Dacortin 5 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Dacortín 5 mg tablets

Prednisone

Read the entire leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. 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 may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Dacortín 5 mg is and what it is used for

The prednisone contained in Dacortín 5 mg is a corticosteroid (glucocorticoid).

Dacortín 5 mg is used for replacement therapy in adrenal insufficiency, including Addison's disease.

Due to its anti-inflammatory and immunosuppressive action, Dacortín 5 mg is used in the treatment of:

• rheumatic diseases, such as rheumatoid arthritis
• autoimmune collagen and blood vessel diseases, such as systemic lupus erythematosus
• bronchial and pulmonary diseases such as asthma
• skin diseases, such as acute severe urticaria and pemphigus
• blood disorders, such as acquired hemolytic anemia, thrombocytopenic purpura, and other tumor-related conditions such as leukemia
• in combination with chemotherapeutic agents or radiotherapy
• gastrointestinal diseases, such as ulcerative colitis and Crohn's disease
• liver diseases, such as autoimmune chronic active hepatitis
• kidney diseases, such as nephrotic syndrome
• certain inflammatory eye disorders, such as allergic conjunctivitis, keratitis, optic neuritis, among others.

2. What you need to know before taking Dacortín 5 mg

Do not take Dacortín 5 mg tablets:

• if you are allergic to prednisone, other glucocorticoids, or any of the other ingredients of this medicine (listed in section 6)
• if you have stomach ulcer, gastritis, or esophagitis (digestive system disorders)
• if you have viral infections (such as ocular herpes simplex, chickenpox), before or after receiving a vaccine

Your doctor may have advised you to take Dacortín despite having one of the following conditions, in which case you will require regular monitoring:

• if you have osteomalacia or osteoporosis (bone disorders)

• if you have severe diabetes

• if you have psychosis (mental disorder) not controlled by treatment

• if you have tuberculosis that is not being treated

• if you have bacterial, fungal, or amoebic infections, or systemic mycosis (fungal infection disseminated throughout the body)

• if you have lymphomas (a type of lymphatic system tumor) that have developed after vaccination against tuberculosis

• if you have any psychiatric illness. Consult your doctor about the advisability of using this medicine

• if you have severe high blood pressure

• if you have asystole (heart disease) with pulmonary edema and uremia (a syndrome characterized by excess nitrogenous substances in the blood)

• if you have myasthenia gravis (muscle disorder)

• if you have renal insufficiency.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Dacortín 5 mg.

Treatment with Dacortín 5 mg may increase the risk of infections, as it can reduce your body's defenses, potentially leading to new infections or reactivation of existing ones (e.g., tuberculosis or hepatitis B). In severe infections or in cases of tuberculosis, Dacortín should only be used in combination with specific anti-infective treatment.

Inform your doctor if you suffer from any type of infection, or if you have been vaccinated or plan to be vaccinated. If symptoms of acute-onset diseases such as infectious, gastrointestinal, or psychiatric disorders appear during treatment, consult your doctor immediately.

You should avoid contact with people who have chickenpox or measles. If during Dacortín treatment you are exposed to these infections, contact a doctor immediately, even if you do not show any symptoms.

This medicine should be administered with caution in patients with stomach ulcers, ulcerative colitis (intestinal disease), diverticulitis (intestinal disease), or enteroanastomosis (after surgery), or in those with mental disorders.

If you suffer from osteoporosis, your doctor may recommend additional calcium and vitamin D supplementation.

Inform your doctor if you have heart disease and require high doses of prednisone.

If you are diabetic, or have heart failure, very high blood pressure, or glaucoma, your doctor will perform regular check-ups.

If you have an overactive thyroid gland (hyperthyroidism): contact your doctor immediately if you experience muscle weakness, muscle pain, cramps, or muscle stiffness while taking prednisone. These may be symptoms of a condition called thyrotoxic periodic paralysis, which may occur in patients with hyperthyroidism treated with prednisone. You may require additional treatment to relieve this condition.

If this medicine is taken together with fluoroquinolones (e.g., ciprofloxacin), the risk of tendon rupture and tendinitis increases.

Your doctor may increase your dose if you experience a stressful condition (infections, surgery, trauma, etc.).

