Fortecortin 40 mg/5ml solution for injection

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Fortecortin 40 mg/5 ml injection solution

Dexamethasone phosphate

Read all of this leaflet carefully before starting to use this medicine, as it contains important information for you.

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

Leaflet contents:

1. What Fortecortin is and what it is used for
2. What you need to know before using Fortecortin
3. How to use Fortecortin
4. Possible side effects
5. How to store Fortecortin
6. Contents of the pack and other information

1. What Fortecortin is and what it is used for

The dexamethasone phosphate contained in Fortecortin is a corticosteroid (glucocorticoid) derived from cortisone. It acts by regulating many metabolic processes in the body and has anti-inflammatory and immunosuppressive activity.

Fortecortin is administered by intravenous or intramuscular route for the treatment of:

• Inflammatory processes associated with brain tumours or cranio-cerebral trauma.
• Traumatic shock (shock state following severe injuries).
• Anaphylactic shock (severe generalized allergic reaction).

2. What you need to know before using Fortecortín

Do not use Fortecortín:

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

• By intravenous administration if you have a systemic infection, unless you are receiving specific anti-infective treatment.

Warnings and precautions

Administration of Fortecortín may induce adrenal insufficiency, especially if high doses are given for prolonged periods.

Avoid abrupt discontinuation of treatment, particularly after long-term therapy, as this may lead to a corticosteroid withdrawal syndrome characterized by general malaise, weakness, muscle pain, difficulty breathing, loss of appetite, nausea, vomiting, fever, low blood pressure, and decreased blood glucose levels.

In certain special situations involving physical stress during treatment with Fortecortín (e.g., febrile disorders, accidents, surgery, childbirth), a temporary increase in the daily corticosteroid dose may be necessary.

Fortecortín may increase the risk of infections and may mask signs of infection and/or make diagnosis more difficult. Latent infections may reactivate during corticosteroid use.

Close medical monitoring will be necessary in the following cases:

• In acute and chronic bacterial infections.
• If you have lymph node inflammation (lymph nodes that help the body's defense) after receiving the tuberculosis vaccine.
• If you have a history of tuberculosis.
• Patients with chronic hepatitis (liver inflammation).
• 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 approximately 8 weeks before or 2 weeks after treatment.
• If you have diabetes, peptic ulcer, gastrointestinal inflammatory diseases, osteoporosis (loss of calcium in bones), heart failure, high blood pressure, or psychiatric disorders.
• If you have glaucoma (increased intraocular pressure), corneal ulcers or lesions, blurred vision, or other visual disturbances.

Long-term treatment with Fortecortín should only be initiated when strictly necessary and must be combined with specific treatment appropriate for each case.

Fortecortín may alter the results of certain laboratory tests.

Particularly during long-term, high-dose treatment with Fortecortín, adequate potassium intake should be ensured, salt intake should be restricted, and blood potassium levels 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), this condition may initially worsen during treatment with Fortecortín.

If intravenous administration of Fortecortín is too rapid, tingling or numbness may occur, lasting a few minutes.

If Fortecortín is administered locally (by intramuscular route), systemic adverse effects may occur.

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

You should inform your doctor if you experience any of the following symptoms of tumor lysis syndrome (TLS), such as muscle cramps, muscle weakness, confusion, visual disturbances, or difficulty breathing, especially if you have a malignant hematological disorder.

Children and adolescents

In children, the doctor must carefully evaluate the benefits of treatment, as glucocorticoid use may affect growth. Dexamethasone should not be routinely used in premature neonates with respiratory problems.

If dexamethasone is administered to a premature infant, cardiac function and structure must be closely monitored.

Elderly patients

In patients over 65 years of age, the doctor must carefully evaluate the benefits and potential risks of treatment, as these patients may be more susceptible to adverse effects, such as osteoporosis.

Use of Fortecortín with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription, homeopathic remedies, herbal medicines, and other health-related products, as it may be necessary to discontinue or adjust the dose of some of them. Note that these instructions may also apply to medicines previously used or that may be used in the future.

