pressure and heart problems (heart failure)
muscle weakness
muscle and joint pain, muscle disorders, reduction in muscle mass
bone fragility (osteoporosis), bone tissue death and loss
joint rupture (especially in the foot) causing pain and/or swelling
vertebral fractures (traumatic 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 calcium levels in urine
reduced response to skin tests
increased blood urea levels
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, talk to your doctor or pharmacist.
You can also report side effects directly via 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 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 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 METILPREDNISOLONE DOC contains
The active substance is methylprednisolone.
Each 4 mg tablet of METILPREDNISOLONE DOC contains 4 mg of methylprednisolone.
The other components are: monohydrate lactose, sucrose, maize starch, sodium starch glycolate, calcium stearate.
Each 16 mg tablet of METILPREDNISOLONE DOC contains 16 mg of methylprednisolone.
The other components are: monohydrate lactose, sucrose, maize starch, liquid paraffin, calcium stearate.

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

Marketing Authorization Holder and Manufacturer
DOC Generici S.r.l. - Via Turati, 40 - 20121 Milan - Italy