During long-term treatment, your doctor will perform regular monitoring to prevent complications, including eye examinations, blood tests, growth monitoring (in children and adolescents), and assessment of your hypothalamic-pituitary-adrenal axis function.

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

During prolonged Dacortín treatment, your doctor may prescribe potassium supplements and recommend reducing sodium (salt) intake.

Consult your doctor before starting Dacortín if you have scleroderma (also known as systemic sclerosis, an autoimmune disorder), as daily doses equal to or greater than 15 mg may increase the risk of a serious complication called scleroderma renal crisis. Signs of scleroderma renal crisis include increased blood pressure and reduced urine output. Your doctor may advise you to monitor your blood pressure and urine output regularly.

The administration of Dacortín to children should be carefully evaluated, and if used, treatment should be intermittent or alternate-day.

When administered to elderly patients, your doctor will monitor the patient regularly. Elderly patients should avoid prolonged treatment with this medicine.

Dacortín may cause false-negative results in skin allergy tests (tuberculin test, allergy patches, etc.).

Use in athletes

This medicine contains prednisone, which may result in a positive doping test.

Treatment should not be stopped abruptly but tapered gradually. Do not stop using this medicine without consulting your doctor (see section 3 “How to take Dacortín”).

Taking Dacortín 5 mg with other medicines

Inform your doctor if you are taking or have recently taken any other medicines, including those obtained without a prescription.

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

Dacortín may interfere with the following medicines:

• Non-steroidal anti-inflammatory drugs (e.g., indomethacin, salicylates)
• Antidiabetic agents
• Enzyme inducers:
  • Carbamazepine, phenytoin, phenobarbital, or primidone (medicines used to treat epilepsy)
  • Rifampicin, rifabutin (antibiotics)
• Enzyme inhibitors such as ketoconazole (used for fungal infections)
• Ephedrine
• Oral anticoagulants (such as Sintrom)
• Estrogens (medicines used for hormonal disorders), oral contraceptives
• Atropine
• Cardiac glycosides (medicines used to treat heart conditions)
• Potassium-depleting diuretics (medicines used to eliminate water) and laxatives
• Praziquantel (antiparasitic medicine)
• Some medicines used to treat high blood pressure
• Some medicines for malaria
• Immunosuppressive agents (medicines used to prevent transplant rejection)
• Non-depolarizing neuromuscular blocking agents (medicines used mainly in ICU or operating room)
• Growth hormone
• Protirelin (a medicine that stimulates the thyroid)
• Fluoroquinolones: may increase the risk of tendon abnormalities
• Antacids
• Salicylates (aspirin-like medicines)

Interference with laboratory tests: allergy tests may be suppressed.

Pregnancy and breastfeeding

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.

Like most medicines, Dacortín should not be used during pregnancy or breastfeeding unless your doctor considers it essential. Therefore, you should inform your doctor as soon as possible if you become pregnant during treatment.

Dacortín passes into breast milk, so breastfeeding should be avoided during treatment, especially during long-term treatment and when high doses are used.

Driving and using machines

It should be noted that long-term treatment may reduce visual acuity. This could negatively affect your ability to drive or operate machinery.

Dacortín 5 mg contains lactose

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

3. How to take Dacortín 5 mg tablets

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

As a general rule, the daily dose should be divided into several doses taken after meals and at bedtime. In some cases, it may be taken as a single daily dose in the morning, either every day or on alternate days, with an adequate amount of liquid.

As soon as a satisfactory response is achieved, you should take the standard maintenance dose. Both doses will be determined by your doctor.

The dose depends on the type and severity of the disease, the individual patient's response, and in prolonged treatments, the maintenance dose should be as low as possible.

The initial dose will be 20 to 90 mg per day in adults and 0.5 to 2 mg per day per kg of body weight in children.

The standard maintenance dose will be 5 to 10 mg per day in adults and 0.25 to 0.5 mg per day per kg of body weight in children. When used in children as an anti-inflammatory and immunosuppressant, doses of 0.05 to 2 mg per day per kg of body weight are recommended.

To discontinue treatment, your doctor will advise you on how to proceed. For long-term treatments, the dose should be gradually reduced: in general, the dose should be decreased by 10% every 8–15 days. For short-term treatments (less than 10 days), gradual dose reduction is not necessary.

