Fortecortin 4 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Fortecortín 4 mg tablets

Dexamethasone

Read the entire 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, 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, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet:

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

1. What Fortecortín 4 mg is and what it is used for

Dexamethasone is a synthetic glucocorticoid (adrenocortical hormone) derived from cortisone that plays a role in regulating many of the body's metabolic processes.

Fortecortín 4 mg is used for the treatment of:

• Inflammatory processes secondary to tumors and brain abscesses, and neurological surgery.
• Acute severe asthma.
• Severe skin diseases.
• Certain autoimmune diseases (e.g. systemic lupus erythematosus).
• Active rheumatoid arthritis.
• Prevention and treatment of nausea and vomiting associated with anticancer therapy.

Fortecortín 4 mg tablets are used for the treatment of coronavirus disease 2019 (COVID-19) in adult and adolescent patients (12 years of age and older with a body weight of at least 40 kg) who have difficulty breathing and require oxygen therapy.

2. What you need to know before taking Fortecortín 4 mg

Do not take Fortecortín 4 mg

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to take this medicine.

Depending on the dose and duration of treatment, glucocorticoid-induced adrenal insufficiency may persist for months and, in individual cases, up to one year after discontinuation of treatment. Acute adrenal insufficiency induced by therapy can be minimized by gradually reducing the dose when withdrawal is planned.

Treatment with this medicine may increase the risk of infections, and diagnosis of such infections may be more difficult. Latent infections (infections without symptoms) may be reactivated, such as tuberculosis or hepatitis B.

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

In some cases, strict monitoring of treatment by your doctor will be required.

You should inform your doctor if you have any of the following conditions:

• Patients suffering from acute and chronic bacterial infections should receive treatment with specific antibiotics; for example, patients with a history of tuberculosis (an infectious disease), who can only receive Fortecortín treatment under the protection of antituberculosis drugs.
• In general, in patients who have received or are going to receive any vaccine, particularly if lymph node swelling (glands that help in the body's defense) occurs after receiving the tuberculosis vaccine.
• In viral infections: hepatitis B, chickenpox, herpes, measles, poliomyelitis, herpetic keratitis. Special caution is advised if you are immunocompromised or if you have not had measles or chickenpox and are in contact with individuals who have measles or chickenpox.
• Infections caused by fungi or parasites.
• In patients with chronic hepatitis (inflammation of the liver).
• Poorly controlled diabetes mellitus (increased blood glucose).
• Osteoporosis (loss of calcium from bones).
• Severe heart failure.
• Poorly controlled arterial hypertension.
• Peptic ulcer.
• Inflammatory diseases of the digestive system.
• If you suffer from psychiatric disorders.
• If you have swollen lymph nodes (glands that help in the body's defense) after receiving the tuberculosis vaccine.
• If you have glaucoma (increased pressure inside the eye) or eye ulcers.
• Symptoms of tumor lysis syndrome such as: muscle cramps, muscle weakness, confusion, visual loss or disturbances, and difficulty breathing, in case you have a malignant hematological disorder.

Long-term treatment with this medicine requires periodic medical monitoring, including vision checks every 3 months.

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

Signs of peritoneal irritation due to gastrointestinal perforation may not appear if you are taking high doses of this medicine.

If you are taking fluoroquinolones (substances with antibiotic activity) and corticosteroids (substances with anti-inflammatory properties), the risk of tendon abnormalities increases.

In cases of fever, accidents, surgery, or childbirth, a temporary increase in the daily dose of this medicine may be necessary.

Severe allergic-type reactions may occur.

Treatment with this medicine may worsen existing myasthenia gravis (a neuromuscular disease).

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

Administration of high doses of dexamethasone may cause a slower heart rate.

Children and adolescents

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

Children's growth should be monitored regularly (see section 4).

Elderly patients

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

Other medicines and Fortecortín 4 mg

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine.

Some medicines may increase the effects of Fortecortín, so your doctor will perform careful monitoring if you are taking these medicines (including some for HIV: ritonavir, cobicistat).

Concomitant use of dexamethasone with any of the following medicines may alter the effect of both dexamethasone and the other medicine:

• Estrogens (e.g., oral contraceptives),
• Enzyme inhibitors such as antifungal medicines (itraconazole, ketoconazole, and amphotericin B),
• Antacids (e.g., aluminum hydroxide, magnesium hydroxide); administration of these medicines should be spaced by two hours,
• Enzyme inducers such as medicines for tuberculosis (rifampicin), antiepileptic medicines (phenytoin, carbamazepine, and primidone),
• Sedatives (barbiturates),
• Central nervous system stimulant (ephedrine),
• Medicines for the heart (digitalis),
• Medicines for high blood pressure or to promote urine elimination (diuretics),
• Laxatives,
• Medicines for diabetes treatment (oral antidiabetics and insulin),
• Medicines to control blood clotting (oral anticoagulants); dose adjustment of the anticoagulant may be required,
• NSAIDs: anti-inflammatory or antirheumatic medicines (e.g., indomethacin or salicylates) increase the risk of gastrointestinal ulcer and bleeding,
• Muscle relaxants used to relieve spasms or contractions of the stomach, intestine, and bladder (rocuronium, vecuronium, atropine, or other anticholinergic medicines),
• Antiparasitic medicine (praziquantel),
• Medicines for malaria (chloroquine, hydroxychloroquine, mefloquine), as they may increase the risk of myopathy and cardiomyopathy (muscle or heart muscle diseases, respectively),
• Growth hormone (somatotropin),
• Medicines for diagnosing thyroid gland problems (protirelin),
• Immunosuppressants and cyclosporine (medicines to prevent rejection of transplanted organs),
• Some antibiotics (fluoroquinolones), which may increase the risk of tendon abnormalities.

