Flebocortid Richter: detailed information

Package leaflet: Information for the patient

Flebocortid Richter 500 mg/5 ml powder and solvent

for injectable solution for intravenous use
Flebocortid Richter 1 g/10 ml powder and solvent
for injectable solution for intravenous use
hydrocortisone
Please read this leaflet carefully before using 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, pharmacist, or nurse.
This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

What Flebocortid Richter is and what it is used for
What you need to know before taking Flebocortid Richter
How to take Flebocortid Richter
Possible side effects
How to store Flebocortid Richter
Contents of the pack and other information

1. What Flebocortid Richter is and what it is used for

Flebocortid Richter contains sodium hydrocortisone hemisuccinate, which belongs to a class of
medicinal products called corticosteroids.
Corticosteroids are hormones that can be used as medicines and perform numerous actions, including an important role in controlling inflammation and allergic reactions.
Flebocortid Richter is indicated in emergency situations requiring a rapid and high blood availability of hydrocortisone, with the aim of achieving a fast and significant therapeutic response essential for survival.
In particular, the administration into a vein (intravenous) of very high doses of hydrocortisone represents a valid treatment for shock states (rapid and severe drop in blood pressure) of various origins, especially if resistant to standard anti-shock therapy.

2. What you should know before taking Flebocortid Richter

Do not take Flebocortid Richter

if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
if you have untreated infectious diseases (e.g. tuberculosis, ocular herpes simplex, acute and chronic infections during pregnancy);
if you have systemic fungal infections;
if you have lesions inside the stomach and intestine that heal with difficulty (ulcers);
if you have mental disorders (psychosis);
if you have diabetes;
if you have a bone disease that reduces bone mass and strength (osteoporosis);
if you have recently received or are planning to receive certain types of vaccination (with live attenuated vaccines). This applies only if you are on long-term therapy or being treated with doses that suppress your immune system. Consult your doctor to determine whether you fall into these categories (see also section “Warnings and precautions”).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Flebocortid Richter.
If you have kidney problems or high levels of uric acid in the blood, contact your doctor before starting
treatment with Flebocortid Richter.
If you suffer from hematological neoplasia, inform your doctor if you experience symptoms of Tumor
Lysis Syndrome such as muscle cramps, muscle weakness, confusion, loss or disturbances of vision,
shortness of breath, seizures, irregular heartbeat, or kidney failure (reduced urine output or dark urine)
(see section "Possible side effects").
Treatment with Flebocortid Richter, even if short and intensive, may cause lesions inside the stomach
that heal with difficulty (peptic ulcer).
If you are being treated with Flebocortid Richter and are under particular stress, have concurrent
infections, high fever, trauma, severe illness, or undergo surgery, your doctor will adjust the dose
according to the severity of the condition.
If you have an infection, medicines belonging to the same class as Flebocortid Richter (glucocorticoids)
may mask its signs, and intercurrent infections may occur during their use. In such cases, your doctor
will assess whether you need appropriate antibiotic therapy.
If you are being treated with Flebocortid Richter, you must not be vaccinated against smallpox.
If you are taking Flebocortid Richter, especially if on long-term therapy or treatment with doses that
suppress your immune system, do not receive vaccinations (unless otherwise advised by your doctor)
and do not take other medicines that affect the body's defense system, due to possible risks of
neurological complications or inadequate immune response.
During treatment, your doctor may recommend a diet to adjust your intake of sodium and potassium to
prevent imbalances in these elements. Electrolyte disturbances, particularly hypokalaemia, may cause
heart problems, even serious ones (arrhythmias).
In particularly hot weather, your doctor may monitor the dosage of Flebocortid Richter, mineralocorticoid, and salt intake.
All medicines in the same class as Flebocortid Richter (glucocorticoids) increase calcium excretion.
After administration of medicines belonging to the same class as Flebocortid Richter (corticosteroids),
worsening of a disease caused by a tumor called pheochromocytoma may occur, which can be fatal.
If you suffer from or suspect you may have pheochromocytoma, inform your doctor, who will assess
whether to administer Flebocortid Richter (see “Side effects”).
Treatment with medicines belonging to the same class as Flebocortid Richter (glucocorticoids) may
cause reduced function of the “adrenal glands”, organs involved in the production of several hormones
(secondary adrenal insufficiency). This condition may be minimized by gradually reducing the dose
and may persist for months after stopping treatment. Therefore, in any stressful situation occurring
during this period, your doctor may restart hormone therapy.
Also in this case, if you have impaired function of a hormone called “mineralocorticoid”, your doctor
may prescribe concomitant administration of sodium chloride (salt) and/or mineralocorticoid.
Replacement therapy must not be stopped abruptly, as it could cause severe malfunctioning of the
“adrenal glands”, organs involved in hormone production (acute adrenal insufficiency). For this reason,
in some cases (if you suffer from adrenal insufficiency), it is recommended to always carry a written
note clearly stating this condition and your treatment (this information is relevant, for example, in case
of accident or emergency treatment).
Consult your doctor to determine whether you fall into these categories.
If you are taking Flebocortid Richter, behavioral changes of various kinds may occur: euphoria,
insomnia, mood or personality changes, severe depression, or signs of other mental illnesses.
If you already have emotional instability or mental disturbances (psychotic tendencies), these may be
worsened by Flebocortid Richter.
If you suffer from any of the following conditions, discuss them with your doctor, as Flebocortid Richter
should be administered with caution in the following cases:

