Package Leaflet: Information for the User

Dacortín 5 mg Tablets

Prednisone

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, ask your doctor or pharmacist.

-This medicine has been prescribed for you only. Do not give it 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.

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

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

3. How to take Dacortín 5 mg

4. Possible side effects

5. Storage of Dacortín 5 mg

6. Contents of the pack and additional information

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

Dacortín 5 mg is used for the treatment of substitution in adrenal insufficiency including among others 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 diseases of collagen and blood vessels, 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 others with tumor involvement, such as leukemia
• along with chemotherapy or radiation therapy
• 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.

Do not take Dacortín 5 mg tablets:

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

Your doctor may have recommended taking Dacortín despite having one of the following conditions and requiring 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 bacterial, fungal, amoebic, or systemic fungal infections
• if you have lymphomas (a type of lymphatic system tumor) that appeared after a tuberculosis vaccination
• if you have any psychiatric illness. Consult your doctor about the suitability of using this medication
• if you have severe high blood pressure

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

• 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 may decrease your body's defenses, leading to new infections or reactivating existing ones (e.g., tuberculosis or hepatitis B). In severe infections or in the case of tuberculosis, Dacortín should only be used in conjunction with treatment for the infection.

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

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

This medication should be administered with caution in people with stomach ulcers, ulcerative colitis (intestinal disease), diverticulitis (intestinal disease), or anastomosis (after surgery) or mental disorders.

If you have osteoporosis, your doctor may recommend taking additional calcium and vitamin D.

Inform your doctor if you have any 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 you are taking fluoroquinolones (e.g., ciprofloxacin), the risk of tendon ruptures and tendinitis increases.

Your doctor may increase the dose if you experience any stressful situation (infections, surgery, trauma, etc.).

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

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

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

Consult your doctor before starting to take Dacortín if you have scleroderma (also known as systemic sclerosis, an autoimmune disorder), as daily doses of 15 mg or more may increase the risk of a severe complication called scleroderma renal crisis. Signs of scleroderma renal crisis include high blood pressure and decreased urine production. Your doctor may advise you to monitor your blood pressure and urine production regularly.

Careful consideration should be given to administering Dacortín to children, and if administered, it should be an intermittent or alternating treatment.

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

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

Use in athletes

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

Treatment should not be stopped abruptly but rather tapered off gradually. Do not stop using this medication without consulting your doctor (see section 3 "How to take Dacortín").

Taking Dacortín 5 mg with other medications

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

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

Dacortín may interact with the following medications:

• Nonsteroidal anti-inflammatory drugs (e.g., indomethacin, salicylates)
• Antidiabetic medications
• Enzyme inducers:
• • carbamazepine, phenytoin, phenobarbital, or primidone (medications used to treat epilepsy)
  • rifampicin, rifabutin (antibiotics)
• Enzyme inhibitors such as ketoconazole (used to treat fungal infections)
• ephedrine
• oral anticoagulants (e.g., Sintrom)
• estrogens (medications used to treat hormonal imbalances), oral contraceptives
• atropine
• cardiac glycosides (medications used to treat heart disease)
• diuretics that eliminate potassium (medications used to eliminate water) and laxatives
• praziquantel (antiparasitic medication)
• some medications used to treat high blood pressure
• some medications used to treat malaria
• immunosuppressive medications (medications used to prevent rejection)
• non-depolarizing neuromuscular blockers (medications used mainly in ICUs or operating rooms)
• growth hormone
• protirelin (medication that stimulates the thyroid)
• fluoroquinolones: may increase the risk of tendon damage
• antacids
• salicylates (medications of the type of aspirin)

Interference with laboratory tests: allergy tests may be suppressed.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Dacortín, like most medications, should not be administered during pregnancy or breastfeeding, unless your doctor considers it essential. You should inform your doctor as soon as possible if you become pregnant during treatment.

Dacortín passes into breast milk, so it is recommended to avoid breastfeeding during treatment, especially in long-term treatments and when high doses are used.

Driving and operating machinery

It should be noted that in long-term treatments, visual acuity may decrease. This may negatively affect your ability to drive and operate machinery.

Dacortín 5 mg contains lactose

This medication contains lactose. If your doctor has indicated that you have a intolerance to certain sugars, consult with them before taking this medication.

Follow exactly the administration instructions for this medication as indicated 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 after meals and at bedtime. In some cases, it may be taken as a single dose in the morning, every day or on alternate days, with sufficient 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 response of the patient, 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 general 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 indicate how to do it. For long treatments, a gradual reduction will be made: in general, the dose should be reduced by 10% every 8-15 days. For short treatments (less than 10 days), it is not necessary to make a gradual reduction in the dose.

In the elderly, 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 Dacortín 5 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 0420, indicating the medication and the amount ingested.

If you forget to take Dacortín 5 mg

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

If you interrupt treatment with Dacortín 5 mg

Do not stop using this medication without consulting your doctor.

If you have any other questions 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.

The observed side effects 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 available data).

Most of the time, adverse reactions occur especially when used at high doses and in long treatments, and are detailed below:

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

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

Eye disorders:glaucoma and cataracts. Blurred vision.

Gastrointestinal disorders:gastric ulcer, 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, decrease or increase in blood pressure, circulatory insufficiency, heart attack.

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

Metabolism and nutrition disorders: retention of fluids (edema), loss of potassium (which may cause alterations in heart rhythm), weight gain, increase in blood sugar, diabetes mellitus, increase in cholesterol and triglycerides in the blood, increase in appetite, delayed growth in children.

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

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

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

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

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

Skin and subcutaneous tissue disorders: acné or other skin problems (allergy, bruises, striae), edemas, changes in skin color, dermatitis around the mouth.

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

Renal and urinary disorders: crisis renal esclerodérmica in patients who already have scleroderma (an autoimmune disorder). The signs of a scleroderma renal crisis are increased blood pressure and decreased urine production.

Reducing the dose quickly after a long treatment may cause muscle and joint pain.

If you consider that any of the side effects you are experiencing is severe 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 that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

No special storage conditions are required.

Keep Dacortín 5 mg Tablets out of sight and reach of children.

Do not use Dacortín 5 mg Tablets after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medicines. By doing so, you will help protect the environment.

Composition of Dacortín 5 mg

• The active ingredient is prednisone. Each tablet contains5mg of prednisone.
• The other components are lactose monohydrate, cornstarch, povidone, carboxymethylcellulose sodium, talc, magnesium stearate, and purified water.

Appearance of the product and contents of the packaging

Dacortín 5 mg is presented in the form of round, white, slightly biconvex tablets with a central groove on one face and “5” engraved on the other.

Dacortín 5 mg is presented in blisters of 30, 60, or 500 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), Spain

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: 09/2017

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/.