ESTILSONA 7 mg/ml ORAL SUSPENSION DROPS

Introduction

Leaflet: information for the user

Estilsona 7 mg/ml oral drops in suspension

Prednisolone esteglate

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

Contents of the leaflet

1. What is Estilsona and what is it used for
2. What you need to know before taking Estilsona
3. How to take Estilsona
4. Possible side effects
5. Storage of Estilsona
6. Package contents and additional information

1. What is Estilsona and what is it used for

Estilsona belongs to a group of hormonal preparations called systemic corticosteroids. It contains a synthetic corticoid 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 disorders.
• Rheumatoid arthritis and other collagen disorders.
• Dermatitis and dermatosis (subacute and chronic eczema, psoriasis, pemphigus, etc.).

2. What you need to know before taking Estilsona

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 simple herpes, herpes zoster, or chickenpox), as well as fungal infections disseminated throughout the body,
• if you have had any psychiatric illness,
• if you are in the period before or after vaccination,
• if you have closed or open-angle glaucoma (eye disease),
• if you have herpetic keratitis (eye disease),
• if you have lymphadenopathy (inflammation of the lymph nodes) after tuberculosis vaccination,
• if you have poliomyelitis (spinal cord disease).

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 (connection), 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 activation of existing ones; furthermore, 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 infection treatment. Some types of infection 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 the effects of Estilsona (glucocorticoids) may be enhanced in these two cases.
• If you are under stress (such as trauma or surgery), you may require an increased dose.
• If you have not had chickenpox or measles, try to avoid contact with people affected. If you are exposed to these infections during Estilsona treatment, you should contact a doctor immediately.
• If you are taking Estilsona, it is recommended that you not be vaccinated.
• If you have tested positive for the tuberculin test (test to determine tuberculosis), you should inform your doctor.
• If you have myasthenia gravis, particularly if you need high-dose glucocorticoid treatment, your doctor will start your treatment with a low dose of Estilsona and gradually increase it.
• During prolonged treatment and at high doses, you should ensure adequate potassium intake, limit sodium intake, and analyze blood potassium levels.
• If your treatment is prolonged, your doctor will perform regular checks to avoid complications in the eyes (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 (the heart does not pump enough blood), or severe hypertension (high blood pressure), your doctor will perform regular checks.
• 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. The signs of a scleroderma renal crisis are increased blood pressure and decreased urine production. Your doctor may advise you to have your blood pressure and urine checked periodically.
• If you are an elderly patient, your doctor will monitor you regularly, especially if you need prolonged treatment.
• Long-term treatment with corticosteroids can cause osteoporosis.
• In order 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 doing so. If administered for a prolonged period, it may inhibit their development. Your doctor should have assessed this factor, among others, when prescribing Estilsona.

Using Estilsona with other medications

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

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

• amphotericin B, clarithromycin, or erythromycin (antibiotics to treat infections),
• rifampicin or rifabutin (antibiotics to treat tuberculosis),
• carbamazepine, phenytoin, phenobarbital, or primidone (to treat epilepsy),
• ketoconazole (for fungal infections),
• theophylline (for asthma and other respiratory problems),
• diltiazem (to treat high blood pressure and control angina pectoris),
• cyclosporin (to prevent rejection in transplants),
• salicylates or other non-steroidal anti-inflammatory drugs (e.g., acetylsalicylic acid or indomethacin, for pain and inflammation),
• anticoagulants (e.g., acenocoumarol, to "thin" the blood and prevent clot formation),
• potassium-eliminating diuretics (e.g., hydrochlorothiazide, to treat high blood pressure),
• antidiabetics (e.g., glibenclamide, to lower blood sugar levels),
• anticholinesterases (e.g., neostigmine or pyridostigmine, for myasthenia gravis),
• estrogens (for hormonal disorders), oral contraceptives,
• cardiac glycosides (e.g., digoxin, to treat 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 monitor you closely if you are taking these medications (including some for HIV: ritonavir, cobicistat).

Estilsona decreases the immune response to vaccines and toxoids and may also enhance the replication of live attenuated vaccine germs.

Taking Estilsona with food, drinks, and alcohol

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

You should avoid consuming large amounts of grapefruit juice, as it may interfere with Estilsona.

You should avoid drinking alcohol during Estilsona treatment to prevent the appearance of stomach or intestinal ulcers.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become 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, you should inform your doctor as soon as possible if you become pregnant during treatment.

Driving and using machines

During Estilsona treatment, do not drive or operate tools or machines.

Important information about some of the components of Estilsona

Athletes are informed that this medication contains a prednisolone derivative, which may produce a positive result in doping tests.

Estilsona contains methylparahydroxybenzoate (E-218)

It may cause allergic reactions (possibly delayed) because it contains methylparahydroxybenzoate (E-218).

