Prednisone Tarbis 2.5 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Prednisona Tarbis 2.5 mg tablets EFG

prednisone

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms of illness, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet.

Leaflet contents

1. What Prednisona Tarbis is and what it is used for
2. What you need to know before taking Prednisona Tarbis
3. How to take Prednisona Tarbis
4. Possible side effects
5. How to store Prednisona Tarbis
6. Contents of the pack and other information

1. What Prednisona Tarbis is and what it is used for

The prednisone contained in Prednisona Tarbis 2.5 mg is a corticosteroid (glucocorticoid) derived from cortisone. It acts by regulating many of the body's metabolic processes.

Prednisona Tarbis 2.5 mg film-coated tablets are indicated for the treatment of:

• acute and chronic rheumatic disorders affecting joints and muscles,
• bronchial asthma and pulmonary fibrosis,
• ulcerative colitis (inflammatory bowel disease),
• hepatitis,
• Addison's disease,
• adrenogenital syndrome,
• kidney and urinary tract disorders,
• allergic and inflammatory skin conditions,
• hemolytic anemias,
• agranulocytosis (absence of white blood cells),
• rheumatic purpura,
• acute leukemia and other hematological disorders,
• certain inflammatory eye diseases (allergic conjunctivitis, keratitis, chorioretinitis, iritis, iridocyclitis).

2. What you need to know before taking Prednisona Tarbis

Do not take Prednisona Tarbis:

• If you are allergic to prednisone or to any of the other ingredients 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 simultaneously treated with chemotherapeutic drugs).
• 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 prednisone 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

• Inform your doctor if you are taking or have recently taken any other medicines, including those obtained without a prescription.
• Some medicines may increase the effects of Prednisona Tarbis, so your doctor will carry out careful monitoring if you are taking these medicines (including some for HIV: ritonavir, cobicistat).
• Contact your doctor if you experience blurred vision or other visual disturbances.

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

• If you have the following risk factors for osteoporosis: family history, advanced age, post-menopausal status, heavy smoking, and lack of physical activity, as treatment with Prednisona Tarbis may cause loss of bone mass. In such cases, your doctor may prescribe treatment to prevent osteoporosis.

• During prolonged treatment with Prednisona Tarbis, your doctor may prescribe potassium supplements and recommend reducing your sodium intake.

• In cases of severe heart failure, careful medical monitoring is required.

• In cases of underactive thyroid (hypothyroidism) or liver cirrhosis, lower than recommended doses may be sufficient.

• If you have an overactive thyroid gland (hyperthyroidism).

• After a long period of treatment, if you must stop or interrupt taking Prednisona Tarbis, you may experience a relapse of another illness, acute adrenal insufficiency (especially if you have an infection or following an accident), or cortisone withdrawal syndrome.

• Chickenpox or measles may be particularly severe in patients receiving glucocorticoid treatment. This should be especially considered in children with weakened immune systems and in individuals who have not had measles or chickenpox.

• In cases of prolonged treatment in children, pancreatic damage may occur.

• Taking prednisone may lead to false results in skin tests for allergies.

• 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. Signs of scleroderma renal crisis include increased blood pressure and decreased urine output. Your doctor may advise you to have your blood pressure and urine monitored regularly.

Contact your doctor immediately if you experience muscle weakness, muscle pain, cramps, or muscle stiffness while using prednisone. These may be symptoms of a condition called thyrotoxic periodic paralysis, which may occur in patients with an overactive thyroid gland (hyperthyroidism) treated with prednisone. You may require additional treatment to relieve this condition.

Interaction of Prednisona Tarbis with other medicines

Inform your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained 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 medicines for diabetes treatment, their effects on blood sugar levels may be reduced.
• If you take coumarin derivatives (medicines to control blood coagulation), their anticoagulant effect may be reduced.
• Taking prednisone together with digitalis, diuretics, or amphotericin B may cause changes 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 together with prednisone.
• Because their activities inhibit each other, prednisone and cyclosporine should not be administered together.
• The concomitant administration of prednisone and cyclophosphamide may alter the effects of the latter.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine. Prednisona Tarbis is not recommended during pregnancy unless prescribed by your doctor.

