PREDNISONA PENSA 10 mg TABLETS

2. What you need to know before taking Prednisona Pensa

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Do not take Prednisona Pensa:

• if you are allergic to prednisona, other glucocorticoids, or any of the other components of this medicine (listed in section 6)

components of this medicine (included in section 6)

• if you have stomach ulcers, gastritis, esophagitis (digestive system diseases)
• if you have viral infections (such as ocular herpes, chickenpox), before or after receiving a vaccine

Your doctor may have recommended taking Prednisona despite suffering from any of the following diseases, and therefore requires regular monitoring:

• if you have osteomalacia and osteoporosis (bone diseases)
• if you have severe diabetes
• if you have uncontrolled psychosis (mental disorder) with treatment
• if you have untreated tuberculosis
• if you have bacterial, fungal, or amoebic infections, or if you have systemic mycosis (infection caused by fungi and disseminated throughout the body)
• if you have lymphomas (a type of tumor of the lymphatic system) that have appeared after tuberculosis vaccination
• if you have any psychiatric illness. Consult your doctor about the convenience 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 severe myasthenia (muscular disease)
• if you have renal insufficiency.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Prednisona.

Treatment with Prednisona may increase the risk of infections since it can decrease the body's defenses, leading to new infections or activating existing ones (e.g., tuberculosis or hepatitis B). In severe infections or in cases of tuberculosis, Prednisona should only be used in conjunction with treatment for the infection.

Inform your doctor if you suffer from any type of infection and if you have been vaccinated or plan to be vaccinated. If symptoms of acute diseases such as infectious, digestive, or mental disorders appear during treatment, consult your doctor.

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

This medicine will be administered with caution in people who suffer from stomach ulcers, ulcerative colitis (intestinal disease), diverticulitis (intestinal disease), or enteric anastomosis (after surgery) or mental disorders.

If you suffer from osteoporosis, your doctor may recommend taking extra calcium and vitamin D.

Inform your doctor if you have heart disease and need high doses of prednisona.

If you are diabetic, or suffer from heart failure and very high blood pressure or glaucoma, your doctor will perform regular checks.

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

Your doctor may increase the dose if you suffer from any stressful situation (infections, surgery, trauma, etc.).

In long-term treatments, your doctor will perform regular checks to avoid complications in the eyes, blood tests, growth control (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.

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

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. The signs of a scleroderma renal crisis are increased blood pressure and decreased urine production. Your doctor may advise you to periodically check your blood pressure and urine.

The administration of Prednisona to children should be carefully evaluated, and if administered, it should be an intermittent or alternating treatment.

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

Taking Prednisona may give false results in skin tests for allergy tests (tuberculin test, allergy patches, etc.).

Use in athletes

This medicine contains prednisona, which may produce a positive result in doping tests.

Treatment should not be interrupted abruptly, but rather gradually. 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 other medicines, including those obtained without a prescription.

Some medicines may increase the effects of Prednisona, so your doctor will perform thorough checks 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)
• Antidiabetics
• Enzyme inducers:

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

or 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-eliminating diuretics (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 the ICU or operating room)

or Growth hormone

or Protirelin (medicine that stimulates the thyroid)

or Fluoroquinolones: may increase the risk of tendon disorders.

or Antacids

or Salicylates (medicines of the aspirin type)

Interference with laboratory tests: Allergy tests may be suppressed.

Pregnancy and lactation

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 administered 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 should be avoided during treatment, especially in long-term treatments and when high doses are used.

Driving and using machines

It should be taken into account that in long-term treatments, visual acuity may decrease. This may negatively affect the ability to drive and use machinery.

Prednisona Pensa contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

Prednisona Pensa contains sodium

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

3. How to take Prednisona Pensa

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

Remember to take your medicine.

The score line is only for breaking the tablet if you find it difficult to swallow it whole, but not for dividing it into equal doses.

The tablets are taken whole or broken, without chewing, and with sufficient liquid. The total daily dose will be divided into three or four doses, during or after meals. In some cases, the prescribed dose may be taken in a single daily dose, during or after breakfast. Sometimes, especially in children, and only when your doctor has indicated it, the treatment will be taken on alternate days.

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

Treatment with prednisona should not be stopped abruptly, but rather the dosage will be gradually reduced.

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

Your doctor will indicate the duration of your treatment with prednisona. Do not suspend treatment before or abruptly, as it may worsen your disease.

If you think the action 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 will be administered until a satisfactory response is observed. When this occurs, your doctor will gradually reduce the dose of prednisona until the maintenance dose is reached, which normally ranges between 5 and 10 mg per day. In bronchial asthma, the procedure is the same, although the attack dose in very severe cases ranges between 40 and 60 mg.

Use in children

Generally, treatment with prednisona in children can be done on alternate days or intermittently. The recommended initial doses are 1 to 3 mg of prednisona per kilogram of body weight and day. The maintenance dose is 0.25 mg of prednisona per weight and 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 Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

No acute intoxications with prednisona are known. In case of overdose, it is expected that the adverse reactions described in this leaflet will 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 for the next dose and follow the normal treatment.

If you interrupt treatment with Prednisona Pensa

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

4. Possible side effects

Like all medicines, Prednisona Pensa can cause side effects, although not everybody gets them.

The side effects observed 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); 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 in long-term treatments, and are 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, disease caused by increased production of a hormone called cortisol); in prolonged treatments, adrenocortical insufficiency (disease characterized by weakness, feeling of tiredness all the time, loss of appetite, and weight loss).

Eye disorders: glaucoma and cataracts. Blurred vision.

Gastrointestinal disorders: stomach ulcers, 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 failure, heart attack.

Infections and infestations: Existing infections may worsen, and new infections may appear, which may be 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 cholesterol and triglyceride levels in the blood, increased appetite, delayed growth in children.

Musculoskeletal and connective tissue disorders: muscle diseases and muscle weakness, tendon disorders, 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 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 or absent menstruation, hirsutism (excessive hair growth).

Skin and subcutaneous tissue disorders: acne or other skin problems (allergy, bruising, stretch marks), edema, skin color changes, dermatitis around the mouth.

Vascular disorders: high blood pressure, increased risk of arteriosclerosis (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). The signs of a scleroderma renal crisis are increased blood pressure and decreased urine production.

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

Frequency not known: decreased heart rate.

If you think any of the side effects you are experiencing is serious, or if you notice any side effects not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can contribute to providing 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 at a temperature above 30°C.

Do not use this medicine after the expiration date shown on the packaging after "CAD". The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Prednisona Pensa Composition

The active ingredient is prednisone. Each tablet contains 10 mg of prednisone.

The other components (excipients) are:

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

Product Appearance and Package Contents

Round, white, and scored tablets on one side.

The tablets are packaged in PVC/Aluminum blisters.

Packages 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 Last Revision of this Leaflet: April 2021.

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