Patient Information Leaflet: Information for the Patient

Prednisone Cinfa 10 mg Tablets

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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must 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 is prednisone cinfa and what it is used for

2. What you need to know before you start taking prednisone cinfa

3. How to take prednisone cinfa

4. Possible side effects

5. Storage of prednisone cinfa

6. Contents of the pack and additional information

Prednisone is a corticosteroid (glucocorticoid) derived from cortisol.

It regulates many of the body's metabolic processes.

Prednisone cinfa is used to treat:

-acute and chronic joint and muscle rheumatic processes,

-asthma bronchial 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 defense blood cells),

-purpura rheumatica,

-acute leukemia and other hematological diseases,

-inflammatory eye diseases (allergic conjunctivitis, keratitis, choroiditis, iritis, iridocyclitis).

Do not take Prednisone Cinfa

• 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 herpes simplex eye, chickenpox), before or after receiving a vaccine

Your doctor may have recommended taking prednisone 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 disease. Consult your doctor about the suitability 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 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 Prednisone Cinfa.

Treatment with prednisone 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 tuberculosis, prednisone should only be used with treatment for the infection.

Inform your doctor if you have 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 diseases, or mental disorders appear during treatment, consult your doctor.

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

This medicine should be administered with caution in people with stomach ulcers, ulcerative colitis (intestinal disease), diverticulitis (intestinal disease), or intestinal 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.

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

Your doctor may increase the dose if you have a 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 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 prednisone, your doctor may prescribe potassium supplements and reduce your sodium (salt) intake.

Consult your doctor before starting to take prednisone 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 regularly.

Careful evaluation is required for the administration of prednisone to children, and if it is 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 medicine.

Prednisone treatment 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 control tests.

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

Taking Prednisone Cinfa with other medicines

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

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

Prednisone may interact with the followingmedicines:

-Nonsteroidal anti-inflammatory drugs (e.g., indomethacin, salicylates)

-Antidiabetic drugs

-Enzyme inducers:

oCarbamazepine, phenytoin, phenobarbital, or primidone (medicines used to treat epilepsy)

oRifampicin, rifabutin (antibiotics)

-Enzyme inhibitors such as ketoconazole (used for fungal infections)

-Ephedrine

-Oral anticoagulants (e.g., Sintrom)

-Estrogens (hormonal medicines), oral contraceptives

-Atropine

-Cardiac glycosides (medicines used to treat heart disease)

-Diuretics that eliminate potassium (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 ICUs or in the operating room)

-Growth hormone

-Protirelin (medicine that stimulates the thyroid)

-Fluoroquinolones: may increase the risk of tendon damage.

-Antacids

-Salicylates (medicines like aspirin)

Interference with laboratory tests: Allergy tests may be suppressed

Pregnancy and breastfeeding

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

Prednisone, like most medicines, 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.

Prednisone 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 the ability to drive and operate machinery.

Prednisone Cinfa 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.

Prednisone Cinfa contains sodium.This medicine contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially "sodium-free".

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

Remember to take your medication.

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

Prednisone should not be stopped abruptly, but the dosage should 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 prednisone cinfa. Do not stop treatment before or abruptly, as this could worsen your condition.

If you estimate that the action of prednisone 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 response of the patient. 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 reaction is observed.

When this occurs, your doctor will gradually reduce the dose of prednisone to reach the maintenance dose, which normally ranges from 5 to 10 mg per day. In bronchial asthma, the same procedure is followed, although the attack dose in severe cases ranges from 15 to 60 mg.

Children:

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

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

If you take more prednisone cinfa 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 04 20, indicating the medication and the amount ingested.

If you forgot to take prednisone cinfa

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

If you interrupt treatment with prednisone 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.

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 an increase in the production of a hormone called cortisol); in prolonged treatments, adrenal insufficiency (a disease characterized by weakness, feeling tired 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, decreased or increased blood pressure, circulatory insufficiency, heart attack.

Infections and infestations:existing infections may worsen and new infections may appear that are 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 levels of cholesterol and triglycerides 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 alterations, 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 appearance of epilepsy.

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

Reproductive 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, striae), edema, 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:renal crisis in patients with scleroderma (a autoimmune disorder). The signs of a renal crisis are high 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 are 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 theSistema Español de Farmacovigilancia de medicamentos de Uso Humano: https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

This medication does not require special storage conditions.

Do not use this medication after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and the

medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and the medications you no longer need. By doing so, you will help protect the environment.

Composition of prednisone cinfa

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

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

Appearance of the product and content of the packaging

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

Prednisone cinfa tablets are packaged in PVC-PVDC/Aluminum blisters.

Prednisone cinfa tabletsare presented in containers holding 30 or 500 (clinical container) tablets.

Only some packaging sizes may be commercially marketed.

Marketing authorization holder and responsible manufacturer:

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Areta Industrial Estate

31620 Huarte (Navarra) - Spain

Last review date of this leaflet:May 2020

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

You can access detailed and updated information on this medication by scanning the QR code included in the leaflet and packaging with your 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