Estilsona 7 mg/ml gotas orales en suspensiÓn

Leaflet: information for the user

Estilsona 7 mg/ml oral suspension drops

Prednisolone acetate

Read this 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 or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Estilsona belongs to a group of hormone preparations called systemic corticosteroids. It contains a synthetic corticosteroid called prednisolone, with anti-inflammatory (reduces inflammation) and immunosuppressive (reduces immune response) actions.

Estilsona is used in the treatment of:

• Bronchial asthma.
• Allergic and inflammatory alterations (allergopathies).
• Rheumatoid arthritis and other collagen alterations (collagenopathies).
• Dermatitis and dermatosis (acute and chronic eczema, psoriasis, pemphigus, etc.).

Do not take Estilsona

• if you are allergic to prednisolone, other glucocorticoids, or any of the other components of this medication (listed in section 6),
• if you have gastric or duodenal ulcers,
• if you have acute or chronic bacterial infections (such as latent or active tuberculosis), acute viral infections (such as herpes simplex, herpes zoster, or varicella), or disseminated fungal infections,
• if you have had any psychiatric illness,
• if you are in the period before or after vaccination,
• if you have glaucoma (open-angle or closed-angle),
• if you have herpes simplex keratitis,
• if you have lymphadenopathy (inflammation of the lymph nodes) after tuberculosis vaccination,
• if you have poliomyelitis.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Estilsona:

• If you have or have recently had intestinal diseases such as gastritis or esophagitis, diverticulitis (intestinal inflammation), ulcerative colitis (with risk of perforation or pus infection), or recent intestinal anastomosis, as there is a risk of intestinal perforation with peritonitis.
• If you have any infection, as it may decrease your body's defenses, leading to new infections or activating existing ones; in addition, corticosteroid treatment may mask the signs of an infection, making it more difficult to diagnose an existing or developing infection.
• In severe infections, Estilsona should only be used in conjunction with treatment for the infection. Some types of infections should not be treated with corticosteroids (see Do not take Estilsona) as they may worsen and put your life at risk.
• If you have hypothyroidism (decreased thyroid function) or cirrhosis (liver disease), as these two conditions may exacerbate the effects of Estilsona (glucocorticoids).
• If you are experiencing stressful situations (such as trauma or surgery), you may require an increased dose.
• If you have not had chickenpox or measles, try to avoid contact with infected people. If you are exposed to these infections during Estilsona treatment, contact a doctor immediately.
• If you are taking Estilsona, it is recommended that you do not be vaccinated.
• If you have tested positive for the tuberculin test (test to determine tuberculosis disease), inform your doctor.
• If you have myasthenia gravis, especially if you need high-dose glucocorticoid treatment, your doctor will initiate treatment with a low dose of Estilsona and gradually increase it.
• During prolonged treatment and at high doses, ensure adequate potassium intake, limit sodium intake, and analyze blood potassium levels.
• If your treatment is prolonged, your doctor will perform regular checks to prevent eye complications (such as cataracts and increased eye pressure).
• Contact your doctor if you experience blurred vision or other visual disturbances.
• If you have severe diabetes (high blood sugar), congestive heart failure (heart not pumping enough blood), or severe hypertension (excessively high blood pressure), your doctor will perform regular checks.
• If you have scleroderma (also known as systemic sclerosis, an autoimmune disorder), as daily doses of 15 mg or more may increase the risk of a severe complication called scleroderma renal crisis. Signs of scleroderma renal crisis include increased blood pressure and decreased urine production. Your doctor may advise you to monitor blood pressure and urine regularly.
• If you are an elderly patient, your doctor will monitor you regularly, especially if you need prolonged treatment.
• Prolonged corticosteroid treatment may cause osteoporosis.
• To reduce the risk of corticosteroid withdrawal syndrome, treatment should not be stopped abruptly but rather gradually. Do not stop using this medication without consulting your doctor.

Children

Estilsona should only be used in children when there are important medical reasons for it. If it is administered for a prolonged period, it may inhibit their development. Your doctor should have evaluated this factor, among others, when prescribing Estilsona.

Use of Estilsona with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to take any other medication, including those purchased without a prescription.

It is essential to inform your doctor if you are using any of the following medications:

• amphotericin B, clarithromycin, or erythromycin (antibiotics for infections),
• rifampicin or rifabutin (antibiotics for tuberculosis),
• carbamazepine, phenytoin, phenobarbital, or primidone (for epilepsy),
• ketoconazole (for fungal infections),
• theophylline (for asthma and other respiratory problems),
• diltiazem (for high blood pressure and angina),
• ciclosporin (to prevent rejection in transplants),
• salicylates or other nonsteroidal anti-inflammatory drugs (e.g., aspirin or indomethacin, for pain and inflammation),
• anticoagulants (e.g., acenocoumarol, to "thin" the blood and prevent clotting),
• diuretics that eliminate potassium (e.g., hydrochlorothiazide, for high blood pressure),
• antidiabetic medications (e.g., glibenclamide, to lower blood sugar),
• cholinesterase inhibitors (e.g., neostigmine or pyridostigmine, for myasthenia gravis),
• estrogens (for hormonal imbalances), oral contraceptives,
• cardiotonic glycosides (e.g., digoxin, for heart problems),
• ion exchange resins (e.g., cholestyramine or colestipol, for cholesterol treatment),
• neuromuscular blockers (used in anesthesia).

