PAIDOCORT 3 mg/ml ORAL SOLUTION

Introduction

Package Leaflet: Information for the User

Paidocort 3 mg/ml Oral Solution

Prednisolone

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again. If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

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

1. What is Paidocort and what is it used for

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

Prednisolone is used in the treatment of:

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

2. What you need to know before taking Paidocort

Do not take Paidocort

• if you are allergic to prednisolone, other glucocorticoids, or any of the other ingredients of this medicine (listed in section 6),
• if you have stomach 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 Paidocort:

• 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, potentially leading to new infections or reactivating existing ones; moreover, corticosteroid treatment may mask the signs of an infection, making it more difficult to diagnose an existing or developing infection.
• In severe infections, Paidocort should only be used in conjunction with infection treatment. Some types of infection should not be treated with corticosteroids (see "Do not take Paidocort") because they could worsen and put your life at risk. - If you have hypothyroidism (decreased thyroid function) or cirrhosis (liver disease), as in these two cases, the effects of Paidocort (glucocorticoids) may be enhanced.
• 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 with these infections. If you are exposed to these infections during treatment with Paidocort, you should contact a doctor immediately.
• If you are taking Paidocort, 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 Paidocort and gradually increase it.
• During prolonged treatment with 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 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 (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 periodically check your blood pressure and urine. - If you are an elderly patient, your doctor will monitor you regularly, especially if you need prolonged treatment.
• Long-term treatment with corticosteroids can produce osteoporosis.
• In order to decrease the risk of corticosteroid withdrawal syndrome, treatment should not be stopped abruptly but rather gradually. Do not stop using this medicine without consulting your doctor.

Children

Paidocort should only be used in children when there are important medical reasons for doing so. If administered for a prolonged period, it could lead to inhibition of their development. Your doctor should have assessed this factor, among others, when prescribing Paidocort.

Using Paidocort with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might 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 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 decrease 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 medicines may increase the effects of Paidocort, so your doctor will monitor you closely if you are taking these medicines (including some for HIV: ritonavir, cobicistat). Paidocort decreases the immune response to vaccines and toxoids and may also enhance the replication of live attenuated vaccine viruses.

Taking Paidocort with food, drinks, and alcohol

To facilitate the correct administration of Paidocort, milk, broth, orange juice, etc., can be used as vehicles (see section 3). You should avoid taking large amounts of grapefruit juice as it may interfere with Paidocort. You should avoid taking alcohol during treatment with Paidocort 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 medicine. Paidocort 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

Do not drive or operate tools or machines during treatment with Paidocort.

Important information about some of the ingredients of Paidocort

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

Paidocort contains Maltitol liquid (or Hydrogenated Glucose Syrup) (E-965), methyl parahydroxybenzoate, sodium salt (E-219), and propyl parahydroxybenzoate, sodium salt (E-217)

This medicine contains maltitol liquid (or Hydrogenated Glucose Syrup) (E-965). If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

It may cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate, sodium salt (E-219), and propyl parahydroxybenzoate, sodium salt (E-217). For the indication of acute bronchial asthma in adults and adolescents from 12 to 17 years, whose recommended dose may reach 50 mg/day (corresponding to 16.7 ml/day), this medicine contains 23.45 mg of sodium (main component of table salt/cooking salt) in each unit dose. This is equivalent to 1.17% of the maximum recommended daily sodium intake for an adult.

For the indication of severe allergic and inflammatory reactions, whose initial dose will be 60 mg/day (corresponding to 20 ml/day), this medicine contains 28.08 mg of sodium (main component of table salt/cooking salt) in each unit dose. This is equivalent to 1.40% of the maximum recommended daily sodium intake for an adult.

For the rest of the indications, this medicine contains less than 23 mg of sodium (1 mmol) per unit dose; that is, it is "essentially sodium-free".

3. How to take Paidocort

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. 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 patient's response. Generally, it is recommended to take 1 mg of prednisolone (corresponding to 0.35 ml of solution) per kg of body weight and day. This dose should be administered in 2 doses per day, every 12 hours.

