Package Insert: Information for the User

Prednisona Kern Pharma 5 mg Tablets EFG

Read this package insert carefully before taking this medicine, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you, and you should not give it to others who have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Prednisone is a corticosteroid (glucocorticoid) obtained from cortisol. It intervenes by regulating many of the body's metabolic processes.

Prednisona Kern Pharma is used for the treatment of:

• acute and chronic joint and muscular rheumatic processes,
• asthma bronchial and pulmonary fibrosis,
• ulcerative colitis (inflammatory disease of the intestine),
• hepatitis,
• Addison's disease,
• adrenogenital syndrome,
• kidney and urinary tract diseases,
• allergic and inflammatory skin processes,
• hemolytic anemias,
• agranulocytosis (absence of defensive blood cells),
• purpura rheumatica,
• acute leukemia and other hematological diseases,
• some inflammatory eye diseases (allergic conjunctivitis, keratitis, coriorretinitis, iritis, iridocyclitis).

Do not take Prednisona Kern Pharma

• If you are allergic to prednisone or any of the other components of this medication (listed in section 6).
• In cases of osteomalacia and osteoporosis.
• If you have diabetes mellitus.
• If you suffer from psychosis.
• In case of peptic ulcer.
• In cases of active tuberculosis (unless using chemotherapy drugs simultaneously).
• In acute bacterial infections.
• If you have chickenpox or herpes.
• In cases of systemic infections caused by fungi.
• If you need to be vaccinated, do not take prednisone for 8 weeks before vaccination or 2 weeks after vaccination.
• In cases of severe high blood pressure.
• If you are allergic to prednisone or any other component of this medication.
• If you have glaucoma.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication.

• If you have the following risk factors for osteoporosis: family predisposition, advanced age, post-menopause, heavy smoking, and lack of physical activity, as prednisone treatment may cause bone loss. In these situations, your doctor may prescribe a treatment to prevent osteoporosis.
• In prolonged treatments with Prednisona Kern Pharma, your doctor may prescribe potassium supplements and reduce your sodium intake.
• In cases of severe heart failure, a careful medical check-up should be performed.
• In cases of poor thyroid function (hypothyroidism) or liver cirrhosis, lower doses than recommended may be sufficient.
• After a long period of treatment, if you need to stop taking Prednisona Kern Pharma or interrupt its use, you may experience a relapse of another disease you have, adrenal insufficiency (especially if you have an infection or after an accident), or corticosteroid withdrawal syndrome.
• Chickenpox or measles may be especially severe in patients undergoing glucocorticoid treatment. This should be taken into account especially in children with weakened immune systems and in people who have not had measles or chickenpox.
• In cases of prolonged treatment in children, the pancreas may be damaged.
• It is reported to athletes that the medication contains a component that may produce a positive result in doping control tests.
• The use of Prednisona Kern Pharma may produce false results in skin tests for allergy tests.
• Contact your doctor if you experience blurred vision or other visual disturbances.
• If you have scleroderma (also known as systemic sclerosis, an autoimmune disorder), because daily doses of 15 mg or more may increase the risk of a severe complication called scleroderma renal crisis. The signs of scleroderma renal crisis are high blood pressure and decreased urine production. Your doctor may advise you to have your blood pressure and urine checked periodically.

Use of other medications

Inform your doctor if you are taking or have recently taken other medications, including those purchased without a prescription.

• Rifampicin, phenytoin, carbamazepine, and barbiturates may reduce the effect of prednisone. Erythromycin and ketoconazole may increase it.
• Contraceptives containing estrogens may increase the effect of prednisone.
• Antacids (aluminum, magnesium) may reduce the absorption and therefore the effectiveness of prednisone.
• If you take prednisone with diabetes medications, the effects of these medications on blood sugar levels may be reduced.
• If you take coumarin derivatives (medications to control blood clotting), the anticoagulant effect may be reduced.
• The concurrent use of prednisone and digoxin, diuretics, or amphotericin B may cause changes in potassium levels.
• The concurrent use of prednisone with non-steroidal anti-inflammatory drugs or antirheumatic drugs (indomethacin, acetylsalicylic acid) may increase the risk of gastrointestinal bleeding.
• The effects of muscle relaxants may be increased if taken with prednisone.
• Because their activity is mutually inhibited, prednisone should not be given concurrently with cyclosporine.
• The concurrent administration of prednisone with cyclophosphamide may modify the effects of the latter.
• Some medications may increase the effects of Prednisona Kern Pharma, so your doctor will perform close monitoring if you are taking these medications (including some for HIV: ritonavir, cobicistat).