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

• Non-steroidal anti-inflammatory drugs (NSAIDs) such as indomethacin and salicylates, as they increase the risk of gastrointestinal ulceration and bleeding.
• Oral antidiabetic agents and insulin, as their effect may be reduced.
• Antiepileptics (carbamazepine), antiarrhythmics (phenytoin), antiasthmatics and bronchodilators (ephedrine), antituberculosis antibiotics (rifampicin), barbiturates, and primidone, as they may reduce the effects of dexamethasone.
• Medicines that inhibit liver metabolism, such as certain antifungal agents (ketoconazole, itraconazole) and certain antiretroviral drugs, as they may increase corticosteroid action. Your doctor will perform careful monitoring if you are taking these medicines (including some for HIV: ritonavir, cobicistat).
• Coumarin derivatives (oral anticoagulants), as their anticoagulant effect may be altered.
• Estrogens (e.g., for contraception), as they may increase the action of dexamethasone.
• Atropine and other anticholinergic drugs, as they may increase intraocular pressure.
• Medicines used to treat heart conditions, such as cardiac glycosides, whose effects may be enhanced due to decreased potassium levels.
• Diuretics/laxatives, as they may increase potassium loss.
• Praziquantel, as glucocorticoids may reduce praziquantel blood levels.
• Antihypertensive medicines (ACE inhibitors), as they may increase the risk of blood component abnormalities.
• Antimalarial medicines (chloroquine, hydroxychloroquine, mefloquine), as they may increase the risk of muscle disorders or heart muscle diseases (myopathies, cardiomyopathies).
• Immunosuppressive agents, as they may increase the risk of infections. Additionally, in the case of cyclosporine, blood levels of cyclosporine may rise, increasing the risk of seizures.
• Non-depolarizing muscle relaxants, as muscle relaxation may be prolonged.
• Protirelin, as its effects on thyroid-stimulating hormone (TSH) may be affected.
• Fluoroquinolones, as they may increase the risk of tendon disorders.
• Amphotericin B, as it may increase the risk of low potassium levels (hypokalemia).
• Albendazole, as blood levels of its active metabolite may increase.
• Vaccines, as the immune response to vaccination may be inadequate.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Dexamethasone crosses the placenta. During pregnancy, especially in the first three months, treatment should only be given after careful assessment of the benefit-risk ratio. Therefore, women should inform their doctor of any existing or suspected pregnancy. Long-term glucocorticoid treatment during pregnancy may not exclude fetal growth disturbances. If glucocorticoids are administered late in pregnancy, the newborn may have impaired adrenal gland function, requiring replacement therapy with low doses in the newborn.

Newborns of mothers who received Fortecortín near the end of pregnancy may have low blood sugar levels after birth.

Breastfeeding

Glucocorticoids, including dexamethasone, pass into breast milk. To date, no harm to the infant has been reported. However, the need for administration during breastfeeding should be carefully evaluated. If high doses are medically necessary, breastfeeding should be discontinued. Consult your doctor immediately.

Fertility

The effects of Fortecortín on fertility have not been studied.

Driving and using machines

There are no data on how Fortecortín affects the ability to drive or operate machinery. Therefore, avoid tasks requiring special attention until you know how you tolerate the medicine.

Fortecortín contains sodium

This medicine contains less than 23 mg (1 mmol) of sodium per ampoule and is therefore considered essentially "sodium-free."

Influence on laboratory test results

This medicine may alter the values of certain laboratory tests. Skin reactions in allergy tests may also be masked.

Use in athletes

This medicine contains a component that may cause a positive result in doping control tests.

3. How to use Fortecortín

Follow exactly the administration instructions for this medicine as given by your doctor. Your doctor will determine the dosage individually. If in doubt, consult your doctor or pharmacist again.

Please note that dosage requirements are variable and must be individualized according to the disease and the patient's response.