if you have a blood disorder such as reduced activity or concentration of prothrombin (hypoprothrombinemia);
if you have a thyroid disorder (hypothyroidism);
if you have an overactive thyroid (you suffer from hyperthyroidism);
if you have a severe liver disorder called hepatic cirrhosis;
if you have intestinal diseases such as: ulcerative colitis, diverticulitis;
if you have recently undergone a surgical procedure such as intestinal anastomosis;
if you have pus collections (abscesses) and tissue infections caused by germs (pyogenic infections);
if you have kidney diseases (renal failure);
if you have high blood pressure;
if you have a muscle disease characterized by severe weakness (severe myasthenia gravis);
if you are allergic to any type of medicine, as appropriate precautions must be taken before administering Flebocortid Richter.

Children
In early infancy, the medicine should be administered only when strictly necessary and under direct
medical supervision.
If hydrocortisone-containing medicines are administered to a premature newborn, monitoring of heart
function and structure may be required.
Prolonged treatments should be avoided in children due to the risk of growth retardation. The child
should be kept under close medical supervision.

Other medicines and Flebocortid Richter
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines, including those obtained without a prescription.
The effects of Flebocortid Richter may be influenced by or may influence the following medicines:

Contraindicated combinations (see Do not take Flebocortid Richter)

certain types of vaccines (live attenuated vaccines): if you are on long-term therapy or treatment with doses that suppress your immune system (consult your doctor to determine whether you fall into these categories), you may develop a potentially fatal vaccine-induced disease.

Combinations that may lead to heart rhythm disturbances (torsades de pointes) and require precautions during use

medicines used to control high blood pressure (diuretics that increase potassium loss) or medicines that dilate the bronchi (e.g. fenoterol, reproterol), because low potassium levels in the blood (hypokalaemia) may occur; your doctor will perform checks and, if necessary, may prescribe supplements;
medicines used in certain heart conditions (digitalis for heart failure): the potassium-lowering effect caused by Flebocortid Richter may increase the toxicity of these medicines; your doctor will perform tests before administration and, if necessary, may recommend ways to restore normal potassium levels in the blood and will continue monitoring you;
medicines that induce heart rhythm disturbances (torsades de pointes) (e.g. medicines regulating heart rhythm (antiarrhythmics), some psychotropic drugs (neuroleptics, antidepressants): increased risk of heart rhythm disturbances (ventricular arrhythmias, particularly torsades de pointes); your doctor will perform tests before administration, may prescribe supplements if necessary, and will continue monitoring you.

Other combinations requiring precautions during use

medicines used to lower blood sugar levels (hypoglycemic agents such as insulin, metformin, sulfonylureas): if you have diabetes, you may require increased insulin or antidiabetic medication due to reduced carbohydrate tolerance caused by Flebocortid Richter treatment; especially at the beginning of treatment, more frequent monitoring, including self-monitoring of blood and urine glucose levels, is necessary, and your doctor may adjust the dose of your antidiabetic medicine during and after treatment with Flebocortid Richter;
medicines that stimulate liver enzyme activity (enzyme inducers), e.g. phenytoin (used for epilepsy), phenobarbital (used for seizures), ephedrine (used to treat low blood pressure), rifampicin (a type of antibiotic), and tacrolimus (used to prevent organ transplant rejection): these may reduce the activity of Flebocortid Richter and may require dose adjustment;
erythromycin and oleandomycin (antibiotics): your doctor may adjust the dose of Flebocortid Richter;
medicines used to slow or reduce blood clotting time (coumarin anticoagulants): Flebocortid Richter may alter the response to these medicines;
non-steroidal anti-inflammatory drugs: acetylsalicylic acid, as it may cause coagulation problems (hypoprothrombinemia);
some medicines may increase the effects of Flebocortid Richter, and your doctor may wish to keep you under close observation if you are taking these medicines (including certain HIV treatments: ritonavir, cobicistat).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning pregnancy, or are breastfeeding, consult
your doctor or pharmacist before taking this medicine.

