Fortecortin 1 mg tablets

Patient Information Leaflet

Introduction

Patient Information Leaflet

Fortecortín 1 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 not effects listed in this leaflet. See section 4.

Leaflet contents:

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

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

Dexamethasone is a synthetic glucocorticoid (adrenocortical hormone) derived from cortisone, which plays a role in regulating many metabolic processes in the body.

Fortecortín 1 mg is used for the treatment of:

• Inflammatory processes secondary to brain tumors and abscesses, and neurological surgery.
• Acute severe asthma.
• Serious 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 1 mg tablets are used for the treatment of coronavirus disease 2019 (COVID-19) in adult and adolescent patients (aged 12 years 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 starting to take Fortecortín 1 mg

Do not take Fortecortín 1 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, adrenal insufficiency caused by glucocorticoids may persist for months and, in individual cases, up to one year after stopping treatment. Acute adrenal insufficiency induced by therapy can be minimized by gradually reducing the dose when discontinuation is planned.

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

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

In some cases, strict medical supervision of treatment will be required. You must inform your doctor if you have any of the following conditions:

• Patients suffering from acute or 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 due 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 recommended if you are immunocompromised or if you have not had measles or chickenpox and are in contact with people 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 in 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 condition.

Long-term treatment with this medicine requires periodic medical monitoring, including a vision check 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 take fluoroquinolones (substances with antibiotic activity) and corticosteroids (substances with anti-inflammatory properties), the risk of tendon disorders 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 assess the benefits and risks of treatment.

Other medicines and Fortecortín 1 mg

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

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).

Taking dexamethasone together 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 medicines for fungal infections (itraconazole, ketoconazole, and amphotericin B),
• Antacids (e.g., aluminum hydroxide, magnesium hydroxide); these should be taken at least two hours apart,
• Enzyme inducers such as medicines for tuberculosis (rifampicin), epilepsy medications (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 (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., indomethacine 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 (diseases of the muscle or heart muscle, 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 disorders.

Interference with laboratory tests

Skin tests for allergy may yield false results.

Do not stop taking any other steroid medication 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 you should stop breastfeeding or discontinue taking this medicine.

Driving and using machines

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

Use in athletes

Athletes should be aware that this medicine contains a component that may result in a positive doping test.

Fortecortín 1 mg contains lactose

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

3. How to take Fortecortín 1 mg

Take Fortecortín 1 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 to be taken, adjusting it to your needs, as well as the duration of treatment.

The dose should be high enough and the treatment duration long enough; however, the lowest effective dose should be maintained for the shortest possible time.

If you feel 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, up to a maximum of 10 days.

Use in adolescents

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

If you take more Fortecortín 1 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 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.

There is no known antidote for dexamethasone.

If you forget to take Fortecortín 1 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 taking Fortecortín 1 mg

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

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

Excessively 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 interrupt long-term treatment, a worsening of your disease symptoms 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, decreased blood pressure, and low 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 will experience them.

The following adverse effects have been observed during the period of use of this medicine, although their frequency cannot be precisely determined:

• 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 bleeding, pancreatitis, gastric discomfort.
• Wounds take longer to heal.
• Hypersensitivity reactions, severe allergic reactions such as: heart rhythm disturbances, bronchospasm, changes in blood pressure, circulatory failure, cardiac arrest.
• Existing infections may worsen, and new infections that are difficult to diagnose may appear.
• Fluid retention (edema), loss of potassium (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 reducing the dose after long-term treatment may cause muscle and joint pain.
• Increased intracranial pressure (especially in children), increased spasms in epileptic patients or onset 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, 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 Fortecortín 1 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 refers to the last day of the month indicated.

Store below 30 °C.

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

6. Contents of the package and other information

Composition of Fortecortín 1 mg

• The active substance is dexamethasone. Each tablet contains 1 mg of dexamethasone.

• The other components are monohydrate lactose, corn starch, talc, and magnesium stearate.

Nature of the product and package contents

Fortecortín 1 mg is presented as white, round, biconvex tablets, with a score line on one side and smooth on the other.

Marketing Authorization Holder

Laboratorios ERN, S.A.

Perú, 228

08020 Barcelona, Spain

Manufacturer

Merck, S.L.

Polígono Merck

08100 Mollet del Vallés (Barcelona)

or

Laboratorios ERN, S.A.

Gorgs Lladó, 188

08210 Barberá del Vallés, Barcelona, Spain.

or

CYNDEA PHARMA, S.L.

Polígono Industrial Emiliano Revilla Sanz.

Avenida de Ágreda, 31 – 42110 Ólvega (Soria)

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

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/.