Estilsona 7 mg/ml oral suspension drops

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Estilsona 7 mg/ml oral suspension drops

Prednisolone tebutate

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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Estilsona is and what it is used for

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

Estilsona is used in the treatment of:

• Bronchial asthma.
• Allergic and inflammatory disorders (allergopathies).
• Rheumatoid arthritis and other collagen disorders (collagenopathies).
• Dermatitis and dermatoses (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 ingredients of this medicine (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 systemic fungal infections,
• if you have had a psychiatric illness,
• if you are in the period before or after receiving vaccinations,
• if you have closed-angle or open-angle glaucoma (eye disease),
• if you have herpetic keratitis (eye disease),
• if you have lymphadenopathy (swollen lymph nodes) after tuberculosis vaccination,
• if you have poliomyelitis (spinal cord disease).

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Estilsona:

• If you currently have or have recently had intestinal disorders such as gastritis or esophagitis, diverticulitis (intestinal inflammation), ulcerative colitis (with risk of perforation or infection with pus), or recent intestinal anastomosis (surgical connection), as there is a risk of intestinal perforation with peritonitis.
• If you have any infection, since corticosteroids may reduce your body's defenses, potentially leading to new infections or reactivating existing ones; additionally, treatment with corticosteroids may mask signs of infection, making it more difficult to diagnose an existing or developing infection.
• In severe infections, Estilsona should only be used alongside specific anti-infective treatment. Some types of infection must not be treated with corticosteroids (see Do not take Estilsona), as they could worsen and become life-threatening.
• If you have hypothyroidism (reduced thyroid function) or cirrhosis (liver disease), as the effects of Estilsona (glucocorticoids) may be enhanced in these conditions.
• If you are under stressful conditions (such as trauma or surgery), you may require an increased dose.
• If you have never had chickenpox or measles, avoid contact with affected individuals as much as possible. If you are exposed to these infections during treatment with Estilsona, contact a doctor immediately.
• Vaccination is not recommended while you are taking Estilsona.
• If you have tested positive for the tuberculin test (a test to detect tuberculosis), inform your doctor.
• If you have myasthenia gravis, particularly if high-dose glucocorticoid treatment is needed, your doctor will start treatment with a low dose of Estilsona and gradually increase it.
• During prolonged treatment with high doses, ensure adequate potassium intake, limit sodium intake, and monitor blood potassium levels.
• If your treatment is long-term, your doctor will perform regular check-ups to prevent eye complications (such as cataracts and increased intraocular pressure).
• Contact your doctor if you experience blurred vision or other visual disturbances.
• If you have severe diabetes (very high blood sugar), congestive heart failure (heart unable to pump enough blood), or severe hypertension (very high blood pressure), your doctor will perform regular monitoring.
• 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 reduced urine output. Your doctor may advise you to monitor your blood pressure and urine regularly.
• If you are elderly, your doctor will monitor you regularly, especially if long-term treatment is required.
• Long-term treatment with corticosteroids may lead to osteoporosis.
• To reduce the risk of corticosteroid withdrawal syndrome, treatment should not be stopped abruptly but tapered gradually. Do not stop using this medicine without consulting your doctor.

Children

Estilsona should only be used in children when there are important medical reasons. If administered long-term, it may inhibit growth and development. Your doctor should have considered this factor, among others, when prescribing Estilsona.

Taking Estilsona with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

It is important that you inform your doctor if you are taking any of the following medicines:

• amphotericin B, clarithromycin, or erythromycin (antibiotics for treating infections),
• rifampicin or rifabutin (antibiotics for treating tuberculosis),
• carbamazepine, phenytoin, phenobarbital, or primidone (for treating epilepsy),
• ketoconazole (for fungal infections),
• theophylline (for asthma and other respiratory problems),
• diltiazem (for treating high blood pressure and controlling angina),
• cyclosporine (to prevent transplant rejection),
• 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 clots),
• potassium-depleting diuretics (e.g., hydrochlorothiazide, for treating high blood pressure),
• antidiabetic agents (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, for treating heart problems),
• ion-exchange resins (e.g., cholestyramine or colestipol, for cholesterol treatment),
• neuromuscular blockers (used in anesthesia).

Some medicines may increase the effects of Estilsona, so your doctor will monitor you closely if you are taking these medicines (including some for HIV: ritonavir, cobicistat).

Estilsona reduces the immune response to vaccines and toxoids and may also enhance replication of organisms in live attenuated vaccines.

Taking Estilsona with food, drinks, and alcohol

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

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

Avoid alcohol during treatment with Estilsona to prevent the development 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 medicine.

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 using machines

During treatment with Estilsona, do not drive or operate tools or machinery.

Important information about some of the ingredients of Estilsona

Athletes should be aware that this medicine contains a derivative of prednisolone, which may result in a positive doping test.

Estilsona contains methyl parahydroxybenzoate (E-218)

May cause allergic reactions (possibly delayed) as it contains methyl parahydroxybenzoate (E-218).

3. How to take Estilsona

Follow exactly the administration instructions for this medicine 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 on 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 per day. This dose should be administered in two doses per day, every 12 hours.