3. How to take Estilsona

Follow the administration instructions for this medication exactly as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

The dose depends on the type and severity of the disease, as well as the individual patient's response. Generally, the recommended dose is 1 mg of prednisolone (0.15 ml of suspension or 6 drops) per kg of body 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 (dropper format), and ml (oral syringe format):

The following are the recommended doses and treatment durations for different indications in adults:

Acute bronchial asthma:

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

Allergic and inflammatory disorders:

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

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

Your doctor may recommend higher doses depending on the severity of the disorder.

Rheumatoid arthritis:

7.5-10 mg/day, i.e., 1.1-1.5 ml/day.

Use in children

Acute bronchial asthma:

Children from 1 month to 11 years:

1-2 mg/kg/day, i.e., 0.15-0.3 ml/kg/day or 6-12 drops/kg/day, for 3 days (or as medically indicated). The maximum dose is 40 mg/day, i.e., 6 ml/day.

Adolescents from 12 to 17 years: The same dose as for adults.

Allergic and inflammatory disorders

Children from 1 month:

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

Administration route

Oral.

It is essential to always shake the bottlecarefully before extracting the medication to avoid the formation of foam that could falsify the administered dose.

10 ml format with dropper

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

The dropper is made of plastic, allowing it to be slightly flexed and placed at the bottom of the bottle to utilize all its contents.

Warnings for correct dosing:

30 ml format with oral syringe

This format includes a graduated oral syringe to dose the medication.

Warnings for correct dosing:

• Shake the bottle carefully.
• To remove the safety cap from the bottle, press on the surface (A) and unscrew it counterclockwise (B). See the drawing below.
• Insert the syringe, pressing into the perforated cap hole.
• Invert the bottle and withdraw the necessary dose.
• Administer the necessary ml according to the dose.
• The syringe should be washed with water after each use.
• Close the bottle well 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 Toxicology 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 (high blood pressure), and edema (swelling).

If you forget to take Estilsona

Do not take a double dose to make up for forgotten doses. Simply continue taking Estilsona as you have been doing until then.

If you interrupt treatment with Estilsona

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

It is essential that treatment not be stopped abruptly, so doses should be reduced gradually. Your doctor will indicate how to do this, as rapid withdrawal of corticosteroids after prolonged treatment can lead to significant complications.

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

For classification, the following frequency definitions have been used: 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 obesity in the abdomen, moon face, accumulation of fat in the epidural canal or thorax, which is reversible), increased blood sugar.

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

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

Cardiac and Vascular Disorders:

Frequent:Sodium and water retention, increased potassium elimination and low potassium levels in the blood. In patients with congestive heart failure (the heart does not pump enough blood), fluid accumulation in the lungs may increase and hypertension (high blood pressure) may appear. Allergic inflammation of blood vessels, increased intracranial pressure with optic nerve inflammation.

Frequency not known:Decreased heart rate.

Disorders of the Skin and Subcutaneous Tissue:

Frequent:Skin alterations (atrophy, striae, acne, bruising, reddish spots).

Rare:Skin rash.

Renal Disorders:

Frequency not known: 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.

Disorders of the Blood and Lymphatic System:

Frequent:Wound healing delay. Increased white blood cell levels in the blood when starting treatment, although this usually disappears over time. Increased platelet count and risk of thrombosis.

Musculoskeletal and Connective Tissue Disorders:

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

Gastrointestinal Disorders:

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

Ocular Disorders:

Rare:Eye injuries such as cataracts, increased eye pressure (glaucoma), cloudy or opaque lens area (cataracts).

Frequency not known:Blurred vision.

Immune System Disorders:

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

Nervous System Disorders:

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

Psychiatric Disorders:

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

If after prolonged treatment with Estilsona it is withdrawn rapidly (not progressively), muscle pain, joint pain, breathing problems, anorexia, nausea, vomiting, fever, low blood pressure, and low blood sugar levels may appear.

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

5. Conservation of Estilsona

Keep this medicine out of sight and reach of children.

No special storage conditions are required.

Do not use this medicine 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 thrown away through drains or into the trash. Deposit the packaging and medicines you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Packaging Content and Additional Information

Composition of Estilsona

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

Appearance of the Product and Packaging Content

Estilsona is a medicine that comes in two sizes of topaz glass packaging containing a white or off-white suspension for oral administration.

10 ml format with dropper:

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

30 ml format with oral syringe:

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

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Sonphar, S.L.

París, 64 Escalera C 1º 3ª

08029 Barcelona

Manufacturer

LABORATORIOS ERN, S.A.

Gorgs Lladó, 188

08210 Barberá del Vallés, Barcelona, Spain

Date of the Last Revision of this Prospectus:August 2016.

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.