Prednisone Pensa 5 mg tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Prednisona Pensa 5 mg tablets EFG

Read the entire 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 and should not be given to other people, 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 effects not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What Prednisona Pensa is and what it is used for
2. What you need to know before taking Prednisona Pensa
3. How to take Prednisona Pensa
4. Possible adverse effects
5. How to store Prednisona Pensa
6. Contents of the pack and additional information

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

Prednisone is a corticosteroid (glucocorticoid) derived from cortisone. It acts by regulating many of the body's metabolic processes.

It is used to treat:

• acute and chronic rheumatic conditions affecting joints and muscles,
• 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 conditions,
• hemolytic anemias,
• agranulocytosis (absence of defense blood cells),
• rheumatic purpura,
• acute leukemia and other hematological disorders,
• certain inflammatory eye diseases (allergic conjunctivitis, keratitis, choroidoretinitis, iritis, iridocyclitis),
• as an adjunct in organ transplantation.

2. What you need to know before taking Prednisona Pensa

Do not take Prednisona Pensa:

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

Your doctor may have advised you to take Prednisona despite having one of the following conditions, in which case regular monitoring will be required:

• if you have osteomalacia or osteoporosis (bone disorders)
• if you have severe diabetes
• if you have uncontrolled psychosis (mental disorder)
• if you have untreated tuberculosis
• if you have a bacterial, fungal, or amoebic infection, or
• systemic mycosis (fungal infection disseminated throughout the body)
• if you have lymphomas (a type of lymphatic system tumor) that have developed after
• vaccination against tuberculosis
• if you have any psychiatric illness. Consult your doctor regarding the
• appropriateness 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 excess nitrogenous substances in the blood)
• if you have myasthenia gravis (muscle disorder)
• if you have renal insufficiency.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Prednisona.

If you have an overactive thyroid gland (hyperthyroidism).

Treatment with Prednisona may increase the risk of infections, as it can reduce your body's defenses, potentially 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 combination with specific treatment for the infection.

Inform your doctor if you suffer from any type of infection, or if you have been vaccinated or plan to be vaccinated. If, during treatment, symptoms of acute-onset diseases appear—such as infectious, digestive, or psychiatric disorders—seek medical attention immediately.

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

This medicine should be administered with caution in patients with stomach ulcers, ulcerative colitis (intestinal disease), diverticulitis (intestinal disease), enteroanastomosis (after surgery), or mental disorders.

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

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

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

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

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

During long-term treatment, your doctor will perform regular monitoring to prevent complications in the eyes, blood tests, growth monitoring (in children and adolescents), and will monitor the function of your hypothalamic-pituitary-adrenal axis.

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

Contact your doctor immediately if you experience muscle weakness, muscle pain, cramps, or muscle stiffness while using prednisone. These may be symptoms of a condition called thyrotoxic periodic paralysis, which may occur in patients with an overactive thyroid gland (hyperthyroidism) treated with prednisone. Additional treatment may be needed to relieve this condition.

During prolonged treatment with Prednisona, your doctor may prescribe potassium supplements and advise you to reduce your sodium (salt) intake.

Consult your doctor before starting Prednisona 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. Signs of scleroderma renal crisis include increased blood pressure and decreased urine output. Your doctor may recommend regular monitoring of blood pressure and urine.

The administration of Prednisona to children should be carefully evaluated, and if used, treatment should be intermittent or alternate-day.

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

Taking Prednisona may lead to false results in skin 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 tapered off. Do not stop using
this medicine without consulting your doctor (see section 3 “How to take Prednisona Pensa”).

Taking Prednisona Pensa with other medicines

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

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

Prednisona may interfere with the following medicines:

• Non-steroidal anti-inflammatory drugs (e.g., indomethacin, salicylates)

• Antidiabetic agents

• Enzyme inducers:

  o Carbamazepine, phenytoin, phenobarbital, or primidone (medicines used to
  treat epilepsy)
  o 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-depleting diuretics (medicines used to eliminate water) and laxatives

• Praziquantel (antiparasitic medicine)

• Some medicines used to treat high blood pressure

• Some medicines for malaria

• Immunosuppressive agents (medicines used to prevent rejection)

• Non-depolarizing neuromuscular blockers (medicines mainly used in ICU or in the
  operating room)

• Growth hormone

• Protirelin (a medicine that stimulates the thyroid)

• Fluoroquinolones: may increase the risk of tendon abnormalities

• Antacids

• Salicylates (medicines of the aspirin type)

Interference with laboratory tests: Allergy tests may be suppressed.

Pregnancy and breastfeeding

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.

Prednisone, like most medicines, should not be used during pregnancy or breastfeeding unless your doctor considers it essential. Therefore, you must inform your doctor as soon as possible if you become pregnant during treatment.

