Patient Information Leaflet: Product Information

Prednisona Tarbis 2.5 mg Tablets EFG

prednisone

Read this 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, consult your doctor or pharmacist or nurse.
• This medicine has been prescribed for you only; do not give it 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 leaflet.

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

2. What you need to know before starting Prednisona Tarbis

3. How to take Prednisona Tarbis

4. Possible side effects

5. Storage of Prednisona Tarbis

6. Contents of the pack and additional information

Prednisone contained in Prednisona Tarbis 2.5 mg is a corticosteroid (glucocorticoid) obtained from cortisol. It intervenes by regulating many of the body's metabolic processes.

Prednisona Tarbis 2.5 mg EFG tablets 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).

Do not take Prednisona Tarbis:

- If you are allergic to prednisone or any of the other components of this medication.

- 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 using chemotherapeutic 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 having been vaccinated.

- 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 present the following risk factors for osteoporosis: family predisposition, advanced age, post-menopause, heavy smokers, and lack of physical activity, as the treatment with Prednisona Tarbis may cause bone mass loss. In these situations, your doctor may prescribe a treatment to prevent osteoporosis.

- In prolonged treatments with Prednisona Tarbis, your doctor may prescribe potassium supplements and reduce your sodium consumption.

- In severe heart failure, a careful medical check-up 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 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 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 defenses and in people who have not had measles or chickenpox.

- In cases of prolonged treatments in children, the pancreas may be damaged.

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

- 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. The signs of a scleroderma renal crisis are high blood pressure and decreased urine production. Your doctor may advise you to have your blood pressure and urine checked periodically.

Prednisona Tarbis interaction 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 decrease the effect of prednisone. Erythromycin and ketoconazole may increase it.

- Contraceptives containing estrogens may increase the effect of prednisone.

- Antacids (aluminum, magnesium) may decrease the absorption, and therefore the effectiveness of prednisone.

- If you take prednisone concurrently with medications for diabetes treatment, 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 decreased.

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

- Concurrent use of prednisone with nonsteroidal anti-inflammatory drugs or antirheumatic drugs (indomethacin, acetylsalicylic acid) may increase the risk of gastrointestinal bleeding.

- The effects of medications that relax muscle tone may be increased if taken concurrently with prednisone.

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

- Concurrent 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.Prednisona Tarbis 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, visit your doctor.

Prednisona Tarbis 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 decrease.

This may negatively affect the ability to drive and operate machinery.

Prednisona Tarbis 2.5 mg tablets EFGcontains 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 should be 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 may be taken in a single daily dose, during or after breakfast. Occasionally, 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.

Generally, the maintenance dose should always be the lowest possible.

Your doctor will inform you of the duration of your treatment with Prednisona Tarbis 2.5 mg. Do not discontinue treatment before or abruptly, as this may worsen your condition.

If you estimate that the action 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 response of the patient. 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 reaction is observed.

When this occurs, your doctor will gradually reduce the dose of Prednisona Tarbis to reach the maintenance dose, which normally 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.

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 Tarbis 2.5 mg should not be discontinued abruptly, but rather the dosage should be gradually reduced.

If you take more Prednisona Tarbis than you should

Acute intoxications with prednisone are not known. In the event of overdose, it is expected that the adverse reactions described in this leaflet will 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, 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

If you forgot to take Prednisona Tarbis 2.5 mg, 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 have adverse effects, although not everyone will experience them. These may include:

- 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.

- 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 with skin striations.

- Some infections may go unnoticed and have less resistance to them.

- Blood alterations: decrease in white blood cell count or increase in red blood cell count.

- Unknown frequency: 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.

• 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 not listed in this prospectus. You can also report them directly through the Spanish 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 2.5 mg tablets EFG

The active ingredient is prednisone. Each tablet contains 2.5 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, cylindrical, biconvex, scored tablets 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 tablets ofPrednisona Tarbis 2.5 mg tablets EFGare packaged in PVC-PVDC / Aluminum blisters.

The tablets ofPrednisona Tarbis 2.5 mg tablets EFGare presented in containers holding 30 tablets.

Marketing authorization holder and responsible for manufacturing

Marketing authorization holder

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

Last review date of this leaflet:October 2021

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