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

Prednisone is not recommended during pregnancy unless your doctor prescribes it.

If during treatment you experience symptoms of acute diseases such as infectious diseases, digestive problems, or mental disturbances, see your doctor.

Prednisone is not recommended during breastfeeding, unless your doctor prescribes it. He will indicate whether you should stop breastfeeding or interrupt the administration of this medication.

Driving and operating machinery

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

Important information about some components of Prednisona Kern Pharma

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

Use in athletes

It is reported to athletes that this medication contains a component that may produce a positive result in doping control tests.

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

Remember to take your medication.

Swallow the tablets whole 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 can be taken in a single daily dose, during or after breakfast. Occasionally, especially in children, and only when your doctor has indicated so, treatment will only be taken on alternate days.

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

Prednisona Kern Pharma should not be stopped abruptly, but the dosage should be gradually reduced.

Generally, the maintenance dose should always be the lowest possible.

Your doctor will inform you of the duration of your treatment with prednisone. Do not discontinue treatment before or abruptly, as this could worsen your condition.

If you estimate that the action of this medication 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 response of the patient. 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 reaction is observed. When this occurs, your doctor will gradually reduce the dose of Prednisona Kern Pharma to reach the maintenance dose, which normally ranges from 5 to 10 mg per day. In bronchial asthma, the same procedure is followed, although the attack dose in severe cases ranges from 40 to 60 mg.

Children

Generally, prednisone treatment in children can be done 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 Kern Pharma than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

No acute intoxications with prednisone are known. In the case of overdose, it is expected that the adverse reactions described in this prospectus will occur to a greater extent. Overdose can cause excitement, anxiety, depression, mental confusion, gastrointestinal bleeding, increased blood pressure, and blood sugar levels, as well as fluid retention (edema).

If you forgot to take Prednisona Kern Pharma

Do not take a double dose to compensate for the missed doses. Wait for the next dose and follow the treatment normally.

If you interrupt treatment with Prednisona Kern Pharma

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

Like all medications, this medication may produce adverse effects, although not all people may experience them.

• In prolonged treatments, certain localized obesity in the abdomen and face (moon face), increased blood sugar, bone calcium loss (osteoporosis), increased blood pressure, appearance of hair, menstrual suppression, impotence in males, and delayed growth in children may appear.
• Glaucoma, cataracts, blurred vision.
• Excitement, irritability, and increased appetite.
• Muscle atrophy and muscle pain.
• Peptic ulcer and gastrointestinal hemorrhage.
• Wounds take longer to heal and may appear stretch marks on the skin.
• Some infections may go unnoticed and have less resistance to them.
• Blood alterations: decrease in the number of white blood cells or increase in the number of red blood cells.
• Renal crisis in patients with scleroderma (an autoimmune disorder). Signs of a renal crisis include increased blood pressure and decreased urine production.
• Decreased heart rate (unknown frequency).

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for human use:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep out of the sight and reach of children.

Do not store above 30°C.

Do not use this medicine after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medicines you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition of Prednisona Kern Pharma

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

The other components (excipients) are:

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

Appearance of the product and content of the packaging

Round, white, and scored tablets.

The tablets can be divided into equal parts.

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

Packaging containing 30 or 60 tablets.

Holder of the marketing authorization and responsible for manufacturing

Kern Pharma, S.L.

Venus, 72 - Pol. Ind.Colón II

08228 Terrassa - Barcelona

Spain

Last review date of this leaflet: May 2021

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