In elderly patients, the same dosing regimen as in adults should be applied, taking into account the recommendations mentioned in section 2 “Warnings and precautions”.

If you take more Dacortín 5 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 number 91 562 0420, stating the medication and the amount ingested.

If you forget to take Dacortín 5 mg

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

If you stop using Dacortín 5 mg

Do not stop using this medicine without consulting your doctor.

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 may cause adverse effects, although not everyone will experience them.

The adverse effects observed, according to their frequency of occurrence, are: 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).

In most cases, adverse reactions occur especially when high doses are used and during long-term treatment, and are detailed below:

Blood and lymphatic system disorders: leukocytosis (increased white blood cells in blood), lymphopenia (decreased lymphocytes in blood), eosinopenia (decreased eosinophils in blood), polycythemia (increased red blood cells in blood).

Endocrine disorders: signs of adrenal hyperactivity (Cushing's syndrome, a disease caused by increased production of a hormone called cortisol); in prolonged treatments, adrenocortical insufficiency (a condition characterized by weakness, constant fatigue, loss of appetite, and weight loss).

Eye disorders: glaucoma and cataracts. Blurred vision.

Gastrointestinal disorders: stomach ulcer, intestinal bleeding, pancreatitis (inflammation of the pancreas).

General disorders and administration site conditions: delayed wound healing.

Immune system disorders: severe allergic-type reactions, including arrhythmias, bronchospasm, decreased or increased blood pressure, circulatory failure, heart attack.

Infections and infestations: existing infections may worsen, and new infections that are difficult to diagnose may appear.

Metabolism and nutrition disorders: fluid retention (edema), loss of potassium (which may cause disturbances in heart rhythm), weight gain, increased blood sugar, diabetes mellitus, increased cholesterol and triglyceride levels in blood, increased appetite, growth retardation in children.

Cardiac disorders (frequency not known): decreased heart rate.

Musculoskeletal and connective tissue disorders: muscle diseases and muscle weakness, tendon abnormalities, tendinitis, tendon ruptures, loss of calcium from bones, osteoporosis, growth retardation in children.

Nervous system disorders: increased intracranial pressure (especially in children), increased seizures in epileptic patients or onset of epilepsy.

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

Reproductive system and breast disorders: irregular menstruation or absence of menstruation, hirsutism (excessive hair growth).

Skin and subcutaneous tissue disorders: acne or other skin problems (allergy, bruising, stretch marks), edema, changes in skin color, perioral dermatitis.

Vascular disorders: high blood pressure, increased risk of atherosclerosis (narrowing and hardening of arteries) and thrombosis (blood clot formation), vasculitis, capillary fragility.

Renal and urinary disorders: scleroderma renal crisis in patients who already have scleroderma (an autoimmune disorder). Signs of scleroderma renal crisis include increased blood pressure and decreased urine output.

Rapidly reducing the dose after long-term treatment may cause muscle and joint pain.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not mentioned in this leaflet, inform your doctor or pharmacist.

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: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Dacortín 5 mg tablets

No special storage conditions are required.

Keep Dacortín 5 mg tablets out of the sight and reach of children.

Do not use Dacortín 5 mg tablets after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE point located at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Dacortín 5 mg

• The active substance is prednisone. Each tablet contains 5 mg of prednisone.
• The other components are monohydrate lactose, corn starch, povidone, sodium carboxymethyl starch, talc, magnesium stearate, and purified water.

Appearance of the product and contents of the pack

Dacortín 5 mg is presented as white, slightly biconvex, round tablets with a central groove on one side and the number "5" engraved on the other.

Dacortín 5 mg is available in packs of 30, 60, or 500 tablets in blister packs.

Marketing Authorization Holder

Laboratorios ERN, S.A.

C/Perú, 228

08020 Barcelona, Spain

Manufacturer

Merck, S.L.

Polígono Merck

08100 Mollet del Vallés (Barcelona), Spain

or

CYNDEA PHARMA, S.L.

Polígono Industrial Emiliano Revilla Sanz

Avenida de Ágreda, 31 - 42110 Ólvega (Soria)

or

Laboratorios ERN, S.A.

C/Gorchs Lladó, 188

Pol. Ind. Can Salvatella

08210 Barberá del Vallés (Barcelona), Spain

Date of the most recent review of this leaflet: January 2026

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