Leaflet: information for the user

Fortecortin 4 mg/ml injectable solution

Dexamethasone phosphate

Read this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and should not be given to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Dexamethasone is a synthetic glucocorticoid (adrenocortical hormone) obtained from cortisol. It intervenes by regulating many of the body's metabolic processes with anti-inflammatory and immunosuppressive activity.

Fortecortín is used for the treatment of:

By intravenous or intramuscular route:

• Inflammatory processes derived from tumors and brain abscesses (accumulation of pus in the brain), head trauma, neurosurgery, or bacterial meningitis.
• Severe traumatic shock (state of shock after severe injuries).
• Severe acute asthma crisis.
• Initial treatment of severe skin diseases.
• Initial treatment of collagen diseases such as systemic lupus erythematosus.
• Severe infectious diseases (typhoid fever, brucellosis, tuberculosis) always accompanying appropriate anti-infective treatment.
• Prevention and treatment of nausea and vomiting that appear during chemotherapy treatment and after surgical interventions.
• Short-term adjunctive treatment during acute episodes or exacerbations of rheumatic diseases (inflammation of the joints).

By intravenous route:

Fortecortín 4 mg/ml injectable solution is used for the treatment of coronavirus disease 2019 (COVID-19) in adult and adolescent patients (12 years of age or older with a body weight of at least 40 kg) with difficulty breathing and requiring oxygen therapy.

By intra-articular route:

• Treatment of persistent inflammation in one or more joints: chronic joint inflammation, activated arthritis, acute shoulder joint injuries (humerus-scapular periartropathy)

Infiltration:

In justified cases, infiltrative treatment in inflammatory processes (non-bacterial tendosynovitis and bursitis, periartropathy, tendinopathy)

No use Fortecortín:

• If you are allergic or have had an allergic reaction to dexamethasone or any of the other components of this medication (listed in section 6). These reactions are more common in patients with a history of allergy to any medication.

• By intravenous administration if you have any systemic infection, unless you receive specific anti-infective treatment.

• If you are to be administered Fortecortín via injection into the joint and present:

• Infections in the joint being treated or very close to it
• Septic arthritis (wear and tear and inflammation of the joints caused by bacterial infection)
• Instability of the joint being treated
• Tendency to bleed (spontaneously or due to anticoagulants)
• Calcification around the joint
• Avascular necrosis (bone damage due to lack of blood supply to the bone)
• Tendon rupture
• Charcot's disease (degenerative disease affecting the joints).

• By infiltration if there is an infection in the application area and you do not receive appropriate complementary treatment.

Warnings and precautions

The administration of Fortecortín may induce adrenal insufficiency, especially if high doses are administered for a prolonged period.

Avoid sudden discontinuation of treatment, especially in prolonged treatments, as it may cause a corticosteroid withdrawal syndrome characterized by general malaise, weakness, and muscle pain, difficulty breathing, loss of appetite, nausea, vomiting, fever, decreased blood pressure, and decreased blood glucose levels.

In certain special situations of physical stress during treatment with Fortecortín (e.g., feverish disorders, accidents, operations, births), it may be necessary to temporarily increase the daily dose of corticosteroid.

Fortecortín may increase the risk of infection as well as mask the signs of an infection and/or make its diagnosis difficult. Latent infections may reactivate during the use of corticosteroids.

In the following cases, close monitoring of treatment by your doctor will be necessary:

• In acute and chronic bacterial infections.
• If you have lymph node inflammation (lymph nodes that help defend the body) after being administered the tuberculosis vaccine.
• If you have a history of tuberculosis.
• Patients with chronic hepatitis (inflammation of the liver).
• Acute viral infections (hepatitis B, herpes, varicella, poliomyelitis, measles).
• Infections caused by fungi or parasites.
• If you need to be vaccinated or have been vaccinated between approximately 8 weeks before and 2 weeks after.
• If you have diabetes, peptic ulcer, or inflammatory diseases of the digestive system, osteoporosis (loss of calcium in the bones), heart failure, high blood pressure, and psychiatric diseases.
• If you present glaucoma (increased intraocular pressure), ulcers or lesions of the cornea, blurred vision, or other visual disturbances.

Long-term treatment with Fortecortín will only be established when strictly necessary and should be associated with specific treatment in each case.

