Leaflet: information for the user

Fortecortin 4 mg tablets

Dexamethasone

Read this leaflet carefully before you start taking 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 cortisone that intervenes in regulating many of the body's metabolic processes.

Fortecortín 4 mg is used for the treatment of:

• Inflammatory processes secondary to brain tumors and abscesses and neurosurgical procedures.
• Severe acute asthma.
• Severe skin diseases.
• Certain autoimmune diseases (lupus erythematosus).
• Active rheumatoid arthritis.
• Prevention and treatment of nausea and vomiting that appear during anticancer treatment.

Fortecortín 4 mg tablets are usedfor 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 who require oxygen therapy.

Do not take Fortecortín 4 mg

• If you are allergic to dexamethasone or any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication.

Depending on the doses and duration of treatment, induced adrenocortical insufficiency by glucocorticoids may persist for months and in individual cases up to one year after discontinuation of treatment. Acute adrenocortical insufficiency induced by therapy may be minimized by a slow reduction in dose if withdrawal is planned.

Treatment with this medication may increase the risk of infections and the diagnosis of the same may be more difficult. Latent infections (infections that did not show symptoms) such as tuberculosis or hepatitis B may be reactivated.

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

In some cases, strict control of treatment by your doctor will be necessary.

You must inform your doctor if you have any of the following symptoms:

• Patients suffering from acute and chronic bacterial infections should receive specific antibiotic treatment, such as patients with a history of tuberculosis (infectious disease), who can only receive Fortecortín treatment under the protection of antitubercular drugs.
• In general, in patients who have received or are to receive any vaccine, particularly if lymph node inflammation (glands that help defend the body) is observed after receiving the vaccine for tuberculosis.
• In viral infections: hepatitis B, varicella, herpes, measles, poliomyelitis, herpetic keratitis. Special caution is recommended if you are immunocompromised or if you have not had measles or varicella and are in contact with people with measles or varicella.
• Infections caused by fungi or parasites.
• In patients with chronic hepatitis (inflammation of the liver).
• Difficult-to-control diabetes mellitus (increase in blood glucose).
• Osteoporosis (loss of calcium in bones).
• Severe heart failure.
• Difficult-to-control high blood pressure.
• Peptic ulcer.
• Inflammatory diseases of the digestive system.
• If you suffer from psychiatric diseases.
• If you have lymph node inflammation (glands that help defend the body) after being administered the tuberculosis vaccine.
• If you have glaucoma (increase in pressure within the eye) or eye ulcers.
• Symptoms of tumor lysis syndrome such as: muscle cramps, muscle weakness, confusion, loss or alteration of vision, and difficulty breathing, in the case of patients with malignant hematological disease.

Long-term treatment with this medication requires periodic medical control, including a vision check every 3 months.

Contact your doctor if you experience blurred vision or other visual disturbances.

The signs of peritoneal irritation due to gastrointestinal perforation may not appear if you are taking high doses of this medication.

If you take fluoroquinolones (substances with antibacterial activity) and corticosteroids (substances with anti-inflammatory properties), the risk of tendon alterations increases.

In cases of fever, accidents, operations, or childbirth, it may be necessary to temporarily increase the daily dose of this medication.

Severe allergic reactions may occur.

Treatment with this medication may exacerbate existing myasthenia gravis (a neuromuscular disease).

High doses of dexamethasone require adequate potassium supplements and dietary sodium restrictions; and plasma potassium levels should be monitored.

High doses of dexamethasone may cause a slower heart rate.

Children and adolescents

Fortecortín should not be used routinely in premature infants with respiratory problems.

Regular monitoring of the growth of children (see section 4) is necessary.

Older patients

In older patients, the doctor should evaluate the benefits and risks of treatment.

Other medications and Fortecortín 4 mg

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Some medications may increase the effects of Fortecortín, so your doctor will make meticulous controls if you are taking these medications (including some for HIV: ritonavir, cobicistat).

The concomitant use of dexamethasone with any of the following medications may modify the effect of both dexamethasone and the medication in question:

• Estrogens (e.g. birth control pills),
• Enzyme inhibitors such as e.g. medications for fungal infections (itraconazole, ketoconazole, and amphotericin B),
• Antacids (e.g. aluminum hydroxide, magnesium hydroxide), the intake of these medications should be spaced two hours apart,
• Enzyme inducers such as e.g. medications for tuberculosis (rifampicin), medications for epilepsy (phenytoin, carbamazepine, and primidone),
• Sedatives (barbiturates),
• Central nervous system stimulants (ephedrine),
• Cardiac medications (digitalis),
• Antihypertensive medications or medications to promote urine elimination (diuretics),
• Laxatives,
• Oral antidiabetic medications or insulin,
• Anticoagulant medications. You may need to adjust the dose of the anticoagulant,
• NSAIDs or antirheumatic medications (e.g. indomethacin or salicylates), which increase the risk of gastrointestinal ulcers and bleeding,
• Medications that relax muscle used for the relief of spasms or contractions of the stomach, intestines, and bladder (rocuronium, vecuronium, atropine, or other anticholinergic medications),
• Antiparasitic medication (praziquantel),
• Malaria medications (chloroquine, hydroxychloroquine, mefloquine), which may increase the risk of myopathy and cardiomyopathy (muscle or heart muscle diseases, respectively),
• Growth hormone (somatotropin),
• Thyroid function diagnostic medications (protirelin),
• Immunosuppressive medications and cyclosporine (medications to prevent organ rejection after transplantation),
• Some antibiotics (fluoroquinolones), which may increase the risk of tendon alterations.

