Patient Information Leaflet

METILPREDNISOLONE EG 4 mg tablets, 16 mg tablets

Methylprednisolone
Please read 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, your child's doctor, or pharmacist.
This medicine has been prescribed for you or your child only. Do not give it to others, even if their symptoms appear to be the same, as it could be harmful.
If you or your child experience any side effects, including those not listed in this leaflet, please contact your doctor, your child's doctor, or pharmacist. See section 4.

Contents of this leaflet:

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

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

METILPREDNISOLONE EG 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 EG 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 EG 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 should know before taking/giving METILPREDNISOLONE EG to your child

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

you are allergic to methylprednisolone or to any of the other ingredients of this medicine (listed in section 6);
you 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 METILPREDNISOLONE EG.
Warnings and precautions
Talk to your doctor or pharmacist BEFORE taking/giving METILPREDNISOLONE EG to your child if:

you have or have previously had tuberculosis;
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 EG may worsen your or your child's condition;
your thyroid gland is underactive ( hypothyroidism ). In this case, doses of METILPREDNISOLONE EG 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 are scheduled for surgery under general anaesthesia involving the use of muscle-blocking drugs (e.g. pancuronium). In this case, there is an increased risk that METILPREDNISOLONE EG 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 or are predisposed to developing 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 EG”);
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 needed to relieve this condition.
Inform your doctor or your child’s doctor if any of the following conditions appear or worsen DURING treatment with METILPREDNISOLONE EG (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 EG;
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 psychiatric 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 METILPREDNISOLONE EG (see section “Do not take/give METILPREDNISOLONE EG to your child if you or your child”). However, you may be vaccinated 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 EG may cause growth retardation, increased intracranial pressure and pancreatitis in newborns and children.
Elderly patients
If you are elderly, long-term treatment with METILPREDNISOLONE EG may increase the risk of developing osteoporosis, excessive fluid retention and high blood pressure. Your doctor will assess your condition and administer this medicine with caution.
Other medicines and METILPREDNISOLONE EG
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 EG, and your doctor may wish 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 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);
HIV medicines such as indinavir, ritonavir and cobicistat (medicines for HIV virus);
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 used 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 EG and beverages
You or your child must not drink grapefruit juice during treatment with METILPREDNISOLONE EG, as the efficacy and toxicity of this medicine may increase.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning 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, your doctor will prescribe METILPREDNISOLONE EG only if strictly necessary.
Breastfeeding
METILPREDNISOLONE EG passes into breast milk and may cause adverse effects in the infant. If you are breastfeeding, your doctor will prescribe METILPREDNISOLONE EG 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 METILPREDNISOLONE EG.
METILPREDNISOLONE EG contains lactose and sucrose
METILPREDNISOLONE EG 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 METILPREDNISOLONE EG 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 on the appropriate dose, how many times per day to take/give the medicine, and the duration of treatment with METILPREDNISOLONE EG.
When the doctor is satisfied with the improvement in the disease, they will advise gradually reducing the dose until reaching 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 EG 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 EG.
If you forget to use METILPREDNISOLONE EG
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 using METILPREDNISOLONE EG
You or your child must not stop taking METILPREDNISOLONE EG suddenly.
Taking METILPREDNISOLONE EG may reduce the activity of the adrenal glands that produce natural corticosteroids, and abrupt discontinuation may lead to death.
Additionally, if treatment with METILPREDNISOLONE EG is stopped abruptly, you or your child may develop withdrawal symptoms such as: anorexia, 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 gradually reduced. Your doctor will advise you on the correct way to do this.
If you have any questions 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 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 face or moon 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 treatment with METILPREDNISOLONE EG”)
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
high levels of fat 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 parts of the body
increased appetite and body weight gain
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
memory difficulties
disturbances in thought processes 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
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 lines 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), death and loss of bone tissue
joint rupture (especially in the foot) causing pain and/or swelling
vertebral fractures (traumatic or spontaneous), tendon ruptures, 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 taken in through 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 disturbances

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 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 stated on the carton, blister, and container after "Exp.". The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

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

Description of the appearance of METILPREDNISOLONE EG and pack contents
The 4 mg METILPREDNISOLONE EG tablets are flat, elliptical, white tablets, with a cross engraved on one side, 7.9 mm long and 5.7 mm wide. The tablets are available in opaque PVC/PVDC and aluminum blisters, in packages containing 30 tablets.
The 16 mg METILPREDNISOLONE EG tablets are flat, elliptical, white tablets, engraved with an “H” 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 aluminum blisters, in packages 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, Italy
Manufacturer
Special Product’s Line S.p.A., Via Fratta Rotonda Vado Largo, 1 - 03012 Anagni (FR), Italy