The administration of Fortecortín may alter the value of some laboratory tests.

Especially with long-term treatment with high doses of Fortecortín, sufficient potassium supplementation and restricted sodium intake should be considered, and potassium levels in the blood should be monitored.

High doses of dexamethasone may cause a decrease in heart rate in some patients.

Severe anaphylactic reactions (hypersensitivity of the immune system) may occur.

If you have myasthenia gravis (severe muscle weakness), it may initially worsen during treatment with Fortecortín.

If intravenous administration of Fortecortín is too rapid, a sensation of tingling or numbness may occur, which may last for a few minutes.

If Fortecortín is administered locally (intramuscularly, intra-articularly, or by infiltration), unwanted systemic effects may occur.

The administration of Fortecortín in the joints increases the risk of joint infection; similarly, long-term use may cause joint wear and tear.

In postmenopausal women, Fortecortín may increase the risk of osteoporosis.

You should inform your doctor if you have any of the following symptoms of tumor lysis syndrome (TLS) such as muscle cramps, muscle weakness, confusion, vision loss or alteration, and difficulty breathing, in the case of hematological malignancy.

Children and adolescents

In children, the doctor should evaluate the benefits of treatment, as the use of glucocorticoids may affect their growth.

Dexamethasone should not be used routinely in premature neonates with respiratory problems.

Older adults

In patients over 65 years old, the doctor should evaluate the benefits of treatment and possible risks, as these patients may experience more adverse effects, such as osteoporosis.

Use of Fortecortín with other medications

Inform your doctor or pharmacist if you are taking or have recently taken any other medication, including those purchased without a prescription, homeopathic, herbal, and other health-related products, as it may be necessary to interrupt treatment or adjust the dose of some of them. Note that these instructions may also apply to medications that have been used before or may be used later.

This is especially important if you are taking the following medications:

• Nonsteroidal anti-inflammatory drugs (NSAIDs) such as indomethacin and salicylates, which increase the risk of ulcers and gastrointestinal bleeding.
• Oral antidiabetic drugs and insulin, which may reduce their effect.
• Antiepileptic drugs (carbamazepine), antiarrhythmic drugs (phenytoin), antihistamines, and bronchodilators (ephedrine), antibiotics (rifampicin), barbiturates, and primidone, which may reduce the effects of dexamethasone.
• Medications that slow down degradation in the liver, such as some antifungal medications (ketoconazole, itraconazole) and certain antiretroviral medications, which may increase the action of corticosteroids.So your doctor will make close controls if you are taking these medications (including some for HIV: ritonavir, cobicistat).
• Coumarin derivatives (oral anticoagulants), which may modify their anticoagulant effect.
• Estrogens (e.g., for contraceptive use) may increase the action of dexamethasone.
• Atropine and other anticholinergic medications, which may increase intraocular pressure.
• Medications used to treat heart disease, such as cardiac glycosides, which may increase their effect due to decreased potassium levels.
• Diuretics/laxatives, which may increase potassium elimination.
• Praziquantel, which may cause a decrease in praziquantel levels in the blood due to glucocorticoids.
• Antihypertensive medications (ACE inhibitors), which may increase the risk of alterations in blood components.
• Antimalarial medications (chloroquine, hydroxychloroquine, mefloquine), which may increase the risk of muscle diseases or heart muscle diseases (myopathies, cardiomyopathies).
• Immunosuppressive medications, which may increase the risk of infections. Additionally, in the case of cyclosporine, levels of cyclosporine in the blood may increase, which increases the risk of seizures.
• Non-depolarizing muscle relaxants, which may prolong muscle relaxation.
• Protirelin, which may affect its effects on thyroid-stimulating hormone (TSH).
• Fluoroquinolones, which may increase the risk of tendon alterations.
• Anidulafungin, which may increase the risk of hypokalemia (low potassium levels).
• Albendazole, which may increase levels of its active metabolite in the blood.
• Vaccines, which may cause an inadequate immune response to the vaccine.

Do not stop taking any other steroid medication unless your doctor has told you to.