The following are guidelines for the recommended doses and treatment duration according to the different indications:

Acute bronchial asthma:

40-50 mg/day (corresponding to 13.4-16.7 ml/day) for at least 5 days.

Allergic and inflammatory disorders:

Start treatment with a daily dose of 10-20 mg/day of prednisolone (which corresponds to 3.5-6.7 ml/day), preferably administered 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 is 2.5-15 mg/day (corresponding to 0.84-5.0 ml/day).

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

Rheumatoid arthritis:

7.5-10 mg/day, i.e., 2.5-3.4 ml/day.

Use in children

Acute bronchial asthma:

Children from 1 month to 11 years:

1-2 mg/kg/day (corresponding to 0.35-0.67 ml/kg/day), maximum 40 mg/day (corresponding to 13.4 ml/day) for 3 days. Treatment may be prolonged if necessary.

Adolescents from 12-17 years:

The same dose as for adults.

Allergic and inflammatory disorders:

Children from 1 month onwards:

The recommended dose is 0.1-2 mg/kg/day (which corresponds to 0.035-0.67 ml/kg/day) in divided doses 1 to 4 times a day.

Method of administration

Oral route

If you take more Paidocort than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 915 62 04 20, indicating the medicine and the amount ingested.

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

If you forget to take Paidocort

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

If you stop taking Paidocort

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

It is essential that treatment is not 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 important complications.

If you have any doubts 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 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), frequency not known (cannot be estimated from available data)

Endocrine Disorders:

Frequent: abnormal fat distribution (such as abdominal obesity, 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 pressure in the skull with optic nerve inflammation.

Frequency not known: Decreased heart rate.

Disorders of the Skin and Subcutaneous Tissue

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). The signs of a scleroderma renal crisis are increased blood pressure and decreased urine production.

Disorders of the Blood and Lymphatic System

Frequent: delayed wound healing. Increased white blood cell counts in 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 risk of fractures.

Rare: muscle weakness, which is usually reversible, although in patients with myasthenia gravis, it could lead to reversible worsening of muscle weakness that could evolve into 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, herpes simplex, or herpes zoster, your condition may worsen, sometimes with serious risk to your health.

Nervous System Disorders

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

Psychiatric Disorders

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

If after prolonged treatment with Paidocort, 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 the prospectus. You can also report it 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 Paidocort

Keep this medicine out of sight and reach of children.

Do not store above 25°C. Store in the original packaging. Do not refrigerate.

The medicine must be used within two months of its first opening.

Do not use this medicine after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and unused medicines in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and unused medicines. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Paidocort

The active ingredient is prednisolone (as sodium phosphate). Each ml of oral solution contains 3 mg of prednisolone (as sodium phosphate).

The other components (excipients) are: methyl parahydroxybenzoate, sodium salt (E-219), propyl parahydroxybenzoate, sodium salt (E-217), disodium edetate, sodium saccharin, sodium dihydrogen phosphate dihydrate, disodium hydrogen phosphate dihydrate, liquid maltitol (E-965), strawberry flavor 90044-33, and purified water.

Appearance of the Product and Package Contents

Paidocort is a colorless or slightly yellowish and transparent solution. It is presented in a 50 ml or 125 ml amber PET (polyethylene terephthalate) bottle and includes a 3 ml or 5 ml dosing syringe, respectively. The 50 ml bottles are presented in individual packaging or clinical packaging of 20 units.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio Aldo-Unión, S.L.

Baronesa de Maldá, 73

08950 Esplugues de Llobregat (Barcelona)

Spain

Manufacturer

Laboratorium Sanitatis, S.L. - Tecnalia

Leonardo da Vinci, 11

Álava Technology Park

Miñano (Álava) SPAIN

or

LABORATORIO ALDO-UNIÓN, S.L.

c/Baronesa de Maldá, 73

08950 Esplugues de Llobregat (Barcelona)

Spain

Date of the Last Revision of this Prospectus:July 2021

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