PREDNISONA KERN PHARMA 30 mg TABLETS

2. What you need to know before you start taking Prednisona Kern Pharma

Do not take Prednisona Kern Pharma

• If you are allergic to prednisona or any of the other ingredients of this medicine (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 chemotherapeutic drugs are used simultaneously).
• In acute bacterial infections.
• If you have chickenpox or herpes.
• In cases of systemic fungal infections.
• If you need to be vaccinated, do not take prednisona during the 8 weeks prior to vaccination or 2 weeks after vaccination.
• In cases of severe arterial hypertension.
• If you are allergic to prednisona or any other ingredient of this medicine.
• If you have glaucoma.

Warnings and precautions

Talk to your doctor or pharmacist before starting this medicine.

• If you have risk factors for osteoporosis: family history, advanced age, post-menopause, heavy smoking, and lack of physical activity, as treatment with prednisona may cause bone mass loss. In these situations, your doctor may prescribe treatment to prevent osteoporosis.
• In prolonged treatments with Prednisona Kern Pharma, your doctor may prescribe potassium supplements and reduce sodium intake.
• In case of severe heart failure, careful medical monitoring is required.
• In cases of poor thyroid function (hypothyroidism) or liver cirrhosis, lower doses than recommended may be sufficient.
• After a long treatment period, if you need to stop taking Prednisona Kern Pharma or interrupt its use, you may experience a relapse of another disease you suffer from, adrenal insufficiency (especially if you have an infection or after an accident), or cortisone withdrawal syndrome.
• Chickenpox or measles can be particularly severe in patients undergoing treatment with glucocorticoids. This should be taken into account especially in children with weakened defenses and in people who have not had measles or chickenpox.
• In cases of prolonged treatment in children, the pancreas may be damaged.
• Athletes are informed that the medicine contains a component that can produce a positive result in doping tests.
• Taking Prednisona Kern Pharma may give incorrect 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 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.

Use of other medicines

Tell your doctor if you are taking or have recently taken any other medicines, including those obtained without a prescription.

• Rifampicin, phenytoin, carbamazepine, and barbiturates may decrease the effect of prednisona. Erythromycin and ketoconazole may increase it.
• Contraceptives containing estrogens may increase the effect of prednisona.
• Antacids (aluminum, magnesium) may decrease the absorption, and therefore the effectiveness, of prednisona.
• If you take medicines for diabetes treatment, the effects of these on blood sugar levels may be reduced.
• If you take coumarin derivatives (medicines to control blood coagulation), the anticoagulant effect of these may be decreased.
• Taking prednisona with digitalis, diuretics, or amphotericin B may cause changes in potassium levels.
• Taking prednisona with non-steroidal anti-inflammatory drugs or antirheumatics (indomethacin, acetylsalicylic acid) may increase the risk of gastrointestinal bleeding.
• The effects of muscle relaxants may be increased if taken with prednisona.
• Because their activity is mutually inhibited, prednisona should not be taken with cyclosporin.
• Concomitant administration of prednisona with cyclophosphamide may alter the effects of the latter.
• Some medicines may increase the effects of Prednisona Kern Pharma, so your doctor will perform thorough checks if you are taking these medicines (including some for HIV: ritonavir, cobicistat).

Pregnancy and breastfeeding

Ask your doctor or pharmacist for advice before taking any medicine.

Prednisona should not be taken during pregnancy unless your doctor prescribes it.

If symptoms of acute diseases such as infectious, digestive, or mental disorders appear during treatment, consult your doctor.

Prednisona should not be taken during breastfeeding unless your doctor prescribes it. He will indicate whether you should stop breastfeeding or interrupt the administration of this medicine.

Driving and using machines

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

Important information about some of the ingredients of Prednisona Kern Pharma

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

Use in athletes

Athletes are informed that this medicine contains a component that can produce a positive result in doping tests.

3. How to take Prednisona Kern Pharma

Follow the instructions for administration of this medicine exactly as indicated by your doctor. If you are unsure, consult your doctor or pharmacist again.

Remember to take your medicine.

Tablets are taken whole 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 if your doctor has indicated it, treatment will be taken on alternate days.

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

Prednisona Kern Pharma should not be stopped abruptly, but 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 stop treatment before or abruptly, as this could worsen your disease.

If you think the effect of this medicine is too strong or too weak, tell 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 Kern Pharma to the maintenance dose, which is usually between 5 and 10 mg per day. In bronchial asthma, the procedure is the same, although the attack dose in very severe cases ranges from 40 to 60 mg.

In the case of adjunctive treatments for organ transplantation, the recommended daily doses may range, depending on the organ being treated, from 30 to 300 mg.

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 kilogram of body weight and 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 Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

Acute intoxications with prednisona are not known. In the case of overdose, it is expected that the adverse reactions described in this package 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 Kern Pharma

Do not take a double dose to make up for forgotten doses. Wait for the next dose and continue treatment as usual.

If you stop taking Prednisona Kern Pharma

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

• In prolonged treatments, certain localized obesity in the abdomen and face (moon face), increased blood sugar, bone mass loss (osteoporosis), increased blood pressure, appearance of hair, suppression of menstruation, sexual impotence in men, and growth retardation in children may appear.
• Glaucoma, cataracts, blurred vision.
• Excitement, irritability, and increased appetite.
• Muscle atrophy and pain.
• Gastroduodenal ulcer and gastrointestinal bleeding.
• Wounds take longer to heal and skin stretch marks may appear.
• Some infections may go unnoticed and there may be less resistance to them.
• Blood disorders: decrease in the number of white blood cells or increase in the number of red blood cells.
• 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.
• Decreased heart rate (frequency not known).

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency's (AEMPS) online system: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Prednisona Kern Pharma

Keep 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 "CAD". The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for proper disposal. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

Composition of Prednisona Kern Pharma

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

The other ingredients (excipients) are:

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

Appearance of the product and pack contents

Round, white, and scored tablets.

Tablets can be divided into equal parts.

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

Packs containing 30 tablets.

Marketing authorization holder and manufacturer

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Date of last revision of this package leaflet: May 2021

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