Interference with laboratory tests

May give false results in skin tests for allergy tests.

Do not stop taking any other steroid medication unless your doctor tells 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.

This medication is not recommended during pregnancy and breastfeeding, unless your doctor prescribes it. He will indicate if you should stop breastfeeding or discontinue administration of this medication.

Driving and operating machinery

No studies have been conducted on the ability to drive and operate machinery.

Use in athletes

Inform athletes that this medication contains a component that may produce a positive result in doping control tests.

Fortecortín 4 mg contains lactose

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medication.

Take Fortecortín 4 mg only as directed by your doctor. Your doctor will decide how long you should take dexamethasone. If in doubt, consult your doctor or pharmacist again.

The tablets should be taken whole, during or after meals, swallowed with sufficient liquid.

In general, the total daily dose will be taken in a single dose, preferably in the morning, during or after breakfast, although it may be necessary to divide the dose into several doses per day in patients who require high doses to achieve the maximum effect.

The treatment dose will depend on the type and severity of the disease and the individual response of the patient. Your doctor will indicate the dose you should take, adjusting it to your needs, as well as the duration of treatment.

The dose should be high enough and the duration of treatment long enough, but on the other hand, it should be maintained at the minimum effective dose for the shortest possible time.

If you estimate that the action of this medication is too strong or too weak, inform your doctor or pharmacist.

For the treatment of Covid-19

In adult patients, it is recommended to take orally 6 mg once a day, up to a maximum of 10 days.

Use in adolescents

It is recommended to administer to pediatric patients (adolescents from 12 years of age) a dose of 6 mg orally once a day, up to a maximum of 10 days.

If you take more Fortecortín 4 mg than you should

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

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

No antidote for dexamethasone is known.

If you forgot to take Fortecortín 4 mg

Do not take a double dose to compensate for the missed doses.

If you forget to take your dose, take it as soon as you remember. However, if the time for the next dose is very close, skip the missed dose and take the next dose at its usual time.

If you interrupt treatment with Fortecortín 4 mg

Do not stop treatment before your doctor indicates or abruptly, as it could worsen your disease.

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

Excessive rapid reduction of the dose after a long treatment period may cause symptoms such as muscle and joint pain. Your doctor will reduce your dose progressively.

If you interrupt a long-term treatment, it may cause an increase in symptoms of your disease or a relapse in the same, acute adrenocortical insufficiency (alteration of the production of certain hormones) and cortisone withdrawal syndrome characterized by general discomfort, weakness, and muscle pain, difficulty breathing, loss of appetite, nausea, vomiting, fever, decrease in blood pressure and blood glucose level, among other symptoms.

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

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

During the period of use of this medicine, the following side effects have been observed, whose frequency has not been established with precision:

• Alteration of blood cells (white blood cells and lymphocytes, among others).
• Localized obesity in the abdomen and face (Cushing's Syndrome).
• Glaucoma, cataracts, worsening of corneal ulcers and infections.
• Peptic ulcer, gastrointestinal hemorrhage, pancreatitis, gastrointestinal discomfort.
• Wounds take longer to heal.
• Severe hypersensitivity reactions, severe allergic reactions such as: cardiac rhythm problems, bronchospasm, blood pressure alterations, circulatory failure, cardiac arrest.
• Existing infections may worsen and new infections may appear that are difficult to diagnose.
• Fluid retention (edema), potassium loss (which may cause cardiac rhythm alterations), weight gain, increased blood sugar, diabetes mellitus, increased levels of cholesterol and triglycerides in the blood, increased appetite, delayed growth in children.
• Muscular diseases and muscle weakness, tendon alterations, tendinitis, tendon ruptures, bone calcium loss, osteoporosis, delayed growth in children.
• Reducing the dose rapidly after a long treatment may cause muscle and joint pain.
• Increased intracranial pressure (especially in children), increased spasms in epileptic patients or appearance of epilepsy.
• Depression, hallucinations, emotional instability, irritability, increased activity, psychosis, mania, euphoria, anxiety, sleep disturbances, suicidal thoughts.
• Irregular menstruation or absence of menstruation, sexual impotence, excessive hair growth.
• Acne or other skin problems (allergy, bruises, striae), edema, skin color changes, dermatitis around the mouth.
• Hypertension, increased risk of arteriosclerosis (narrowing and hardening of the arteries) and thrombosis (formation of blood clots), vasculitis, capillary fragility.
• Visual disturbances, loss of vision, blurred vision.
• Hypopituitarism.

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 prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use:www.notificaram.es.

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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.

No special storage conditions are required.

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

Composition of Fortecortín 4 mg

• The active ingredient is dexamethasone. Each tablet contains 4 mg of dexamethasone.
• The other components are lactose monohydrate, cornstarch, microcrystalline cellulose, talc, povidone, and magnesium stearate.

Appearance of the product and contents of the packaging

Fortecortín 4 mg is presented in the form of white, round tablets, with a “4” engraved on one face and smooth on the other face. Each package contains 30 tablets.

Holder of the marketing authorization

Laboratorios ERN, S.A.

Perú, 228

08020 Barcelona, Spain

Responsible for manufacturing

Merck, S.L.

Merck Industrial Estate

08100 Mollet del Vallés (Barcelona)

or

CYNDEA PHARMA, S.L.

Emiliano Revilla Sanz Industrial Estate.

Avenida de Ágreda, 31 – 42110 Ólvega (Soria)

or

Laboratorios ERN, S.A.

Gorgs Lladó, 188

08210 Barberá del Vallés, Barcelona. Spain

Last review date of this leaflet: July 2023.

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