DACORTIN 5 mg TABLETS

Introduction

Package Leaflet: Information for the User

Dacortin 5 mg Tablets

Prednisone

Read all of this 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

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

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

Prednisone contained in Dacortin 5 mg is a corticosteroid (glucocorticoid).

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

Due to its anti-inflammatory and immunosuppressive action, Dacortin 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 and severe urticaria and pemphigus
• blood diseases, such as acquired hemolytic anemia, thrombocytopenic purpura, and other tumors, such as leukemia
• in combination with chemotherapeutic agents or radiotherapy
• gastrointestinal diseases, such as ulcerative colitis and Crohn's disease
• liver diseases, such as chronic active autoimmune hepatitis
• kidney diseases, such as nephrotic syndrome
• some inflammatory eye diseases, such as allergic conjunctivitis, keratitis, optic neuritis, among others.

2. What you need to know before you take Dacortin 5 mg

Do not take Dacortin 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 ulcers, gastritis, esophagitis (digestive system diseases)
• if you have viral infections (such as simple ocular herpes, chickenpox), before or after you have been given a vaccine

Your doctor may have recommended that you take Dacortin despite suffering from some of the following diseases and therefore need regular monitoring:

• if you have osteomalacia and osteoporosis (bone diseases)
• if you have severe diabetes
• if you have uncontrolled psychosis (mental disorder)
• if you have untreated tuberculosis
• if you have any bacterial, fungal, or amoebic infection, or if you have systemic mycosis (infection caused by fungi and disseminated throughout the body)
• if you have lymphomas (a type of tumor of the lymphatic system) that have appeared after vaccination against tuberculosis
• if you have any psychiatric illness. Consult your doctor about the convenience of using this medicine
• if you have severe high blood pressure

• if you have asystole (heart disease) with pulmonary edema and uremia (syndrome characterized by an excess of nitrogenous substances in the blood)
• if you have severe myasthenia (muscle disease)

• if you have renal insufficiency.

Warnings and precautions

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

Treatment with Dacortin 5 mg may increase the risk of infections since it can decrease the body's defenses, leading to new infections or activating existing ones (e.g., tuberculosis or hepatitis B). In severe infections or in the case of tuberculosis, Dacortin should only be used in combination with treatment for the infection.

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

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

This medicine will be administered with caution in people who suffer from stomach ulcers, ulcerative colitis (intestinal disease), diverticulitis (intestinal disease), or enteric anastomosis (after surgery) or mental disorders.

If you suffer from osteoporosis, your doctor may recommend taking extra calcium and vitamin D.

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

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

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

Your doctor may increase the dose if you suffer from a stressful situation (infections, surgery, trauma, etc.).

In long-term treatments, your doctor will perform regular checks to avoid complications in the eyes, blood tests, growth control (in children and adolescents), and will check the function of your hypothalamic-pituitary-adrenal axis.

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

In prolonged treatments with Dacortin, your doctor may prescribe potassium supplements and reduce sodium (salt) consumption.

Consult your doctor before starting to take Dacortin if you have scleroderma (also known as systemic sclerosis, an autoimmune disorder), because daily doses equal to or greater than 15 mg may increase the risk of a serious complication called scleroderma renal crisis. The signs of a scleroderma renal crisis are increased blood pressure and decreased urine production. Your doctor may advise you to periodically check your blood pressure and urine.

The administration of Dacortin to children should be carefully evaluated, and if administered, it should be an intermittent or alternating treatment.

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

Taking Dacortin may give false results in skin tests for allergy tests (tuberculin test, allergy patches, etc.).

Use in athletes

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

Treatment should not be stopped abruptly, but rather gradually. Do not stop using this medicine without consulting your doctor (see section 3 "How to take Dacortin").

