Prednisone Pensa 10 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Prednisona Pensa 10 mg tablets

Read all of this 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 must not be given to other people, even if they have the same symptoms, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if the side effects are 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

Contents of the pack and other 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 in the treatment of:

• acute and chronic rheumatic disorders affecting joints and muscles,
• bronchial asthma and pulmonary fibrosis,
• ulcerative colitis (inflammatory bowel disease),
• hepatitis,
• Addison's disease,
• adrenogenital syndrome,
• kidney and urinary tract disorders,
• 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, other glucocorticoids, or any of the other
  components of this medicine (listed in section 6)
• if you have stomach ulcer, gastritis, or esophagitis (digestive system disorders)
• if you have viral infections (such as ocular herpes,
  chickenpox), before or after receiving a vaccine

Your doctor may have recommended taking Prednisona even if you have one of the following conditions, which would require regular monitoring:

• 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
• systemic mycosis (fungal infection spread throughout the body)
• if you have lymphomas (a type of tumor of the lymphatic system) that have developed after
  vaccination against tuberculosis
• 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 (muscular 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 promptly.

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 who have 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 any 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 taken 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. You may require additional treatment to relieve this condition.

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

Consult your doctor before starting to take 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 advise you to
monitor your blood pressure and urine output regularly.

The administration of Prednisona to children should be carefully evaluated, and if used, it should be given intermittently or on alternate days.

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 enhance 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 (an antiparasitic medicine)
• Some medicines used to treat high blood pressure
• Some medicines for malaria
• Immunosuppressants (medicines used to prevent transplant rejection)
• Non-depolarizing neuromuscular blockers (medicines mainly used in ICU or in the operating room)
• Growth hormone
• Protirelin (a medicine that stimulates the thyroid gland)
• 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 might 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 should inform your doctor as soon as possible if you become pregnant during treatment.

Prednisone passes into breast milk, so breastfeeding is recommended to be avoided
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 and use 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; therefore, 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.

The score line is intended only to divide the tablet if you have difficulty swallowing it whole, but not to split it into equal doses.

The tablets should be taken whole or split, without chewing, and 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 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 determine the dose you should take, adjusting it according to your individual needs.

Treatment with prednisone must not be stopped abruptly; instead, the dosage should be progressively reduced.

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

Your doctor will inform you of the duration of your prednisone treatment. 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 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 usually ranges 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 number: 91 562 04 20, indicating the medicine and the amount ingested.

Acute intoxications with prednisone are not known. In the event of 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 your next scheduled dose and continue your treatment as normal.

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 may cause adverse effects, although not everyone experiences 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: leukocytosis (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), loss of potassium (which may cause disturbances in heart rhythm), weight gain, increased blood sugar, diabetes mellitus, increased levels of cholesterol and triglycerides in blood, increased appetite, growth retardation in children.

Musculoskeletal and connective tissue disorders: muscle disorders and muscle weakness, tendon disorders, tendinitis, tendon rupture, 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 (formation of blood clots), 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 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 the 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 packaging at a SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and their packaging. 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 10 mg of prednisone.

The other components (excipients) are:

Monohydrate lactose, 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 for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/