Fortecortín is usually administered by slow intravenous injection (over 2–3 minutes), but it may also be given by intramuscular route. The dose and duration of treatment depend on the indication and the severity of the disease being treated. After an initial favorable response, your doctor will establish the most appropriate maintenance dose for you. Dose reduction as well as discontinuation of treatment should always be carried out gradually.

Renal and hepatic impairment

No specific dose adjustment is required for patients with renal impairment.

In patients with hepatic impairment, comparatively lower doses may be sufficient or dose reduction may be necessary.

Use in children and adolescents

In general, the recommended daily dose in children is 0.08–0.3 mg/kg, depending on the severity and type of disease.

If you use more Fortecortín than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount used.

Acute intoxications with dexamethasone are not known. In the event of overdose, the adverse reactions described in this leaflet are expected to occur to a greater extent.

If you stop treatment with Fortecortín

Do not stop treatment earlier than instructed by your doctor or abruptly, as this could worsen your condition.

Dose reduction should be performed gradually. Likewise, discontinuation of treatment must always be done gradually.

Excessively rapid dose reduction after prolonged treatment may cause symptoms such as muscle and joint pain. Your doctor will gradually reduce the dose you are taking.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

The terms used to describe the frequency of adverse effects conform 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 adverse effects of Fortecortín 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 resembling Cushing's syndrome (moon face, trunk obesity).

Eye disorders: Glaucoma (increased intraocular pressure), cataracts, worsening of corneal ulcer symptoms; ocular infections, ptosis, pupil dilation (mydriasis), burning sensation, scleral perforation, and in rare cases reversible exophthalmos.

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

Gastrointestinal disorders: Gastric discomfort, ulcer, gastrointestinal bleeding, inflammation of the pancreas.

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

Infections and infestations: Masking of infections, worsening or reactivation of existing infections, 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 abnormalities, osteoporosis, aseptic osteonecrosis, growth retardation in children, epidural lipomatosis.

Note: Excessively rapid dose reduction 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 onset of epilepsy (seizures).

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

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

Skin and subcutaneous tissue disorders: Acne, perioral dermatitis, striae, skin atrophy, petechiae, telangiectasias, bruising, hypertrichosis, changes in skin color.

Cardiac disorders: Heart failure.

Frequency not known: Thickening of the heart muscle (hypertrophic cardiomyopathy) in premature infants, which usually resolves after discontinuation of treatment.

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

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Fortecortín

Do not store above 25°C. Keep the ampoules in the outer packaging to protect them from light.

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 the month indicated.

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

Only clear solutions without particles should be used.

Do not use this medicine if visible signs of deterioration are observed.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and empty containers to the SIGRE point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused medicines and their packaging. This helps protect the environment.

6. Package contents and other information

Composition of Fortecortín 40 mg/5 ml

• The active substance is dexamethasone phosphate. Each ampoule of injectable solution (5 ml) contains 40 mg of dexamethasone phosphate (as dexamethasone sodium phosphate, 43.72 mg).

Each ml of injectable solution contains 8 mg of dexamethasone phosphate (as dexamethasone sodium phosphate, 8.75 mg).

• The other components are: sodium citrate, creatinine, disodium edetate, sodium hydroxide, and water for injections.

Presentation of the product and contents of the container

It is presented as colorless type I glass ampoules. Pack sizes containing 5, 25, and 50 ampoules of injectable solution.

Marketing Authorization Holder

LABORATORIOS ERN, S.A.

Perú, 228

08020 Barcelona

Spain

Manufacturer

LABORATORIOS ERN, S.A.

Gorgs Lladó, 188

08210 Barberà del Vallès, Barcelona, Spain

Date of the most recent revision of this leaflet: January 2022

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es/

This information is intended for healthcare professionals only:

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

If Fortecortín is used in combination with infusion solutions, attention must be paid to the information regarding compatibility, contraindications, adverse reactions, and interactions provided by the manufacturers of the solutions.