Talk to your doctor, pharmacist, or nurse before you are administered this medication.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

Dexamethasone crosses the placenta. During pregnancy, especially in the first three months, treatment should only be administered after carefully weighing the risk-benefit ratio. Therefore, women should inform their doctor about an existing or impending pregnancy. Long-term treatment with glucocorticoids during pregnancy cannot be ruled out as causing fetal growth disorders. If glucocorticoids are administered at the end of pregnancy, the newborn may develop a deficiency in adrenal function, which requires initiation of a reduced-dose treatment in the newborn.

Breastfeeding

Glucocorticoids, including dexamethasone, pass into breast milk. So far, no damage to the infant has been reported. However, the need for administration during breastfeeding should be carefully examined. If high doses are necessary for medical reasons, breastfeeding should be interrupted. Consult your doctor immediately.

Fertility

The effects of Fortecortín on fertility have not been studied.

Driving and operating machinery

No data are available on how Fortecortín affects driving or operating machinery, so try not to perform tasks that require special attention until you check how you tolerate the medication.

Fortecortín contains sodium

This medication contains less than 23 mg (1 mmol) of sodium per vial, so it is considered essentially "sodium-free".

Influence on laboratory results

This medication may alter the values of certain laboratory tests. Additionally, skin reactions in allergy tests may be masked.

Use in athletes

This medication contains a component that may produce a positive result in doping control tests.

Take Fortecortín only as your doctor has instructed.Your doctor will determine the individualized dose and decide for how long you should receive dexamethasone. In case of doubt, consult your doctor or pharmacist again.

The dosing requirements are variable and should be individualized based on the disease and patient response.

Fortecortín is injected slowly intravenously, although it can also be administered, depending on the indication, by intramuscular injection, intra-articular injection, or through infiltration.

Intravenous or intramuscular:

Fortecortín is usually injected slowly (over 2-3 minutes) intravenously, but it can also be administered by intramuscular injection. The dose and duration of treatment depend on the indication and severity of the disease being treated. After an initial favorable response, your doctor will establish the most suitable maintenance dose for you. Reducing the dose and suspending treatment should always be done progressively.

For the treatment of Covid-19

In adult patients, it is recommended to administer 7.2 mg of dexamethasone phosphate (equivalent to 6 mg of dexamethasone base) intravenously once a day, for a maximum of 10 days.

Use in adolescents

It is recommended to administer 7.2 mg of dexamethasone phosphate (equivalent to 6 mg of dexamethasone base) intravenously once a day to pediatric patients (adolescents aged 12 years or older) for a maximum of 10 days.

Renal and hepatic insufficiency

No specific dose adjustment is necessary for patients with renal insufficiency.

In patients with hepatic insufficiency, lower doses may be sufficient or the dose may need to be reduced.

Use in children and adolescents

The recommended daily dose in children is generally 0.08-0.3 mg/kg, depending on the severity and type of disease.

Intra-articular or infiltration:

Intra-articular injections are considered open joint surgery and should be performed under strict aseptic conditions. A single intra-articular injection is usually sufficient to alleviate symptoms. If additional doses are considered necessary, they should not be administered before at least 3 or 4 weeks have passed since the first dose. The number of injections per joint should be limited to 3 or 4 at most. Medical follow-up of the joint, especially in cases of repeated injections, is recommended.

Local injections or infiltrations are usually administered at doses of 0.2-6 mg of dexamethasone, depending on the size of the joints.

If you use more Fortecortín than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service at 91 562 04 20, indicating the medication and amount used.

No acute intoxications with dexamethasone have been reported. In the case of overdose, it is expected that the adverse reactions described in this prospectus will occur to a greater extent.

If you interrupt treatment with Fortecortín

Do not discontinue treatment before your doctor indicates or abruptly, as this could worsen your condition.

The dose reduction should be done progressively. Similarly, the suspension of treatment should always be done progressively.

A too rapid decrease in dose after long-term treatment may cause symptoms such as muscle and joint pain. Your doctor will reduce your dose progressively.

If you have any other doubts about the use of this product, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

The terms used to describe the frequency of side effects are adjusted to the following definitions: Very common (may affect more than 1 in 10 people), common (may affect up to 1 in 10 people), uncommon (may affect up to 1 in 100 people), rare (may affect up to 1 in 1,000 people), very rare (may affect up to 1 in 10,000 people), frequency not known (cannot be estimated from available data).

Due to the wide range of therapeutic use, dosage, and duration of treatment, the frequency of side effects of Fortecortin is not known.

