Prednisone Pensa 30 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Prednisona Pensa 30 mg tablets EFG

Read the entire leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. 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 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 reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents:

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 side effects
5. How to store Prednisona Pensa

Pack contents and other information

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

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

It is used in the treatment of:

• acute and chronic rheumatic joint and muscular disorders,
• 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, chorioretinitis, 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, to other glucocorticoids, or to 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 any 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 tuberculosis that is not being treated
• if you have bacterial, fungal, or amoebic infections, or if you have
• systemic mycosis (fungal infection disseminated throughout the body)
• if you have lymphomas (a type of lymphatic system tumor) that have appeared after
• a tuberculosis vaccination
• if you have any psychiatric disorder. Consult your doctor about the
• advisability 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 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 advice 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 used with caution in patients suffering from stomach ulcers, ulcerative colitis (intestinal disease), diverticulitis (intestinal disease), or enteroanastomosis (after surgery), or in those with mental disorders.

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

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

Your doctor may increase your dose if you experience a stressful condition (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 taking 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 sodium (salt) intake.

Consult your doctor before starting Prednisona 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. Signs of scleroderma renal crisis include elevated
blood pressure and reduced urine output. Your doctor may advise you to
monitor your blood pressure and urine output regularly.

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-negative results in skin allergy tests (tuberculin test, allergy patch tests, 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 closely monitor you if you are taking these medicines (including some 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 conditions)
• 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 transplant rejection)
• Non-depolarizing neuromuscular blockers (medicines mainly used in ICU or surgery)
• Growth hormone
• Protirelin (a medicine that stimulates the thyroid)
• Fluoroquinolones: may increase the risk of tendon abnormalities
• Antacids
• Salicylates (medicines such as aspirin)

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.

Prednisona, like most medicines, should not be used 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 is recommended to be avoided
during treatment, especially during long-term treatment and when high doses are used.

Driving and using machines

Please note that long-term treatment may reduce visual acuity. This could negatively affect your ability to drive or operate machinery.

Prednisona Pensa contains lactose

This medicine contains lactose. If your doctor has informed you of 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; essentially "sodium-free".

3. How to take Prednisona Pensa

Follow exactly the instructions given by your doctor for using this medicine. 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 without chewing, 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. Occasionally, 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; the dosage should be gradually reduced.

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

Your doctor will advise you on the duration of your prednisone treatment. Do not stop treatment earlier or abruptly, as this could worsen your condition.

If you feel that the effect of the 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 on 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 to reach the maintenance dose, which is normally between 5 and 10 mg daily. In bronchial asthma, the same approach is followed, although the initial dose in severe cases ranges from 40 to 60 mg.

Use in children

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

Acute intoxications with prednisone are not known. In the case of overdose, the adverse reactions described in this leaflet may 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 forgotten 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, according to their frequency of occurrence, are: 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, and are detailed below:

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

Endocrine disorders: signs of adrenal hyperactivity (Cushing's syndrome, a disease caused by increased production of a hormone called cortisol); in prolonged treatments, adrenal 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), potassium loss (which may cause disturbances in heart rhythm), weight gain, increased blood sugar, diabetes mellitus, increased cholesterol and triglyceride levels in blood, increased appetite, growth retardation in children.

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

Nervous system disorders: increased intracranial pressure (especially in children), increased seizures 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 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: Decrease in heart rate.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effect 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 via 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 should not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Prednisona Pensa

The active substance is prednisone. Each tablet contains 30 mg of prednisone.

The other components (excipients) are:

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

Appearance of the product and contents of the pack

Round, white tablets, scored on one side.

The tablets are packaged in PVC/aluminum blisters.

Packs containing 30 tablets.

Marketing Authorization Holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (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 medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/