Pregnancy
Use Flebocortid Richter during the first trimester of pregnancy only after discussing with your doctor the
potential benefits and risks for you and the unborn child from different treatment options. This is because
Flebocortid Richter may increase the risk of a baby being born with cleft lip and/or cleft palate (openings
or splits in the upper lip and/or palate). If you are pregnant or planning pregnancy, discuss the use of
Flebocortid Richter with your doctor.

Breastfeeding
Breastfeeding during treatment with Flebocortid Richter is not recommended, as the medicine is excreted
in breast milk.

Driving and using machines
Glucocorticoids have an excitatory (euphoric) effect: caution is required when driving or operating
machinery.

For those engaged in sports
Using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping
test.

Flebocortid Richter 500 mg/5 ml contains sodium: this medicine contains 39 mg of sodium (main component of table salt) per 500 mg dose. This corresponds to 1.9% of the maximum daily intake recommended in an adult's diet.

Flebocortid Richter 1 g/10 ml contains sodium: this medicine contains 78 mg of sodium (main component of table salt) per 1 g dose. This corresponds to 3.9% of the maximum daily intake recommended in an adult's diet.

3. How to take Flebocortid Richter

Take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is:
Intravenous use (administration by injection into a vein), either directly or after dilution in an intravenous infusion: 20 to 50 mg or more per kg per day (as a single bolus or divided into several doses).
The maintenance dose should always be the lowest dose capable of controlling symptoms; dose reduction should always be performed gradually.

If you take more Flebocortid Richter than you should
If you are taking high doses of Flebocortid Richter, especially in combination with the medicines listed in the section "Other medicines and Flebocortid Richter", disturbances in the body's electrolyte balance may occur. Your doctor will therefore monitor you closely.
In case of overdose or prolonged treatment, the main effects observed have been: decreased potassium levels in the blood (hypokalaemia), significant reduction of chloride in the body (hypochloraemic alkalosis), sodium and fluid retention with high blood pressure (arterial hypertension), reduced glucose tolerance, weight gain, overexcitement with psychological and sleep disturbances, sometimes menstrual irregularities, decreased skin thickness (cutaneous atrophy), delayed wound healing, bruising, and acne.

If you stop treatment with Flebocortid Richter
After long-term use of Flebocortid Richter, if treatment needs to be discontinued, follow your doctor's advice. Your doctor may gradually reduce the dose of medicine you are taking until you stop completely.
Sudden discontinuation of treatment may cause:

steroid withdrawal syndrome (see section 4)
adrenal insufficiency (low cortisol levels), or
a relapse (return) of the underlying condition being treated.

If you have any doubts about how to use 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.
During treatment with Flebocortid Richter, especially when using high doses for prolonged periods, some of the following side effects may occur:

Side effects with unknown frequency (frequency cannot be estimated from the available data):

disturbances in the body's electrolyte balance (alteration of water and electrolyte balance), which, rarely and in particularly predisposed patients, may lead to:
- high blood pressure (hypertension)
- heart problems (congestive heart failure),
changes affecting muscles and skeleton (osteoporosis, bone fragility, myopathies),
gastrointestinal disorders that may progress to the development or activation of serious lesions (peptic ulcer),
skin-related changes such as:
- delayed wound healing
- thinning and fragility of the skin
- itching, irregular skin rash (urticaria),
eye-related changes such as:
- visual disturbances due to posterior subcapsular cataract
- increased pressure in the eye (intraocular pressure)
- retinal disease (chorioretinopathy)
- blurred vision
dizziness,
headache (cephalalgia),
increased pressure in the skull (intracranial pressure),
interference with the function of a body system involving the pituitary and adrenal glands (hypothalamic-pituitary-adrenal axis interference), particularly under stressful conditions,
menstrual irregularities,
changes in certain hormone-secreting glands: worsening of a condition caused by a tumour called phaeochromocytoma, which mainly presents with arterial hypertension, headache, sweating, palpitations, anxiety, and hot flushes (see "Warnings"),
symptoms resembling those of patients affected by Cushing's syndrome (Cushingoid appearance),
reduced tolerance to sugars and possible onset of diabetes mellitus,
euphoria, mood or personality changes, severe depression, or signs of mental illness,
insomnia,
increased loss of protein (negative nitrogen balance),
hiccups,
weight gain secondary to reduced cortisol production (long-term use),
Tumour Lysis Syndrome has been reported in patients with haematological neoplasia. Tumour Lysis Syndrome may be detected by the doctor based on blood test changes such as increased levels of uric acid, potassium, or phosphorus, and decreased calcium levels, and may cause symptoms such as muscle cramps, muscle weakness, confusion, vision loss or disturbances, shortness of breath, seizures, irregular heartbeat, or kidney failure (reduced urine output or dark urine). If you experience any of these symptoms, you must inform your doctor immediately (see section "Warnings and precautions"),
although not all people experience them, the following side effects have been observed after sudden discontinuation of Flebocortid Richter following prolonged use: symptoms such as fever, loss of appetite, nausea, weakness, restlessness, joint pain, skin peeling, low blood pressure, and weight loss (steroid withdrawal syndrome).