If symptoms of acute-onset diseases such as infectious, gastrointestinal, or psychiatric disorders appear during treatment, consult your doctor.

Prednisona Tarbis is not recommended during breastfeeding unless prescribed by your doctor. Your doctor will advise whether you should discontinue breastfeeding or stop taking this medicine.

Driving and use of machines:

It should be noted that prolonged treatment may reduce visual acuity.

This could negatively affect your ability to drive or operate machinery.

Prednisona Tarbis 2.5 mg tablets EFG contains lactose.

If your doctor has informed you of an intolerance to certain sugars, consult with him before taking this medicine.

Use in athletes

Athletes should be aware that this medicine contains a component that may lead to a positive result in doping control tests.

3. How to take Prednisona Tarbis

Always follow exactly the instructions for administration of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Remember to take your medicine.

The tablets should be taken whole with sufficient liquid. The total daily dose should be divided into three or four doses, taken during or after meals. In some cases, the prescribed dose may be taken as a single daily dose during or after breakfast. Occasionally, especially in children and only if specifically instructed by your doctor, treatment may be administered on alternate days.

Your doctor will determine the dose you should take, adjusting it according to your individual needs.

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

Your doctor will inform you about the duration of your treatment with Prednisona Tarbis 2.5 mg. Do not stop the treatment prematurely or abruptly, as this could worsen your condition.

If you feel that the effect of Prednisona Tarbis 2.5 mg is too strong or too weak, inform your doctor or pharmacist.

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 are administered until a satisfactory response is observed.

Once this occurs, your doctor will gradually reduce your dose of Prednisona Tarbis to reach the maintenance dose, which usually ranges between 5 and 10 mg daily.

In bronchial asthma, the same approach is followed, although the initial dose in severe cases ranges from 15 to 60 mg.

Children:

In general, prednisone treatment in children may be administered 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. Prednisona Tarbis 2.5 mg should not be discontinued abruptly; instead, the dosage should be progressively reduced.

If you take more Prednisona Tarbis than you should

Acute intoxication with prednisone is not known. In the case of overdose, the adverse reactions described in this leaflet may 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).

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 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 dose. Wait until the next scheduled dose and continue your treatment as usual.

If you stop treatment with Prednisona Tarbis

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

4. Possible adverse effects

Like all medicines, Prednisona Tarbis may have adverse effects, although not everyone will experience them. These may include:

• With prolonged treatment, certain localized obesity may appear in the abdomen and face (moon face), increased blood sugar, loss of calcium from bones (osteoporosis), increased blood pressure, appearance of body hair, acne, suppression of menstruation, sexual impotence in men, and growth delay in children.
• Glaucoma, cataracts.
• Excitement, irritability, and increased appetite.
• Muscle atrophy and muscle pain.
• Gastroduodenal ulcer and gastrointestinal bleeding.
• Wounds may take longer to heal, and stretch marks may appear on the skin.
• Some infections may go unnoticed, and resistance to infections may be reduced.
• Blood disorders: decrease in the number of white blood cells or increase in the number of red blood cells.
• Frequency not known: Scleroderma renal crisis in patients who already have scleroderma (an autoimmune disorder). Signs of a scleroderma renal crisis include increased blood pressure and decreased urine production.
  • Frequency not known: Decrease in heart rate

Blurred vision.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Prednisona Tarbis

Keep this medicine out of 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 refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Unused containers and medicines should be taken to the SIGRE point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Prednisona Tarbis 2.5 mg tablets EFG

The active substance is prednisone. Each tablet contains 2.5 mg of prednisone.

The other components (excipients) are:

Monohydrate lactose, sodium carboxymethyl starch Type A (from potato), magnesium stearate, anhydrous colloidal silica and talc.

Appearance of the product and contents of the container

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

The tablets may be divided into equal parts.

Prednisona Tarbis 2.5 mg tablets EFG are packaged in PVC-PVDC/Aluminum blisters.

Prednisona Tarbis 2.5 mg tablets EFG are 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 - Areta Industrial Estate

31620 Huarte - Pamplona (Navarra) - Spain

Date of the most recent review of this leaflet: January 2026

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