Some medications may increase the effects of Estilsona, so your doctor will perform thorough checks if you are taking these medications (including some for HIV: ritonavir, cobicistat).

Estilsona reduces the immune response to vaccines and toxoids, and may also potentiate the replication of live attenuated vaccine viruses.

Administration of Estilsona with food, drinks, and alcohol

To facilitate the correct administration of Estilsona, vehicles such as milk, broth, orange juice, etc. may be used (see section 3).

Avoid taking large amounts of grapefruit juice as it may interfere with Estilsona.

Avoid drinking alcohol during Estilsona treatment to prevent the development of stomach or intestinal ulcers.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Estilsona should not be used during pregnancy or breastfeeding, unless your doctor considers it essential. Therefore, inform your doctor as soon as possible if you become pregnant during treatment.

Driving and operating machinery

Do not drive or operate tools or machines during Estilsona treatment.

Important information about some components of Estilsona

It is informed to athletes that this medication contains a prednisolone derivative, which may produce a positive result in doping control tests.

Estilsona contains parahydroxybenzoic acid methyl ester (E-218)

It may cause allergic reactions (possibly delayed) because it contains parahydroxybenzoic acid methyl ester (E-218).

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

The dose depends on the type and severity of the disease as well as the individual response of the patient. Generally, the recommended dose is 1 mg of prednisolone (0.15 ml of suspension or 6 drops) per kilogram of weight and day. This dose should be administered in 2 doses per day, every 12 hours.

The following table shows the equivalence between the recommended doses in mg (of prednisolone), drops (format with dropper) and ml (format with oral syringe):

Below are the recommended doses and treatment duration for the different indications, in adults:

Asthma bronchial acute:

40-50 mg/day, that is 6-7.5 ml/day, for at least 5 days.

Allergic and inflammatory alterations::

Starting treatment dose: 10-20 mg/day, that is 1.5-3 ml/day, preferably in the morning after breakfast. This dose can be reduced in a few days, but it may be necessary to continue for weeks or months.

Maintenance dose: 2.5-15 mg/day, that is 0.4-2.3 ml/day or 15-90 drops/day.

Your doctor may recommend higher doses according to the severity of the disorder.

Rheumatoid arthritis::

7.5-10 mg/day, that is 1.1-1.5 ml/day.

Use in children

Asthma bronchial acute:

Children from 1 month to 11 years:

1-2 mg/kg/day, that is 0.15-0.3 ml/kg/day or 6-12 drops/kg/day, for 3 days (or according to medical criteria). The maximum dose is 40 mg/day, that is 6 ml/day.

Adolescents from 12-17 years: The same dose as in adults.

Allergic and inflammatory alterations:

Children from 1 month:

0.1-2 mg/kg/day, that is 0.015-0.3 ml/kg/day or 1-12 drops/kg/day, in divided doses 1 to 4 times a day.

Administration form

Oral route.

It is essentialto shake the bottlecarefully before extracting the medication, to avoid foam formation that could falsify the administered dose.

Format of 10 ml with dropper

This format includes a dropper for dosing the medication that provides 40 drops per ml. Do not use other droppers, as they may provide an incorrect dose.

The dropper is made of plastic so that its flexibility allows it to lean slightly on the lower end of the bottle and thus make the most of its content.

Advertencias for correct dosing:

Format of 30 ml with oral syringe

This format includes an oral syringe graduated for dosing the medication.

Advertencias for correct dosing:

• Shake the bottle carefully.
• To remove the safety cap from the bottle, press on the surface of the bottle (A) and at the same time unscrew in the opposite direction of the clock (B). See diagram below.
• Insert the syringe, pressing on the orifice of the perforated cap.
• Invert the bottle and withdraw the necessary dose.
• Administer the necessary ml according to the dose.
• The syringe must be washed with water after each dose.
• Close the bottle tightly after each administration.

If you take more Estilsona than you should

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.

The symptoms observed in overdose are: anxiety, depression, mental confusion, spasms or gastrointestinal hemorrhages, hyperglycemia (increased blood sugar), hypertension (elevated blood pressure), and edema (swelling).

If you forgot to take Estilsona

Do not take a double dose to compensate for the missed doses. Simply continue taking Estilsona as you have been doing until then.

If you interrupt the treatment with Estilsona

Do not interrupt the treatment with this medication without consulting your doctor first.

