PREDNISONA TARBIS 2.5 mg TABLETS

2. What you need to know before taking Prednisona Tarbis

Do not take Prednisona Tarbis:

• If you are allergic to prednisona or any of the other components of this medicine.
• In cases of osteomalacia and osteoporosis.
• If you have diabetes mellitus.
• If you suffer from psychosis.
• In cases 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 have glaucoma.

Warnings and precautions

• Tell 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 Tarbis, so your doctor will monitor you closely if you are taking these medicines (including some for HIV: ritonavir, cobicistat).
• Contact your doctor if you experience blurred vision and other visual disturbances.

Consult your doctor or pharmacist before starting to take Prednisona Tarbis.

• If you have risk factors for osteoporosis: family history, advanced age, post-menopause, significant smoking, and lack of physical activity, as treatment with Prednisona Tarbis may cause bone mass loss. In these situations, your doctor may prescribe treatment to prevent osteoporosis.
• In prolonged treatments with Prednisona Tarbis, your doctor may prescribe potassium supplements and reduce sodium intake.
• In cases of severe heart failure, careful medical monitoring is required.
• In cases of poor thyroid function (hypothyroidism) or liver cirrhosis, lower doses than those recommended may be sufficient.
• After a long treatment period, if you need to stop taking Prednisona Tarbis or interrupt its use, you may experience a relapse of another disease you suffer from, acute 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 diminished defenses and in people who have not had measles or chickenpox.
• In cases of prolonged treatment in children, the pancreas may be damaged.
• Taking prednisona may give false results in skin tests for

allergy.

• If you have scleroderma (also known as systemic sclerosis, an autoimmune disorder), because daily doses equal to or greater than 15mg 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 have your blood pressure and urine checked periodically.

Interaction of Prednisona Tarbis with other medicines

Tell your doctor or pharmacist if you are using or have recently used 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 the latter on blood sugar levels may be reduced.
• If you take coumarin derivatives (medicines to control blood coagulation), the anticoagulant effect of the latter may be reduced.
• 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.
• Due to mutual inhibition of their activity, prednisona should not be given with cyclosporine.
• The administration of prednisona with cyclophosphamide may modify the effects of the latter.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.Prednisona Tarbis is not recommended 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 Tarbis is not recommended 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 may negatively affect the ability to drive and use machinery.

Prednisona Tarbis 2.5 mg tablets EFGcontain lactose.

If your doctor has told you that you have an intolerance to certain sugars, consult him before taking this medicine.

Use in athletes

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

3. How to take Prednisona Tarbis

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

Remember to take your medicine.

The tablets should be 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 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.

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

Your doctor will indicate the duration of your treatment with Prednisona Tarbis 2.5 mg. Do not stop treatment before or abruptly, as this may worsen your disease.

If you think the effect of Prednisona Tarbis 2.5 mg is too strong or too weak, tell your doctor or pharmacist.

Adults:

The treatment dose will depend on the type and severity of the disease and the individual patient's response. The initial dose is usually 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 Tarbis until the maintenance dose is reached, which is usually between 5 and 10 mg per day.

In bronchial asthma, the procedure is the same, although the initial dose in severe cases may be between 15 and 60 mg.

Children:

In general, 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. Prednisona Tarbis 2.5 mg should not be stopped abruptly, but the dosage will be gradually reduced.

If you take more Prednisona Tarbis than you should

Acute overdoses with prednisona are not known. In the event of an overdose, it is expected that the adverse reactions described in this package leaflet will occur to a greater extent. The overdose may cause excitement, anxiety, depression, mental confusion, gastrointestinal bleeding, increased blood pressure, and blood sugar levels, as well as fluid retention (edema).

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.

If you forget to take Prednisona Tarbis

If you forget to take Prednisona Tarbis 2.5 mg, do not take a double dose to make up for the missed doses, wait for the next dose and continue treatment as usual.

If you interrupt treatment with Prednisona Tarbis

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

4. Possible side effects

Like all medicines, Prednisona Tarbis can have side effects, although not everyone gets them. These can be:

• In prolonged treatments, some localized obesity may appear in the abdomen and face (moon face), increased blood sugar, loss of calcium from the bones (osteoporosis), increased blood pressure, appearance of hair, acne, suppression of menstruation, sexual impotence in men, and growth retardation in children.
• Glaucoma, cataracts.
• Excitement, irritability, and increased appetite.
• Muscle atrophy and pain.
• Gastroduodenal ulcer and gastrointestinal bleeding.
• Wounds take longer to heal, and stretch marks may appear on the skin.
• 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.
• Unknown frequency: 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.
  • Unknown frequency: Decreased heart rate

Blurred vision.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Prednisona Tarbis

Keep this medicine out of the sight and reach of children.

No special storage conditions are required.

Do not use Prednisona Tarbis after the expiry date stated on the packaging after "EXP". The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the pharmacy's SIGRE collection point. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Prednisona Tarbis 2.5 mg tablets EFG

The active ingredient is prednisona. Each tablet contains 2.5 mg of prednisona.

The other ingredients (excipients) are:

Lactose monohydrate, sodium carboxymethyl starch Type A (potato), magnesium stearate, colloidal anhydrous silica, and talc.

Appearance of the product and packaging contents

White, cylindrical, biconvex tablets, scored on one side with the inscription PD and with the inscription 2.5 on the other.

The tablets can be divided into equal parts.

The Prednisona Tarbis 2.5 mg tablets EFGare packaged in PVC-PVDC/Aluminum blisters.

The Prednisona Tarbis 2.5 mg tablets EFGare available in packs containing 30 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Tarbis Farma, S.L.

Gran Vía Carlos III, 94

08028 Barcelona – Spain

Manufacturer

Laboratorios Cinfa, S.A.

C/ Olaz-Chipi, 10 - Polígono Industrial Areta.

31620 Huarte - Pamplona (Navarra)-Spain

Date of the last revision of this package leaflet:October 2021

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