Taking Dacortin 5 mg with other medicines

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

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

Dacortin may interfere with the following medicines:

• Non-steroidal anti-inflammatory drugs (e.g., indomethacin, salicylates)
• Antidiabetics
• 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 diseases)
• Potassium-eliminating diuretics (medicines used to eliminate water) and laxatives
• Praziquantel (antiparasitic medicine)
• Some medicines used to treat high blood pressure
• Some medicines for malaria
• Immunosuppressive substances (medicines used to prevent rejection)
• Non-depolarizing neuromuscular blockers (medicines used mainly in the ICU or operating room)
• Growth hormone
• Protirelin (medicine that stimulates the thyroid)
• Fluoroquinolones: may increase the risk of tendon disorders.
• Antacids
• Salicylates (medicines of the aspirin type)

Interference with laboratory tests: allergy tests may be suppressed.

Pregnancy and lactation

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.

Dacortin, like most medicines, should not be administered 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.

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

Driving and using machines

It should be taken into account that in long-term treatments, visual acuity may decrease. This could negatively affect the ability to drive and use machinery.

Dacortin 5 mg contains lactose

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

3. How to take Dacortin 5 mg tablets

Follow exactly the instructions for administration of this medicine indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

As a general rule, the daily dose will be divided into several doses after meals and at bedtime. In some cases, it may be taken in the form of a single dose in the morning, every day or every other day, and with a sufficient amount of liquid.

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

The dose depends on the type and severity of the disease and 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 kilogram of body weight in children.

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

To stop treatment, your doctor will indicate how to do it. For long-term treatments, a gradual reduction will be made: in general, the dose should be reduced by 10% every 8-15 days. For short-term treatments (less than 10 days), it is not necessary to perform a gradual reduction of the dose.

In elderly patients, the same posology as in adults will be applied, taking into account the recommendations mentioned in section 2 "Warnings and precautions".

If you take more Dacortin 5 mg than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 0420, indicating the medicine and the amount ingested.

If you forget to take Dacortin 5 mg

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

If you stop treatment with Dacortin 5 mg

Do not stop using this medicine without consulting your doctor.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The side effects observed are, according to their frequency of presentation: very common (may affect more than 1 in 10 patients); common (may affect up to 1 in 10 patients); uncommon (may affect up to 1 in 100 patients); rare (may affect up to 1 in 1,000 patients); very rare (may affect up to 1 in 10,000 patients); frequency not known (cannot be estimated from the available data).

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

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

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

Eye disorders:glaucoma and cataracts. Blurred vision.

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

General disorders and administration site conditions:delayed wound healing.

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

Infections and infestations:existing infections may worsen, and new infections may appear, which may be difficult to diagnose.

Metabolism and nutrition disorders:fluid retention (edema), potassium loss (which may cause cardiac arrhythmias), weight gain, increased blood sugar, diabetes mellitus, increased cholesterol and triglyceride levels in the blood, increased appetite, delayed growth in children.

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

Musculoskeletal and connective tissue disorders:muscle diseases and muscle weakness, tendon disorders, tendinitis, tendon ruptures, bone calcium loss, osteoporosis, delayed growth in children.

Nervous system disorders:increased intracranial pressure (especially in children), increased spasms 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 or absent menstruation, hirsutism (excessive hair growth).

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

Vascular disorders:high blood pressure, increased risk of arteriosclerosis (narrowing and hardening of the 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). The signs of a scleroderma renal crisis are increased blood pressure and decreased urine production.

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

If you consider that any of the side effects you are experiencing is serious or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

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 not mentioned in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Dacortin 5 mg tablets

No special storage conditions are required.

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

Do not use Dacortin 5 mg tablets after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need in the SIGRE collection point at the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Packaging Content and Additional Information

Composition of Dacortín 5 mg

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

Product Appearance and Packaging Content

Dacortín 5 mg is presented in the form of white, slightly biconvex, round tablets with a central score on one side and "5" engraved on the other.

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

Marketing Authorization Holder

Laboratorios ERN, S.A.

Perú, 228

08020 Barcelona, Spain

Manufacturer

Merck, S.L.

Merck Industrial Estate

08100 Mollet del Vallés (Barcelona), Spain

or

CYNDEA PHARMA, S.L.

Emiliano Revilla Sanz Industrial Estate

Ágreda Avenue, 31 - 42110 Ólvega (Soria)

or

LABORATORIOS ERN, S.A.

Gorgs Lladó, 188

08210 Barberá del Vallés, Barcelona, Spain

Date of the last revision of this prospectus: 09/2017

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.