It is essential that the treatment not be suspended abruptly, so the doses must be reduced gradually. Your doctor will indicate how to do it, as the rapid withdrawal of the corticosteroid after prolonged treatment can lead to serious complications.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

The following definitions of frequencies have been used for classification: Frequent (may affect up to 1 in 10 people), infrequent (may affect up to 1 in 100 people), rare (may affect up to 1 in 1,000 people), very rare (may affect up to 1 in 10,000 people).

Endocrine disorders:

Frequent:Abnormal fat distribution (such as abdominal obesity, moon face, fat accumulation in the epidural canal or chest, which is reversible), increased blood sugar.

Infrequent:Weight gain, diabetes, changes in blood fat levels (such as cholesterol or triglycerides), irregular menstrual cycles, excessive hair growth.

Rare:Impotence, problems with adrenal cortex hormone production, delayed growth in children, increased protein metabolism (accompanied by increased urea levels in the blood).

Cardiac and vascular disorders:

Frequent:Water and sodium retention, increased potassium excretion and low potassium levels in the blood. In patients with congestive heart failure (the heart does not pump enough blood), it may increase fluid accumulation in the lungs and cause high blood pressure. Allergic inflammation of blood vessels, increased intracranial pressure with optic nerve inflammation.

Unknown frequency:Decreased heart rate.

Skin and subcutaneous tissue disorders:

Frequent:Skin changes (atrophy, striae, acne, bruises, red spots).

Rare:Skin rash.

Renal disorders:

Unknown frequency:Renal crisis in patients with scleroderma (an autoimmune disorder). Signs of a renal crisis include high blood pressure and decreased urine production.

Disorders of the blood and lymphatic system:

Frequent:Delayed wound healing. Increased white blood cell levels in the blood at the start of treatment, although this usually disappears over time. Increased platelet count and risk of thrombosis.

Musculoskeletal and connective tissue disorders:

Frequent:Osteoporosis (loss of minerals in the bone). In severe cases, with a risk of fractures.

Rare:Reversible muscle weakness. In patients with myasthenia gravis, it may cause worsening of muscle weakness, which could lead to a myasthenic crisis (severe respiratory problems).

Very rare:Death of bone tissue in the hip or shoulder, tendon rupture (especially in people with previous tendon injury, diabetes, or high uric acid levels in the blood). In high-dose and long-term treatments, muscle changes (such as muscle mass loss) may occur.

Gastrointestinal disorders:

Rare:Stomach or duodenal ulcers, with pancreatitis (pancreas inflammation), peritonitis (severe gastrointestinal infection), or abdominal discomfort.

Eye disorders:

Rare:Eye damage such as cloudy cornea, increased eye pressure (glaucoma), cloudy or opaque area of the cornea (cataracts).

Unknown frequency:Blurred vision.

Immune system disorders:

Infrequent:Decreased body defenses and increased risk of infection. If you have a viral disease such as chickenpox, herpes simplex, or herpes zoster, your condition may worsen, in some cases with a serious risk to your health.

Nervous system disorders:

Rare:Seizures, headaches, dizziness, and sleep disturbances.

Mental disorders:

Rare:Appearance or worsening of mental disorders (euphoria, mood or personality changes, severe depression, psychosis).

If after a prolonged treatment with Estilsona you stop quickly (not progressively) you may experience muscle pain, joint pain, respiratory problems, anorexia, nausea, vomiting, fever, low blood pressure, low blood sugar levels.

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 that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

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

No special storage conditions are required.

Do not use this medication 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 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 Estilsona

• The active principle is prednisolone estolate. Each ml of suspension contains 7 mg of prednisolone as prednisolone estolate.
• The other components are: polysorbate 80 (E-433), mannitol (E-421), dioctylsulfosuccinate sodium (E-480), disodium edetate (E-386), povidone, methyl parahydroxybenzoate (E-218), sodium citrate (E-331) and purified water.

Appearance of the product and contents of the packaging

Estilsona is a medication that is presented in two sizes of topaz glass containers containing a white or off-white suspension for oral administration.

10 ml format with dropper:

Topaz glass bottle, closed with a Pilfer-Proof stopper, which acts as a guarantee seal. Each bottle contains 10 ml of oral suspension, for oral administration in drops. Additionally, a dropper with a screw cap is included inside a plastic bag for dosing.

30 ml format with oral syringe:

Topaz glass bottle, with stopper and white polypropylene cap with safety features for children. Each bottle contains 30 ml of oral suspension for oral administration in ml. It is accompanied by an oral syringe of 2 ml, with printed divisions for dosing.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratorios Sonphar, S.L.

Paris, 64 Escalera C 1º 3ª

08029 Barcelona

Responsible for manufacturing

LABORATORIOS ERN, S.A.

Gorgs Lladó, 188

08210 Barberá del Vallés, Barcelona. Spain

Date of the last review of this leaflet:August 2016.

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