Interference with laboratory tests

Skin tests for allergy may yield false results.

Do not stop taking any other steroid medicine unless your doctor has instructed you to do so.

Talk to your doctor, pharmacist, or nurse before this medicine is administered to you.

Pregnancy, breastfeeding, and fertility

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

This medicine is not recommended during pregnancy and breastfeeding unless prescribed by your doctor. Your doctor will advise you whether to stop breastfeeding or discontinue administration of this medicine.

Driving and using machines

No studies have been conducted on the ability to drive or use machines.

Use in athletes

Athletes are informed that this medicine contains a component that may result in a positive doping test.

Fortecortín 4 mg contains lactose

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

3. How to take Fortecortín 4 mg

Take Fortecortín 4 mg only as prescribed 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, with sufficient liquid.

In general, the total daily dose should be taken as a single dose, preferably in the morning, during or after breakfast. However, it may be necessary to divide the dose into several administrations per day in patients requiring high doses to achieve maximum effect.

The treatment dose will depend on the type and severity of the disease and on the individual patient's response. 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 treatment duration long enough to achieve the desired effect, but at the same time, the lowest effective dose should be maintained for the shortest possible time.

If you consider that the effect of this medicine is too strong or too weak, inform your doctor or pharmacist.

For the treatment of Covid-19

In adult patients, an oral dose of 6 mg once daily is recommended, for up to a maximum of 10 days.

Use in adolescents

It is recommended to administer an oral dose of 6 mg once daily to pediatric patients (adolescents aged 12 years and older), for up to a maximum of 10 days.

If you take more Fortecortín 4 mg than you should

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

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.

There is no known antidote for dexamethasone.

If you forget to take Fortecortín 4 mg

Do not take a double dose to make up for missed doses.

If you forget to take your scheduled dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and take the next dose at your regular time.

If you stop treatment with Fortecortín 4 mg

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

Dose reduction should be done gradually. Likewise, discontinuation of treatment should always be carried out progressively.

Rapid dose reduction after long-term treatment may cause symptoms such as muscle and joint pain. Your doctor will gradually reduce your dose.

If you discontinue long-term treatment, an increase in symptoms of your disease or relapse may occur, along with acute adrenocortical insufficiency (impaired production of certain hormones) and cortisone withdrawal syndrome, characterized by general malaise, weakness and muscle pain, difficulty breathing, loss of appetite, nausea, vomiting, fever, low blood pressure, and decreased blood glucose levels, among other symptoms.

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 experiences them.

During the period of use of this medicine, the following adverse effects have been observed, whose frequency cannot be precisely determined:

• Blood cell abnormalities (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 bleeding, pancreatitis, gastric discomfort.
• Wounds take longer to heal.
• Hypersensitivity reactions, severe allergic reactions such as: heart rhythm disturbances, bronchospasm, blood pressure changes, circulatory failure, cardiac arrest.
• Existing infections may worsen, and new infections that are difficult to diagnose may appear.
• Fluid retention (edema), potassium loss (which may cause heart rhythm disturbances), weight gain, increased blood sugar, diabetes mellitus, increased blood cholesterol and triglyceride levels, increased appetite, growth delay in children.
• Muscle disorders and muscle weakness, tendon abnormalities, tendinitis, tendon ruptures, loss of calcium from bones, osteoporosis, growth delay in children.
• Rapidly decreasing the dose after long-term treatment may cause muscle and joint pain.
• Increased intracranial pressure (especially in children), increased seizures in epileptic patients or onset of epilepsy.
• Depression, hallucinations, emotional instability, irritability, increased activity, psychosis, mania, euphoria, anxiety, sleep disturbances, suicidal thoughts.
• Irregular or absent menstruation, sexual impotence, excessive hair growth.
• Acne or other skin problems (allergy, bruising, stretch marks), edema, changes in skin color, perioral dermatitis.
• Hypertension, increased risk of atherosclerosis (narrowing and hardening of arteries) and thrombosis (blood clot formation), vasculitis, capillary fragility.
• Visual disturbances, vision loss, blurred vision.
• 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 Fortecortin 4 mg

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 is the last day of the month indicated.

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, please ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Fortecortín 4 mg

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

Appearance of the product and contents of the pack

Fortecortín 4 mg is presented as white, round tablets, with a "4" engraved on one side and smooth on the other. Each pack contains 30 tablets.

Marketing Authorization Holder

Laboratorios ERN, S.A.

Perú, 228

08020 Barcelona, Spain

Manufacturer

Merck, S.L.

Polígono Merck

08100 Mollet del Vallés (Barcelona)

or

CYNDEA PHARMA, S.L.

Polígono Industrial Emiliano Revilla Sanz.

Avenida de Ágreda, 31 – 42110 Ólvega (Soria)

or

Laboratorios ERN, S.A.

Gorgs Lladó, 188

08210 Barberá del Vallés, Barcelona, Spain

Date of the most recent revision of this leaflet: July 2023.

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