Prednisone Tarbis 5 mg tablets EFG
Spain
Table of Contents
Patient Information Leaflet
Introduction
Package Leaflet: Information for the patient
Prednisona Tarbis 5 mg tablets EFG
prednisone
Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, ask 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 or pharmacist or nurse, even if such effects are not listed in this leaflet.
Leaflet Contents:
- What Prednisona Tarbis is and what it is used for
- What you need to know before taking Prednisona Tarbis
- How to take Prednisona Tarbis
- Possible side effects
- How to store Prednisona Tarbis
- Contents of the pack and other information
1. What Prednisona Tarbis is and what it is used for
Prednisone is a corticosteroid (glucocorticoid) derived from cortisone.
It acts by regulating many of the body's metabolic processes.
Prednisona Tarbis 5 mg tablets are used to treat:
- acute and chronic rheumatic conditions affecting joints and muscles,
- bronchial asthma and pulmonary fibrosis,
- ulcerative colitis (inflammatory bowel disease),
- hepatitis,
- Addison's disease,
- adrenogenital syndrome,
- diseases of the kidneys and urinary tract,
- allergic and inflammatory skin conditions,
- hemolytic anemias,
- agranulocytosis (lack of defensive 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 any of the other components of Prednisona Tarbis 5 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 simultaneously using chemotherapeutic drugs).
- In acute bacterial infections.
- If you have chickenpox or herpes.
- In cases of systemic fungal infections.
- If vaccination is required, 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 perform 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 predisposition, advanced age, post-menopausal status, heavy smoking, and lack of physical activity, as treatment with prednisone 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 sodium intake.
- In cases of severe heart failure, careful medical monitoring should be performed.
- In cases of reduced thyroid function (hypothyroidism) or hepatic cirrhosis, doses lower than those recommended may be sufficient.
- If you have an overactive thyroid gland (hyperthyroidism).
- After a long period of treatment, if you need to stop or interrupt taking Prednisona Tarbis, you may experience a relapse of another illness you have, acute adrenal cortex insufficiency (especially if you have an infection or after 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 Prednisona Tarbis may lead to false results in skin tests for allergy testing.
- 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 production. Your doctor may advise you to periodically monitor your blood pressure and urine.
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 thus the effectiveness of prednisone.
- If you take medicines for the treatment of diabetes, their effects on blood sugar levels may be reduced.
- If you take coumarin derivatives (medicines to control blood clotting), their anticoagulant effect may be diminished.
- Taking prednisone together with digitalis, diuretics, or amphotericin B may cause disturbances 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 mutually 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.
It is not recommended to take Prednisona Tarbis 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.
It is not recommended to take Prednisona Tarbis 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 the ability to drive and use machinery.
Prednisona Tarbis 5 mg tablets contain lactose.
If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.
Use in athletes
Athletes are advised that this medicine contains a component that may produce a positive result in doping control tests.
3. How to take Prednisona Tarbis
Follow exactly the instructions for use of this medicine provided 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 to your individual needs.
Prednisona Tarbis 5 mg tablets must not be stopped abruptly; instead, the dosage should be gradually reduced.
In general, the maintenance dose should always be the lowest possible.
Your doctor will advise you on the duration of your treatment with Prednisona Tarbis 5 mg tablets.
Do not stop treatment prematurely or abruptly, as this could worsen your condition.
If you feel that the effect of Prednisona Tarbis 5 mg tablets is too strong or too weak, inform your doctor.
Adults:
The treatment dose will depend on the type and severity of the disease and on 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.
Once this occurs, your doctor will gradually reduce your dose of Prednisona Tarbis until reaching 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 given 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.
If you take more Prednisona Tarbis than you should
Acute intoxications with prednisone are not known. In case of overdose, the adverse reactions described in this leaflet are expected to 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 medication and the amount ingested.
If you forget to take Prednisona Tarbis
Do not take a double dose to make up for missed doses. Wait until your next scheduled dose and continue 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 produce adverse effects, although not everyone experiences them.
- In prolonged treatments, certain localized obesity may appear, affecting the abdomen and face (moon face), increased blood sugar, loss of calcium from bones (osteoporosis), increased blood pressure, growth of body hair, acne, suppression of menstruation, sexual impotence in men, and growth retardation 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: decreased number of white blood cells or increased 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 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 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 refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.
6. Contents of the container and other information
Composition of Prednisona Tarbis 5 mg tablets
The active substance is prednisone. Each tablet contains 5 mg of prednisone.
The other components (excipients) are:
Lactose monohydrate, sodium carboxymethyl starch Type A (from potato), magnesium stearate, colloidal anhydrous silica and talc.
Appearance of the product and contents of the container
White cylindrical biconvex tablets, scored on one side and marked with "PD5" on the other.
The tablets may be divided into equal parts.
Prednisona Tarbis 5 mg tablets EFG are packaged in PVC-PVDC/Aluminum blisters.
Prednisona Tarbis 5 mg tablets EFG are available in packs containing 30 or 60 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 most recent revision of this package leaflet: January 2026
Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) www.aemps.gob.es/