PREDNISONA TARBIS 10 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 Prednisona Tarbis 10 mg tablets.
• 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 have glaucoma.

Warnings and Precautions

• Tell your doctor if you are taking or have recently taken other medications, including those purchased without a prescription.
• Some medications may increase the effects of Prednisona Tarbis, so your doctor will closely monitor you if you are taking these medications (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 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 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 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 glucocorticoid treatment. 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 Tarbis may give false results in skin tests for allergy tests.
• If you have scleroderma (also called 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 periodically check your blood pressure and urine.

Interaction of Prednisona Tarbis with other medications

Tell your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

• Rifampicin, phenytoin, carbamazepine, and barbiturates may decrease the effect of prednisona. Erythromycin and ketoconazole may increase them.
• 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 medications for diabetes treatment, the effects of the latter on blood sugar levels may be less.
• If you take coumarin derivatives (medications to control blood coagulation), the anticoagulant effect of the same 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.
• Due to mutual inhibition of activity, prednisona should not be given together with cyclosporine.
• Concomitant 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 plan to become pregnant, consult your doctor or pharmacist before using this medication.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 suspend breastfeeding or interrupt the administration of this medication.

Driving and Using Machines

It should be noted that in long-term treatments, visual acuity may decrease.

This could negatively affect the ability to drive and use machinery.

Prednisona Tarbis 10 mg tabletscontain lactose.

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

Athletes

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

3. How to take Prednisona Tarbis

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

Remember to take your medication.

The 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 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.

Prednisona Tarbis 10 mg tablets 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 Tarbis 10 mg tablets. Do not suspend treatment before or abruptly, as this may worsen your illness. If you think the effect of Prednisona Tarbis 10 mg tablets 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 Tarbis 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 initial dose in very severe cases ranges between 15 and 60 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 weight and day.

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 leaflet will occur to a greater extent. The overdose may cause excitement, anxiety, depression, mental confusion, gastrointestinal bleeding, increased blood pressure, and increased 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 medication and the amount ingested.

If you forget to take Prednisona Tarbis

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

If you interrupt treatment with Prednisona Tarbis

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

4. Possible side effects

Like all medications, Prednisona Tarbis can cause side effects, although not everyone will experience them.

• In prolonged treatments, certain localized obesity may appear in the abdomen and face (moon face), increased blood sugar, loss of bone calcium (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 skin stretch marks may appear.
• Some infections may go unnoticed, and there is 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 side effects

If you experience any type of side effect, 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 Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Prednisona Tarbis

Keep this medication out of sight and reach of children.

No special storage conditions are required.

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

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Prednisona Tarbis 10 mg tablets

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

The other components (excipients) are:

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

Appearance of the product and package contents

White, cylindrical, biconvex tablets, scored on one side and with the inscription PD10 on the other.

The tablets can be divided into equal parts.

Prednisona Tarbis 10 mg tabletsare packaged in PVC-PVDC/Aluminum blisters.

Prednisona Tarbis 10 mg tabletsare presented in packages 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 leaflet:October 2021

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