Package Insert: Information for the User

Prednisona pensa 5 mg tablets EFG

Read this package insert carefully before starting to take the medication, because

it contains important information for you.

• Keep this package insert, 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 and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Prednisona is a corticosteroid (glucocorticoid) that is obtained from cortisone. It intervenes by regulating many of the body's metabolic processes.

It is used for the treatment of:

• arthritic and muscular processes, acute and chronic,
• asthma bronchial and pulmonary fibrosis,
• ulcerative colitis (inflammatory disease of the intestine),
• hepatitis,
• Addison's disease,
• adrenogenital syndrome,
• kidney and urinary tract diseases,
• allergic and inflammatory skin processes,
• hemolytic anemias,
• agranulocytosis (absence of defensive blood cells),
• purpura rheumatica,
• acute leukemia and other hematological diseases,
• some inflammatory eye diseases (allergic conjunctivitis, keratitis, choroidoretinitis, iritis, iridocyclitis),
• as a coadjuvant in organ transplantation.

.

Do not take Prednisona Pensa:

• 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, varicella), before or after receiving a vaccine

Your doctor may have recommended taking Prednisona 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 mycosis infections
• if you have systemic mycosis (infection caused by fungi and spread throughout the body)
• if you have lymphomas (a type of lymphatic system tumor) that appeared after a
• vaccination against tuberculosis
• if you have any psychiatric disease. 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 (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 Prednisona treatment.

Prednisona treatment may increase the risk of infections as it can decrease your body's defenses, leading to new infections or reactivating existing ones (e.g., tuberculosis or hepatitis B). In severe infections or tuberculosis, Prednisona should only be used 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 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 Prednisona treatment, contact a doctor immediately, even if you do not have any symptoms.

This medication will 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.

If this medication is administered with fluoroquinolones (e.g., ciprofloxacin), the risk of tendon rupture 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 control of the hypothalamic-pituitary-adrenal axis function.

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

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

Consult your doctor before starting Prednisona treatment 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.

Prednisona should be carefully evaluated for administration in 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.

Prednisona treatment 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 interrupted abruptly but rather gradually. Do not stop using this medication without consulting your doctor (see section 3 "How to take Prednisona Pensa").

Taking Prednisona Pensa 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 interact with the following medications:

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

- Antidiabetic medications

- 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 (e.g., Sintrom)

- Estrogens (medications used for hormonal disorders), 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 for malaria

- Immunosuppressive substances (medications used to prevent rejection)

- Non-depolarizing neuromuscular blockers (medications used mainly in ICUs or in the operating room)

- 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 think you may be 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. You should inform your doctor as soon as possible if you become pregnant during treatment.

Prednisona 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 could negatively affect your ability to drive and operate machinery.

Prednisona Pensa contains lactose

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

Prednisona Pensa contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per tablets; it is essentially "sodium-free".

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

Remember to take your medication.

Prednisone tablets can be divided into equal doses.

Prednisone tablets or their fractions are taken without chewing 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 can be taken in a single daily dose, during or after breakfast. Occasionally, especially in children, and only when your doctor has indicated so, the 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.

Generally, the maintenance dose should always be the lowest possible.

Your doctor will indicate the duration of your treatment with prednisone. Do not stop treatment before or abruptly, as this could worsen your condition.

If you estimate that the action of this medication is too strong or too weak, inform your doctor.

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 prednisone dose to reach the maintenance dose, which usually 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 40 to 60 mg.

Use in children

Generally, prednisone treatment 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 Prednisona Pensa 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.

No acute intoxications with prednisone are known. In the case of overdose, it is expected that the adverse reactions described in this prospectus will occur to a greater extent. Overdose can cause excitement, anxiety, depression, mental confusion, digestive bleeding, increased blood pressure, and blood sugar levels, as well as fluid retention (edema).

If you forgot to take Prednisona Pensa

Do not take a double dose to compensate for the missed doses. Wait for the next dose and follow the normal treatment.

If you interrupt the treatment with Prednisona Pensa

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

Like all medicines, Prednisona Pensa may cause side effects, although not everyone will 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); infrequent (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); unknown frequency (cannot be estimated from available data).

Most 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 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: stomach 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: 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.

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 existing scleroderma (a autoimmune disorder). The signs of a renal crisis are

increased blood pressure and decreased urine production.

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

Unknown frequency: Decreased heart rate.

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 the 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.

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

Do not store at a temperature above 86°F (30°C).

Do not use this medicationafter 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 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 medications you no longer need. By doing so, you will help protect the environment.

Composition of Prednisona Pensa

The active ingredient is prednisone. Each tablet contains 5 mg of prednisone.

The other components (excipients) are:

Lactose monohydrate, cornstarch, povidone, carboxymethylcellulose sodium from potato (Type A), magnesium stearate, and microcrystalline cellulose.

Appearance of the product and contents of the packaging

Round, white, and scored tablets on one side.

The tablets are packaged in PVC/Aluminum blisters.

Packages containing 30 or 60 tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Responsible for Manufacturing

Kern Pharma, S.L.

Polígono Ind.Colón II

Venus, 72

08228 Terrassa (Barcelona)

Revision Date of this leaflet:April 2021

The detailed information of this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/