Prednisone Kern Pharma 5 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Prednisona Kern Pharma 5 mg tablets EFG

Prednisona Kern Pharma 10 mg tablets

Prednisona Kern Pharma 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, 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 only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Prednisona Kern Pharma is and what it is used for

Prednisone is a corticosteroid (glucocorticoid).

This medicine is used for replacement therapy in adrenal insufficiency, including Addison's disease.

Due to its anti-inflammatory and immunosuppressive action, prednisone is used in the treatment of:

• rheumatic diseases, such as rheumatoid arthritis
• collagen and blood vessel autoimmune diseases, such as systemic lupus erythematosus
• bronchial and pulmonary diseases such as asthma
• skin diseases, such as acute severe urticaria and pemphigus
• blood disorders, such as acquired hemolytic anemia, thrombocytopenic purpura, and other conditions with tumoral involvement, such as leukemia
• in combination with chemotherapy drugs or radiotherapy
• gastrointestinal diseases, such as ulcerative colitis and Crohn's disease
• liver diseases, such as autoimmune chronic active hepatitis
• kidney diseases, such as nephrotic syndrome
• certain inflammatory eye disorders, such as allergic conjunctivitis, keratitis, optic neuritis, among others.

2. What you need to know before starting to take Prednisona Kern Pharma

Do not take Prednisona Kern Pharma

• If you are allergic to prednisone, to other glucocorticoids, or to any of the other ingredients 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 simplex, chickenpox), before or after having received a vaccine

Your doctor may have recommended taking Prednisona Kern Pharma despite you having one of the following conditions, in which case regular monitoring will be required:

• if you have osteomalacia and osteoporosis (bone disorders)
• if you have severe diabetes
• if you have psychosis (mental disorder) that is not controlled with treatment
• if you have tuberculosis that is not being treated
• if you have an infection caused by bacteria, fungi, amoebae, or if you have systemic mycosis (fungal infection spread 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 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

Talk to your doctor or pharmacist before starting to take this medicine.

• If you have an overactive thyroid gland (hyperthyroidism)

Treatment with Prednisona Kern Pharma 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 Kern Pharma should only be used in combination with treatment for the infection.

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 need additional treatment to relieve this condition.

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

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

This medicine should be administered with caution in patients with stomach ulcer, 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 monitoring.

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 check-ups 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.

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

Consult your doctor before starting this medicine 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 Kern Pharma to children should be carefully evaluated, and if administered, treatment should be intermittent or alternate.

When administered to elderly patients, regular monitoring by the doctor is required. Elderly patients should avoid prolonged treatment with this medicine.

Taking Prednisona Kern Pharma may lead to false results in skin allergy tests (tuberculin test, allergy patches, etc.).

Use in athletes

This medicine contains prednisone, which may result in a positive finding in doping control tests.

Treatment should not be stopped abruptly but gradually. Do not stop using this medicine without consulting your doctor (see section 3 “How to take Prednisona Kern Pharma”).

Taking Prednisona Kern Pharma 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 Kern Pharma, so your doctor will closely monitor you if you are taking these medicines (including some used for HIV: ritonavir, cobicistat).

Prednisona Kern Pharma may interfere with the following medicines:

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

• Antidiabetic agents

• Enzyme inducers:

  • Carbamazepine, phenytoin, phenobarbital, or primidone (medicines used to treat epilepsy)
  • 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 remove water) and laxatives

• Praziquantel (an 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 used mainly in intensive care units or in the operating room)

• Growth hormone

• Protirelin (a medicine that stimulates the thyroid)

• Fluoroquinolones: may increase the risk of tendon disorders.

• Antacids

• Salicylates (aspirin-like medicines)

Interference with laboratory tests: allergy tests may be suppressed.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Prednisona Kern Pharma, like most medicines, should not be administered 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.

Prednisona Kern Pharma passes into breast milk; therefore, breastfeeding should be avoided during treatment, especially for long-term treatments and when high doses are used.

Driving and operating machinery

It should be noted that with long-term treatment, visual acuity may be reduced. This could negatively affect the ability to drive and operate machinery.

Prednisona Kern Pharma contains lactose

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

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

3. How to take Prednisone Kern Pharma

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

As a general rule, the daily dose should be divided into several doses taken after meals and at bedtime. In some cases, it may be taken as a single daily dose in the morning, every day or on alternate days, with an adequate amount of liquid.

As soon as a satisfactory response is achieved, you should take the usual maintenance dose. Both doses will be determined by your doctor.

The dose depends on the type and severity of the disease, the individual patient's response, and in prolonged treatments, the maintenance dose should be as low as possible.

The initial dose will be 20 to 90 mg per day in adults and 0.5 to 2 mg per day per kg of body weight in children.

The usual maintenance dose will be 5 to 10 mg per day in adults and 0.25 to 0.5 mg per day per kg of body weight in children. When used in children as an anti-inflammatory and immunosuppressant, doses of 0.05 to 2 mg per day per kg of body weight are recommended.

To discontinue treatment, your doctor will advise you on how to proceed. For long-term treatments, the dose should be gradually reduced: in general, the dose should be decreased by 10% every 8–15 days. For short-term treatments (less than 10 days), gradual dose reduction is not necessary.

In elderly patients, the same dosage regimen as in adults should be applied, taking into account the recommendations stated in section 2, “Warnings and precautions”.

If you take more Prednisone Kern Pharma 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.

If you forget to take Prednisone Kern Pharma

Do not take a double dose to make up for missed doses.

If you stop using Prednisone Kern Pharma

Do not stop using this medicine without consulting your doctor.

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

4. Possible adverse effects

Like all medicines, this medicine 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 available data).

In most cases, adverse reactions occur especially when high doses are used and during long-term treatments, 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, 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 blood, increased appetite, growth retardation in children.

Cardiac disorders (frequency not known): decreased heart rate.

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 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 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.

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 via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Prednisone Kern Pharma

Keep 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 containers and medicines at the SIGRE collection point at your pharmacy. If in doubt, 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 Kern Pharma

The active substance is prednisone.

Each tablet contains 5 mg, 10 mg or 30 mg of prednisone.

The other components (excipients) are:

Monohydrate lactose, corn starch, povidone, sodium carboxymethyl starch from potato (type A), magnesium stearate and microcrystalline cellulose.

Appearance of the product and contents of the pack

Prednisona Kern Pharma 5 mg

Round, white, scored tablets. The tablets may be divided into equal parts.

Prednisona Kern Pharma 10 mg

Round, white, scored tablets. The score is intended only to facilitate breaking the tablet for ease of swallowing and not for dividing the tablet into equal doses.

Prednisona Kern Pharma 30 mg

Round, white, scored tablets.

The tablet can be divided into equal doses.

Prednisona Kern Pharma tablets are packaged in PVC/aluminum blisters.

Pack sizes:

Prednisona Kern Pharma 5 mg

Pack containing 30 or 60 tablets.

Prednisona Kern Pharma 10 mg and Prednisona Kern Pharma 30 mg

Pack containing 30 tablets.

Marketing Authorization Holder and Manufacturer

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

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 of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).