Blood and lymphatic system disorders: Alteration of blood cells (white blood cells and lymphocytes among others).

Endocrine disorders: Adrenal suppression and induction of symptoms similar to Cushing's syndrome (moon face, truncal obesity).

Eye disorders: Glaucoma (increased intraocular pressure), cataracts, worsening of symptoms of corneal ulcers; eye infections, ptosis, pupil dilation (mydriasis), burning, perforation of the sclera, in rare cases reversible exophthalmos.

Visual disturbances, blurred vision, loss of vision, frequency not known.

Gastrointestinal disorders: Gastrointestinal discomfort, ulcers, gastrointestinal bleeding, pancreatitis.

Immune system disorders: Hypersensitivity reactions, severe allergic reactions such as: cardiac rhythm problems, bronchospasm, blood pressure alterations, circulatory failure, cardiac arrest.

Infections and infestations: Masking of infections, existing infections may worsen or reactivate and new infections may appear, activation of intestinal parasitic diseases (strongyloidiasis).

Metabolism and nutrition disorders: Fluid retention (edema), potassium loss (which may cause arrhythmias), weight gain, increased blood sugar, diabetes mellitus, hypercholesterolemia, hypertriglyceridemia, increased appetite.

Musculoskeletal and connective tissue disorders: Muscle atrophy and weakness, myopathy, tendon alterations, osteoporosis, aseptic osteonecrosis, growth retardation in children, epidural lipomatosis.

Note: Excessive rapid reduction in dose after long-term treatment may cause symptoms such as muscle and joint pain.

Nervous system disorders: Increased intracranial pressure (pseudotumor cerebri), increased spasms in epileptic patients or appearance of epilepsy (seizures).

Psychiatric disorders: Psychosis, mania, depression, hallucinations, emotional instability, irritability, increased activity, euphoria, anxiety, sleep disturbances, suicidal thoughts.

Reproductive and breast disorders: Alteration of sex hormone secretion (amenorrhea, excessive hair growth, impotence).

Skin and subcutaneous tissue disorders: Acne, dermatitis around the mouth, striae, skin atrophy, petechiae, telangiectasias, ecchymoses, hirsutism, skin color changes.

Cardiac disorders: Heart failure.

Vascular disorders: Hypertension, increased risk of arteriosclerosis and thrombosis, vasculitis (also as a symptom of withdrawal after long-term treatment), fragility of small blood vessels.

General disorders and administration site conditions: Delayed wound healing, hiccups.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Do not store at a temperature above 25°C. Store the ampoules in the outer packaging to protect them from light.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication is for single use and must be administered immediately after opening. Any unused portion must be discarded.

Only transparent and particle-free solutions should be used.

Do not use this medication if you observe visible signs ofdegradation.

Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGREcollection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Fortecortin 4 mg/ml

• The active ingredient is dexamethasone phosphate. Each ampoule of injectable solution contains 4 mg of dexamethasone phosphate (as sodium phosphate of dexamethasone, 4.37 mg) (equivalent to 3.33 mg of dexamethasone base).
• The other components are: sodium citrate, creatinine, disodium edetate, sodium hydroxide, and water for injectable preparations.

Appearance of the product and content of the packaging

It is presented in the form of type I glass ampoules that are colorless. Containers containing 3, 100, and 200 ampoules of injectable solution.

Holder of the marketing authorization

LABORATORIOS ERN, S.A.

Perú, 228

08020 Barcelona

Spain

Responsible for manufacturing

LABORATORIOS ERN, S.A.

Gorgs Lladó, 188

08210 Barberá del Vallés, Barcelona. Spain

Last review date of this leaflet: January 2022

The detailed and updated information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/

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This information is intended solely for healthcare professionals:

Fortecortin should not be mixed with other medications due to lack of compatibility data. Preferably, it should be administered directly by intravenous injection or injected into the infusion line. However, the injectable solution of Fortecortin is compatible with the following infusion solutions (250 ml and 500 ml each) and must be used within 24 hours: isotonic saline solution, Ringer's solution, and 5% glucose solution.

If Fortecortin is used combined with infusion solutions, attention should be paid to the information related to compatibility, contraindications, adverse reactions, and interactions provided by the manufacturers of the solutions.