Prednisone passes into breast milk; therefore, breastfeeding is not recommended
during treatment, especially during long-term treatment or when high doses are used.

Driving and using machines

It should be noted that long-term treatment may reduce visual acuity. This could negatively affect your ability to drive or use machinery.

Prednisona Pensa contains lactose

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

Prednisona Pensa contains sodium

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

3. How to take Prednisona Pensa

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Remember to take your medication.

Prednisone tablets can be divided into equal doses.

The whole tablets or fractions thereof should be taken unchewed with sufficient liquid. The total daily dose should be divided into three or four doses, taken during or after meals. In some cases, the prescribed dose may be taken as a single daily dose during or after breakfast. Sometimes, especially in children, and only if specifically instructed by your doctor, treatment may be administered on alternate days.

Your doctor will decide the dose you should take, adjusting it according to your individual needs.

Prednisone must not be stopped abruptly; instead, the dosage should be gradually reduced.

In general, the maintenance dose should always be the lowest possible.

Your doctor will indicate how long your treatment with prednisone should last. Do not stop the treatment prematurely or abruptly, as this could worsen your condition.

If you feel that the effect of this medicine 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 patient's response. Generally, the initial dose is 20 to 60 mg (milligrams) per day, as prescribed by your doctor. These initial doses are administered until a satisfactory response is observed. Once this occurs, your doctor will gradually reduce your prednisone dose until reaching the maintenance dose, which usually ranges between 5 and 10 mg daily. In bronchial asthma, the same approach is followed, although the initial dose in very severe cases ranges from 40 to 60 mg.

Use in children

In general, prednisone treatment in children may be administered 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 typically 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

Acute intoxications with prednisone are not known. In the event of an overdose, the adverse reactions described in this leaflet are expected to occur to a greater extent. Overdose may cause excitement, anxiety, depression, mental confusion, gastrointestinal bleeding, increased blood pressure and blood sugar levels, as well as fluid retention (edema).

If you forget to take Prednisona Pensa

Do not take a double dose to make up for missed doses. Wait until the next scheduled dose and continue your treatment as usual.

If you stop treatment with Prednisona Pensa

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

4. Possible adverse effects

Like all medicines, Prednisona Pensa can cause adverse effects, although not everyone will experience them.

The adverse effects observed are listed below according to their frequency of occurrence: 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 high doses are used and during long-term treatment, as detailed below:

Blood and lymphatic system disorders: Leukocytosis (increased white blood cells in the blood), lymphopenia (decreased lymphocytes in the blood), eosinopenia (decreased eosinophils in the blood), polycythemia (increased red blood cells in the blood).

Endocrine disorders: Signs of adrenal hyperactivity (Cushing's syndrome, a disease caused by increased production of a hormone called cortisol); in prolonged treatments, adrenocortical insufficiency (a condition characterized by weakness, constant fatigue, 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-type reactions, including arrhythmias, bronchospasm, decreased or increased blood pressure, circulatory failure, heart attack.

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

Metabolism and nutrition disorders: Fluid retention (edema), loss of potassium (which may cause disturbances in heart rhythm), weight gain, increased blood sugar, diabetes mellitus, increased levels of cholesterol and triglycerides in the blood, increased appetite, growth retardation in children.

Musculoskeletal and connective tissue disorders: Muscle disorders and muscle weakness, tendon abnormalities, tendinitis, tendon ruptures, loss of calcium from bones, osteoporosis, growth retardation 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 menstruation or absence of menstruation, hirsutism (excessive hair growth).

Skin and subcutaneous tissue disorders: Acne or other skin problems (allergy, bruising, stretch marks), edema, changes in skin color, perioral dermatitis.

Vascular disorders: High blood pressure, increased risk of atherosclerosis (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). Signs of scleroderma renal crisis include increased blood pressure and decreased urine output.

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

Frequency not known: Decreased heart rate.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Prednisona Pensa

Keep this medicine out of sight and reach of children.

Do not store above 30°C.

Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the container and Additional Information

Composition of Prednisona Pensa

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

The other components (excipients) are:

Lactose monohydrate, corn starch, povidone, sodium carboxymethyl starch from potato (Type A), magnesium stearate and microcrystalline cellulose.

Appearance of the product and contents of the container

Round, white tablets, scored on one side.

The tablets are packed in PVC/Aluminum blisters.

Containers containing 30 or 60 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorellés (Barcelona)

Spain

Manufacturer

Kern Pharma, S.L.

Polígono Ind. Colón II

Venus, 72

08228 Terrassa (Barcelona)

Date of the most recent review of this leaflet: January 2026

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