Parenteral administration (by injection)
Following parenteral administration, the following have been reported:

allergic-like reactions (anaphylactoid reactions),
increased or decreased skin pigmentation (hyper- or hypopigmentation),
thinning of the skin (cutaneous and subcutaneous atrophy),
small collections of non-infectious fluid within tissues (sterile abscesses),
sensation of warmth following administration of the medicine into a joint (intra-articular use),
joint diseases (Charcot-type arthropathy).

Intrathecal administration (direct injection of the medicine into the fluid (cerebrospinal fluid) surrounding the brain)
Following intrathecal administration, cases of inflammation of a membrane covering part of the brain (arachnoiditis) have been reported.

Inhalation use
Following inhalation use, the following disorders have been reported:

headache (cephalalgia),
loss of appetite (anorexia),
irritation of certain parts of the throat (retropharynx and pharynx).

Additional side effects in children

growth disturbances in children
thickening of the heart muscle (hypertrophic cardiomyopathy) in premature infants.

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.
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Flebocortid Richter

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging 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 Flebocortid Richter contains
500 mg/5 ml powder and solvent for injectable solution for intravenous use

The active substance is sodium hydrocortisone succinate. One vial of powder contains 668 mg of sodium hydrocortisone succinate equivalent to 500 mg of hydrocortisone.
The other components are: sodium phosphate.

One ampoule of solvent contains: water for injection.
1 g/10 ml powder and solvent for injectable solution for intravenous use

The active substance is sodium hydrocortisone succinate. One vial of powder contains 1,337 mg of sodium hydrocortisone succinate equivalent to 1 g of hydrocortisone.
The other components are: sodium phosphate.

One ampoule of solvent contains: water for injection.
Description of the appearance of Flebocortid Richter
Flebocortid Richter is presented as powder and solvent for injectable solution:

500 mg/5 ml powder and solvent for injectable solution for intravenous use: 1 vial + 1 ampoule of 5 ml solvent
1 g/10 ml powder and solvent for injectable solution for intravenous use: 1 vial + 1 ampoule of 10 ml solvent

The powder is presented in vials as a compact, uniform porous mass which may undergo fragmentation and pulverization with reduction in volume.
This does not in any way impair the activity of the product.
Marketing Authorization Holder
Fidia Farmaceutici S.p.A.
Via Ponte della Fabbrica, 3/A - 35031 Abano Terme (PD)
Manufacturer
Sanofi S.r.l.
Via Valcanello, 4 – 03012 Anagni (FR) - Italy
Fidia Farmaceutici S.p.A.
Via Ponte della Fabbrica, 3/A - 35031 Abano Terme (PD)

Patient information leaflet

Flebocortid Richter 100 mg/2 ml powder and solvent for

injectable, nebulizable, or rectal solutions
hydrocortisone
Please read this leaflet carefully before using this medicine, as it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

What Flebocortid Richter is and what it is used for
What you need to know before using Flebocortid Richter
How to use Flebocortid Richter
Possible side effects
How to store Flebocortid Richter
Package contents and other information

1. What Flebocortid Richter is and what it is used for

Flebocortid Richter contains sodium hydrocortisone hemisuccinate, which belongs to a class of
medicines called corticosteroids.
Corticosteroids are hormones that can be used as medicines and perform numerous functions, including an important role in controlling inflammation and allergic reactions.
Flebocortid Richter is particularly indicated in emergency situations requiring a rapid, high level of hydrocortisone in the bloodstream, with the aim of achieving a rapid and significant therapeutic response essential for survival.
Flebocortid Richter is indicated:

For treatments via intravenous or intramuscular injection (systemic use):
- reduced production of cortisone by the body (adrenal crisis in Addison's disease and in adrenalectomized patients);
- severe and sudden allergic reactions (severe allergic anaphylactic states, bronchial asthma, drug reactions, angioneurotic edema and glottal edema) unresponsive to conventional therapy;
- complications following blood transfusion (transfusion reactions);
- severe shock resistant to standard anti-shock therapy.
For local treatments:
- narrowing of inflamed bronchi (bronchial asthma and asthmatic bronchitis), allergic rhinitis, by administration of Flebocortid Richter via aerosol and inhalation;
- inflammation and fluid accumulation between the membranes lining the lungs (exudative pleuritis and traumatic pleural effusions) and tumors of the lungs and their surrounding membranes (pleuropulmonary neoplasms), by administration of Flebocortid Richter into the pleural space (endopleural instillation);
- adjunctive therapy for short-term administration to manage new episodes (acute episodes) or worsening of existing conditions (exacerbations) in cases of

joint inflammation (rheumatoid arthritis, scapulohumeral periarthritis, bursitis, and tenosynovitis), joint stiffness, by administration of Flebocortid Richter via injection into or around the joint (intra-articular and periarticular);

back pain (lumbosciatica and radicular pain) and inflammation of the membranes within the skull and spinal column (tuberculous meningitis with subarachnoid block, in addition to antitubercular therapy), by administration of Flebocortid Richter via injection near these membranes (epidural and subarachnoid);
to enhance the effect of other medicines (as an adjunctive medicinal agent) in inflammatory conditions of the lower intestine with hard-to-heal lesions (ulcerative proctocolitis), by administration of Flebocortid Richter via enema.

2. What you should know before taking Flebocortid Richter

Do not take Flebocortid Richter

if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
if you have untreated infectious diseases (e.g. tuberculosis, ocular herpes simplex, acute and chronic infections during pregnancy);
if you have systemic fungal infections;
if you have lesions inside the stomach and intestine that heal with difficulty (ulcers);
if you have mental disorders (psychosis);
if you have diabetes;
if you have a bone disease that reduces bone mass and strength (osteoporosis);
if you have recently undergone or are planning to undergo certain types of vaccination (with live attenuated vaccines). This applies only if you are on long-term therapy or receiving doses that suppress your immune system. Consult your doctor to determine whether you fall into these categories (see also section “Warnings and precautions”).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Flebocortid Richter.
If you have kidney problems or high levels of uric acid in your blood, contact your doctor before starting
treatment with Flebocortid Richter.
If you have hematological neoplasia, inform your doctor if you experience symptoms of Tumor Lysis
Syndrome such as muscle cramps, muscle weakness, confusion, loss or disturbances of vision, shortness
of breath, seizures, irregular heartbeat, or kidney failure (reduced urine output or dark urine) (see section
"Possible side effects").
Treatment with Flebocortid Richter, even if short and intensive, may cause lesions inside the stomach
that heal with difficulty (peptic ulcer).
If you are being treated with Flebocortid Richter and are experiencing particular stress, concurrent
infections, high fever, trauma, severe illness, or undergoing surgery, your doctor will adjust the dose
according to the severity of the condition.
If you have an infection, medicines belonging to the same class as Flebocortid Richter (glucocorticoids)
may mask its signs, and concurrent infections may occur during treatment. In such cases, your doctor
will assess whether you need appropriate antibiotic therapy.
You must not be vaccinated against smallpox while undergoing treatment with Flebocortid Richter.
If you are taking Flebocortid Richter, especially if on long-term therapy or receiving doses that suppress
your immune system, do not get vaccinated (unless otherwise advised by your doctor) and do not take
other medicines that affect the body's defense system, due to possible risks of neurological complications
or inadequate immune response.
During treatment, your doctor may recommend a diet to adjust your intake of sodium and potassium to
prevent imbalances of these elements. Electrolyte disturbances, particularly hypokalaemia, may cause
heart problems, even serious ones (arrhythmias).
In particularly hot weather, your doctor may monitor the dosage of Flebocortid Richter, mineralocorticoid
levels, and salt intake.
All medicines of the same class as Flebocortid Richter (glucocorticoids) increase calcium excretion.
After administration of medicines belonging to the same class as Flebocortid Richter (corticosteroids),
worsening of a disease caused by a tumor called pheochromocytoma, which can be fatal, may occur.
If you suffer from or suspect you may have pheochromocytoma, inform your doctor, who will evaluate
whether to administer Flebocortid Richter (see “Side effects”).
Treatment with medicines belonging to the same class as Flebocortid Richter (glucocorticoids) may
cause reduced function of the “adrenal glands”, organs involved in the production of several hormones
(secondary adrenal insufficiency). This condition may be minimized by gradually reducing the dose and
may persist for months after stopping treatment. Therefore, in any stressful situation occurring during this
period, your doctor may restart hormone therapy.
In such cases, if you have impaired production of a hormone called “mineralocorticoid”, your doctor
may prescribe concomitant administration of sodium chloride (salt) and/or mineralocorticoid.
Replacement therapy must not be stopped abruptly, as it could cause severe malfunction of the “adrenal
glands”, organs involved in the production of several hormones (acute adrenal insufficiency). For this
reason, in some cases (if you suffer from adrenal insufficiency), it is recommended to always carry a note
explicitly stating this condition and its treatment (this information is relevant, for example, in case of an
accident or emergency treatment).
Consult your doctor to determine whether you fall into these categories.
While taking Flebocortid Richter, various behavioral changes may occur: euphoria, insomnia, mood or
personality changes, severe depression, or signs of other mental illnesses.
If you already have emotional instability or mental disturbances (psychotic tendencies), these may be
worsened by Flebocortid Richter.
If you suffer from any of the following conditions, discuss them with your doctor, as Flebocortid Richter
should be administered with caution in the following cases:

if you have a blood disorder such as reduced activity or concentration of prothrombin (hypoprothrombinemia);
if you have a thyroid disorder (hypothyroidism);
if you have an overactive thyroid (you suffer from hyperthyroidism);
if you have a severe liver disorder called hepatic cirrhosis;
if you have intestinal diseases such as: ulcerative colitis, diverticulitis;
if you have recently undergone a surgical procedure such as intestinal anastomosis;
if you have pus collections (abscesses) and tissue infections caused by germs (pyogenic infections);
if you have kidney diseases (renal failure);
if you have high blood pressure;
if you have a muscle disease characterized by severe weakness (myasthenia gravis);
if you are allergic to any type of medicine, as appropriate precautions must be taken before administering Flebocortid Richter.

Contact your doctor if you experience blurred vision or other visual disturbances.
Medicines of the same class as Flebocortid Richter (corticosteroids) may increase the risk of tendon inflammation (tendinitis) or even, in some cases, tendon rupture. This risk increases if you are also taking antibiotics of the fluoroquinolone class and if you have malfunction of glands producing hormones (parathyroid glands), kidney dysfunction, are undergoing dialysis, or have had a kidney transplant.
Contact your doctor immediately if you experience muscle weakness, muscle pain, cramps, or stiffness during hydrocortisone use. These may be symptoms of a condition called thyrotoxic periodic paralysis, which may occur in patients with overactive thyroid (hyperthyroidism) treated with hydrocortisone. Additional treatment may be required to relieve this condition.
If Flebocortid Richter is administered into your joints (intra-articular administration), the injection may produce both systemic effects (throughout the body) and local effects.
Your doctor will perform tests to rule out active infections (septic processes).
Your doctor or healthcare provider will not administer Flebocortid Richter if your joints are infected.
If you experience increased pain, swelling (local edema), further reduced joint mobility, fever, or malaise, you may have joint inflammation due to bacterial infection (septic arthritis).
If your doctor confirms the diagnosis, they will prescribe appropriate antibacterial therapy.
If you have an unstable joint, your doctor will not inject Flebocortid Richter into it.
If you have inflammation of bones and joints (osteoarthritis), your doctor will not perform repeated injections of Flebocortid Richter into the affected joints, as this could accelerate joint destruction.
Your doctor must avoid direct injection of Flebocortid Richter into tendons.

Children
In early infancy, the medicine should be administered only when strictly necessary and under direct medical supervision.
If hydrocortisone-containing medicines are administered to a premature newborn, monitoring of heart function and structure may be required.
Prolonged treatment in children should be avoided due to the risk of growth retardation. The child must be closely monitored by the doctor.

Other medicines and Flebocortid Richter
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine, including those obtained without a prescription.
The effects of Flebocortid Richter may be influenced by or may influence the following medicines:

Contraindicated combinations (see Do not take Flebocortid Richter)

certain types of vaccines (live attenuated vaccines): if on long-term therapy or receiving doses that suppress your immune system (consult your doctor to determine whether you fall into these categories), you may develop a potentially fatal vaccine-induced disease.

Combinations that may cause heart rhythm disturbances (torsades de pointes) and require precautions during use

medicines used to control high blood pressure (diuretics that increase potassium loss) or medicines that dilate the bronchi (e.g. fenoterol, reproterol), as they may cause reduced potassium levels in the blood (hypokalaemia); your doctor will perform checks and, if necessary, may prescribe potassium supplements;
medicines used in certain heart conditions (digitalis for heart failure): the potassium reduction caused by Flebocortid Richter may increase the toxicity of these medicines; your doctor will perform tests before administration, may recommend ways to restore normal potassium levels if necessary, and will continue monitoring;
medicines that induce heart rhythm disturbances (torsades de pointes) (e.g. medicines regulating heart rhythm (antiarrhythmics), certain neuroleptic psychotropic drugs, antidepressants): increased risk of heart rhythm disturbances (ventricular arrhythmias and particularly torsades de pointes); your doctor will perform tests before administration, may prescribe supplements if necessary, and will continue monitoring.

