PREDNISONA CINFA 10 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

Prednisona Cinfa 10 mg Tablets

Read the package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

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

1. What is Prednisona Cinfa and what is it used for

Prednisona is a corticosteroid (glucocorticoid) derived from cortisone.

It regulates many of the body's metabolic processes.

Prednisona Cinfa is used to treat:

• articular and muscular rheumatic processes, acute and chronic,
• bronchial asthma and pulmonary fibrosis,
• ulcerative colitis (inflammatory bowel disease),
• hepatitis,
• Addison's disease,
• adrenogenital syndrome,
• kidney and urinary tract diseases,
• allergic and inflammatory skin processes,
• hemolytic anemias,
• agranulocytosis (absence of blood defense cells),
• rheumatic purpura,
• acute leukemia and other hematological diseases,
• some inflammatory eye diseases (allergic conjunctivitis, keratitis, chorioretinitis, iritis, iridocyclitis).

2. What you need to know before taking Prednisona Cinfa

Do not take Prednisona Cinfa

• if you are allergic to prednisona, other glucocorticoids, or any of the other components of this medication (listed in section 6)

• if you have stomach ulcers, gastritis, esophagitis (digestive system diseases)
• if you have viral infections (such as ocular herpes simplex, chickenpox) before or after receiving a vaccine

Your doctor may have recommended taking prednisona despite suffering from some of the following diseases, and therefore requires 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, or amoebic infections, or 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 medication

• if you have severe high blood pressure

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Prednisona Cinfa.

Treatment with prednisona may increase the risk of infections, as it can decrease the body's defenses, leading to new infections or reactivating existing ones (e.g., tuberculosis or hepatitis B). In severe infections or in cases of tuberculosis, Prednisona should only be used in conjunction with infection treatment.

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 prednisona, you should contact a doctor immediately, even if you do not present any symptoms.

This medication 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 prednisona.

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

If this medication 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 monitoring of the hypothalamic-pituitary-adrenal axis function.

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

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

Consult your doctor before starting to take Prednisona Cinfa 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. The signs of a scleroderma renal crisis are increased blood pressure and decreased urine production. Your doctor may advise you to have your blood pressure and urine checked periodically.

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

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

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

Use in athletes

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

Treatment should not be interrupted abruptly, but rather gradually. Do not stop using this medication without consulting your doctor (see section 3 "How to take Prednisona Cinfa").

Taking Prednisona Cinfa 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 prednisona, so your doctor will perform thorough checks if you are taking these medications (including some for HIV: ritonavir, cobicistat).

Prednisona may interfere with the followingmedications:

• Non-steroidal anti-inflammatory drugs (e.g., indomethacin, salicylates)
• Antidiabetics
• Enzyme inducers:

or carbamazepine, phenytoin, phenobarbital, or primidone (medications used to treat epilepsy)

or rifampicin, rifabutin (antibiotics)

• Enzyme inhibitors such as ketoconazole (used for fungal infections)
• Ephedrine
• Oral anticoagulants (such as Sintrom)
• Estrogens (medications used for hormonal disorders), oral contraceptives
• Atropine
• Cardiac glycosides (medications used to treat heart diseases)
• Potassium-eliminating diuretics (medications used to eliminate water) and laxatives
• Praziquantel (antiparasitic medication)
• Some medications used to treat high blood pressure
• Some medications for malaria
• Immunosuppressive substances (medications used to prevent rejection)
• Non-depolarizing neuromuscular blockers (medications used mainly in the ICU or operating room)
• Growth hormone
• Protirelin (medication that stimulates the thyroid)
• Fluoroquinolones: may increase the risk of tendon disorders.
• Antacids
• Salicylates (medications 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 medication.

Prednisona, like most medications, 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.

Prednisona 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 may negatively affect the ability to drive and use machinery.

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

Prednisona Cinfa contains sodium.This medication contains less than 23 mg of sodium (1 mmol) per tablet; this is, essentially "sodium-free".

3. How to take Prednisona Cinfa

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

Remember to take your medication.

The tablets should be taken whole with sufficient liquid. The total daily dose will be divided into three or four doses, during or after meals. In some cases, the prescribed dose may be taken in a single daily dose, during or after breakfast. Sometimes, especially in children, and only when your doctor has indicated it, the treatment will be taken on alternate days. Your doctor will decide the dose you should take, adjusting it to your needs.

Prednisona should not be discontinued abruptly, but rather the dosage will be gradually reduced. In general, the maintenance dose should always be the lowest possible.

The tablet can be divided into equal doses.

Your doctor will indicate the duration of your treatment with Prednisona Cinfa. Do not suspend treatment before or abruptly, as it may worsen your disease.

If you think the effect of Prednisona Cinfa is too strong or too weak, inform your doctor or pharmacist.

Adults:

The treatment dose will depend on the type and severity of the disease and the individual patient's response. Generally, the initial dose is 20 to 60 mg (milligrams) per day, as prescribed by your doctor. These initial doses will be administered until a satisfactory response is observed.

When this response is achieved, your doctor will gradually reduce the dose of prednisona until the maintenance dose is reached, which usually ranges between 5 and 10 mg per day. In bronchial asthma, the procedure is the same, although the attack dose in very severe cases ranges between 15 and 60 mg.

Children:

Generally, treatment with prednisona in children can be done on alternate days or intermittently. The recommended initial doses are 1 to 3 mg of prednisona per kilogram of body weight and day.

The maintenance dose is 0.25 mg of prednisona per kilogram of body weight and day.

If you take more Prednisona Cinfa 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 04 20, indicating the medication and the amount ingested.

If you forget to take Prednisona Cinfa

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

If you interrupt treatment with Prednisona Cinfa

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.

4. Possible side effects

Like all medications, this medication can cause side effects, although not all people experience them.

The observed side effects are, according to their frequency of presentation: very frequent (may affect more than 1 in 10 patients); frequent (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).

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 in blood), eosinopenia (decrease in eosinophils in blood), polycythemia (increase in red blood cells in blood).

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 fatigue all the time, loss of appetite and weight).

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, difficult to diagnose.

Metabolism and nutrition disorders:Fluid retention (edema), potassium loss (which can cause cardiac arrhythmias), weight gain, increased blood sugar, diabetes mellitus, increased cholesterol and triglyceride levels in 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 think any of the side effects you are experiencing is serious, or if you notice any side effect not mentioned in this package leaflet, inform your doctor or pharmacist.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for human use medications: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Prednisona Cinfa

Keep this medication out of sight and reach of children.

This medication does not require special storage conditions.

Do not use this medication after the expiration date shown on the packaging after "CAD". The expiration date is the last day of the month indicated.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need in the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Packaging Content and Additional Information

Prednisona Cinfa Composition

• The active ingredient is prednisone. Each tablet contains 10 mg of prednisone.
• The other components (excipients) are:

Lactose monohydrate, sodium carboxymethyl starch (type A) (potato), magnesium stearate, anhydrous colloidal silica, and talc.

Product Appearance and Packaging Content

White, cylindrical, biconvex tablets, scored on one side and with the inscription PD10 on the other.

Prednisona Cinfa tablets are packaged in PVC-PVDC/Aluminum blisters.

Prednisona Cinfa tablets are available in packages containing 30 or 500 (clinical package) tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer:

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Date of the Last Revision of this Prospectus:May 2020

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

You can access detailed and updated information about this medication by scanning the QR code included in the prospectus and packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/75649/P_75649.html

QR code to: https://cima.aemps.es/cima/dochtml/p/75649/P_75649.html