Leaflet: information for the user

Paidocort 3 mg/ml oral solution

Prednisolone

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.

1. What Paidocort is and what it is used for

2. What you need to know before you start taking Paidocort

3. How to take Paidocort

4. Possible side effects

5. Storage of Paidocort

6. Contents of the pack and additional information

Paidocort 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.

Prednisolone is used in the treatment of:

- Asthma.

- Allergic and inflammatory alterations.

- Rheumatoid arthritis and other collagen alterations.

- Dermatitis and dermatosis (acute and chronic eczema, psoriasis, pemphigus, etc.).

Do not take Paidocort

• if you are allergic to prednisolone, other glucocorticoids, or any of the other components of this medication (listed in section 6),
• if you have stomach ulcers 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 (closed or open angle),
• 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, 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, Paidocort should only be used in conjunction with treatment for the infection. Some types of infection should not be treated with corticosteroids (see Do not take Paidocort) as they may 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 potentiated.
• 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 people who are infected. If you are exposed to these infections during Paidocort treatment, 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 for tuberculosis disease), inform your doctor.
• If you have myasthenia gravis, especially 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 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), or congestive heart failure (heart not pumping enough blood), or severe 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 serious complication called scleroderma renal crisis. Signs of scleroderma renal crisis include high blood pressure and decreased urine production. Your doctor may advise you to monitor your 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 gradually. Do not stop using this medication without consulting your doctor.

Children

Paidocort 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 growth. Your doctor should have evaluated this factor, among others, at the time of Paidocort prescription.

Use of Paidocort with other medications

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

It is essential to inform your doctor if you are taking 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 pectoris),
• ciclosporin (to prevent rejection in transplants),
• salicylates or other non-steroidal 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 glucosides (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 Paidocort, so your doctor will perform thorough checks if you are taking these medications (including some for HIV: ritonavir, cobicistat). Paidocort reduces the immune response to vaccines and toxoids, and it may also potentiate 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., may be used as vehicles (see section 3). Avoid taking large amounts of grapefruit juice as it may interfere with Paidocort. Avoid taking alcohol during Paidocort 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, or plan to become pregnant, consult your doctor or pharmacist before using this medication. Paidocort 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 machines

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

Important information about some components of Paidocort

It is informed to athletes that this medication contains a prednisolone derivative, which may produce a positive result in doping control 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 medication contains maltitol liquid (or Hydrogenated Glucose Syrup) (E-965). If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

Paidocort 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 aged 12 to 17 years, whose recommended dose may reach 50 mg/day (corresponding to 16.7 ml/day), this medication contains 23.45 mg of sodium (main component of table salt/for cooking) in each unit dose. This is equivalent to 1.17% of the maximum daily sodium intake recommended 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 medication contains 28.08 mg of sodium (main component of table salt/for cooking) in each unit dose. This is equivalent to 1.40% of the maximum daily sodium intake recommended for an adult.

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

Follow exactly the administration instructions of this medication 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 response of the patient. Generally, 1 mg of prednisolone (corresponding to 0.35 ml of solution) per kilogram of body weight and day is recommended. This dose should be administered in 2 doses per day, every 12 hours.

Below are the recommended doses and treatment duration for 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 (corresponding to 3.5-6.7 ml/day), preferably administered 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 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 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 12-17 years:

The same dose as in adults.

Allergic and inflammatory disorders:

Children from 1 month:

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

Administration form

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 Toxicological Information Service, phone 915 62 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 Paidocort

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

If you interrupt the treatment with Paidocort

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

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

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

Like all medicines,this medicinecan 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), frequency not known (cannot be estimated from available data)

Endocrine disorders:

Frequent: abnormal fat distribution (such as abdominal obesity, moon face, fat accumulation 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), 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).

Cardiovascular and vascular disorders

Frequent: sodium and water 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 hypertension (high blood pressure). 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, striae, acne, bruises, red spots).

Rare: skin rash.

Renal disorders

Frequency not known:renal crisis in patients with scleroderma (an autoimmune disorder). The signs of a renal crisis are 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:muscle weakness, which is usually reversible, although in patients with myasthenia gravis, it could cause reversible worsening of muscle weakness that could progress 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 alterations (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 injuries such as cloudy cornea, increased eye pressure (glaucoma), cloudy or opaque area of the cornea (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 a serious risk to your health.

Nervous system disorders

Rare:seizures, headaches, 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 a prolonged treatment with Paidocort you are withdrawn 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 the prospectus. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products 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.

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

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

Do not use this medication after the expiration date that appears 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 packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Paidocort

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

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

Appearance of the product and contents of the packaging

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

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratorio Aldo-Unión, S.L

Baronesa de Maldá, 73

08950 Esplugues de Llobregat (Barcelona)

Spain

Responsible for manufacturing

Laboratorium Sanitatis, S.L. - Tecnalia

Leonardo da Vinci, 11

Parque Tecnológico de Álava

Miñano (Álava) SPAIN

or

LABORATORIO ALDO-UNIÓN, S.L.

c/Baronesa de Maldá, 73

08950 Esplugues de Llobregat (Barcelona)

Spain

Last review date of this leaflet:July 2021

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