Package Insert: Information for the Patient

Prednisona Tarbis 30 mg Tablets EFG

prednisona

Read this package insert carefully before starting to take 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 or nurse.
• This medicine has been prescribed only for you and should not be given to others, even if they have the same symptoms of the disease, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist or nurse, even if they are not listed in this package insert.

1. What is Prednisona Tarbis and how is it used

2. What you need to know before starting to take Prednisona Tarbis

3. How to take Prednisona Tarbis

4. Possible side effects

5. Storage of Prednisona Tarbis

6. Contents of the package and additional information

Prednisone is a corticosteroid (glucocorticoid) derived from cortisol.

It intervenes by regulating many of the body's metabolic processes.

Prednisona Tarbis 30 mg tablets EFG are used for the treatment of:

- acute and chronic rheumatic joint and muscle processes,

- bronchial asthma and pulmonary fibrosis,

- ulcerative colitis (inflammatory bowel disease),

- hepatitis,

- Addison's disease,

- adrenogenital syndrome,

- kidney and urinary tract diseases,

- allergic and inflammatory skin processes,

- hemolytic anemias,

- agranulocytosis (absence of defensive blood cells),

- rheumatic purpura,

- acute leukemia and other hematological diseases,

- some inflammatory eye diseases (allergic conjunctivitis, keratitis, choroidoretinitis, iritis, iridocyclitis),

- as an adjunct in organ transplantation.

Do not take Prednisona Tarbis

- If you are allergic to prednisone or any of the other components of Prednisona Tarbis 30 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 using chemotherapy drugs simultaneously).

- In acute bacterial infections.

- If you have chickenpox or herpes.

- In cases of systemic infections caused by fungi.

- If you are to be vaccinated, do not take prednisone during the 8 weeks prior to vaccination or 2 weeks after vaccination.

- In cases of severe high blood pressure.

- If you have glaucoma.

Warnings and precautions

• Inform 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 perform thorough checks 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 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 prednisone, your doctor may prescribe potassium supplements and reduce your sodium intake.

- In severe heart failure, careful medical monitoring 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 must stop taking prednisone or interrupt its use, you may experience a relapse of another disease you have, acute 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.

- Taking prednisone may produce false results in skin tests for allergy tests.

- If you have scleroderma (also known as systemic sclerosis, an autoimmune disorder), because daily doses of 15mg or more may increase the risk of a severe complication called scleroderma renal crisis. Signs of scleroderma renal crisis are high blood pressure and decreased urine production. Your doctor may advise you to monitor your blood pressure and urine production periodically.

Interaction of Prednisona Tarbis with other medications

Inform 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 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 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.

- Taking prednisone and digoxin, diuretics, or amphotericin B may cause alterations in potassium levels.

- Taking 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.

- Due to mutual inhibition of activity, prednisone should not be given with cyclosporine.

- The administration of prednisone with cyclophosphamide may modify the effects of the latter.

Pregnancy, lactation, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.This medication is not recommended during pregnancy unless your doctor prescribes it.

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

This medication is not recommended during lactation, 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.

Prednisona Tarbis 30 mg tablets EFGcontain 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 informed 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 indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Remember to take your medication.

Tablets are taken 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. Sometimes, especially in children, and only when your doctor has indicated so, the treatment will only be taken on alternate days. Your doctor will decide on the dose you should take, adjusting it to your needs.

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 90 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 Tarbis to achieve the maintenance dose, which usually 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 15 to 60 mg.

In the case of adjunctive treatments for organ transplants, the recommended daily doses may range, depending on the organ involved, from 30 to 300 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 set at 0.25 mg of prednisone per kilogram of body weight per day.

Prednisona Tarbisshould not be discontinued abruptly, but rather the dosage should be gradually reduced. In general, the maintenance dose should always be the lowest possible.

Your doctor will indicate 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 ofPrednisona Tarbisis too strong or too weak, inform your doctor.

If you take more Prednisona Tarbis than you should

No acute intoxications with prednisone are known. In the event of overdose, it is expected that the adverse reactions described in this prospectus will occur to a greater degree. 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 Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Prednisona Tarbis

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

If you interrupt treatment with Prednisona Tarbis

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

Like all medications, Prednisona Tarbis 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, acne, menstrual suppression, impotence in males, and delayed growth in children may appear.

- Glaucoma, cataracts.

- Excitement, irritability, and increased appetite.

- Muscle atrophy and pain.

- Gastric and duodenal ulcers and digestive 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.

- 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 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 theSpanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es.By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

No special storage conditions are required.

Do not use Prednisona Tarbis 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 the packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Prednisona Tarbis 30 mg tablets EFG

The active ingredient is prednisone. Each tablet contains 30 mg of prednisone.

The other components (excipients) are:

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

Appearance of the product and contents of the packaging

White, oblong, biconvex, and scored tablets.

The tablets can be divided into equal parts.

The tablets ofPrednisona Tarbis 30 mg tablets EFGare packaged in PVC-PVDC / Aluminum blisters.

The tablets ofPrednisona Tarbis 30 mg tablets EFGare presented in containers holding 20 or 30 tablets.

Holder of the marketing authorization and responsible for manufacturing:

Holder of the marketing authorization

Tarbis Farma, S.L.

Gran Vía Carlos III, 94

08028 Barcelona - Spain

Responsible for manufacturing

Laboratorios Cinfa, S.A.

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

31620 Huarte - Pamplona (Navarra)-Spain

Date of the last review of this leaflet:October 2021

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