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

The following are the recommended doses and treatment durations according to the various indications in adults, provided as a guide:

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 treatment may need 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 condition.

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 per physician's judgment). The maximum dose is 40 mg/day, i.e. 6 ml/day.

Adolescents aged 12–17 years: Same dose as in adults.

Allergic and inflammatory disorders

Children from 1 month of age:

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 daily.

Method of administration

Oral use.

It is important to always shake the bottle thoroughly before withdrawing the medication, to avoid foam formation, which could lead to inaccurate dosing.

10 ml bottle with dropper

This package includes a dropper to measure the medication, delivering 40 drops per ml. Do not use other droppers, as they may deliver an incorrect dose.

The dropper is made of plastic, allowing its flexibility to rest slightly on the bottom of the bottle, thus enabling complete use of the bottle's contents.

Warnings for correct dosing:

30 ml pack with oral syringe

This pack includes a graduated oral syringe for measuring the medication dose.

Warnings for correct dosing:

• Shake the bottle well.
• To remove the safety cap, press down on its surface (A) while simultaneously unscrewing it counterclockwise (B). See illustration below.
• Insert the syringe into the pierced opening of the cap.
• Invert the bottle and draw up the required dose.
• Administer the number of millilitres prescribed.
• The syringe should be washed with water after each use.
• Close the bottle tightly after each administration.

If you take more Estilsona than you should

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.

Symptoms observed in overdose include: anxiety, depression, mental confusion, gastrointestinal spasms or bleeding, hyperglycaemia (increased blood sugar), hypertension (elevated blood pressure), and oedema (swelling).

If you forget to take Estilsona

Do not take a double dose to make up for missed doses. Simply continue taking Estilsona as previously directed.

If you stop taking Estilsona

Do not stop treatment with this medicine without first consulting your doctor.

It is essential that treatment is not stopped abruptly; doses must be gradually reduced. Your doctor will advise you on how to do this, as rapid withdrawal of corticosteroids after prolonged treatment may lead to serious complications.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

The following frequency definitions have been used for classification:
Frequent (may affect up to 1 in 10 people),
Uncommon (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.

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

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

Cardiac and vascular disorders:

Frequent: Sodium and water retention, increased potassium excretion and low blood potassium levels. In patients with congestive heart failure (heart unable to pump sufficient blood), fluid accumulation in the lungs and hypertension (high blood pressure) may occur. Allergic inflammation of blood vessels, increased intracranial pressure with optic nerve inflammation.

Frequency not known: Decreased heart rate.

Skin and subcutaneous tissue disorders:

Frequent: Skin changes (atrophy, stretch marks, acne, bruising, red spots).

Rare: Skin rash.

Renal disorders:

Frequency not known: Scleroderma renal crisis in patients who already have scleroderma (an autoimmune disorder). Signs of scleroderma renal crisis include increased blood pressure and reduced urine production.

Blood and lymphatic system disorders:

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

Musculoskeletal and connective tissue disorders:

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

Rare: Reversible muscle weakness. In patients with myasthenia gravis, it may worsen muscle weakness, potentially leading to a myasthenic crisis (severe respiratory problems).

Very rare: Death of bone tissue in the hip or shoulder (avascular necrosis), tendon rupture (especially in individuals with prior tendon injury, diabetes, or high blood uric acid levels). With long-term, high-dose treatment, muscle disorders (such as loss of muscle mass) may occur.

Gastrointestinal disorders:

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

Eye disorders:

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

Frequency not known: Blurred vision.

Immune system disorders:

Uncommon: Reduced body defenses and increased risk of infection. If you have a viral disease such as chickenpox, simple herpes, or shingles, your condition may worsen, sometimes seriously endangering your health.

Nervous system disorders:

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

Psychiatric disorders:

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

If Estilsona is stopped rapidly (not gradually) after prolonged treatment, muscle pain, joint pain, breathing difficulties, anorexia, nausea, vomiting, fever, low blood pressure, and low blood sugar levels may occur.

Reporting of adverse effects:

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via 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 Estilsona

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

No special storage conditions are required.

Do not use this medicine 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 medicines and their packaging at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the container and additional information

Composition of Estilsona

• The active substance is prednisolone stearate. Each ml of suspension contains 7 mg of prednisolone as prednisolone stearate.
• The other components are: polysorbate 80 (E-433), mannitol (E-421), sodium dioctyl sulfosuccinate (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 container

Estilsona is a medicine available in two sizes of amber glass containers holding a white or whitish oral suspension.

10 ml format with dropper:

Amber glass bottle closed with a Pilfer-Proof cap, which acts as a tamper-evident seal. Each bottle contains 10 ml of oral suspension for administration in drops. A plastic bag included in the package contains a dropper with screw cap for dosing.

30 ml format with oral syringe:

Amber glass bottle with stopper and white polypropylene child-resistant closure. Each bottle contains 30 ml of oral suspension for administration in ml. It is supplied with a 2 ml oral syringe with printed graduations 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 most recent revision of this package leaflet: August 2016.

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