Other combinations requiring precautions during use

medicines used to lower blood sugar levels (hypoglycaemic agents such as insulin, metformin, sulfonylureas): if you have diabetes, you may require increased insulin or antidiabetic medicines due to reduced carbohydrate tolerance caused by Flebocortid Richter therapy; especially at the beginning of treatment, increased monitoring, including self-monitoring of blood and urine glucose levels, is necessary, and your doctor may adjust the dose of your antidiabetic medicine during and after Flebocortid Richter therapy;
medicines that stimulate liver enzyme activity (enzyme inducers), e.g. phenytoin (used for epilepsy), phenobarbital (used for seizures), ephedrine (used to treat low blood pressure), rifampicin (an antibiotic), and tacrolimus (used to prevent organ transplant rejection): these may reduce the activity of Flebocortid Richter and require dose adjustment;
erythromycin and oleandomycin (antibiotics): your doctor may adjust the dose of Flebocortid Richter;
medicines used to slow or reduce blood clotting time (coumarin anticoagulants): Flebocortid Richter may alter the response to these medicines;
non-steroidal anti-inflammatory drugs: acetylsalicylic acid, as it may cause coagulation problems (hypoprothrombinemia);
certain medicines may increase the effects of Flebocortid Richter, and your doctor may wish to closely monitor you if you are taking these medicines (including certain HIV treatments: ritonavir, cobicistat).

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Use Flebocortid Richter during the first trimester of pregnancy only after discussing with your doctor the potential benefits and risks for you and the unborn child of the available treatment options. This is because Flebocortid Richter may increase the risk of a child being born with cleft lip and/or cleft palate (openings or splits in the upper lip and/or palate). If you are pregnant or planning a pregnancy, discuss the use of Flebocortid Richter with your doctor.
Breastfeeding
Breastfeeding during treatment with Flebocortid Richter is not recommended, as the medicine is excreted in breast milk.

Driving and using machines
Glucocorticoids have an excitatory (euphoric) effect: caution is required when driving and operating machinery.

For athletes:
Using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.

Flebocortid Richter contains:

methyl p-hydroxybenzoate and propyl p-hydroxybenzoate: may cause allergic reactions such as skin irritation (contact dermatitis, urticaria) or breathing difficulties (bronchospasm);
less than 1 mmol (23 mg) of sodium per 100 mg dose, i.e. essentially “sodium-free”.

3. How to take Flebocortid Richter

Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
The recommended dose is:
By intravenous route (administration by injection into a vein):
100 to 200 mg or more per dose, repeated according to your clinical condition.
In shock states: 20 to 50 mg/kg/day as a single bolus or divided into several doses.
By intramuscular route (administration by injection into a muscle):
25-50 or 100 mg two to four times daily.
Intramuscular administration must be performed deeply into large muscles.
By aerosol and inhalation:
25 mg once or twice daily (possibly in combination with antibiotics and bronchodilators).
By endopleural route (into the membranes lining the lungs):
Initial dose of 50-100 mg, followed by 25 mg per dose at intervals of 3 to 8 days (possibly in
combination with other medicines, if prescribed by the doctor).
By intra-articular and periarticular route (injection into and around the joint):
50 to 100 mg for large joints;
25 mg for small joints: the number of administrations will be determined by the doctor according to
your clinical condition.
By epidural and subarachnoid route (injection near and between the membranes):
25 mg per dose, administered at intervals as advised by the doctor.
By rectal route (dilute the product in water or physiological solution):
25-50 mg in 100 ml of fluid, or 100 mg in 300-500 ml, for a standard enema or administered slowly
drop by drop.
The maintenance dose should always be the lowest dose capable of controlling symptoms; dose
reduction should always be gradual.
If you take more Flebocortid Richter than you should
If you are taking high doses of Flebocortid Richter, especially in combination with the medicines listed
under "Other medicines and Flebocortid Richter", disturbances in the body's electrolyte balance may
occur, which your doctor will therefore monitor closely.
In case of overdose or prolonged treatment, the main effects observed have been: reduced potassium
levels in the blood (hypokalaemia), significant reduction of chloride in the body (hypochloraemic
alkalosis), sodium and fluid retention with high blood pressure (arterial hypertension), reduced glucose
tolerance, weight gain, overexcitement with psychological and sleep disturbances, sometimes menstrual
irregularities, reduced skin thickness (cutaneous atrophy), delayed wound healing, bruising and acne.
If you stop treatment with Flebocortid Richter
After long-term use of Flebocortid Richter, if treatment needs to be discontinued, follow your doctor's
advice. Your doctor may gradually reduce the amount of medicine you are taking until you stop
completely.
Sudden discontinuation of treatment may cause:

steroid withdrawal syndrome (see section 4)
adrenal insufficiency (low cortisol levels), or
a relapse (return) of the underlying condition being treated. If you have any doubts about how to use 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.

During treatment with Flebocortid Richter, especially with high-dose and prolonged treatments, some of the following side effects may occur:

Side effects with unknown frequency (frequency cannot be estimated from the available data):

disturbances in the body's electrolyte balance (disturbance of water and electrolyte balance), which rarely and in particularly predisposed patients may lead to:
- high blood pressure (hypertension)
- heart problems (congestive heart failure),
skeletal and muscular disorders (osteoporosis, bone fragility, myopathies),
gastrointestinal disorders that may progress to the development or activation of severe lesions (peptic ulcer),
skin disorders such as:
- delayed wound healing
- thinning and fragility of the skin
- itching, irregular skin rash (urticaria),
eye disorders such as:
- visual disturbances due to posterior subcapsular cataract
- increased pressure inside the eye (intraocular pressure)
- retinal disease (chorioretinopathy)
- blurred vision,
dizziness,
headache (cephalalgia),
increased pressure in the skull (intracranial pressure),
interference with the function of a body system involving the pituitary and adrenal glands (hypothalamic-pituitary-adrenal axis suppression), particularly under stressful conditions,
menstrual irregularities,
disorders of certain hormone-secreting glands: worsening of a disease caused by a tumour called phaeochromocytoma, which mainly presents with arterial hypertension, headache, sweating, palpitations, anxiety and flushing (see "Warnings"),
symptoms resembling those of patients with Cushing's syndrome (Cushingoid appearance),
reduced tolerance to sugars and possible onset of diabetes mellitus,
euphoria, mood or personality changes, severe depression or signs of mental illness,
insomnia,
increased protein loss (negative nitrogen balance),
hiccups,
weight gain secondary to reduced cortisol production (long-term use),
Tumour Lysis Syndrome has been reported in patients with haematological neoplasia. Tumour Lysis Syndrome may be detected by the physician based on blood test abnormalities such as increased levels of uric acid, potassium or phosphate, and decreased calcium levels, and may cause symptoms such as muscle cramps, muscle weakness, confusion, visual loss or disturbances, shortness of breath, seizures, irregular heartbeat or renal failure (reduced urine output or dark urine). If you experience any of these symptoms, you must inform your doctor immediately (see section "Warnings and precautions"),
although not all people experience them, the following side effects have been observed after sudden discontinuation of Flebocortid Richter following prolonged use: symptoms such as fever, loss of appetite, nausea, weakness, restlessness, joint pain, skin peeling, low blood pressure and weight loss (steroid withdrawal syndrome).

Parenteral administration (by injection)
Following parenteral administration, the following have been reported:

reactions similar to allergic reactions (anaphylactoid reactions),
increased or decreased skin pigmentation (hyper- or hypopigmentation),
thinning of the skin (atrophy of the skin and subcutaneous tissue),
small collections of non-infectious fluid within tissues (sterile abscesses),
sensation of warmth following administration into a joint (intra-articular use),
joint diseases (Charcot-type arthropathy).

Inhalation use
Following inhalation use, disorders such as the following have been reported:

headache (cephalalgia),
loss of appetite (anorexia),
irritation of certain parts of the throat (retropharynx and pharynx).

Additional side effects in children

growth disorders in children,
thickening of the heart muscle (hypertrophic cardiomyopathy) in premature infants.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You may 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 Flebocortid Richter

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging 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 you no longer use. This will help protect the environment.

6. Package contents and other information

What Flebocortid Richter contains

The active substance is: sodium hydrocortisone succinate. One vial of powder contains 133.7 mg of sodium hydrocortisone succinate, equivalent to 100 mg of hydrocortisone.
The other components are: sodium phosphate; methyl p-hydroxybenzoate; propyl p-hydroxybenzoate.

One vial of solvent contains: sodium chloride; water for injections.

Description of the appearance of Flebocortid Richter
Flebocortid Richter is supplied as a powder and solvent for injectable solutions, to be nebulized or administered rectally, in a pack containing 1 vial of powder + 1 vial of solvent (2 ml).

The powder presents in the vials as a compact, uniform, porous mass which may undergo fragmentation and pulverization with reduction in volume.
This does not in any way impair the medicinal product's activity.

Marketing Authorization Holder
Fidia Farmaceutici S.p.A.
Via Ponte della Fabbrica, 3/A - 35031 Abano Terme (PD)

Manufacturer
Sanofi S.r.l.
Via Valcanello, 4 – 03012 Anagni (FR) - Italy
Fidia Farmaceutici S.p.A.
Via Ponte della Fabbrica, 3/A - 35031 Abano Terme (PD)